Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

Yes
The device description explicitly mentions "Proposing automatic solutions to the user, such as an automatic delineation... towards improving standardization of processes/ performance / reducing user tedious / time consuminq involvement." and "generate automatically... the contours for the organs at risk and healthy lymph nodes on CT images." While the terms AI or ML are not directly used in the "Mentions AI, DNN, or ML" section, the functionality described (automatic delineation/segmentation based on medical practices) is a common application of AI/ML in medical imaging. The performance studies also focus on "Autosegmentation performances," further supporting the use of automated algorithms likely powered by AI/ML.

Therapeutic

No

Explanation: The device is a software tool used for image processing and assisting in the contouring process for radiotherapy planning. It does not directly treat or prevent diseases, but rather supports the planning phase of a therapeutic intervention.

Diagnostic

No.

The device is intended to assist in the contouring process for radiotherapy planning, which is a treatment planning step, not a diagnostic step. It helps in delineating anatomical regions on images, but it does not diagnose a condition or provide a medical diagnosis on its own.

SaMD (Software as a Medical Device)

Yes

The device is described as a software application comprised of two modules, SmartFuse and Annotate, that processes, renders, reviews, stores, displays, and distributes DICOM data. The description focuses solely on software functionalities and does not mention any associated hardware components that are part of the device itself.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to provide information for diagnosis, monitoring, or screening.
ART-Plan's Function: ART-Plan is a software designed to assist in the contouring process on medical images for radiotherapy planning. It processes and visualizes existing medical images (CT, PET, MR) of cancer patients. It does not analyze biological samples from the patient's body.
Intended Use: The intended use clearly states that the software assists in the contouring of anatomical regions on 3D images. This is an image processing and visualization task, not an in vitro diagnostic test.
Device Description: The device description focuses on image processing, rendering, review, storage, and display of DICOM compliant datasets. It describes functionalities related to image fusion, segmentation, and visualization.
Lack of Biological Sample Analysis: There is no mention of the device analyzing any biological samples or providing diagnostic information based on such analysis.

Therefore, ART-Plan falls under the category of medical image processing and analysis software, not an in vitro diagnostic device.

PCCP (Predetermined Change Control Plan) Authorized

No
The provided text explicitly states "Control Plan Authorized (PCCP): Not Found," and it does not contain any language indicating that the FDA has reviewed, approved, or cleared a PCCP for this device.

Overview

Intended Use / Indications for Use

ART-Plan is a software designed to assist the contouring process of the target anatomical regions on 3D-images of cancer patients for whom radiotherapy treatment has been planned.

The SmartFuse module allows the user to register combinations of anatomical and functional images and display them with fused and non-fused displays to facilitate the comparison and delineation of image data by the user.

The images created with rigid or elastic registrations, potential modifications, and then the validation of a trained user with professional qualifications in anatomy and radiotherapy.

With the Annotate module, users can edit manually and semi-automatically the contours for the regions of interest. It also allows to generate automatically, and based on medical practices, the contours for the organs at risk and healthy lymph nodes on CT images.

The contours created automatically, semi-automatically or manually require verifications, and then the validation of a trained user with professional qualifications in anatomy and radiotherapy.

The device is intended to be used in a clinical setting, by trained professionals only.

Product codes (comma separated list FDA assigned to the subject device)

QKB

Device Description

The ART-Plan application is comprised of two kev modules: SmartFuse and Annotate, allowing the user to display and visualize 3D multi-modal medical image data. The user may process, render, review, store, display and distribute DICOM 3.0 compliant datasets within the system and/or across computer networks. Supported modalities include static and gated CT (computerized tomography), PET (positron emission tomography), and MR (magnetic resonance).

The overview of the product, in terms of input/output, functionalities and integration within the current clinical workflow for radiation therapy planning.

The ART-Plan technical functionalities claimed by TheraPanacea are the following:

Proposing automatic solutions to the user, such as an automatic delineation, automatic multimodal image fusion, etc. towards improving standardization of processes/ performance / reducing user tedious / time consuminq involvement.
Offering to the user a set of tools to assist semi-automatic delineation, semi-automatic registration towards modifying/editing manually automatically generated structures and addinq/removing new/undesired structures or imposing user-provided correspondences constraints on the fusion of multimodal images.
Presenting to the user a set of visualization methods of the delineated structures, and registration fusion maps.
Saving the delineated structures / fusion results for use in the dosimetry process.
Enabling rigid and deformable registration of patients images sets to combine information contained in different or same modalities.

Mentions image processing

Yes

Mentions AI, DNN, or ML

Yes

Input Imaging Modality

Registration: Static and gated CT, MR, PET (via the registration of the CT of said PET)
Segmentation: CT (injected or not), DICOM RTSTRUCT

Anatomical Site

head and neck, thorax/breast (for male/female), abdomen, pelvis (for male only), brain.
target anatomical regions
organs at risk and healthy lymph nodes

Indicated Patient Age Range

Not stated

Intended User / Care Setting

trained professionals only, in a clinical setting.

