Predicate Devices

Reference Devices

AI/ML (Artificial Intelligence / Machine Learning)

Yes
The device description explicitly states that it uses "deep-learning-based algorithms" for automatic contouring, which is a form of machine learning.

Therapeutic

No
Explanation: This device is a post-processing software that automatically contours DICOM CT imaging data, which may be used as input for clinical workflows including external beam radiation therapy treatment planning. It does not directly provide therapy or treatment.

Diagnostic

No

The device is a post-processing software that generates contours for radiation therapy treatment planning. It is not intended to automatically detect or contour lesions, and its output is used as input for clinical workflows by trained medical professionals for treatment planning, not for diagnosing diseases or conditions.

SaMD (Software as a Medical Device)

Yes

The device description explicitly states "AI-Rad Companion Organs RT is a post-processing software" and details its functionality as software-based processing of DICOM CT data. There is no mention of accompanying hardware components that are part of the medical 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 medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health.
Device Function: AI-Rad Companion Organs RT is a software that processes medical images (CT scans) to automatically contour organs. It does not analyze biological samples.
Intended Use: The intended use is to generate contours for use in radiation therapy treatment planning, which is a clinical workflow based on imaging data, not biological samples.
Input: The input is DICOM CT imaging data, not biological specimens.

Therefore, AI-Rad Companion Organs RT falls under the category of medical imaging software or a medical device used in the context of radiation oncology, but it is not an In Vitro Diagnostic device.

PCCP (Predetermined Change Control Plan) Authorized

No
The input letter does not contain any explicit statement that the FDA has reviewed and approved or cleared a Predetermined Change Control Plan (PCCP) for this specific device.

Overview

Intended Use / Indications for Use

AI-Rad Companion Organs RT is a post-processing software intended to automatically contour DICOM CT imaging data using deep-learning-based algorithms.

Contours that are generated by AI-Rad Companion Organs RT may be used as input for clinical workflows including external beam radiation therapy treatment planning. AI-Rad Companion Organs RT must be used in conjunction with appropriate software such as Treatment Planning Systems and Interactive Contouring applications, to review, edit, and accept contours generated by AI-Rad Companion Organs RT.

The output of AI-Rad Companion Organs RT in the format of RTSTRUCT objects are intended to be used by trained medical professionals.

The software is not intended to automatically detect or contour lesions. Only DICOM images of adult patients are considered to be valid input.

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

QKB

Device Description

AI-Rad Companion Organs RT is a post-processing software used to automatically contour DICOM CT imaging data using deep-learning-based algorithms. AI-Rad Companion Organs RT contouring workflow supports CT input data and produces RTSTRUCT outputs. The configuration of the organ database and organ templates defining the organs and structures to be contoured based on the input DICOM data is managed via a configuration interface. Contours that are generated by AI-Rad Companion Organs RT may be used as input for clinical workflows including external beam radiation therapy treatment planning.

The output of AI-Rad Companion Organs RT, in the form of RTSTRUCT objects, are intended to be used by trained medical professionals. The output of AI-Rad Companion Organs RT must be used in conjunction with appropriate software such as Treatment Planning Systems and Interactive Contouring applications, to review, edit, and accept contours generated by AI-Rad Companion Organs RT application.

At a high-level, AI-Rad Companion Organs RT includes the following functionality:

Automated contouring of Organs at Risk (OAR) workflow
a. Input -DICOM CT
b. Output DICOM RTSTRUCT
Organ Templates configuration (incl. Organ Database)
Web-based preview of contouring results to accept or reject the generated contours

Mentions image processing

Yes

Mentions AI, DNN, or ML

Mentions AI, deep-learning-based algorithms, deep learning algorithm.

Input Imaging Modality

CT imaging data

Anatomical Site

Head & Neck, Thorax, Abdomen & Pelvis

Indicated Patient Age Range

Adult use only / AI-Rad Companion Organs RT is designed for use only in adult populations.

Intended User / Care Setting

Trained medical professionals / Designed to be used by trained clinicians. / Healthcare professionals familiar with the post processing of computed tomography images in the context of radiation oncology.

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

The performance of the AI-Rad Companion Organs RT has been validated in a retrospective performance study on CT data previously acquired for RT treatment planning (N= 113, data from multiple clinical sites across the North American and Europe). Ground truth annotations were established following RTOG and clinical guidelines using manual annotation.

