Grayscale, invert,
emboss, brightness,
contrast, gamma,
sharpen, median,
despeckle, hue,
saturation, equalize,
flip, mirror, masking,
rotate, magnify,
annotation,
cephalometric tracing,
ceph growth,
projections, implant
simulations, film view,
zooming, whitening,
nerve canal tracing,
memo

Brightness, contrast,
sharpness, inverse,
film view, rotate,
zooming, whitening,
nerve canal tracing,
memo

Clever One can view,
transfer and process
3D radiographs.
Furthermore, it
supports Smart Click,
Smart Clipping,
Implant Simulation
and Canal Draw.

Includes interface to
3D imaging software,
Ez3D-i. EzDent-i
imaging software does
not view, transfer or
process 3D
radiographs.

Ez3D-I can view,
transfer and process
3D radiographs.
Furthermore, it
supports Smart Click,
Smart Clipping,
Implant Simulation
and Canal Draw.

Test, paint, ellipse,
pointer, select, draw,
magnify, line,
rectangle, polygon,
ruler, protractor,
smile library, smudge,
brush, redeye
reduction, select
region, copy / paste

Text, paint, ellipse,
pointer, select, draw,
magnify, line,
rectangle, polygon,
ruler, protractor,
smile library, smudge,
brush, redeye
reduction, select
region, copy / paste

Distribution of
USB, EzUpdater
EzUpdater
USB, EzUpdater

Manufacturer
website, phone
number, and e-mail
information provided.


File information, Dose
indicator (if
applicable)

Pre-integrated
Clever Dent, Weclever
Clever Dent, Weclever
Clever Dent, Weclever

Send e-mail,
attachment, compress
to zip file, signature,
convert report to,
converted image to,
patient information
anonymization


DHT8B: Division of Radiological Imaging Devices and

Office of Product Evaluation and Quality


Subject Device
Primary Predicate
Additional Predicate

Manufacturer
Disior Ltd
Disior Ltd
Disior Ltd

Trade Name
Trade Name
SMART PCFD
SMART Bun-Yo-Matic

SMART PCFD software
includes AI-powered
algorithms and is
intended to be used to
support orthopedic
healthcare professionals
in the diagnosis and
surgical planning of
Progressive Collapsing
Foot Deformity (PCFD)
in a hospital or clinic
environment. The
medical image modality
intended to be used in
the software is weight-
bearing CT (WBCT).

SMART Bun-Yo-Matic CT
software is to be used by
orthopaedic healthcare
professionals for diagnosis
and surgical planning in a
hospital or clinic
environment. The medical
imaging type intended to be
used as the input of the
software is Computed
Tomography (CT).
SMART Bun-Yo-Matic CT
software provides:
• Visualization report of
the three-dimensional

Bonelogic software is to
be used by orthopaedic
healthcare professionals
for diagnosis and surgical
planning in a hospital or
clinic environment.
Bonelogic software
provides:
• Semi-automatic
segmentation with
manual or assisted
input of bony
structure
identification from
CT imaging input,

image processing, measuring and planning capabilities, and user interface.


surgical instrument
parameters combined
with the measurements is
intended to be used to
support orthopedic
healthcare professionals
in surgical planning of
PCFD.

Weight Bearing CT
DICOM Computed
tomography

Computed tomography
DICOM Computed
tomography

Automated case report of
the 3D model of patient
anatomy, surgical
instrument parameters,
and visualization of
implant

3D model of patient
anatomy and case report
of the 3D model patient
anatomy

Perform measurements
for presurgical planning

Graphical user interface
(GUI) to a web
application used with a
standard web browser.

Graphical user interface
(GUI) built on the Unity
development engine.


Subject Device:
Contour ProtégéAI+
(K250035)

Predicate Device:
Contour ProtégéAI
(K231765)

Server-based application
supporting:
• Linux-based OS
• Local deployment on
Windows or Mac

Modalities
CT and MR
CT and MR
No change

Automatically
contour
imaging data
using
machine-
learning

Neural
(1.0.0 models)
(1.0.0 models)
The subject device contains

Table 1 – Comparison to Predicate Device.


• Head and Neck CT
• Prostate CT
• Thorax CT
• Liver CT
• Prostate MR
(1.1.0 model)
• Prostate MR
(2.0.0 models)
• Head and Neck CT
• Prostate CT
• Thorax CT
• Abdomen CT
• Lungs and Liver CT
(3.1.0 models)*
• Head and Neck CT
• Prostate CT
• Thorax CT
• Abdomen CT
• Lungs and Liver CT
• MRT Additional Structures
CT
(4.0.0 models)
• Head and Neck CT
• Thorax CT
• Abdomen CT
• Pelvis CT
• SurePlan MRT CT
(4.1.0 models)
• Head and Neck CT
• Thorax CT
• Whole Body –
Physiological
• Uptake Organs CT
(4.2.0 models)

one new neural network
model and three updated
neural network models
compared to the predicate.
These 4 models were all
trained on the same
architecture as the
predicate without any
changes. These 4 models
cover all the existing
structures for contouring
and additional, new
structures, which are
denoted in bold font.
These 4 models were all
tested according to the
same procedures and
acceptance criteria as the
predicate. No unexpected
results were observed. The
changes do not raise new
questions for safety and
effectiveness.


• Thorax CT
- LN_IMN_L
- LN_IMN_R
- LN_Sclav_L
- LN_Sclav_R
- LN_Ax_L1_L
- LN_Ax_L1_R
- LN_Ax_L2_L
- LN_Ax_L2_R
- LN_Ax_L3_L
- LN_Ax_L3_R
- BrachialPlex_L***
- BrachialPlex_R***
- Breast_L***
- Breast_R***
- Breast_L_RTOG**
- Breast_R_RTOG**
- Bronchus
- Carina
- Cricoid
- Esophagus
- Glnd_Thyroid
- GreatVes***
- Heart***
- Humerus_Head_L
- Humerus_Head_R
- Kidney_L
- Kidney_R
- Larynx***
- Liver
- Lung_L
- Lung_R
- Musc_Constrict
- Pancreas
- SpinalCord
- Stomach***
- Trachea
- Ribs**
- Chestwall_L**
- Chestwall_R**
- A_Asc_Aorta**
- A_LAD**
• Abdomen CT
- Bladder
- Bowel***


- Bowel Bag***
- Cauda Equina
- Left Kidney
- Right Kidney
- Liver
- Spinal Cord
- Stomach***
• Female Pelvis CT**
- Bowel Bag**
- Bowel**
- LN Pelvics**
- Bladder**
- Uterocervix**
- Colon Sigmoid**
- Cauda Equina**
- Sacral Plexus**
- Sacrum**
- Rectum**
- Femur Head L**
- Femur Head R**
• SurePlan MRT CT
- Bone***
- Glnd_Lacrimal_L
- Glnd_Lacrimal_R
- Glnd_Submand_L
- Glnd_Submand_R
- Glnd_Thyroid
- Kidney_L (Kidney_L w/o
Renal Pelvis)
- Kidney_R (Kidney_R
w/o Renal Pelvis)
- Liver
- Lung_L
- Lung_R
- Parotid_L
- Parotid_R
- Spleen

* The 3.1.0 models share the same training images and architecture as the 3.0.0 models. Some errors and style

inconsistencies in the training segmentations were corrected before re-training, resulting in the 3.1.0 models.


Table 2 – Dice, MDA, and external evaluation results.


4.2.0 CT Models
MIM Atlas
Contour ProtégéAI

Table 3 – 4.2.0 CT Models cumulative APL.


4.2.0 CT Models
Structure
Relevant FOV
Whole Body CT

Table 4 – 4.2.0 CT Models localization accuracy.


Medical Image Management And
Processing System

PeekMed web is a system designed to
help healthcare professionals carry out
pre-operative planning for several surgical
procedures, based on their imported
patients’ imaging studies. Experience in
usage and a clinical assessment is
necessary for the proper use of the system
in the revision and approval of the output
of the planning. The multi-platform system
works with a database of digital
representations related to surgical
materials supplied by their manufacturers.
This medical device consists of a decision
support tool for qualified healthcare
professionals to quickly and efficiently
perform the pre-operative planning for
several surgical procedures, using medical
imaging with the additional capability of

Table 1: Summary of Predicate and Subject Device Characteristics to Demonstrate Substantial Equivalence


capability of planning the 2D or 3D
environment. The system is designed for
the medical specialties within surgery and
no specific use environment is mandatory,
whereas the typical use environment is a
room with a computer. The patient target
group is adult patients who have an injury
or disability diagnosed previously. There
are no other considerations for the
intended patient population.

No contraindications specific to this
device.

PeekMed web allows the surgeon to
perform orthopedic pre-surgical planning
efficiently in the musculoskeletal system
(e.g., Hip procedures, Knee procedures)

PeekMed web allows the surgeon to
perform the pre-surgical planning
efficiently in the following anatomical
regions:
- Hip
- Knee
- Upper limb
- Foot

Patient Population
Adults
Adults
Yes
---


End users
Healthcare Professionals
Healthcare Professionals
Yes
---

Software is cloud-based (not installable)
and can be displayed on any personal
device or workstation that can run on a
web browser

Distributed system (cloud-based). This
distributed system is a combination of
software modules placed on servers that
are able to communicate with each other.

The workflow is as follows: Import case
images, configure images, identify the
case, pre-surgical planning, and export
the case.

Internet connection
Required
Required
Yes
---

Receives medical images from various
sources

The software processes data to provide
an overlap and dimensioning of digital
representations of the prosthetic material

Allows the overlap of models and the
intersection of the models


Support for digital
prosthetic
materials provided
by the
manufacturers

Human
intervention for
image
interpretation

Ability to add
additional modules
when available

Automatic bone
Yes
Yes
Yes
The subject device includes new ML


model variants for segmentation.
Both devices allow the planning for
foot region with CT scans but the
subject device also allows with X-ray
images.
This does not constitute an intended
purpose update nor does it raise
questions of safety and performance,
since the development, verification,
validation, and deployment processes
are the same for both devices.

Automatic or Manual
- Hip (X-ray and CT scan)
- Knee (X-ray and CT scan)
- Upper limb (CT scan)
- Foot (CT scan)

Automatic or Manual
- Hip (X-ray and CT scan)
- Knee (X-ray and CT scan)
- Upper limb (CT scan)
- Foot (X-ray and CT scan)

The subject device includes new ML
model variants for landmarking.
Both devices allow the planning for
foot region with CT scans but the
subject device also allows with X-ray
images.
This does not constitute an intended
purpose update nor does it raise
questions of safety and performance,
since the development, verification,
validation, and deployment processes
are the same for both devices.


MVision AI Oy
Paciuksenkatu 29, 6th floor
00270 Helsinki, Finland
Tel: +358 040 5489229
Website: www.mvision.ai

Kalpana Jha
VP of Regulatory and Market Strategy
kalpana.jha@mvision.ai
Tel: +358 44 9214 354


System, Planning, Radiation Therapy Treatment

Medical charged-particle radiation therapy system
(21 CFR 892.5050)


System, Planning, Radiation
Therapy Treatment

Dose+ is a software-only medical
device intended for use by qualified,
trained radiation therapy
professionals (including but not
limited to medical physicists,
radiation oncologists, and medical
dosimetrists).The device is intended
for male patients with localized
prostate cancer or prostate cancer
with pelvic lymph node involvement
who are undergoing external beam
radiation therapy treatment. The
software uses machine
learning-based algorithms to
automatically produce 3D dose
distributions from patient-specific
anatomical geometry and target
dose prescription.
The predicted dose distribution
output is required to be transferred
to a radiotherapy treatment
planning system (TPS) or reviewed
by any DICOM-RT compliant
software prior to further use in
clinical workflows. Dose+ is
intended to provide additional
information during the treatment
planning process facilitating the
creation and review of a treatment
plan.