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

Non-Clinical Tests (Performance/Physical Data):

Usability Testing: The ART-Plan was assessed with regards to usability for compliance with IEC 62366. Results: Passed.
Autosegmentation performances: The study gathers the information on the 3 tests performed on the automatic segmentation performances on European data. Results: Passed.
Autosegmentation performances according to AAPM requirements: The testing demonstrated that the auto-segmentation algorithm of the module Annotate provides acceptable contours for the concerned structures on an image of a patient. Results: Passed.
Autosegmentation performances against MIM: The testing demonstrated that the auto-segmentation algorithm of the module Annotate provides acceptable contours for the concerned structures on an image of a patient. Results: Passed.
Qualitative validation of autoseqmentation performances: The testing demonstrated that the auto-segmentation algorithm of the module Annotate provides acceptable contours for the concerned structures on an image of a patient. Results: Passed.
External Contour performances according to AAPM requirements: The testing demonstrated that the External Contour Automatic Segmentation algorithm of the module Annotate provides acceptable contours for the patient's body on an image of a patient. Results: Passed.
Fusion performances according to AAPM recommendations: The testing evaluated the quality of the rigid and deformable registration tools of the SmartFuse module on retrospective intra-patient images and inter-patient images of different modalities, to ensure the safety of the device for clinical use. Results: Passed.
Registration performances on POPI-model: The testing evaluated the quality of the deformable registration tools of the SmartFuse module on intra-patient CT images. Testing was conducted according to POPI-model protocol on corresponding public data. Results: Passed.
Autosegmentation performances on US data: The testing demonstrated that the autosegmentation algorithm of the Annotate module provides clinically acceptable contours for the concerned structures when applied to US patients. Results: Passed.
Pilot study for sample size estimation - literature review: The testing was a pilot study estimating a consistent sample size of dataset for our performance testing's considering the state-of-art studies in image registration and segmentation. The literature review was completed on the most cited articles in the field of medical vision. Results: Passed.
System Verification and Validation Testing: The system verification and validation testing was performed to verify the software of the ART-Plan. Results: Passed.

Clinical Studies: No clinical studies were conducted as part of submission to prove substantial equivalence.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K191928, K130393, K181572, K071964

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

Regulation Number and Section

§ 892.2050 Medical image management and processing system.

(a)
Identification. A medical image management and processing system is a device that provides one or more capabilities relating to the review and digital processing of medical images for the purposes of interpretation by a trained practitioner of disease detection, diagnosis, or patient management. The software components may provide advanced or complex image processing functions for image manipulation, enhancement, or quantification that are intended for use in the interpretation and analysis of medical images. Advanced image manipulation functions may include image segmentation, multimodality image registration, or 3D visualization. Complex quantitative functions may include semi-automated measurements or time-series measurements.(b)
Classification. Class II (special controls; voluntary standards—Digital Imaging and Communications in Medicine (DICOM) Std., Joint Photographic Experts Group (JPEG) Std., Society of Motion Picture and Television Engineers (SMPTE) Test Pattern).

Summary

0

January 14, 2021

Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA text logo on the right. The FDA text logo is in blue and includes the letters "FDA" followed by "U.S. FOOD & DRUG ADMINISTRATION" in a stacked format.

TheraPanacea % Mr. Edwin Lindsay QA/RA Consultant Pépinière Cochin Paris Santé 29 rue du Faubourg Saint-Jacques Paris. 75014 FRANCE

Re: K202700

Trade/Device Name: ART-Plan Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: Class II Product Code: QKB Dated: December 9, 2020 Received: December 14, 2020

Dear Mr. Lindsay:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part

1

801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4. Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

For

Thalia T. Mills, Ph.D. Director Division of Radiological Health OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

2

Indications for Use

510(k) Number (if known) K202700

Device Name ART-Plan

Indications for Use (Describe)

ART-Plan is a software designed to assist the contouring process of the target anatomical regions on 3D-images of cancer patients for whom radiotherapy treatment has been planned.

The SmartFuse module allows the user to register combinations of anatomical and functional images and display them with fused and non-fused displays to facilitate the comparison and delineation of image data by the user.

The images created with rigid or elastic registrations, potential modifications, and then the validation of a trained user with professional qualifications in anatomy and radiotherapy.

With the Annotate module, users can edit manually and semi-automatically the contours for the regions of interest. It also allows to generate automatically, and based on medical practices, the contours for the organs at risk and healthy lymph nodes on CT images.

The contours created automatically, semi-automatically or manually require verifications, and then the validation of a trained user with professional qualifications in anatomy and radiotherapy.

The device is intended to be used in a clinical setting, by trained professionals only.

Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)	Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

3

510(k) Summary

This 510(k) Summary is submitted in accordance with 21 CFR Part 807, Section 807.92.