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

Study Type: Retrospective performance study.
Sample Size: N= 113 cases.
Key Results:

The subject device achieved a median DICE score > 80% across all automatically contoured organs at risk with a median 95% Hausdorff (HD) value of 2.0 mm.
In a subcohort analysis performance results were found to be consistent on CT data across multiple vendors.
In comparison to the predicate device, AccuContour, both the DICE score and HD value were similar in nature and achieves appropriate quality not only for the unmodified organs but also for the newly supported automatically contoured organs and structures.
The performance of the subject device and predicate device are comparable in DICE and Hausdorff Distance.

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

DICE coefficient, absolute symmetric surface distance (ASSD), fail rate, 95% Hausdorff (HD) value.

	DICE	95% Hausdorff Distance (HD)
AccuContour (K191928)	0.85 – 0.95	≤ 3.5 mm
AI-Rad Companion Organs RT VA20	MED: 0.85	MED: 2.0 mm

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

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.

K192065

Predetermined Change Control Plan (PCCP) - All Relevant Information

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

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November 6, 2020

Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health and Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

Siemens Medical Solutions USA, Inc. % Ms. Lauren Bentley Senior Manager, Regulatory Affairs 40 Liberty Blvd. Mail Code 65-3 MALVERN PA 19355

Re: K193562

Trade/Device Name: AI-Rad Companion Organs RT Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: Class II Product Code: QKB Dated: September 29, 2020 Received: September 30, 2020

Dear Ms. Bentley:

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/cfpmp/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 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

1

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

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Image /page/2/Picture/0 description: The image contains the logo for Siemens Healthineers. The word "SIEMENS" is written in teal, and the word "Healthineers" is written in orange below it. To the right of the text is a graphic of several orange dots arranged in a circular pattern.

DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below.

Indications for Use

510(k) Number (if known)

K193562

Device Name AI-Rad Companion Organs RT

Indications for Use (Describe)

AI-Rad Companion Organs RT is a post-processing software intended to automatically contour DICOM CT imaging data using deep-learning-based algorithms.

Contours that are generated by AI-Rad Companion Organs RT may be used as input for clinical workflows including external beam radiation therapy treatment planning. AI-Rad Companion Organs RT must be used in conjunction with appropriate software such as Treatment Planning Systems and Interactive Contouring applications, to review, edit, and accept contours generated by AI-Rad Companion Organs RT.

The output of AI-Rad Companion Organs RT in the format of RTSTRUCT objects are intended to be used by trained medical professionals.

The software is not intended to automatically detect or contour lesions. Only DICOM images of adult patients are considered to be valid input.

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)	☑ Prescription Use (Part 21 CFR 801 Subpart D)	☐ Over-The-Counter Use (21 CFR 801 Subpart C)
☑ Prescription Use (Part 21 CFR 801 Subpart D)	☐ Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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

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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:

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FORM FDA 3881 (7/17)	Page 1 of 1	PSC Publishing Services (301) 443-6740 EF
----------------------	-------------	-------------------------------------------

Siemens Medical Solutions USA, Inc

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510(k) SUMMARY FOR AI-RAD COMPANION ORGANS RT

Submitted by: Siemens Medical Solutions USA, Inc. 40 Liberty Boulevard Malvern, PA 19355 Prepared: September 29, 2020 K193562

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of Safe Medical Devices Act of 1990 and 21 CFR §807.92.

1. Submitter

| Importer/Distributor | Siemens Medical Solutions USA, Inc.
40 Liberty Boulevard
Malvern, PA 19355
Mail Code: 65-1A
Registration Number: 2240869 |
|----------------------|--------------------------------------------------------------------------------------------------------------------------------------|
| Manufacturing Site | Siemens Healthcare GmbH
Henkestrasse 127
Erlangen, Germany 91052
Registration Number: 3002808157 |

2. Contact Person

Lauren Bentley Senior Regulatory Affairs Manager Siemens Medical Solutions USA, Inc. 40 Liberty Boulevard Mail Code: 65-3 Malvern, PA 19355 Phone: +1 (610) 241 - 6736 Email: lauren.bentley(@siemens-healthineers.com

3. Device Name and Classification

Product Name:	AI-Rad Companion Organs RT
Trade Name:	AI-Rad Companion Organs RT
Classification Name:	Picture Archiving and Communication System
Classification Panel:	Radiology
CFR Section:	21 CFR §892.2050
Device Class:	Class II
Product Code:	QKB

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Image /page/4/Picture/1 description: The image contains the logo for Siemens Healthineers. The word "SIEMENS" is in teal, and the word "Healthineers" is in orange. To the right of the word "SIEMENS" is a graphic of orange dots.