Oncospace is used to
configure and review
radiotherapy treatment
plans for a patient with
malignant or benign
disease in the prostate,
head, and neck regions.
It allows for the set up of
radiotherapy treatment
protocols, association of
a potential treatment plan
with the protocol(s),
submission of a dose
prescription and
achievable dosimetric
goals to a treatment
planning system, and
review of the treatment
plan. It is intended for use
by qualified, trained
radiation therapy
professionals (such as
medical physicists,
oncologists, and
dosimetrists). This device
is for prescription use by
order of a physician.

Both devices provide
dosimetric guidance for
external beam
radiotherapy treatment
planning.

predicate device that support the claim of substantial equivalence.


Dose+ is not intended to be used
for disease diagnosis and treatment
decision purposes in clinical
workflows.

Radiation therapy professionals,
including medical physicists,
oncologists, and dosimetrists

Patients with malignant or benign
disease in the prostate undergoing
external beam radiation therapy

Patients with malignant or
benign disease in the
prostate, head, and neck
regions undergoing
external beam radiation
therapy

The subject device is not
indicated for head and
neck treatments

Client-Server Architecture
(Clinic-provided client machines or
cloud servers controlled by the
manufacturer)

Client-Server Architecture
(Clinic-provided client
machines or cloud
Windows servers
controlled by the
manufacturer)

Same architecture;
Different only in the
operating system of the
cloud servers

Different only in the OS of
the cloud servers

Connected to or
Controlling of Radiation
Delivery Devices

A patient’s CT images, RT Structure
sets and target dose prescription in
ROI names

A patient’s CT images,
RT Structure sets and
target dose in treatment
protocols or user
specified

Same patient-specific
data. Input explicitly
provided to Dose+, while
the predicate device
requires user input or the
creation of protocol
templates.

Processes input using locked
machine learning (ML) models
trained on patient-specific
anatomical geometry to generate
the predicted 3D dose distribution

Processes treatment plan
data using locked
machine learning (ML)
models trained on
patient-specific
anatomical geometry to
predict achievable
dosimetric goals/
objectives for OARs

Same processing
fundamentals but
different ML models
(complete 3D dose
prediction vs. dosimetric
objectives prediction for
OARs).


Exports DICOM RT Dose objects
with complete 3D dose distribution
that may be reviewed using a
third-party DICOM-RT compliant
software or that may be directly
transferred to a radiotherapy
treatment planning system (TPS)
for review prior to further use in
clinical workflows

Exports dosimetric goals/
objectives in different
specific formats for
review in a treatment
planning system (TPS)
prior to further use in
clinical workflows

Different output formats
but both devices provide
dosimetric information to
assist with plan
optimization during
treatment planning.

Does not include treatment plan
review features.

Contains integrated
features and GUI for
treatment plan review,
including DVH
visualization

Different.
Dose+ relies on existing
third party TPS review
functionality.


EPIQ and Affiniti Series
EPIQ and Affiniti Series

Diagnostic Ultrasound System
Diagnostic Ultrasound System

Remote Software Management
provides capabilities to remotely
upgrade to major software
releases on EPIQ and Affiniti.
RSM is capable of deploying the
following packages onto the
system:
OS Packages
Device Drivers
Printer Drivers

The Remote Software
Management feature allows
remote update capabilities, such
as bug fixes and patches. System
upgrades are performed by Field
Service Engineer

The proposed RSM will
provide the patch
upgrade, major releases,
Automatic and scheduled
downloads of the
software where the
predicated RSM had only
the bug fixed and patch
upgrades. The subject of
this submission is to
provide upgrades with
the full RSM.

substantially equivalent to the predicate devices (K242020).


BIOS/UEFI Version
Application Packages
Service Application Packages
Automatic backup/restore of
existing system settings
Along with the above
functionalities, it also supports
Automatic and Scheduled
software downloads/installation.

The system must be connected to
the Philips Remote Server. The
user can go into Philips Support
Connect and navigate the
download and installation process
for system updates and upgrades.
Additionally, Remote Software
Management supports automatic
and scheduled software
downloads and installations.

The system must be connected to
the Philips Remote Server. The
user can go into Philips Support
Connect and navigate the
download and installation process
for system updates only.

The proposed RSM will
provide an automatic,
Scheduled download to
the user where the
predicate device requires
the user to connect
Philips Support and
navigate
system manually. There
is no change to the
user’s functionality with
full RSM feature.

Remote Service Engineer
performs verification post
installation, verify all settings and
customizations are retained.
Installation is verified through the
Philips Remote Service portal.

Field service engineer performs
full upgrade activities.

Subject of this
Submission.
Verification and
Validation Testing has
been conducted on the
RSM feature to support
the Application
performance is
equivalent to the
predicate device.


StrokeSENS ASPECTS
Brainomix 360 e-ASPECTS (K221564)

Manufactured by Circle Cardiovascular Imaging Inc.

StrokeSENS ASPECTS is a computer-aided diagnosis (CADx) software device
used to assist the clinician in the assessment and characterization of brain
tissue abnormalities using CT image data.
The Software automatically registers images and uses an Atlas to segment and
analyze ASPECTS Regions. StrokeSENS ASPECTS extracts image data from
individual voxels in the image to provide analysis and computer analytics and
relates the analysis to the atlas defined ASPECTS regions. The imaging
features are then synthesized by an artificial intelligence algorithm into a single
ASPECT (Alberta Stroke Program Early CT) Score.
StrokeSENS ASPECTS is indicated for evaluation of patients presenting for
diagnostic imaging workup with known MCA or ICA occlusion, for evaluation of
extent of disease. Extent of disease refers to the number of ASPECTS regions
affected which is reflected in the total score. StrokeSENS ASPECTS provides
information that may be useful in the characterization of ischemic brain tissue
injury during image interpretation (within 12 hours from time last known well).
StrokeSENS ASPECTS provides a comparative analysis to the ASPECTS
standard of care radiologist assessment by providing highlighted ASPECTS
regions and an automated editable ASPECTS score for clinician review.
StrokeSENS ASPECTS presents the original and annotated images for
concurrent reads. StrokeSENS ASPECTS additionally provides a visualization
of the voxels contributing to the automated ASPECTS score.
Limitations:
1. StrokeSENS ASPECTS is not intended for primary interpretation of
CT images. It is used to assist physician evaluation.
2. StrokeSENS ASPECTS has been validated in patients with known
MCA or ICA occlusion prior to ASPECTS scoring.
3. Use of StrokeSENS ASPECTS in clinical settings other than brain
ischemia within 12 hours from time last known well, caused by known
ICA or MCA occlusions, has not been tested.
4. StrokeSENS ASPECTS has only been validated and is intended to be
used in patient populations aged over 21.

Brainomix 360 e-ASPECTS is a computer-aided diagnosis (CADx) software
device used to assist the clinician in the assessment and characterization of
brain tissue abnormalities using CT image data.
The software automatically registers images and uses an Atlas segment to
analyze ASPECTS regions. Brainomix 360 e-aspects extracts image data from
individual voxels in the image to provide analysis and computer analytics and
relates the analysis to the atlas defined ASPECTS regions. The imaging
features are then synthesized by an artificial intelligence algorithm into a single
ASPECTS (Alberta Stroke Program Early CT) Score.
Brainomix 360 e-ASPECTS is indicated for evaluation of patients presenting for
diagnostic imaging workup with known MCA or ICA occlusion, for evaluation of
extent of disease. Extent of disease refers to the number of ASPECTS regions
affected which is reflected in the total score. Brainomix 360 e-ASPECTS
provides information that may be useful in the characterization of ischemic
brain tissue injury during image interpretation (within 6 hours from time last
known well).
Brainomix 360 e-ASPECTS provides a comparative analysis to the ASPECTS
standard of care radiologist assessment by providing highlighted ASPECTS
regions and an automated editable ASPECTS score for clinician review.
Brainomix 360 e-ASPECTS additionally provides a visualization of the voxels
contributing to the automated ASPECTS score and the voxels excluded from
the automated ASPECTS score.
Limitations:
1. Brainomix 360 e-ASPECTS is not intended for primary interpretation
of CT images. It is used to assist physician evaluation.
2. Brainomix 360 e-ASPECTS has ben validated in patients with known
MCA or ICA occlusion prior to ASPECTS scoring.
3. Brainomix 360 e-ASPECTS is not suitable for use on brain scans
displaying neurological pathologies other than acute stroke, such as
tumours or abscesses, haemorrhagic transformation and hematoma.
4. Use of Brainomix 360 e-ASPECTS Module in clinical settings other
than brain ischemia within 6 hours from time last known well, caused
by known ICA or MCA occlusions has not been tested.


Contraindications:
• StrokeSENS ASPECTS is contraindicated for use on brain scans
displaying neurological pathologies other than acute ischemic stroke, such
as tumours or abscesses, haemorrhagic transformation and hematoma.
Cautions:
• Patient motion: Excessive patient motion leading to artifacts that make the
scan technically inadequate.

5. Brainomix 360 e-ASPECTS has only been validated and is intended
to be used in patient populations aged over 21.
6. Brainomix 360 e-ASPECTS has been validated and is intended to be
used on Siemens Somatom Definition scanners.
7. Brainomix 360 e-ASPECTS is not intended for mobile diagnostic use.
Images viewed on a mobile platform are compressed preview images
and not for diagnostic interpretation.
Contraindications/Exclusions/Cautions:
• Patient motion: Excessive patient motion leading to artifacts that make
the scan technically inadequate.
• Haemorrhagic Transformation, Hematoma.


Predicate Device
Brainomix 360 e-ASPECTS (K221564)
Manufactured by Brainomix Limited

Radiological computer-assisted diagnostic software for lesions
suspicious of cancer.

Regulation Number
21 CFR 892.2060
21 CFR 892.2060

Input Data Type
Non-contrast head CT scans
Non-contrast head CT scans

Technical Implementation
ML/AI (Deep Learning)
ML/AI (Random Forest)

Standard off-the-shelf server or virtual server

ASPECTS regions, highlighted by algorithms.
Voxel-wise analysis visualized as a heat map.

Users must confirm ICA or MCA occlusion prior to accessing ASPECTS
results

Table 2. Regulatory and technological features comparison.


Regulation Number
Regulation Name
Product Code

Medical Image Management and Processing System

Regulation Number, Name and Product Code:


Manufacturer Name:
Clarius Mobile Health Corp.

Automated Radiological Image Processing Software


Clarius Ultrasound Transducers
L7 HD3; L15 HD3; L20 HD3

Clarius Ultrasound App (Clarius App) for iOS;
Clarius Ultrasound App (Clarius App) for Android

cleared in K213436). Clarius Median Nerve AI is not a stand-alone software device.


Criteria
SUBJECT DEVICE
PREDICATE DEVICE
RATIONALE

Device Trade Name
Clarius Median Nerve AI
Clarius AI
predicate device)

510(k) Holder/ Manufacturer
Clarius Mobile Health Corp.
Clarius Mobile Health Corp.
Same as predicate device.

Submission Reference
Current Submission
K222406
Not applicable

Primary Product Code
QIH
QIH
Same as predicate device.

Automated Radiological
Image Processing Software

Medical Image Management and
Processing System

Regulation Number
21 CFR § 892.2050
21 CFR § 892.2050
Same as predicate device.

Intended for use as an assistive
tool during the acquisition and
interpretation of ultrasound
images utilizing an artificial
intelligence/machine-learning
algorithm for segmentation and
measurement of anatomical
structures.

Non-invasive processing of
ultrasound images using
automatic image segmentation
and measurement of anatomical
structures utilizing artificial
intelligence/ machine learning
algorithms.