Submitter's Name:

TheraPanacea

Submitter's Address:

Pépinière Cochin Paris Santé 29 rue du Faubourg Saint-Jacques 75014 Paris France

Telephone: +33 9 62 52 78 19

Establishment Registration Number:

Still to be established

Contact Person:

Edwin Lindsay

Telephone +44 (0) 7917134922

Date Prepared:

7th September 2020

4

Below summaries the Device Classification Information regarding the TheraPanacea ART-Plan:

Primary Product Code:

| Regulation
Number | Device | Device
Class | Product
Code | Classification
Panel |
|----------------------|---------------------------------------|-----------------|-----------------|-------------------------|
| 892.2050 | Medical device software,
radiology | Class 2 | QKB | Radiology |

Device Trade Name:

ART-Plan

Device Common Name:

ART-Plan

Intended/ Indications Use:

ART-Plan is a software designed to assist the contouring process of the target anatomical reqions on 3D-images of cancer patients for whom radiotherapy treatment has been planned.

The SmartFuse module allows the user to register combinations of anatomical and functional images and display them with fused and non-fused displays to facilitate the comparison and delineation of image data by the user.

The images created with rigid or elastic registration require verifications, potential modifications, and then the validation of a trained user with professional qualifications in anatomy and radiotherapy.

With the Annotate module, users can edit manually and semi-automatically the contours for the regions of interest. It also allows to generate automatically, and based on medical practices, the contours for the orqans at risk and healthy lymph nodes on CT images.

The contours created automatically, semi-automatically or manually require verifications, potential modifications, and then the validation of a trained user with professional qualifications in anatomy and radiotherapy.

The device is intended to be used in a clinical setting, by trained professionals only.

5

Summary of Substantial Equivalence:

The following predicate devices have been that the ART-Plan can claim equivalence with and these are detailed below