4. Predicate Device

Product Name:	AccuContour
Propriety Trade Name:	AccuContour
510(k) Number:	K191928
Clearance Date:	February 28, 2020
Classification Name:	Picture archiving and communications system
Classification Panel:	Radiology
CFR Section:	21 CFR §892.2050
Device Class:	Class II
Product Code:	QKB
Recall Information:	There have been no recalls for this device

5. Indications for Use

AI-Rad Companion Organs RT is a post-processing software intended to automatically contour DICOM CT imaging data using deep-learning-based algorithms.

Contours that are generated by AI-Rad Companion Organs RT may be used as input for clinical workflows including external beam radiation therapy treatment planning. AI-Rad Companion Organs RT must be used in conjunction with appropriate software such as Treatment Planning Systems and Interactive Contouring applications, to review, edit, and accept contours generated by AI-Rad Companion Organs RT.

The output of AI-Rad Companion Organs RT in the format of RTSTRUCT objects are intended to be used by trained medical professionals.

The software is not intended to automatically detect or contour lesions. Only DICOM images of adult patients are considered to be valid input.

6. Device Description

AI-Rad Companion Organs RT is a post-processing software used to automatically contour DICOM CT imaging data using deep-learning-based algorithms. AI-Rad Companion Organs RT contouring workflow supports CT input data and produces RTSTRUCT outputs. The configuration of the organ database and organ templates defining the organs and structures to be contoured based on the input DICOM data is managed via a configuration interface. Contours that are generated by AI-Rad Companion Organs RT may be used as input for clinical workflows including external beam radiation therapy treatment planning.

The output of AI-Rad Companion Organs RT, in the form of RTSTRUCT objects, are intended to be used by trained medical professionals. The output of AI-Rad Companion Organs RT must be used in conjunction with appropriate software such as Treatment Planning Systems and Interactive Contouring applications, to review, edit, and accept contours generated by AI-Rad Companion Organs RT application.

At a high-level, AI-Rad Companion Organs RT includes the following functionality:

1. Automated contouring of Organs at Risk (OAR) workflow
- a. Input -DICOM CT
- b. Output DICOM RTSTRUCT
1. Organ Templates configuration (incl. Organ Database)
1. Web-based preview of contouring results to accept or reject the generated contours

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7. Substantially Equivalent (SE) Comparison and Technological Characteristics

The indented use of the predicate device and the subject device are equivalent. The main difference is that AI-Rad Companion Organs RT is a dedicated solution for auto-contouring, minimizing the need of user interaction, while AccuContour additionally provides (among other features) manual contouring capabilities, treatment evaluation and treatment adaption.

The subject device, AI-Rad Companion Organs RT, is substantially equivalent with regards to performance and some technology of the predicate. AI-Rad Companion Organs RT and AccuContour both use a deep learning algorithm to support their AI claims. Additionally, they both process CT data in DICOM format, making them vendor agnostic and create outputs which can be used by any TPS system. The deep learning algorithm within AI-Rad Companion Organs RT has been enhanced from the algorithm in syngo.via RT Image Suite (K192065). syngo.via RT Image Suite serves as a reference device within this submission and a dedicated comparison of technological characteristics is provided.

The risk analysis and non-clinical data support that both devices perform equivalently and do not raise different questions of the safety and effectiveness.

| | Subject Device | Predicate
Device | Reference Device |
|------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device
Manufacturer | Siemens | Xiamen
Manteia LTD. | Siemens |
| Device Name | AI-Rad Companion
Organs RT | AccuContour | syngo.via RT Image Suite |
| 510(k) Number | K193562 | K191928 | K192065 |
| Indications for
Use | AI-Rad Companion
Organs RT is a post-
processing software
intended to automatically
contour DICOM CT
imaging data using deep-
learning-based
algorithms.
Contours that are
generated by AI-Rad
Companion Organs RT
may be used as input for
clinical workflows
including external beam
radiation therapy
treatment planning. AI-
Rad Companion Organs
RT must be used in
conjunction with
appropriate software
such as Treatment
Planning Systems and
Interactive Contouring | It is used by
radiation
oncology
department to
register
multimodality
images and
segment (non-
contrast) CT
images, to
generate needed
information for
treatment
planning,
treatment
evaluation and
treatment
adaptation. | syngo.via RT Image Suite is a
3D and 4D image
visualization, multi-modality
manipulation and
contouring tool that helps the
preparation and response
assessment of treatments such
as, but not limited to those
performed with radiation (for
example, Brachytherapy,
Particle Therapy, External
Beam Radiation Therapy).
It provides tools to efficiently
view existing contours, create,
edit, modify, copy contours of
regions of the body, such as
but not limited to, skin
outline, targets and organs-at-
risk. It also provides
functionalities to create and
modify simple treatment
plans. Contours, images and
treatment plans can
subsequently be exported to a
Treatment Planning System.
The software combines |