Clarius Median Nerve AI is
intended for segmentation
and semi-automatic non-
invasive measurements of the
median nerve cross-sectional
area on ultrasound data
acquired by the Clarius
Ultrasound Scanner (i.e.,
linear array scanners). The
user shall be a healthcare
professional trained and
qualified in ultrasound. The
user retains the responsibility
of confirming the validity of
the measurements based on
standard practices and clinical

Clarius AI is intended to semi-
automatically place calipers for
non-invasive measurements of
musculoskeletal structures (e.g.,
Achilles’ tendon, plantar fascia,
patellar tendon) on ultrasound
data acquired by the Clarius
Ultrasound Scanner (i.e., L7 and
L15). The user shall be a
healthcare professional trained
and qualified in MSK
(musculoskeletal) ultrasound. The
user shall retain the ultimate
responsibility of ascertaining the
measurements based on standard
practices and clinical judgment.

Both the predicate device and
subject device are indicated for
semi-automated measurements
of anatomical (musculoskeletal)
structures on ultrasound image
data acquired by the Clarius
Ultrasound Scanner using AI/ML-
based technology. Both devices
detect the anatomical structure,
perform segmentation, and
perform measurements of the
structure. Both the predicate and
subject devices are intended for
use as an adjunctive ‘tool’ or aid
by the user for the segmentation
and anatomical measurements of

Table 1 - Comparison of the Subject Device to the Legally Marketed Device


judgment. Clarius Median
Nerve Al is indicated for use
in adult patients only.

ultrasound images and are not
intended to replace clinical
decision-making. The minor
differences in the indications for
use do not impact the safety and
effectiveness of the subject
device relative to the predicate
device.

Radiological application/
Ultrasound
Ultrasound
Same as predicate device.

Ultrasound image processing
software implementing artificial
intelligence utilizing non-adaptive
machine learning algorithms
trained with clinical and/or
artificial data intended for
segmentation and measurements
of ultrasound data.

Quantitative and/or Qualitative
Analysis

Median nerve cross-sectional area
measurement

Equivalent to the predicate
device. The subject device
performs semi-automated
measurements of the median
nerve cross-sectional area,
whereas the predicate device
performs semi-automated
measurements of tendon
thickness.

Yes – Segmentation of anatomical
structures (median nerve)

Yes – Segmentation of anatomical
structures (tendons)

Equivalent to the predicate
device. The only difference is the
anatomical structure (median
nerve vs. tendons).

Yes – Measurement of anatomical
structures (median nerve cross-
sectional area)

Yes – Measurement of anatomical
structures (tendon thickness of


Criteria
SUBJECT DEVICE
PREDICATE DEVICE
RATIONALE

Device Trade Name
Clarius Median Nerve AI
Clarius AI
predicate device)

the Achilles’ tendon, plantar
fascia, patellar tendon)

anatomical structure (median
nerve vs. tendons).

Artificial Intelligence (AI)/Machine
Learning (ML)
Image segmentation for border
detection, and median nerve view
classification using a Deep Neural
Network.

Artificial Intelligence (AI)/Machine
Learning (ML)
Image segmentation for border
detection, and tendon view
classification using a Deep Neural
Network.

Automation
Yes
Yes
Same as predicate device.

Manual adjustment/Manual
Yes
Yes
Same as predicate device.

Healthcare setting (e.g., hospital,
clinic)

The difference in anatomical site
does not impact the safety and
effectiveness of the subject
device relative to the predicate
device.

Intended Users
Licensed healthcare professionals
Licensed healthcare professionals
Same as predicate device.

Patient Population
Adults
Adults
Same as reference device.

Operating System Compatibility
iOS and Android
iOS and Android
Same as predicate device.

Embedded in the Clarius
ultrasound app for use with the
Clarius Ultrasound Scanner
system


IEC 62304:2006 + A1:2015 - Medical device software — Software life cycle processes

ISO 14971:2019 Medical devices — Application of risk management to medical devices

NEMA PS 3.1 - 3.20 (2022d) Digital Imaging and Communications in Medicine (DICOM) Set

IEC 62366-1:2015 + A1:2020 Medical devices — Part 1: Application of usability engineering to
medical devices

ISO 15223-1:2021 Medical devices — Symbols to be used with medical device labels, labelling
and information to be supplied

following FDA-recognized consensus standards:


subjects. The geographic distribution of data collected is shown in Table 1:


Table 2: Non-Inferiority Test Result Summary for Clinical Performance of Clarius Median Nerve AI

p-value
Equivalence Margin
Mean Difference

Clarius Median Nerve AI
vs Human Experts

The non-inferiority performance testing summary is shown in Table 2:


Table 3: Jaccard Scores of Segmentation masks

Reviewer 1 vs Clarius Median Nerve AI
0.62 [95%CI: 0.62, 0.68]

Reviewer 2 vs Clarius Median Nerve AI
0.71 [95%CI: 0.69, 0.74]

Reviewer 3 vs Clarius Median Nerve AI
0.68 [95%CI: 0.65, 0.71]


Modification
Rationale
Testing Methods
Impact Assessment

Modification of training
hyperparameters (initial
learning rate, width
multiplier, dropout rate)

Improvement and
optimization of Clarius
Median Nerve AI’s
performance

Re-training of the
Median Nerve AI model
with modified
hyperparameters to
optimize its performance

Improved
performance
metrics of modified
Median Nerve AI
model with

Summary of planned modifications to Clarius Median Nerve AI per the PCCP:


followed by internal
testing and a comparison
of the original Median
Nerve AI model to the
modified Median Nerve
AI model (using
performance metrics)
followed with clinical
performance testing
(verification and
validation).

increased accuracy
and more robust
measurements
displayed to users.
Benefit-Risk
Analysis:
Benefits: Improved
performance;
generalization.
Risks: Overfitting;
unintended bias.
Risk Mitigation:
Proper
regularization
techniques and
cross-validation and
dropout will be
employed to
mitigate overfitting.
Internal testing and
verification will be
conducted to
mitigate unintended
biases.

Modification of post-
processing algorithms
(adjustments to
measurement validity
thresholds)

Improvement and
optimization of Clarius
Median Nerve AI’s
performance and
robustness

Internal testing and a
comparison of the
original Median Nerve AI
model to the modified
Median Nerve AI model
(using performance
metrics) and clinical
performance testing
(verification and
validation).

Improved
performance
metrics of modified
Median Nerve AI
model.
Benefit-Risk
Analysis:
Benefits: Improved
performance;
generalization.
Risks: Overfitting;
unintended bias.
Risk Mitigation:
Proper
regularization
techniques and
cross-validation and


dropout will be
employed to
mitigate overfitting.
Internal testing and
verification will be
conducted to
mitigate unintended
biases.

Modification of data
input sources (Clarius
probes)

To add data from
current Clarius
scanners and future
510(k) cleared
scanners to the Clarius
Median Nerve AI
model so the model
can be deployed on
more scanners.

Re-training of the
Median Nerve AI model
to expand its use with
additional data input
sources (i.e., 510(k)-
cleared models of the
Clarius Ultrasound
Scanner), internal
testing, and clinical
performance testing
(verification and
validation) to assesses its
performance with the
new data input sources.

By accommodating a
wider array of image
geometries and
characteristics with
the use of new
510(k)-cleared
Clarius ultrasound
scanners, the
updated Median
Nerve AI model will
be better equipped
to handle different
transducer models
of the Clarius
Ultrasound Scanner
used in varying
clinical scenarios.
Benefit-Risk
Analysis:
Benefits: Enhanced
compatibility;
Flexibility for diverse
clinical settings.
Risks: Data skewing
and concept drift.
Risk Mitigation:
Internal testing and
verification datasets
within the intended
patient population
will ensure that data
skewing and
concept drift are
mitigated.


Classification Name:
System, Nuclear Magne

The subject Swoop Port
able MR Imaging System


Specification
Subject Swoop Portable MR Imaging
Predicate Swoop Portable MR Imaging

The Swoop Portable MR Imaging
System is a portable, ultra-low field
magnetic resonance imaging device for
producing images that display the
internal structure of the head where
full diagnostic examination is not
clinically practical. When interpreted
by a trained physician, these images
provide information that can be useful
in determining a diagnosis.

Adult and pediatric patients (≥ 0 years)

At the point of care in professional
health care facilities such as
emergency rooms, intensive/critical
care units, hospitals, outpatient, or
rehabilitation centers.

The table below compares the subject device to the predicate.


Field strength
64.9 mT (nominal)
63.3 ± 2.0 mT

Patient accessible bore size
36.0 in. width, 13.4 in. height
24.0 in. width, 12.4 in. height

Patient weight capacity
1.6kg-200 kg
Same

• T1 (Standard), T1 (Gray/White)
• Advanced Gridding reconstruction

• T2, T2 (Fast)
• Advanced Gridding reconstruction

• FLAIR, FLAIR (Fast)
• Advanced Gridding reconstruction

• DWI/ADC, DWI/ADC (Fast)
• Advanced Gridding + FISTA

• Advanced Denoising
• Image orientation transform
• Geometric distortion correction
• Receive coil intensity correction
• Advanced Interpolation
• DICOM output


Test
Test Description
Applicable Standard(s)

Verification testing in accordance with the
design requirements.

• IEC 62304:2015
• FDA Guidance, “Content of
Premarket Submissions for Device
Software Functions”
• NEMA MS 1-2008 (R2020)
• NEMA MS 3-2008 (R2020)
• NEMA MS 9-2008 (R2020)
• NEMA MS 12-2016
• NEMA MS 8-2016
• American College of Radiology
(ACR) Phantom Test Guidance for
Use of the Large MRI Phantom for
the ACR MRI Accreditation Program
• American College of Radiology
standards for named sequences
• FDA Guidance, “Cybersecurity in
Medical Devices: Quality System
Considerations and Content of
Premarket Submissions”

Validation to ensure the subject device meets
user needs and performs as intended.

• FDA Guidance, “Content of
Premarket Submissions for Device
Software Functions”
• FDA Guidance, “Applying Human
Factors and Usability Engineering to
Medical Devices
• IEC 62366-1:2015+AMD1:2020

Biocompatibility evaluation of patient-
contacting materials.

Cleaning and disinfection evaluation of patient-
contacting materials.

• FDA Guidance, “Reprocessing
Medical Devices in Health Care
Settings: Validation Methods and
Labeling”
• ISO 17664:2021
• ASTM F3208-20
• AAMI TIR12:2020
• ANSI/AAMI ST98:2022

standards to support substantial equivalence to the predicate.


Electrical Safety, EMC, and Essential
Performance testing.


Atrophy, Cerebellar Infarct, Chronic Infarct, Demyelinating diseases, Embolic
Infarct, Hydrocephalus, Infarct, Intracerebral Hemorrhage, Intraparenchymal
Hemorrhage, Lesion, M1 Occlusion, Mass Effect, Seizure, Stroke, Subdural
Hemorrhage, Traumatic Brain Injury, Tumor, White Matter Disease, White
Matter Lesion


Atrophy, Cerebella Infarct, Chronic Infarct, Demyelinating Diseases, Embolic
Infarct, Infarct, Intracerebral Hemorrhage, Intraparenchymal Hemorrhage,
Lesion, M1 Occlusion, Mass Effect, Stroke, Subdural Hemorrhage, Traumatic
Brain Injury, Tumor, White Matter Disease


Atrophy, Demyelinating diseases, Embolic Infarct, Infarct, Intracereberal
Hemorrhage, Intraparenchymal Hemorrhage, Lesion, Resection, Stroke,
Thrombectomy, Tumor, White Matter Disease, White Matter Hyperintensity,
White Matter Lesion


Included pathology: Atrophy, Chronic Infarct, Demyelinating diseases, Embolic
Infarct, Hemorrhage, Hydrocephalus, Infarct, Intracereberal Hemorrhage,
Intraparenchymal Hemorrhage, Lesion, M1 Occlusion, Mass Effect, Stroke,
Subdural Hemorrhage, Traumatic Brain Injury, Tumor, White Matter Disease

each sequence-available image orientation (axial, sagittal, coronal) were used.