General Comparison

		General Information
Property	Proposed Device
ART-Plan	Primary
Predicate
AccuContour	Secondary
Predicate
RTx	Secondary
Predicate
Workflow Box	Secondary Predicate
MIM4.1 (SEASTAR)	Comment
Common
Name	Radiological
image processing
software for
radiation therapy	Radiological
image processing
software for
radiation therapy	System, image
processing,
radiological	System, image
processing,
radiological	System, image processing,
radiological	N/A
Device
Manufacturer	TheraPanacea	Xiamen Manteia
Technology LTD	Mirada Medical Ltd.	Mirada Medical Ltd.	MIMvista Corp (now MIM Software
Inc)	N/A
510k	N/A	K191928	K130393	K181572	K071964	N/A
Device
Classification	II	II	II	II	II	N/A
Primary
Product
Code	QKB	QKB	LLZ	LLZ	LLZ	As advised by the FDA the new
product code, QKB, has been
created in-lieu of LLZ which uses
Al algorithms and is intended for
radiation therapy, and is the
proposed product code for ART-
Plan.
Secondary
Product
Code	-	-	-	-	-	N/A
Target
Population	Any patient type
for whom relevant
modality scan data
is available	Not stated	Any patient type for
whom relevant
modality scan data
is available.	Any patient type for
whom relevant
modality scan data
is available.	Not stated	The proposed device has
identical target populations to the
secondary predicates.
Environment	Hospital	Hospital	Hospital	Hospital	Hospital	The proposed device and
predicates have identical
target environments
Intended
Use/
Indication for	Intended Use
ART-Plan is a
software designed	It is used by
radiation
oncology	Workflow Box is a
system designed to
allow users to route	RTx is intended to
be used by trained
medical	Intended Use
MIM 4.1 (SEASTAR) software is
intended for trained medical	The intended use and
indications for use of the
proposed device, ART-Plan
		General Information
Property	Proposed Device
ART-Plan	Primary
Predicate
AccuContour	Secondary
Predicate
RTx	Secondary
Predicate
Workflow Box	Secondary Predicate
MIM4.1 (SEASTAR)	Comment
Use	to assist the
contouring
process of the
target
anatomical
regions on 3D-
images of cancer
patients for whom
radiotherapy
treatment has
been planned.
The SmartFuse
module allows the
user to register
combinations of
anatomical and
functional images
and display them
with fused and
non-fused displays
to facilitate the
comparison and
delineation of
image data by the
user.
The images
created with rigid
or elastic
registration require
verifications,
potential
modifications, and
then the validation
of a trained user
with professional
qualifications in
anatomy and
radiotherapy.
With the Annotate
module, users can	department to
register
multimodality
images and
segment (non-
contrast) CT
images, to
generate needed
information for
treatment
planning,
treatment
evaluation and
treatment
adaptation.	DICOM-compliant
data to and from
automated
processing
components.
Workflow Box
includes processing
components for
automatically
contouring imaging
data using
deformable image
registration and
machine learning
based algorithms.
Workflow Box must
be used in
conjunction with
appropriate
software to review
and edit results
generated
automatically by
Workflow Box
components, for
example image
visualization
software must be
used to facilitate the
review and edit of
contours generated
by Workflow Box
component
applications.
Workflow Box is not
intended to
automatically detect
lesions.	professionals
including, but not
limited to,
radiologists, nuclear
medicine
physicians,
radiation
oncologists,
dosimetrists and
physicists.
RTx is a software
application intended
to display and
visualize 2D & 3D
multi-modal medical
image data. The
user may process,
render, review,
store, print and
distribute DICOM
3.0
compliant datasets
within the system
and/or across
computer networks.
Supported
modalities
include static and
gated a, PET, MR,
SPECT and planar
NM. The user may
also create, display,
print, store and
distribute reports
resulting from
interpretation of the
datasets.
RTx allows the user
to register
combinations of	professionals including, but not
limited to, radiologists,
oncologists, physicians, medical
technologists, dosimetrists and
physicists.
MIM 4.1 (SEASTAR) is a
medical image and information
management system that is
intended to receive, transmit,
store, retrieve, display, print and
process digital medical images,
as well as create, display and
print reports from those images.
The medical modalities of these
medical imaging systems
include, but are not limited to,
CT, MRI, CR, DX, MG, US,
SPECT, PET and XA as
supported by ACR/NEMA
DICOM 3.0.
MIM 4.1 (SEASTAR) provides
the user with the means to
display, register and fuse
medical images from multiple
modalities. Additionally, it
evaluates cardiac left ventricular
function and perfusion, including
left ventricular end-diastolic
volume, end-systolic volume,
and ejection fraction. The
Region of Interest (ROI) feature
reduces the time necessary for
the user to define objects in
medical image volumes by
providing an initial definition of
object contours. The objects
include, but are not limited to,
tumors and normal tissues.	and the primary predicate
AccuContour are the same in
that they are software
applications intended for
professional use to
display and visualize multi-
modal medical image data.
Supported modalities include
CT, PET, and MR.
The proposed device is also
identical to the primary
predicate in that it offers the
same two key features of the
planning process in
radiotherapy: image
registration and
segmentation.
In both devices, segmentation
can only be performed on CT
modality; registration can be
done from every supported
modality toward a CT with
deformable registration.
The proposed device may
differ from the primary
predicate in a) the list of
structures included in
automatic segmentation
algorithm b) the presence or
not of a rigid registration
algorithm, which is a
reduction compared to the
deformable registration that is
provided by ART-Plan.
However, not enough
information on these two
aspects is provided on the
Property	Proposed Device
ART-Plan	Primary
Predicate
AccuContour	Secondary
Predicate
RTx	Secondary Predicate
Workflow Box	General Information
Secondary Predicate
MIM4.1 (SEASTAR)	Comment
	edit manually and
semi-automatically
the contours for
the regions of
interest. It
also allows to
generate
automatically, and
based on medical
practices, the
contours for the
organs at risk and
healthy lymph
nodes on CT
images.
The contours
created
automatically,
semi-automatically
or manually
require
verifications,
potential
modifications, and
then the validation
of a trained user
with professional
qualifications in
anatomy and
radiotherapy.
The device is
intended to be
used in a clinical
setting, by trained
professionals only.			anatomical and
functional images
and display
them with fused and
non-fused displays
to facilitate the
comparison of
image data by the
user. The result of
the registration
operation can assist
the user in
assessing changes
in image
data; either within or
between
examinations and
aims to help the
user obtain a better
understanding of
the combined
information that
would otherwise
have to be visually
compared
disjointedly.
RTx provides a
number of tools
such as rulers and
region of interests,
which are intended
to
be used for the
assessment of
regions of an image
to support a clinical
workflow. Examples
of
such workflows
include, but are not	MIM 4.1 (SEASTAR) provides
tools to quickly create,
transform, and modify
contours for applications
including, but not limited to,
quantitative analysis, aiding
adaptive therapy, transferring
contours to radiation therapy
treatment planning systems and
archiving contours for patient
follow-up and management.

MIM 4.1 (SEASTAR) also aids
in the assessment of
PET/SPECT brain scans. It
provides automated quantitative
and statistical analysis by
automatically registering
PET/SPECT brain scans to a
standard template and
comparing intensity values to a
reference database or to other
PET/SPECT scans on a voxel
by voxel basis, within
stereotactic surface projections
or standardized regions of
interest.