InferOperate Suite is medical imaging
software that is intended to provide trained
medical professionals with tools to aid them
in reading, interpreting, reporting, and
treatment planning for patients, including both
preoperative surgical planning and
intraoperative image display. InferOperate
Suite accepts DICOM compliant medical
images acquired from a variety of imaging
devices.
This product is not intended for use with or
for the primary diagnostic interpretation of
Mammography images.
It provides several categories of tools. It
includes basic imaging tools for general
images, including 2D viewing, volume
rendering and 3D volume viewing, orthogonal
Multi-Planar Reconstructions (MPR), surface
rendering, measurements, surgical planning,
reporting, storing, general image management

Visible Patient Suite is medical
imaging software that is intended to
provide trained medical professionals
with tools to aid them in reading,
interpreting, reporting. and treatment
planning for both pediatric and adult
patients. Visible Patient Suite accepts
DICOM compliant medical images
acquired from a variety of imaging
devices, including CT, MR.
This product is not intended for use
with or for the primary diagnostic
interpretation of Mammography
images.
The software provides several
categories of tools. It includes basic
imaging tools for general images,
including 2D viewing, volume
rendering and 3D volume viewing.
orthogonal Multi-Planar

Detailed Comparison of the Subject and Predicate Devices:


and administration tools, etc.
It includes a basic image processing workflow
and a custom UI to segment anatomical
structures. The processing may include the
generation of preliminary segmentations of
anatomy using software that employs machine
learning and other computer vision
algorithms, as well as interactive
segmentation tools, etc.
InferOperate Suite is designed for use by
trained professionals and is intended to assist
the clinician who is responsible for making all
final patient management decisions.
InferOperate Suite utilizes machine learning-
based algorithms for adult patients
undergoing CT chest, abdominal, or pelvic
scans. For image data of other anatomical
regions or modalities, patients under 21 years
of age, or patients with unknown age, we
provide non-ML software functions, such as
STL viewer.

Reconstructions (MPR), image fusion,
surface rendering. measurements,
reporting, storing, general image
management and administration tools,
etc.
It includes a basic image processing
workflow and a custom UI to segment
anatomical structures, which are visible
in the image data (bones, organs,
vascular/airway structures. etc.),
including interactive segmentation
tools, basic image filters, etc.
It also includes detection and labeling
tools of organ segments (liver, lungs
and kidneys), including path definition
through vascular/airway, approximation
of vascular/airway territories from
tubular structures and interactive
labeling.
The software is designed to be used by
trained professionals (including
physicians, surgeons and technicians)
and is intended to assist the clinician
who is solely responsible for making all
final patient management decisions.

Intended User
Trained professionals
Trained professionals
Same


Orthogonal Multi-
Planar
Reconstructions
(MPR)

Anatomical Region
Thorax, abdomen, pelvis, etc.
Thorax, abdomen, pelvis, etc.
Same

General image data
management and
administration tools


Distance (HD95) (mm) is summarized below:


The uMR Jupiter system is
indicated for use as a
magnetic resonance
diagnostic device (MRDD)
that produces sagittal,
transverse, coronal, and
oblique cross sectional
images, and spectroscopic
images, and that display
internal anatomical structure
and/or function of the head,
body and extremities.


These images and the
physical parameters derived
from the images when
interpreted by a trained
physician yield information
that may assist the diagnosis.
Contrast agents may be used
depending on the region of
interest of the scan.
The device is intended for
patients > 20 kg/44 lbs.

Type of Magnet
Superconducting
Superconducting
Same

≤ 1.3 ppm @ 50cm DSV
≤ 0.45 ppm @ 45cm DSV
≤ 0.19 ppm @ 40cm DSV
≤ 0.08 ppm @ 30cm DSV
≤ 0.015 ppm @ 20cm DSV
≤ 0.0009 ppm @ 10cm DSV

Resonant frequencies
210.794 MHz
210.794 MHz
Same


Support
ECG/Respiratory/Pulse
signal triggering the scan


The intended use of SuperFlex Large-24 is similar to previously cleared SuperFlex Small-
24. There are two differences between them. One is that the size of SuperFlex Large-24
is bigger than SuperFlex Small-24. Another is the applied body parts.

t-ACS (temporal AI-assisted Compressed Sensing) is a dynamic magnetic resonance
imaging technique which combines traditional Compressed Sensing algorithm with deep
learning priors. It outputs multi-phase images.
The difference did not raise new safety and effectiveness concerns.

Easy FACT is a function which based on the FACT sequence, automatically places the
ROI (Regions of Interest) of 5 suitable locations on the liver and performs numerical
statistics of quantitative values (FF and R2*), including mean, maximum, minimum and
other information, and outputs online reporting.
The difference did not raise new safety and effectiveness concerns.

tFAST further accelerates acquisition in time dimension on the basis of FAST
(Framework for Acceleration STrategy) parallel acceleration technology to improve
scanning speed. Suitable for dynamic imaging:
It can be used for real-time cardiac imaging and perfusion imaging.
The difference did not raise new safety and effectiveness concerns.


Table 2 Comparison to reference device#1


Table 3 Comparison to reference device#2


covers UIH MRI systems with various magnetic field strengths (1.5T, 3T, and 5T).


age groups and BMI groups as shown in the table below.


Type I: Non-periodic physiological
movement

ABDOMEN
Type II: Contrast enhancement
108


Type I: Non-periodic physiological
movement


The subgroup information of EasyFACT images in testing data is summarized below.


demographic distributions covering various genders, age groups.


In addition, the SW architecture was changed to separate the image communication

platform from the Briefcase-Triage SW. The subject device consists of only the algorithm analysis

module which can be integrated with image communication platforms that meet the Briefcase-Triage

Triage for iPE (K213886) are identical in most aspects and differ mostly with respect to their algorithm


Aidoc Briefcase-Triage for iPE (K213886)

BriefCase-Triage is a radiological computer
aided triage and notification software
indicated for use in the analysis of contrast-
enhanced images that include the lungs in
adults or transitional adolescents age 18
and older. The device is intended to assist
hospital networks and appropriately trained
medical specialists in workflow triage by
flagging and communication of suspect
cases of incidental Pulmonary Embolism
(iPE) pathologies.
BriefCase-Triage uses an artificial
intelligence algorithm to analyze images
and highlight cases with detected findings
in parallel to the ongoing standard of care
image interpretation. The user is presented
with notifications for suspect cases.
Notifications include compressed preview
images that are meant for informational
purposes only and not intended for
diagnostic use beyond notification. The
device does not alter the original medical
image and is not intended to be used as a
diagnostic device.
The results of BriefCase-Triage are
intended to be used in conjunction with
other patient information and based on their
professional judgment, to assist with
triage/prioritization of medical images.
Notified clinicians are responsible for
viewing full images per the standard of
care.

BriefCase is a radiological computer aided
triage and notification software indicated for
use in the analysis of contrast-enhanced chest
CTs (not dedicated CTPA protocol) in adults or
transitional adolescents age 18 and older. The
device is intended to assist hospital networks
and appropriately trained medical specialists in
workflow triage by flagging and communication
of suspect cases of incidental Pulmonary
Embolism (iPE) pathologies. The device is
intended to be used on single-energy exams
only.
BriefCase uses an artificial intelligence
algorithm to analyze images and flag suspect
cases on a standalone desktop application in
parallel to the ongoing standard of care image
interpretation. The user is presented with
notifications for suspect cases. Notifications
include compressed preview images that are
meant for informational purposes only and not
intended for diagnostic use beyond
notification. The device does not alter the
original medical image and is not intended to
be used as a diagnostic device.
The results of BriefCase are intended to be
used in conjunction with other patient
information and based on their professional
judgment, to assist with triage/prioritization of
medical images. Notified clinicians are
responsible for viewing full images per the
standard of care.

Hospital networks and appropriately trained
medical specialists


Contrast enhanced chest CTs (not dedicated
CTPA protocol)

Notification-
only
(/notification
alerts),
parallel
workflow tool

No. No cases are removed from
desktop app or deprioritized

Inclusion/
Exclusion
criteria for
clinical
performance
testing

Inclusion Criteria
● Contrast-enhanced images that
include the lungs
● Single and dual energy exams
● Scans performed on adults/
transitional adolescents ≥ 18 years
of age.
● Slice thickness; 0.5 - 5.0 mm axial.
Exclusion Criteria
● All studies that have an inadequate
field of view.

Inclusion Criteria:
● Contrast-enhanced chest CTs
(not dedicated CTPA protocol
● Single energy exams
● Scans performed with a 64-
slice or greater number of
detectors
● Scans performed on
adults/transitional adults ≥ 18
years of age
● Slice thickness; 0.5 - 3.0 mm
axial
Exclusion Criteria
● All studies that are technically
inadequate, including studies
with motion artifacts, severe
metal artifacts, or inadequate
field of view

Artificial intelligence algorithm with
database of images.

- Integrated with image routing module via
image communication platform (ICP)
(image acquisition).
- Algorithm module (image processing)
- Integrated with desktop application for
workflow integration (feed and non-
diagnostic Image Viewer).

- AHS module ( image acquisition);
- ACS module (image processing);
- Aidoc Desktop Application for workflow
integration (Feed/Worklist (alternate
names) and non-diagnostic Image
Viewer).


Exclusion ● Contrast-enhanced images that ● Contrast-enhanced chest CTs


Time -to-notification
Mean
N
95% Lower
95% Upper
Median

Table 2. Time-to- notification comparison for Briefcase-Triage devices (Seconds)


Table 4. Frequency Distribution of Gender *


Table 5. Frequency Distribution of Manufacturer


Regulation Number
21 CFR 892.2050
21 CFR 892.2050
Yes
–

Medical Image Management And
Processing System

PeekMed web is a system designed to
help healthcare professionals carry out
pre-operative planning for several surgical
procedures, based on their imported
patients’ imaging studies. Experience in
usage and a clinical assessment is
necessary for the proper use of the system
in the revision and approval of the output
of the planning. The multi-platform system
works with a database of digital
representations related to surgical
materials supplied by their manufacturers.

SurgiTwin is a web-based platform
designed to help healthcare
professionals carry out pre-operative
planning for knee reconstruction
procedures, based on their patients'
imported imaging studies. Experience in
usage and a clinical assessment is
necessary for the proper use of the
system in the revision and approval of
the output of the planning.
The system works with a database of
digital representations related to surgical
materials supplied by their
manufacturers. SurgiTwin generates a
PDF report as an output. End users of
the generated SurgiTwin reports are
trained healthcare professionals.
SurgiTwin does not provide a diagnosis
or surgical recommendation.

The last three sentences have been
added for clarification but do not alter the
intended use compared to the predicate.

Table 1: Summary of predicate and subject device characteristics and rationale for substantial equivalence


This medical device consists of a decision
support tool for qualified healthcare
professionals to quickly and efficiently
perform the pre-operative planning for
several surgical procedures, using medical
imaging with the additional capability of
planning the 2D or 3D environment. The
system is designed for the medical
specialties within surgery and no specific
use environment is mandatory, whereas
the typical use environment is a room with
a computer. The patient target group is
adult patients who have an injury or
disability diagnosed previously. There are
no other considerations for the intended
patient population.

This medical device consists of a
decision support tool for qualified
healthcare professionals to quickly and
efficiently perform the pre-operative
planning for total knee arthroplasty
procedures, using medical imaging with
the additional capability of planning the
2D or 3D environment. The system is
designed for medical specialties within
surgery and no specific use environment
is mandatory. The typical use
environment is a room with a computer.
The intended patient group is patients
over 22 years old identified to require
knee reconstruction surgery without any
existing material in the operated lower
limb.

SurgiTwin allows the surgeon to perform
the pre-surgical planning efficiently in the
knee, while the predicate allows planning
in the hip, knee, upper limb, and foot. The
anatomical region and surgical procedure
covered in SurgiTwin are included in its
predicate. Comparison of the indications
for use therefore supports substantial
equivalence.


No contraindications specific to this device.

SurgiTwin is contraindicated as follows:
- Patients under 22 years of age
- Presence of orthopedic
hardware in the joint to be
operated
- Pathological anomaly in the limb
to be operated including fracture,
tumor, or significant bone loss
- Patients with severe limb
deformities
- Contraindications for each
implant as given by the implant
manufacturer

Contraindications are added as a
precautionary measure to enhance user
awareness and ensure safe and
appropriate use of the device within its
intended population. They do not indicate
a fundamental difference in SurgiTwin’s
technological characteristics, intended
use, or performance compared to the
predicate.

PeekMed web allows the surgeon to
efficiently perform orthopedic pre-surgical
planning in the musculoskeletal system

SurgiTwin allows the surgeon to
efficiently perform orthopedic
pre-surgical planning in the knee

SurgiTwin allows the surgeon to perform
the pre-surgical planning efficiently in the
knee, while PeekMed® web allows
planning in the hip, knee, upper limb, and
foot. The anatomical region and surgical
procedure covered in SurgiTwin are
included in its predicate. Comparison of
the general purpose therefore supports
substantial equivalence.

PeekMed web allows the surgeon to
perform the pre-surgical planning in the
following anatomical regions:
- Hip
- Knee
- Upper limb
- Foot


End Users
Healthcare Professionals
Healthcare Professionals
Yes
–

Software is cloud-based (not installable)
and can be displayed on any personal
device or workstation that can run on a
web browser

Distributed system (cloud-based). This
distributed system is a combination of
software modules placed on servers that
are able to communicate with each other.

The workflow is as follows: Import case
images, configure images, identify the
case, pre-surgical planning, and export the
case.

Internet Connection
Required
Required
Yes

Receives medical images from various
sources

The software processes data to provide an
overlap and dimensioning of digital
representations of the prosthetic material

Allows the overlap of models and the
intersection of the models


Support for digital
prosthetic materials
provided by the
manufacturers

Human intervention for
image interpretation

Tools for surgical
simulation and planning

Yes, including distance and angle
measurement

Machine learning
models for image
segmentation


Automatic placement of
anatomical landmarks

Approval of anatomical
landmarks by user

See discussion of technological
differences below.


95th percentile of the boundary based HD 95


Otawara-shi, Tochigi-ken, Japan 324-8550

3.
OFFICIAL CORRESPONDENT/CONTACT PERS
ON

UltraExtend NX CUW-U001S V2.0 Ultrasound

Medical Image Management and Processing
System

Ultrasonic Pulsed Doppler Imaging System –

Ultrasonic Pulsed Echo Imaging System – Pro


Regulation Number
& Classification
Product Code

UltraExtend FX, Ultrasound
Workstation Package, V2.02
(Primary predicate device)

Aplio i900/i800/i700
Diagnostic Ultrasound
System, Software Version
7.0
(Reference device)


Subject Device
Primary predicate device
Secondary predicate
Comparison

Device Name
3mensio Workstation
3mensio Workstation
TOMTEC
/

Similar, the subject device
implements AI/ML
algorithms

Medical image
management and
processing system

Standalone diagnostic
bioimaging software is
intended to measure and
visualize cardiovascular
structures.

3mensio Workstation is a
software solution that is
intended to provide
Cardiologists, Radiologists
and Clinical Specialists
additional information to
aid them in reading and
interpreting DICOM
compliant medical images
of structures of the heart
and vessels.

TOMTEC-ARENA software
is a clinical software
package designed for
review, quantification and
reporting of structures and
function based
on multi-dimensional
digital medical data
acquired with different
modalities. TOMTEC-
ARENA is not intended to

Same, both the subject
device and primary
predicate device generally
share the intended use to
enable visualization and
measurement of
cardiovascular structures.


3mensio Structural Heart
enables the user to:
• Visualize and measure
(diameters, lengths,
areas, volumes, angles)
structures of the heart
and vessels
• Quantify calcium
(volume, density)
3mensio Vascular enables
the user to:
• Visualize and assess
stenosis, aneurysms and
vascular structures
• Measure the dimensions
of vessels (diameters,
lengths, areas, volumes,
angles)

be used for reading of
mammography images.

Standalone software for
medical image analysis
intended for advanced
visualization and
quantitative analysis for
diagnostics in the field of
cardiology or radiology by
means of enabling
visualization and
measurement of the heart
and vessels for:
• Pre-operational planning
and sizing for
cardiovascular
interventions and
surgery
• Postoperative evaluation
• Support of clinical
diagnosis by quantifying
dimensions of coronary
arteries
• Support of clinical
diagnosis by quantifying
calcifications (calcium
scoring)
To facilitate the above, the
3mensio Workstation
provides general
functionality such as:
• Segmentation of
cardiovascular structures
• Automatic and manual
centerline detection
• Visualization and image
reconstruction
techniques: 2D review,
Volume Rendering, MPR,
Curved MPR, Stretched
CMPR, Slabbing, MIP,
AIP, MinIP
• Measurement and
annotation tools
• Reporting tools

3mensio Workstation
enables visualization and
measurement of
structures of the heart and
vessels for:
• Pre-operational planning
and sizing for
cardiovascular
interventions and
surgery
• Postoperative evaluation
• Support of clinical
diagnosis by quantifying
dimensions in coronary
arteries
To facilitate the above, the
3mensio Workstation
provides general
functionality such as:
• Segmentation of
cardiovascular structures
• Automatic and manual
centerline detection
• Visualization and image
reconstruction
techniques: 2D review,
Volume Rendering, MPR,
Curved MPR, Stretched
CMPR, Slabbing, MIP,
AIP, MinI
• Measurement and
annotation too
• Reporting tools

Indications for use of
TomTec-Arena TTA2
software are quantification
and reporting of
cardiovascular, fetal,
abdominal structures and
function of patients with
suspected disease to
support the physician in
the diagnosis.

Same for the subject device
and primary predicate
device. Additionally, the
subject device includes
functionality for calcium
quantification in in other
cardiovascular structures
then only coronary arteries.
For the secondary predicate
device, only quantification
and reporting of
cardiovascular structures is
applicable for this
comparison. Other
anatomical structures are
not relevant for the
comparison.

Segmentation,
quantification, review, and
reporting of cardiovascular
structures

Segmentation,
quantification, review, and
reporting of
cardiovascular, fetal and
abdominal structures.

Same for the subject device
and primary predicate
device. For the secondary
predicate device, only
quantification and reporting

510(k) Summary – K250330 3mensio Workstation


of cardiovascular structures
is applicable for this
comparison. Other
anatomical structures are
not relevant for the
comparison.

Software as a medical
device: standalone and
web-based (on-premise
and in the cloud)

Software as a medical
device (standalone)

The subject device can be
deployed either standalone
or web-based (on-premise
and in the cloud) but this
difference does not impact
the intended use,
indications for use, safety
and performance of the
device. Any risks related to
web-based availability (both
on-premise and in the
cloud) are mitigated by
cybersecurity measures.

• Vendor independent
• CT data in DICOM format
• X-Ray data in DICOM
format
• Ultrasound data (2D and
3D) in DICOM format

• Vendor independent
• CT data in DICOM format
• X-Ray data in DICOM
format
• Ultrasound data (2D) in
DICOM format

• Vendor independent
• Ultrasound data (2D and
3D) in DICOM format

Same, the subject device
includes data types of both
predicate device combined.

• Study list overview
• Deleting
• Exporting
• Anonymizing
• Search

Note: features not
mentioned since they are
not relevant for this
comparison.

Same, the subject device
and primary predicate
device use the same types
of data management
functionality.

• Realign orthogonal
MPR’s
• Segmentation toolset:
- Automatic
segmentation (both AI
and non-AI)
- Manual segmentation
- Automatic centerline
- Manual centerline
- Growing centerline
- Centerline editing
• Volume sculpting

• Realign orthogonal
MPR’s
• Segmentation toolset:
- Automatic
segmentation (non-AI)
- Manual segmentation
- Automatic centerline
- Manual centerline
- Growing centerline
- Centerline editing
Volume sculpting

Both the subject and
primary predicate device
include automated and
manual segmentation
functionality and both
devices include the option
for the physician to review
and edit the segmentation.
The segmentation toolset in
the subject device
additionally includes ML
features.

• Linear (length and
diameter), area and
angle measurements
• Volume measurements
• C-arm angulation
calculation
• Text, arrow and 3D
annotations
• Calcium scoring
• Valve assessment

• Linear (length and
diameter), area and
angle measurements
• Volume measurements
• Text, arrow and 3D
annotations

Same, the subject device
and primary predicate
device use the same image
assessment functionality.
Also the secondary
predicate device uses
relevant image assessment
types for analysis of 3D
ultrasound images.

• Orthogonal, oblique,
double-oblique, curved,
cross-curved, stretched
MPR, curved MPR views
• MIP, AIP, MinIP and color
volume slabs
• Volume rendering
• 2D slice review and stack
comparison
• 4D cine
• Multi-tissue color and
opacity control
• Virtual device displays

• Orthogonal, oblique,
double-oblique, curved,
cross-curved, stretched
MPR, curved MPR views
• MIP, AIP, MinIP and color
volume slabs
• Volume rendering
• 2D slice review and stack
comparison
• 4D cine
• Multi-tissue color and
opacity control
Virtual device displays

• Oblique, double-oblique
views
• Volume rendering
• 4D cine

Same, both the subject
device and primary
predicate device use the
same types of image display.
The secondary predicate
device uses relevant image
display features for analysis
of 3D ultrasound images.


Predicate Device: iNtuition-Structural Heart Module
(K191585)

The AiORTA - Plan tool is an image analysis software
tool. It provides visualization and measurements
based on 3D reconstruction, computed from
cardiovascular CTA scans. The device is intended to
provide adjunct information to a licensed healthcare
practitioner (HCP) in addition to clinical data and other
inputs, as a measurement tool used in assessment of
aortic aneurysm, pre-operative evaluation, planning
and sizing for cardiovascular intervention and surgery,

iNtuition-Structural Heart Module is a software solution
that is intended to assist Cardiologists, Radiologists and
Clinical Specialists with the visualization and
measurements of structures of the heart and vessels.
iNtuition-Structural Heart Module enables the user to:
• Visualize and measure (diameters, lengths,
angles, areas and volumes) structures of the
heart and vessels for pre-operative planning


Predicate Device: iNtuition-Structural Heart
Module (K191585)

Manufacturer
ViTAA Medical Solutions Inc.
TeraRecon Inc.

Classification
21 CFR 892.2050
21 CFR 892.2050

Intended end-user
Healthcare Practitioner
Healthcare Practitioner

Aorta, aortic valves, mitral valve, pulmonic
valve, atria and atrial appendages, and
ventricles

CT, MR, Nuc, PET, Angio, US/Echo, SPECT
scans

Operating system
Microsoft Windows
Microsoft Windows

System configuration
Web application
Server or workstation

Semi-automatic analysis pipeline
requiring input from ViTAA Analysts.

Fully automated analysis performed in real-
time within the software.

Table 2: Substantial Equivalence Comparison


Provides tools for measuring vessel
geometry, including diameters, lengths,
and volumes.

Provides tools for measuring vessel geometry,
including diameters, lengths, volumes, areas,
and angles.

Semi-automatic segmentation using
automasking algorithm. End-users
(clinicians) able to review and modify
segmentations as needed.

Automatic and manual segmentation
available within the software, with end-users
(clinicians) able to edit and adjust
segmentations as needed.

Automatic centerline detection within
the analysis pipeline.