Indications for Use

MIM 4.1 (SEASTAR) software is
used by trained medical
professionals as a tool to aid in
evaluation and information
management of digital medical
images. The
medical image modalities
include, but are not limited to,
CT, MRI, CR, DX, MG | side of the primary predicate. | |
| | | General Information | | | | | |
| Property | Proposed Device
ART-Plan | Primary
Predicate
AccuContour | Secondary
Predicate
RTx | Secondary
Predicate
Workflow Box | Secondary Predicate
MIM4.1 (SEASTAR) | Comment | |
| | | | | limited to, the
evaluation of the
presence or
absence of
lesions,
determination of
treatment response
and follow-up.
RTx supports the
loading and saving
of DICOM RT
objects and allows
the user to define,
import, display,
transform, store and
export such objects
including regions of
interest
structures and dose
volumes to radiation
therapy planning
systems. RTx
allows the user to
transform regions of
interest associated
with a particular
imaging dataset to
another,
supporting atlas-
based contouring
and rapid re-
contouring of the
same patient. | US, SPECT, PET and XA as
supported by ACR/NEMA
DICOM 3.0. MIM 4.1
(SEASTAR) assists in the
following indications:

Receive, transmit, store,
retrieve, display, print, and
process medical images
and DICOM objects.
Create, display and print
reports from medical images.
Registration, fusion display,
and review of medical images
for diagnosis,
treatment evaluation, and
treatment planning.
Evaluation of cardiac left
ventricular function and
perfusion, including left
ventricular end-diastolic volume,
end-systolic volume, and
ejection fraction.
Localization and definition of
objects such as tumors and
normal tissues in
medical images.
Creation, transformation, and
modification of contours for
applications
including, but not limited to,
quantitative analysis, aiding
adaptive therapy,
transferring contours to radiation
therapy treatment planning
systems, and
archiving contours for patient
follow-up and management.
Quantitative and statistical
analysis of PET/SPECT brain | | |
| Property | Proposed Device
ART-Plan | Primary
Predicate
AccuContour | Secondary
Predicate
RTx | Secondary
Predicate
Workflow Box | Secondary Predicate
MIM4.1 (SEASTAR) | Comment | |
| | | | | | registered PET/SPECT brain
scans