Both automatic and manual centerline
detection are offered, with the ability to edit
and refine the centerline by the end-user.

Reports automated measurements
describing changes between two
studies.

-Report in PDF format
-Viewports: Session state

-Structured reporting with xml, text, xls
output
-Word and html report
-DICOM SC
-Workflow scenes: restore saved state

-General controls (lock viewpoints,
switch to single/quad view, etc.)
-2D CT image controls (pan, window,
level, etc.)
-3D map controls (rotate, pan, zoom)

Identical to or
more extensive than subject device

Class II SaMD Premarket Notification 510(k): AiORTA - Plan


Length: renal to right iliac bifurcation

acceptability of the device’s measurements.


Manufacturer
Device Name
Application No.


can retrieve by looking at the original NCCT.


The Viz HDS device is intended for
automatic labeling, visualization, and
quantification of segmentable brain
structures from a set of Non-Contrast
CT (NCCT) head scans. The software
is intended to automate the current
manual process of identifying, labeling,
and quantifying the volume of
segmentable brain structures identified
on NCCT images. Viz HDS provides
volumes from NCCT scans acquired at
a single time point. The Viz HDS
software is indicated for use in the
analysis of the following structures:
Intracranial Hyperdensities, Lateral
Ventricles and Midline Shift. The device
output should be reviewed along with
patient’s original images by a physician.

The Viz Subdural+ (Subdural Plus)
device is intended for automatic
labeling, visualization and
quantification of collections in the
subdural space from a set of
Non-Contrast Head CT (NCCT)
images. The software is intended to
automate the current manual process
of identifying, labeling and quantifying
the volume of collections in the
subdural space identified on NCCT
images. Viz Subdural+ provides
volumes from NCCT images acquired
at a single time point.
The Viz Subdural+ software is
intended for labeling subdural
collections and reporting the
grayscale value of the collection,
widest width of the subdural
collection, and midline shift. The
device output should be reviewed
along with the patient’s original
images by a physician qualified to
interpret brain CT images.

Non-contrast CT from a single time
point

Intracranial hyperdensities, lateral
ventricles and midline shift

Intracranial hyperdensities volume;
lateral ventricles volume;
midline shift

Subdural collections volume;
Subdural collections widest width;
midline shift

Acquires medical image data from
DICOM compliant imaging devices and
modalities.


Multiple electronic reports with
measurements quantifying brain
structures and midline shift;
annotated DICOM Images.

Multiple electronic reports with
measurements quantifying subdural
collections and midline shift;
annotated DICOM Images.


Metric
Mean Absolute Error (MAE)
DICE Score

Subdural Collection
Maximum (Widest)
Thickness
(N=203)

NCCT imaging assessment after presenting to one of the participating sites.


Predicate Device
Reference Device
Subject Device
Remark/

Device Name
CoLumbo
Spine CAMP™ (1.1)
CoLumboX

Manufacturer
Smart Soft Healthcare
Medical Metrics, Inc.
Smart Soft Healthcare

Proposed:
21 CFR 892.2050
(Medical image
management and processing
system)
QIH

Device Class
Class II
Class II
Class II
Same

Intended to assist the
radiologist, spine- and
neuro-surgeon in
performing routine
evaluations of lumbar spine
MRI exams and producing
a report of findings
summarizing the results of
the evaluation.

Spine CAMP™ is a fully-
automated image
processing software device.
It is designed to be used
with X-ray images and is
intended to aid medical
professionals in the
measurement and
assessment of spinal
parameters. Spine CAMP™
is capable of calculating
distances, angles, linear
displacements, angular
displacements, and
mathematical combinations
of these metrics to
characterize the
morphology, alignment, and
motion of the spine. These
analysis results are
presented in the form of
reports, annotated images,
and visualizations of
intervertebral motion to
support their interpretation.

Intended to assist the
radiologist, spine- and
neuro-surgeon in
performing routine
evaluations of lumbar spine
x-ray images.

CoLumbo is an image post-
processing and
measurement software tool
that provides quantitative
spine measurements from
previously-acquired
DICOM lumbar spine
Magnetic Resonance (MR)
images for users’ review,
analysis, and interpretation.
It provides the following

Spine CAMP™ is a fully-
automated software that
analyzes Xray images of the
spine to produce reports
that contain static and/or
motion metrics. Spine
CAMP™ can be used to
obtain metrics from sagittal
plane radiographs of the
lumbar and/or cervical
spine and it can be used to

CoLumboX is an image
post-processing and
measurement software tool
that provides quantitative
spine measurements from
previously-acquired
DICOM lumbar spine x-ray
images for users’ review,
analysis, and interpretation.
It provides the following
functionality to assist users

Table 1 – Comparison of Technological Characteristics with Predicate Device


functionality to assist users
in visualizing, measuring
and documenting out-of-
range measurements:
•Feature segmentation;
•Feature measurement;
•Threshold-based labeling
of out-of-range
measurement; and
•Export of measurement
results to a written report
for user’s review, revise
and approval.
CoLumbo does not produce
or recommend any type of
medical diagnosis or
treatment. Instead, it simply
helps users to more easily
identify and classify
features in lumbar MR
images and compile a
report. The user is
responsible for
confirming/modifying
settings, reviewing and
verifying the software-
generated measurements,
inspecting out-of-range
measurements, and
approving draft report
content using their medical
judgment and discretion.
The device is intended to be
used only by hospitals and
other medical institutions.
Only DICOM images of
MRI acquired from lumbar
spine exams of patients
aged 18 and above are
considered to be valid
input. CoLumbo does not
support DICOM images of
patients that are pregnant,
undergo MRI scan with
contrast media, or have
post-operative
complications, tumors,
infections.

visualize intervertebral
motion via an image
registration method referred
to as “stabilization.” The
radiographic metrics can be
used to characterize and
assess spinal health in
accordance with established
guidance. For example,
common clinical uses
include assessing spinal
stability, alignment,
degeneration, fusion,
motion preservation, and
implant performance. The
metrics produced by Spine
CAMP™ are intended to be
used to support qualified
and licensed professional
healthcare practitioners in
clinical decision-making for
skeletally mature patients of
age 18 and above.

in visualizing, measuring
and documenting
measurements:
•Feature segmentation;
•Feature measurement;
•Threshold-based labeling
of out-of-range
measurement; and
•Export of measurement
results.
CoLumboX does not
produce or recommend any
type of medical diagnosis or
treatment. Instead, it simply
helps users to more easily
identify and classify
features in lumbar x-ray
images and potentially
compile a report. The user
is responsible for
confirming/modifying
settings, reviewing the
software-generated
measurements, and utilizing
CoLumboX output using
their medical judgment and
discretion.
The device is intended to be
used only by hospitals and
other medical institutions.
Only DICOM x-ray images
of patients aged 18 and
older are considered to be
valid input. CoLumboX
does not support DICOM
images of patients who are
pregnant or those
with post-operative
complications, tumors, or
infections.

The intended patient
population is not subject to
any restrictions.
Automation support
requires images of patients
of 18 years and older, not

Skeletally mature patients
of age 18 and above

Skeletally mature patients
of age 18 and older that are
not pregnant and do not
have post-operative
complications, tumors,
infections.

CoLumboX 510(k) Premarket Notification Smart Soft Healthcare


pregnant, without post-
operative complications,
tumors, infections.

Threshold-
Based Out-of-
Range
Measurements


Axial3D Insight
Axial Medical Printing Limited
K232841


Axial3D Insight
Axial3D Insight (Predicate

Device Manufacturer
Axial Medical Printing Limited
Axial Medical Printing Limited

Device Name
Axial3D Insight
Axial3D Insight

Automated Radiological Image
Processing Software

Table 2 – Predicate Device Comparison: Intended Use


Axial3D Insight is intended for
use as a cloud-based service and
image segmentation framework
for the transfer of DICOM
imaging information from a
medical scanner to an output file.
The Axial3D Insight output file
can be used for fabrication of
physical replicas of the output file
using additive manufacturing
methods.
The output file or physical replica
can be used for treatment
planning.
The output file or physical replica
can be used for diagnostic
purposes in the field of trauma,
orthopedic, maxillofacial, and
cardiovascular applications.
Axial3D Insight should be used in
conjunction with other diagnostic
tools and expert clinical
judgement.

Axial3D Insight is intended for use
as a cloud-based service and
image segmentation framework for
the transfer of DICOM imaging
i nformation from a medical scanner
to an output file.
The Axial3D Insight output file can
be used for fabrication of physical
replicas of the output file using
additive manufacturing methods.
The output file or physical replica
can be used for treatment
planning.
The output file or physical replica
can be used for diagnostic
purposes in the field of trauma,
orthopedic, maxillofacial, and
cardiovascular applications.
Axial3D Insight should be used in
conjunction with other diagnostic
tools and expert clinical judgement.

Axial Medical Printing Limited,
Axial3D Insight provides patient-
specific 1:1 scale replica models,
either as a digital file or as a 3D
printed physical model.
The digital file or 3D printed
physical model is intended to be
used in conjunction with the
DICOM images and expert clinical
judgement. The applications for
using the physical 3D printed
model as a presurgical planning
tool are as follows:
Preoperative planning of surgical
treatment options including
planning for surgical instruments,
aiding decisions on implants, and
aiding the surgical treatment plan.,
All planning using the 3D replica
model should be carried out with
the assistance of the DICOM
images
Communication with the surgical
team to discuss the surgical


Communication with the surgical
team to discuss the surgical
treatment plan in conjunction with
DICOM images
Communication with the patient
to discuss the surgical treatment
plan in conjunction with DICOM
images
Education tool for surgical
planning.
The 3D printed physical model
can be used for surgical planning
in the following applications:
orthopedics, trauma,
maxillofacial, and cardiac
surgery.

Used in conjunction with other
diagnostic tools and expert
clinical judgment.

Use Environment
Hospital
Hospital
Equivalent

Different – the premise
of this 510k is to have
the PCCP approved


A combination of automated
tools with smart editing tools

Orthopedics / Trauma
Cardiovascular
Cranio- Maxillofacial

Region/volume of
interest
measurements
and size
measurements


Cardiac CT/CTa
Neuro CT/CTa
Ortho CT
Trauma CT


Lightspeed Pro 16
Lightspeed Pro 32
Revolution CT
Optima CT660
Discovery CT750 HD

SOMATOM Definition Flash
SOMATOM Definition Edge
SOMATOM Definition AS
SOMATOM Definition AS+
SOMATOM Perspective
SOMATOM Force
Sensation 16
AXIOM-Artis
Emotion 16

IQON Spectral CT
iCT 128
iCT 256
Ingenuity Core 128
Brilliance 62


ID
Summary
Trigger for Retrain
Timeframe

Increasing Volume of
Training, Tuning and
Testing data

Newly available or identified
source(s) of data representing
the original intended use
population

Internal R&D activities
demonstrating benefits from
introducing semantic sub-
labelling that increase the
effectiveness of AxialML output
as utilized by Axial3D internal
engineers

Internal R&D activities
demonstrating performance
benefits from introducing
assistive labels that increases
the effectiveness of AxialML
output as utilized by Axial3D
internal engineers

Model Parameter and
Hyperparameter Tuning

Internal R&D activities
demonstrating performance
benefits from parameter and
hyperparameter tuning that
increases the effectiveness of
AxialML output as utilized by
Axial3D internal engineers

Newly available library or
dependency updates, of
component utilized in the
original device that increases
the effectiveness of AxialML
output as utilized by Axial3D
internal engineers


Device Trade Name
SCENARIA View Phase 5.0

Common Name
Computed tomography x-ray system

Classification Name
Computed tomography x-ray system


Predicate Device Trade Name
SCENARIA View 4.2


Predicate Device
SCENARIA View 4.2 (K231574)

There are no differences between the two systems.

Types of maximum load capacity:
250kg, 300kg

Different specifications do not
constitute a new intended use.
There are no significant
changes in technological
characteristics. For safety, this
item is controlled and tested
according to same regulations
and/or standards as the
predicate device.

Features
There are the following differences between the two systems.

Supported body parts:
Heart (Cardio Still Shot),
Chest (Body Still Shot)

Supported body part:
Heart (Cardio Still Shot)

Supported body parts:
Head, Chest, Head and Neck,
Neck, C-spine, Heart, Chest-
Abdomen, Chest-Upper Abdomen,
Abdomen-Pelvis, Abdomen, Pelvis,
T-spine, L-spine, T-L-spine


Collection site
Clinical sites in the USA


Collection site Clinical sites in the USA


GE Medical Systems, LLC
3200 N Grandview Blvd. Waukesha, WI USA 53188

GE Medical Systems, LLC
3200 N Grandview BLVD. Waukesha, WI USA 53188

Glen Sabin
Director, Regulatory Affairs
GE HealthCare
Phone: 262- 5216848
E-mail: glen.sabin@gehealthcare.com

Huande Li
Manager, Regulatory Affairs, MR
Phone: 86-18101131237
E-mail: huande.li@gehealthcare.com

Magnetic Resonance Diagnostic Device per 21 CFR
892.1000

In accordance with 21 CFR 807.92 the following summary of information is provided:


1.5T Superconducting Magnet with
active shielding.

SIGNA Prime Elite
uses a magnet
equivalent to that of the
predicate SIGNA
Victor.

Water cooled gradient coil with active
shielding

SIGNA Prime Elite
uses an equivalent
gradient subsystem as
the predicate SIGNA
Victor.

Transmit with integrated body coil and
local T/R coil.

SIGNA Prime Elite
uses an equivalent RF
transmit subsystem as
the predicate SIGNA
Victor.

Digitize-Per-Pin (DPP) receive chain
architecture.

SIGNA Prime Elite
uses the identical DPP
architecture as
the predicate SIGNA
Victor.

Comprehensive suite of detachable coils
for imaging all anatomies

Coils used by SIGNA
Prime Elite are
identical with those
used by the predicate
SIGNA Victor.

Comprehensive suite of software
features, pulse sequences, and image
processing applications to support MR
imaging of all anatomies.

SIGNA Prime Elite
uses equivalent
software with SIGNA
Champion.


Manufacturer
Galileo CDS Inc
CorTechs Labs, Inc.
Quibim S.L.

Classification
Class II
Class II
Class II
Same

Medical image
management and
processing system.

Automated
Radiological Image
Processing Software

MR imaging data
post processing
software


GBrain MRI is a
post processing
medical device
software intended
for analyzing and
quantitatively
reporting signal
hyperintensities in
the brain on FLAIR
MR images in the
context of diagnostic
radiology.
GBrain MRI is
intended to provide
automatic
segmentation,
quantification, and
reporting of derived
image metrics. It is
not intended for the
detection or specific
diagnosis of any
disease nor for the
detection of signal
hyperintensities.
GBrain MRI should
not be used in-lieu of
a full evaluation of
the patient’s MRI
scans. The physician
retains the ultimate
responsibility for
making the final
patient management
and treatment
decisions.

OnQ Neuro is a fully
automated post
processing medical
device software
intended for analyzing
and evaluating
neurological MR image
data.
OnQ Neuro is intended
to provide automatic
segmentation,
quantification, and
reporting of derived
image metrics.
OnQ Neuro is
additionally intended to
provide automatic
fusion of derived
parametric maps with
anatomical MRI data.
OnQ Neuro is intended
for use on brain tumors,
which are
known/confirmed to be
pathologically
diagnosed cancer.
OnQ Neuro is intended
for comparison of
derived image metrics
from multiple time
points.
The physician retains
the ultimate
responsibility for
making the final
diagnosis and treatment
decision.

QP-Brain® is a medical
imaging processing
application intended for
automatic labeling and
volumetric quantification
of segmentable brain
structures and white
matter hyperintensities
(WMH) from a set of
adults and adolescents 18
and older MR images.
Volumetric
measurements may be
compared to reference
percentile data. The
application is used by
clinicians with proper
training, as a support tool
in assessment of
structural MRIs. Patient
management decisions
should not be based
solely on the results of
the device.

The indications for use
are similar to the
predicate devices. The
subject device analyzes
signal hyperintensities
regardless of location
similar to the primary
predicate and also
detects hyperintensities
in white matter similar
to the secondary
predicate. As with the
secondary predicate,
the subject device has a
general indication and
is not specific to a
particular disease or
condition.

Hospital, Clinic,
Imaging Center,
Medical Offices

Adult patients aged
21
and above with a
brain MRI study.

Patients with brain
tumors, which are
known/confirmed to be

Adult patients and
adolescent patients aged
18
through 21 with brain
MRI

Similar to secondary
predicate and the
majority of the primary
predicate’s population.


Radiologists,
Imaging
Professionals, and
other Clinicians
working with
radiological images.
The application
should be
used as a support
tool in assessment of
structural MRIs.
Patient management
decisions should not
be based solely on
the results of the
device.

The application should
be
used by clinicians with
proper training, as a
support
tool in assessment of
structural MRIs. Patient
management decisions
should not be based
solely on the results of
the device.

Automated
segmentation using
deep learning
followed by volume
calculations, and
report generation.
Results displayed on
PACS.

Automated
segmentation using deep
learning followed by
volume calculations.
Results displayed on
PACS.

Software package-
Operates on off-the-
shelf hardware
(multiple vendors).

Software package-
Operates on multiple
platforms

Software package-
Operates on on off-the-
shelf hardware (multiple
vendors).

Supports DICOM
format as input from
the MRI scanner or
the PACS.

Supports DICOM
format as input from the
MRI scanner.

Same with the addition
of input from the
PACS.

Provides volumetric
measurements of
regions with
hyperintense signal
on T2w FLAIR
images.
Includes segmented
color overlays and

Provides volumetric
measurements of
different regions of
brain tumors including
but not restricted to
regions with
hyperintense signal on
T2w FLAIR images.
Includes segmented

Provides volumetric
measurements of
different brain structures
on T1 MR images, as
well as of White Matter
Hyperintensities on T2w
FLAIR images.
Includes segmented color
overlays and volumetric


Results displayed in
text and graphical
formats

Results displayed in
tabular and graphical
formats

Automated quality
control function:
scan protocol
verification.
Results must be
reviewed
by a clinician with
proper
training.

Display/measurement
data can be viewed,
accepted, or rejected by
a physician.


Company Name:
Taiwan Medical Imaging Co., Ltd.

3F., No. 1, Fuxing 4th Rd., Qianzhen Dist.,
Kaohsiung City 806611
Taiwan


Radiological Image Processing Software for Radiation Therapy

Medical Image Management and Processing System


contour images and offers automated
segmentation for Gross Tumor
Volume (GTV) contours of brain
metastases. The software is an
adjunctive tool and not intended for
replacing the users’ current standard
practice of manual contouring
process. All automatic output
generated by the software shall be
thoroughly reviewed by a trained
medical professional prior to
delivering any therapy or treatment.
The physician retains the ultimate
responsibility for making the final
diagnosis and treatment decision.
TAIMedImg DeepMets is intended
to be used by medical professionals
trained in the use of the device.
Only DICOM images of adult
patients are considered valid input.
DeepMets does not support DICOM
images of patients that have one of
the following exclusions:
(i) presence of prior craniotomy, (ii)
patients with clinical imaging
diagnosis of brain tumors other than
BM, (iii) Images with patient motion:
excessive motion leading to artifacts
that make the scan technically
inadequate.
Medical professionals must finalize
(confirm or modify) the contours
generated by TAIMedImg
DeepMets, as necessary, using an
external platform available at the
facility that supports DICOM-RT
viewing/editing functions, such as
image visualization software and
treatment planning system.

diagnosis. VBrain is intended only
for generating Gross Tumor Volume
(GTV) contours of brain metastases,
meningiomas, and acoustic neuromas
on axial T1 contrast-enhanced MRI
images; It is not intended to be used
with images of other brain tumors.
The user must know the tumor type
when they use VBrain. VBrain is
intended to be used on adult patients
only.
Medical professionals must finalize
(confirm or modify) the contours
generated by VBrain, as necessary,
using an external platform available
at the facility that supports DICOM-
RT viewing/editing functions, such
as image visualization software and
treatment planning system.

The software is only used by trained
medical professionals.

Trained medical professionals
including, but not limited to,
radiologists, oncologists, physicians,


medical technologists, dosimetrists,
and physicists.

Adult patients with known primary
cancer (outside brain) and brain
metastasis scheduled for radiation
therapy.

Adult patients with known
(diagnosed) brain metastases,
meningiomas, or acoustic neuromas
scheduled for radiation therapy.

Axial T1-weighted contrast-
enhanced (T1WI+C) brain magnetic
resonance (MR) images

Known (imaging diagnosed) brain
metastases with a diameter of ≥ 10
mm

Qualified brain tumors - brain
metastases, meningiomas, and
acoustic neuromas

A performance evaluation of
TAIMedImg DeepMets for brain
metastasis segmentation is
proceeded, the clinical testing dataset
comprised 158 cases from 16 MRI
scan sources in US. Five metrics are
calculated and evaluated: (1) lesion-
wise sensitivity, (2) false positive
rate, (3) Dice Similarity Coefficient,
(4) Hausdorff distance and (5)
centroid distance between DeepMets’
segmentation and clinicians’
segmentation.

VBrain AI software for brain tumor
contouring (segmentation)
performance test data sets consisted
of 116 cases acquired from 4
different institutions (3 US and 1
non-US). Five metrics are evaluated:
(1) lesion-wise sensitivity, (2) false-
positive rate, (3) lesion-wise Dice
coefficient, (4) average Hausdorff
distance, and (5) average centroid
distance between VBrain’s
segmentation and clinicians’
segmentation.

Design: Data
Visualization/
Graphical
User Interface


Table B: Summary of DeepMets performance


4. Legally Marketed Pred
icate and Ref
erence Device

Classification Name:
Magnetic Res
onance Diagnostic
Device
(MRDD)

Classification Name:
Picture Archi
ving and Communic
ations
System


- New Magnet
- New Gradient Coil
- New RF System
- New Local Coils
- New Patient Tables
- New Computer Systems

- AutoMate Cardiac
- Quick Protocols
- BLADE with SMS acceleration for non-diffusion
imaging
- Deep Resolve Swift Brain
- Fast GRE Reference Scan
- Ghost reduction
- Fleet Reference Scan
- SMS Averaging
- Select&GO extension
- myExam Spine Autopilot
- New Startup-Timer

- Improvements for Pulse Sequence Type SPACE
- Improved Gradient ECO Mode Settings
- Inline Image Filter switchable for users

to the predicate device MAGNETOM Sola with software syngo MR XA61A (K232535):


Predicate Device
FDA Clearance Number
Product
Manufacturer

Siemens Shenzhen
Magnetic Resonance Ltd.


Performance Test
Source/Rationale for test

Coils, new and modified
software features, pulse
sequence types

Guidance for Submission of
Premarket Notifications for

The following performance testing was conducted on the subject devices.


Deep Resolve Boost:
Deep Resolve Sharp:
Deep Resolve Swift Brain:

• TSE: more than
25,000 slices
• HASTE: pre-trained
on the TSE dataset
and refined with
more than 10,000
HASTE slices
• EPI Diffusion: more
than 1,000,000
slices
The data covered a
broad range of body
parts, contrasts, fat
suppression
techniques,
orientations, and field
strength.

on more than 10,000
high resolution 2D
images.
The data covered a
broad range of body
parts, contrasts, fat
suppression techniques,
orientations, and field
strength.