Lossy compressed mammographic images and
digitized film screen images must not be reviewed for
primary image interpretations. Images that are printed to film
must be printed using a FDA-approved printer for the
diagnosis of digital mammography images.
Mammographic images must be viewed on a display
system that has been cleared by the FDA for the diagnosis of
digital mammography images. The software is not to be used | | |
| General Information | | | | | | | |
| | | System Information | | | | | |
| Property | Proposed
Device
ART-Plan | Primary
Predicate
AccuContour | Secondary
Predicate
RTx | Secondary
Predicate
Workflow Box | Secondary Predicate
MIM 4.1 (SEASTAR) | Comment | |
| Method of Use | Standalone
software
application
accessed via a
compliant
browser (Chrome
or Mozilla
Firefox) on a
personal
computer, tablet
or phone (In
case of
connection to the
platform with a
screen of a
phone or a
tablet, the user
must choose the
option for the
desktop site of
his
communication
device. The
platform is
optimally used
with 17 inches
and up screen.
Facilitates
display and
visualization of
data by user. | Standalone
software | Standalone software
application | Standalone software
application | Standalone software package | The proposed device and
predicates have identical
methods of use | |
| Computer
Platform and
Operating
System | Full web platform
Launch from
Google Chrome
or Mozilla Firefox | Windows | Workstation and
Server based
application
supporting Windows
Server 2008 R2 | Server based
application
supporting Microsoft
Windows 10 (64-bit)
and Microsoft | Windows 2000/XP | The proposed devices and
predicates are compatible with
identical operating systems | |
| | System Information | | | | | | |
| Property | Proposed
Device
ART-Plan | Primary
Predicate
AccuContour | Secondary
Predicate
RTx | Secondary
Predicate
Workflow Box | Secondary Predicate
MIM 4.1 (SEASTAR) | Comment | |
| | | | SP1 and Windows 7
(64-bit) | Windows Server
2016. | | | |
| Data
Visualization /
Graphical
Interface | Yes | Yes | Yes | None - the
proposed device
has no data
visualization
functionality. All data
processing is
automated and does
not require user
interaction. A control
interface is provided
for system
administration and
configuration only. | Yes | The proposed device is identical
to the primary predicate, and
secondary predicate, MIM 4.1, in
that it has a graphical interface.
Workflow Box is Al based but
has no interface. RTx is not Al
based but has an interface and
thus most of the tools of
Annotate for contour
edition/display | |
| Supported
Modalities | Registration:
Static and gated
CT, MR, PET
(via the
registration of
the CT of said
PET)
Segmentation:
CT (injected or
not), DICOM
RTSTRUCT | Registration:
Multimodality
DICOM fixed and
moving images
including CT,
MR, PET
Segmentation:
Non-contrast CT | Static and gated CT
and PET, MR,
SPECT, NM,
DICOM RT | CT, MR, DICOM
RTSTRUCT for
image
processing
Any valid DICOM
data for data routing | Medical image modalities include,
but are not limited to, CT, MRI,
CR, DX, MG, US, SPECT, PET
and XA as supported by
ACR/NEMA DICOM 3.0. | The proposed device is
compatible with the same
modalities as the primary
predicate on the registration
feature, which are CT, MR and
PET images in a DICOM format.
For both devices, supported
images can be fixed (static) or
moving (gated).
The primary predicate device
and ART-Plan are both
compatible only with CT images
on the segmentation feature.
The predicate device claims to
handle only non-injected CTs
while ART-Plan can be used
with injected CT images as well. | |
| | | System Information | | | | | |
| Property | Proposed
Device
ART-Plan | Primary
Predicate
AccuContour | Secondary
Predicate
RTx | Secondary
Predicate
Workflow Box | Secondary Predicate
MIM 4.1 (SEASTAR) | Comment | |
| | | | | | | explicitly mention the format
RTStruct in supported
modalities which correspond to
the format used to store
segmentation masks in
radiotherapy. The terms
"medical images and DICOM
data" are used by the primary
predicate device, which can
imply the management of
DICOM RTStruct.
Compared to secondary
predicates, ART-Plan claims
less supported modalities. | |
| Data Export | Distribution of
DICOM
compliant
Images into
other DICOM
compliant
systems. | Allows export of
medical images
and DICOM data | Distribution of
DICOM compliant
Images into other
DICOM compliant
systems. | Supports routing
and distribution of
images to other
DICOM nodes
including to custom
executables
determined by the
user. | The system has the ability to send
data to DICOM-ready devices for
image storage, retrieval and
transmission. | The proposed device and
primary predicates have
identical data export
capabilities. | |
| Comtibility | Compatible with
data from any
DICOM
compliant
scanners for the
applicable
modalities. | No Limitation on
scanner model,
DICOM 3.0
compliance
required.
Compatible with
Microsoft
Windows. | Compatible with
data from any
DICOM compliant
scanners for the
applicable
modalities. | Compatible with
data from any
DICOM compliant
scanners for the
applicable
modalities.
Integration with
Mirada DBx
application launcher | The software can receive,
transmit, store, retrieve, display,
print, and process DICOM objects
and medical image modalities
including, but not limited to, CT.
MRI, CR, DX, MG, US, SPECT,
PET and XA as supported by
ACR/NEMA DICOM 3.0. | The proposed device and
primary predicates have
identical compatibilities | |
| | | System Information | | | | | |
| Property | Proposed
Device
ART-Plan | Primary
Predicate
AccuContour | Secondary
Predicate
RTx | Secondary
Predicate
Workflow Box | Secondary Predicate
MIM 4.1 (SEASTAR) | Comment | |
| | | No Limitation on
treatment
planning system
(TPS) model,
DICOM 3.0
compliance
required. | | and data browser | | | |
| | | Technical Information | | | | | |
| Property | Proposed
Device
ART-Plan | Primary
Predicate
AccuContour | Secondary
Predicate
RTx | Secondary
Predicate
Workflow Box | Secondary Predicate
MIM4.1 (SEASTAR) | Comment | |
| Delineation
Method | Al | Al | Atlas | Al | Atlas | The proposed device, primary
predicate and secondary
predicate Workflow Box share
an Al delineation method. | |
| Image
registration | Multi-modal
and mono-
modal.
Rigid and
deformable
Automatic and
manual
initialization
(landmarks,
fusion box,
alignment).
Registration for
the purposes of
replanning/
recontouring
and Al-based
automatic
contouring. | Automatic
registration.
Multi-modal and
mono-modal.
Deformable
registration.
Intensity based
algorithm
Registration for
the purpose of
treatment
planning,
treatment
evaluation and
treatment
adaptation. | Manual and Landmark
Rigid. Automatic multi-
modal rigid. Mono-
modal and multi-modal
deformable registration.
Motion correction in
hybrid scans and gated
scans.
Registration for the
purposes of
replanning/recontouring
and atlas-based
contouring. | Registration for the
purposes of
replanning/
re-contouring and
Al based
contouring. The
algorithms used
for image
registration are the
same for both RTx
and Workflow Box
devices. | Registration, fusion display, and
review of medical images for
diagnosis, treatment
evaluation, and treatment
planning. | Both the predicate device and
ART-Plan offer mono-modal (CT-
CT) and multi-modal (CT/MR,
CT/PET) deformable registration.
The SmartFuse module of ART-
Plan also offers rigid
registration, which is a
reduction of the deformable
registration since the degree of
freedom of the transformation
are constrained.
Both devices offer an automatic
solution for registration. ART-
Plan also offers semi-automatic
registration by including manual
initialization tools in addition to
automatic initialization.
Secondary devices offer the
same options as the proposed
device: rigid and deformable
transformation. No information
is given on the possible
automatization of this process. | |
| Segmentation
Features | Automatically
delineates
OARs and
healthy lymph
nodes (on any | Automatically
delineates OAR
(on non-contrast
CT images) | Automatically
delineates any structure
(OAR or lymph node)
included in the atlas | Not stated. | The software automatically
generates contours using a
deformable registration technique
which registers pre-contoured
patients to target patients. | The proposed device and
primary predicate are capable of
automatically contouring the
organ-at-risk (OAR). | |
| | | Technical Information | | | | | |
| Property | Proposed
Device
ART-Plan | Primary
Predicate
AccuContour | Secondary
Predicate
RTx | Secondary
Predicate
Workflow Box | Secondary Predicate
MIM4.1 (SEASTAR) | Comment | |
| | CT images)
Deep learning
algorithm.
Automatic
segmentation
includes the
following
localizations:

head and
neck
thorax/breast
(for
male/female)
abdomen
pelvis (for
male only)
brain. | Deep learning
algorithm.
It can
automatically
contour the
organ-at-risk,
including head
and neck,
thorax, abdomen
and pelvis (for
both male and
female), | images.
Atlas algorithm (contour
registration)
Automatic
segmentation supports
any anatomy included
in atlas images. | | Registrations are either
between a serial pair of intra-
patient volumes or between a pre-
existing atlas of contoured patients
and a patient volume. This process
facilitates contour creation or re-
contouring for adaptive therapy. | They differ in that ART-Plan can
also delineate healthy lymph
nodes.
Plus, there is a difference in
intended anatomies. The
common localizations are the
head and neck, thorax, abdomen
and male pelvis. ART-Plan does
not claim to offer automatic
segmentation on female pelvis.
However, in addition to the 4
upper common localizations,
ART-Plan can also be used for
brain localizations.
Secondary predicate using
atlas-based algorithms can be
applied on any localization and
for any type of structure
contained in atlas images used
by the center. | |
| View
Manipulation
and
Volume
Rendering | Window and
level, pan,
zoom, cross-
hairs, slice
navigation.
Maximum,
average and
minimum
intensity
projection (MIP,
AVG, MinIP),
color rendering,
multi-planar
reconstruction
(MPR), fused
views,
gallery views. | Not stated | Window and level, pan,
zoom, cross-hairs, slice
navigation.
Maximum or minimum
intensity projection
(MIP),
volume rendering, color
rendering, surface
rendering,
multi-planar
reconstruction (MPR),
fused views,
gallery views. | None - Not
applicable | Not stated | No information has been found
regarding view manipulation and
volume rendering concerning
the primary predicate. The
predicate device claims to offer
a feature to review the
processed image and perform
manual contouring, which
implies at least the display of
DICOM images with slice
navigation.
The proposed device has the
majority of the same tools as the
secondary RTx predicate, apart
from volume and surface | |
| | | Technical Information | | | | | |
| Property | Proposed
Device
ART-Plan | Primary
Predicate
AccuContour | Secondary
Predicate
RTx | Secondary
Predicate
Workflow Box | Secondary Predicate
MIM4.1 (SEASTAR) | Comment | |
| | | | | | | rendering
The Workflow Box secondary
predicate does not offer a
graphical interface. | |
| Regions and
Volumes
of Interest
(ROI) | Al Based
autocontouring,
Registration
based contour
projection (re-
contouring),
Manual ROI
manipulation
and
transformation
(margins,
booleans
operators,
interpolation). | Automatic target
volume
delineation
system.
Automatically
delineates
organs-at-risk
(OAR)
Manual Contour | 2D and 3D ROIs, semi-
automatic ROI
definition, isocontour
ROIs using threshold
and percentage of
maximum, one-click
seed-pointing
contouring, manual ROI
manipulation, ROI
transformation, Atlas-
based contouring. | Atlas Based
contouring,
registration based
recontouring,
machine learning
based contouring | Atlas based contouring, tools to
quickly create, transform, and
modify contours. | Both the proposed device and
the primary predicate allow Al
automatic contouring and
manual contouring | |
| Region/volume
of
interest
measurements
and
size
measurements | Intensity,
Hounsfield
units and SUV
measurements
Size
measurements
include 2D and
3D
measurements
(number of
slices, volume
of a structure,
static ruler) | Not stated | Intensity, Hounsfield
units, activity and SUV
measurements
including min, max,
mean, peak, standard
deviation, total
glycolytic activity,
median, histogram, max
and mean ratio to
reference region.
Gray for RT Dose.
Size measurements
include 2D and 3D
measurements
including rulers and
volume, line profile. | None - not
applicable | Quantitative analysis tools. | ART-Plan offers the same
Intensity, Hounsfield units and
SUV
measurements and size
measurements including 2D and
3D measurements (volume and
ruler) as secondary predicate
RTx. However, this is only a
fraction of the tools claimed by
secondary predicate RTx. | |
| | | Technical Information | | | | | |
| Property | Proposed
Device
ART-Plan | Primary
Predicate
AccuContour | Secondary
Predicate
RTx | Secondary
Predicate
Workflow Box | Secondary Predicate
MIM4.1 (SEASTAR) | Comment | |
| Region/Volume
Quantification | None | Not stated | Regions table with
charting supports
analysis of
measurement over
multiple studies using
standard protocols such
as RECIST, PERCIST
and WHO | None - not
applicable | Quantitative analysis tools. | The secondary predicate RTx
offers a range of tools for
region/volume quantification.
ART-Plan does not offer these
kinds of tools. It is a reduction in
claim or equivalent to the
primary predicate for which no
information was found. | |

Page 3 of 19

6

Page 4 of 19

7

8

9

10

System Information Comparison

Page 8 of 19

11

12

Page 10 of 19

13

14

Technical Information Comparison

Page 12 of 19

15

Page 13 of 19

16

17

18

Device Description:

The ART-Plan application is comprised of two kev modules: SmartFuse and Annotate, allowing the user to display and visualize 3D multi-modal medical image data. The user may process, render, review, store, display and distribute DICOM 3.0 compliant datasets within the system and/or across computer networks. Supported modalities include static and gated CT (computerized tomography), PET (positron emission tomography), and MR (magnetic resonance).

The overview of the product, in terms of input/output, functionalities and integration within the current clinical workflow for radiation therapy planning.

The ART-Plan technical functionalities claimed by TheraPanacea are the following:

. Proposing automatic solutions to the user, such as an automatic delineation, automatic multimodal image fusion, etc. towards improving standardization of processes/ performance / reducing user tedious / time consuminq involvement.
. Offering to the user a set of tools to assist semi-automatic delineation, semi-automatic registration towards modifying/editing manually automatically generated structures and addinq/removing new/undesired structures or imposing user-provided correspondences constraints on the fusion of multimodal images.
. Presenting to the user a set of visualization methods of the delineated structures, and registration fusion maps.
. Saving the delineated structures / fusion results for use in the dosimetry process.
. Enabling rigid and deformable registration of patients images sets to combine information contained in different or same modalities.

Technological Characteristics:

A comparative review of the ART-Plan with the predicate device found that the technology. mode of operation, and general principles for treatment with this device were substantially equivalent.as the predicate device.

Non-Clinical Tests (Performance/Physical Data):

The ART-Plan was evaluated for its safety and effectiveness based on the following testing:

Test Name	Test Description	Results
Usability Testing	The ART-Plan was assessed with
regards to usability for compliance
with IEC 62366	Passed
Autosegmentation
performances	The study gathers the information on
the 3 tests performed on the
automatic segmentation performances
on European data.	Passed
Test Name	Test Description	Results
Autosegmentation
performances according to
AAPM requirements	The testing demonstrated that the
auto-segmentation algorithm of the
module Annotate provides acceptable
contours for the concerned structures
on an image of a patient.	Passed
Autosegmentation
performances against MIM	The testing demonstrated that the
auto-segmentation algorithm of the
module Annotate provides acceptable
contours for the concerned structures
on an image of a patient.	Passed
Qualitative validation of
autoseqmentation
performances	The testing demonstrated that the
auto-segmentation algorithm of the
module Annotate provides acceptable
contours for the concerned structures
on an image of a patient.	Passed
External Contour
performances according to
AAPM requirements	The testing demonstrated that the
External Contour Automatic
Segmentation algorithm of the module
Annotate provides acceptable
contours for the patient's body on an
image of a patient.	Passed
Fusion performances
according to AAPM
recommendations	The testing evaluated the quality of
the rigid and deformable registration
tools of the SmartFuse module on
retrospective intra-patient images and
inter-patient images of different
modalities, to ensure the safety of the
device for clinical use.	Passed
Registration performances
on POPI-model	The testing evaluated the quality of
the deformable registration tools of the
SmartFuse module on intra-patient CT
images.
Testing was conducted according to
POPI-model protocol on
corresponding public data.	Passed
Test Name	Test Description	Results
Autosegmentation
performances on US data	The testing demonstrated that the
autosegmentation algorithm of the
Annotate module provides clinically
acceptable contours for the concerned
structures when applied to US
patients.	Passed
Pilot study for sample size
estimation - literature
review	The testing was a pilot study
estimating a consistent sample size of
dataset for our performance testing's
considering the state-of-art studies in
image registration and segmentation.
The literature review was completed
on the most cited articles in the field of
medical vision.	Passed
System Verification and
Validation Testing	The system verification and validation
testing was performed to verify the
software of the ART-Plan.	Passed

19

20

Software Verification and Validation Testing

Software verification and validation testing were conducted, and documentation was provided as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices."

The software for this device was considered as a "major" level of concern, since a failure or latent design flaw could directly result in death or serious injury to the patient or a failure or provide diagnostic information that directly drives a decision regarding treatment or therapy, such that if misapplied it could result in serious injury or death.

Animal Studies

No animal studies were conducted as part of submission to prove substantial equivalence.

Clinical Studies

No clinical studies were conducted as part of submission to prove substantial equivalence.

Safety and Effectiveness/Conclusion:

Based on the information presented in these 510(k) premarket notifications the TheraPanacea ART-Plan is considered substantially equivalent.

Based on testing and comparison with the predicate devices, TheraPanacea ART-Plan indicated no adverse indications or results. It is our determination that the TheraPanacea ART-

Page 18 of 19

21

Plan is safe, effective and performs within its design specifications and is substantially equivalent to the predicate device.