29,740 2D slices:
• Training: 20,076 slices
• 1.5T Validation: 3,616 slices;
3T Validation: 6,048 slices

Test Statistics
and Test
Results
Summary

The impact of the
network has been
characterized by
several quality metrics
such as peak signal-to-
noise ratio (PSNR) and
structural similarity
index (SSIM). Most

The impact of the
network has been
characterized by several
quality metrics such as
peak signal-to-noise
ratio (PSNR), structural
similarity index (SSIM),
and perceptual loss. In

The impact of the network has
been characterized by several
quality metrics such as peak
signal-to-noise ratio (PSNR),
structural similarity index (SSIM)
and normalized mean squared
error (NMSE). Additionally,
images were inspected visually


importantly, the
performance was
evaluated by visual
comparisons to
evaluate e.g., aliasing
artifacts, image
sharpness and
denoising levels.

addition, the feature
has been verified and
validated by inhouse
tests. These tests
include visual rating and
an evaluation of image
sharpness by intensity
profile comparisons of
reconstructions with
and without Deep
Resolve Sharp.

to ensure that potential artefacts
are detected that are not well
captured by the metrics listed
above.
After successful passing of the
quality metrics tests, work-in-
progress packages of the
network were delivered and
evaluated in clinical settings with
collaboration partners.

No clinical subgroups have been defined for the collected dataset.

Due to reasons of data privacy, we did not record gender, age and ethnicity during
data collection.

The acquired datasets
(as described above)
represent the ground
truth for the training
and validation. Input
data was
retrospectively created
from the ground truth
by data manipulation
and augmentation.
This process includes
further under-sampling
of the data by
discarding k-space
lines, lowering of the
SNR level by addition
Restricted of noise and
mirroring of k-space
data.

The acquired datasets
represent the ground
truth for the training
and validation. Input
data was
retrospectively created
from the ground truth
by data manipulation. k-
space data has been
cropped such that only
the center part of the
data was used as input.
With this method
corresponding low-
resolution
data as input and high-
resolution data as
output / ground truth
were created for
training and validation.

The acquired datasets represent
the ground truth for the training
and validation. Input data was
retrospectively created from the
ground truth by data
manipulation and augmentation.
This process includes further
under-sampling of the data by
discarding k-space lines, lowering
of the SNR level by addition of
Gaussian noise to k-space data
and uniformly-random cropping
of the training data along the
readout direction.


[1] Pruessmann KP, Weiger M, Scheidegger MB, Boesiger P. SENSE: Sensitivity
encoding for fast MRI. Magn Reson Med. 1999;42:952-962.
[2] Demir et al., Optimization of Magnetization Transfer Contrast for EPI FLAIR Brain
Imaging, Magn Reson Med. 2022;87:2380-2387. DOI: 10.1002/mrm.29141
[3] Yu S, Park B, Jeong J. Deep iterative down-up CNN for image denoising. In: Proc.
IEEE Conf. Comput. Vis. Pattern Recognit.; 2019:9.
[4] Hammernik K, Schlemper J, Qin C, Duan J, Summers RM, Rueckert D. Σ-net:
Systematic evaluation of iterative deep neural networks for fast parallel MR image
reconstruction. ArXiv191209278 Cs Eess. December 2019.
http://arxiv.org/abs/1912.09278. Accessed January 9, 2020.
[5] Hammernik K, Schlemper J, Qin C, Duan J, Summers RM, Rueckert D. Systematic
evaluation of iterative deep neural networks for fast parallel MRI reconstruction
with sensitivity‐weighted coil combination. Magn. Reson. Med. 2021;86(4):1859-
1872. doi:10.1002/mrm.28827
[6] Wang Z, Bovik AC, Sheikh HR, Simoncelli EP. Image quality assessment: From error
visibility to structural similarity. IEEE Trans Image Process. 2004;13(4):600-612.
doi:10.1109/TIP.2003.819861
[7] Clifford et al., An artificial intelligence-accelerated 2-minute multi-shot echo
planar imaging protocol for comprehensive high-quality clinical brain imaging,
Magn Reson Med. 2022;87:2453–2463, DOI: 10.1002/mrm.29117
[8] Zbontar J, Knoll F, Sriram A, et al. fastMRI: An open dataset and benchmarks for
accelerated MRI. arXiv:181108839 [physics, stat]. December 2019.
http://arxiv.org/abs/1811.08839. Accessed March 5, 2020.
[9] Altmann et al., Ultrafast Brain MRI Protocol at 1.5 T Using Deep Learning and
Multi-shot EPI, Acad Radiol, Volume 30, Issue 12, P2988-2998, December 2023,
DOI: https://doi.org/10.1016/j.acra.2023.04.019
[10] Altmann et al., Ultrafast Brain MRI with Deep Learning Reconstruction for
Suspected Acute Ischemic Stroke, Radiology 2024; 310(2):e231938,
https://doi.org/10.1148/radiol.231938

[11] Xie Y, Yang Q, Xie G, Pang J, Fan Z, Li D: Improved black-blood imaging using
DANTE-SPACE for simultaneous carotid and intracranial vessel wall evaluation,
Magn Reson Med, 2016 Jun, 75(6):2286-94. doi: 10.1002/mrm.25785. Epub 2015
Jul 8. PMID: 26152900; PMCID: PMC4706507
[12] Li L, Miller KL, Jezzard P: DANTE-prepared pulse trains: a novel approach to
motion-sensitized and motion-suppressed quantitative magnetic resonance
imaging, Magn Reson Med, 2012 Nov, 68(5):1423-38. doi: 10.1002/mrm.24142.
Epub 2012 Jan 13. PMID: 22246917
[13] Tagawa H, Fushimi Y, Funaki T, Nakajima S, Sakata A, Okuchi S, Hinoda T, Grinstead
J, Ahn S, Hidaka Y, Yoshida K, Miyamoto S, Nakamoto Y: Vessel wall MRI in
moyamoya disease: arterial wall enhancement varies depending on age, arteries,
and disease progression, Eur Radiol, 2023 Oct 5, doi: 10.1007/s00330-023-10251-
9. Epub ahead of print. PMID: 37798407

[14] Wang X, Greer JS, Dimitrov IE, Pezeshk P, Chhabra A, Madhuranthakam AJ:
Frequency Offset Corrected Inversion Pulse for B0 and B1 Insensitive Fat
Suppression at 3T: Application to MR Neurography of Brachial Plexus, J Magn
Reson Imaging, 2018 Oct 48(4):1104-1111. doi: 10.1002/jmri.26021. Epub 2018
Sep 15. PMID: 30218576

[15] Mugler JP 3rd: Optimized three-dimensional fast-spin-echo MRI, J Magn Reson
Imaging, 2014 Apr 39(4):745-67. doi: 10.1002/jmri.24542. Epub 2014 Jan 8. PMID:
24399498.


Product Area
Title of Standard
Number and
Development

Medical electrical
equipment - part 1:
general requirements
for basic safety and
essential performance

Medical electrical
equipment - Part 1-2:
General requirements
for basic safety and
essential performance -
Collateral Standard:
Electromagnetic
disturbances -
Requirements and tests

Medical electrical
equipment - Part 2-33:
Particular requirements
for the basic safety and
essential performance
of magnetic resonance
equipment for medical
diagnosis

Medical devices -
Application of risk
management to medical
devices

Medical devices - Part 1:
Application of usability
engineering to medical
devices

Medical device software
- Software life cycle
processes

62304 Edition 1.1
2015-06
CONSOLIDATED
VERSION

Acoustic Noise
Measurement
Procedure for
Diagnosing Magnetic


Standards Publication
Characterization of
Phased Array Coils for
Diagnostic Magnetic
Resonance Images

Digital Imaging and
Communications in
Medicine (DICOM) Set

Biological evaluation of
medical devices - part 1:
evaluation and testing
within a risk
management process.
(Biocompatibility)


Brainlab AG; Olof-Palme Str.9; 81829, Munich, Germany

System, planning, radiation therapy treatment

Predicate Device
RT Elements (4.0); K223279

Contouring 5.0 (part of Brainlab Elements 7.0 – K243633)

Sadwini Suresh
QM Consultant
Phone: +49 89 99 15 68 0
Email: regulatory.affairs@brainlab.com

Chiara Cunico
Senior Manager Regulatory Affairs
Phone: +49 89 99 15 68 0
Email: chiara.cunico@brainlab.com


Multiple Brain Mets SRS provides optimized planning and display for
cranial multi-metastases radiation treatment planning.

Cranial SRS provides optimized planning and display for cranial
radiation treatment planning.

Spine SRS provides optimized planning and display for spine
metastases.

Cranial SRS w/ Cones provides planning and display for functional
diseases (e.g. trigeminal neuralgia) or cranial lesion radiation
treatment.

RT Contouring contains features to outline, refine, combine and
manipulate structures in patient image data for planning of cranial
and extracranial radiotherapy treatments. The Cranial Tumor
Segmentation feature uses AI/Ml. The algorithm was trained on MRI
image data with contrast-enhancing tumors from multiple clinical
sites, including a wide variety of scanner models and patient
characteristics.

RT QA contains features for patient specific quality assurance. Use
RT QA to recalculate patient treatment plans on a phantom to verify
that the patient treatment plan fulfills the planning requirements.

Dose Review contains features for review of isodose lines, review of
DVHs, dose comparison and dose summation.

Retreatment Review allows the preparation and analysis of the next
treatment by providing a 3D visualization of all previously treated and
new metastases and review options for the summed dose of previous
treatment plans.

The Physics Administration is a tool that allows to administer
measured beam data and machine profiles for RT Elements software.
The Software can be used to define and edit Hounsfield to electron
density conversion tables.

The device consists of the following software modules:


Predicate Device
(RT Elements 4.0 - K223279)

The device is intended for
radiation treatment planning for
use in stereotactic, conformal,
computer planned, Linac based
radiation treatment and indicated
for cranial, head and neck and
extracranial lesions.

• Multiple Brain Mets SRS
• Cranial SRS
• Spine SRS
• Cranial SRS w/ Cones
• RT QA – Recalculation
• RT QA – Patient Specific QA
• RT QA – Beam Model
Verification
• Dose Review
• Brain Mets Retreatment Review
• Physics Administration
• Phantom Definition
• Tissue Model
• SmartBrush (RT; RT Spine;
Angio)
• Object Management

The device is composed by
software only and can be
controlled via mouse and
keyboard. The software is
displayed on a computer screen.
The input of the Brainlab RT
Elements are co-registered
DICOM image sets with
segmented objects.
The output is a DICOM RT dose
plan for further processing and
finally to control the radiation
delivery to a patient using a linear
accelerator.

The device is composed by software
only and can be controlled via mouse
and keyboard. The software is
displayed on a computer screen.
Based on co-registered DICOM image
sets, the software can create 3D
structures or objects which are further
used for the creation of RT dose plans.
The output is a DICOM RT dose plan for
further processing and finally to control
the radiation delivery to a patient using
a linear accelerator.


Topic/ Feature
Predicate Device
Subject Device

(RT Elements 4.0 - K223279)
(RT Elements 4.5)

• Windows 10 1507
• Windows 10 1607
• Windows 10 1809
• Windows 10 21H2
• Windows Server 2012 R2
64-bit
• Windows Server 2016
• Windows Server 2019
• Windows Server 2022

• Windows 10 1607
• Windows 10 1809
• Windows 10 v 21H2
• Windows Server 2016
• Windows Server 2019
• Windows Server 2022

• DICOM Images
• DICOM Segmentation
• DICOM Registration
• DICOM Key Object
Selection Document
• DICOM Raw (Brainlab
Load/Save)
• DICOM RT Dose
• DICOM RT Structure Set
• Machine Profiles
• HuToEd-Tables

The intended users are medical
professionals who perform
radiation treatment planning
(medical physicists, radiation
oncologists, dosimetrists,
physicians, etc.).