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Image /page/6/Picture/0 description: The image contains the logo for Siemens Healthineers. The word "SIEMENS" is written in teal, and the word "Healthineers" is written in orange below it. To the right of the words is a graphic of orange dots arranged in a circular pattern.

applications, to review, following digital image processing and visualization edit, and accept contours tools: generated by AI-Rad • Multi-modality viewing and Companion Organs RT. contouring of anatomical, The output of AI-Rad functional, and multi-Companion Organs RT parametric images such as but in the format of not limited to CT, PET, RTSTRUCT objects are PET/CT, MRI, Linac Cone Beam CT (CBCT) intended to be used by images and dose distributions trained medical • Multiplanar reconstruction professionals. (MPR) thin/thick, minimum The software is not intensity projection (MIP), intended to automatically volume rendering technique detect or contour lesions. (VRT) Only DICOM images of · Freehand and semiautomatic contouring of adult patients are regions-of-interest on any considered to be valid orientation including input. oblique • Creation of contours on any type of images without prior assignment of a planning CT • Manual and semi-automatic registration using rigid and deformable registration · Supports the user in comparing, contouring, and adapting contours based on datasets acquired with different imaging modalities and at different time points · Supports the user in comparing images and contours of different patients • Supports multi-modality image fusion • Visualization and contouring of moving tumors and organs • Management of points of interest including but not limited to the isocenter • Management of simple treatment plans • Generation of a synthetic CT based on multiple predefine MR acquisitions

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Segmentation Feature & Technological Characteristics
Algorithm	Deep Learning	Deep Learning	Atlas-based, machine
learning and deep-learning
based contouring
Segmentation of
Organ at Risk in
the Anatomic
Regions	Head & Neck, Thorax,
Abdomen & Pelvis	Head & Neck, Thorax,
Abdomen &
Pelvis	Head & Neck, Thorax,
Abdomen & Pelvis
Compatible
Modality	CT Images	Non-Contrast
CT	CT Images
Compatible
Scanner Models	No Limitation on
scanner model,
DICOM compliance
required.	No Limitation
on scanner
model,
DICOM 3.0
compliance
required.	No Limitation on scanner
model, DICOM
compliance required.
Compatible
Treatment
Planning System	No Limitation on TPS
model, DICOM
compliance required.	No Limitation
on TPS model,
DICOM 3.0
compliance
required.	No Limitation on TPS
model, DICOM 3.0
compliance required.
Contraindications	-Adult use only	-Adult use only
-Not intended
to be used as a
stand-alone
diagnostic
device	There are no known
specific situations that
contraindicate the use of
this device.
Target
Population	AI-Rad Companion
Organs RT is designed
for use only in adult
populations.
AI-Rad Companion
Organs RT is designed
for any patient for
whom relevant
modality scans are
available. More
specifically, the
software is validated
on previously acquired
CT DICOM volumes
for radiation therapy
treatment planning,
including, head and	Any patient
type for whom
relevant
multimodality
images and
segment (non-
contrast) CT
images are
available.	Any patient type for whom
the relevant modality scan
data is available.
	neck, thorax, abdomen,
and pelvis.
Clinical
condition the
device is
intended to
diagnose, treat or
manage	Limited to patients
previously selected for
Radiation Therapy.	Limited to
patients
previously
selected for
Radiation
Therapy.
However,
AccuContour
can be used for
treatment
evaluation and
treatment
adaptation.	Limited to patients
previously selected for
Radiation Therapy.
Software
Architecture	AI-Rad Companion
(Engine) architecture
enabling the
deployment of AI Rad
Companion Organs RT
in the Cloud. The UI is
provided using a web-
based interface.	Cloud and/or
Server based	Client-server architecture
where the server processes
and renders the data. Client
provides the UI for
interactive image viewing
and processing
Deployment
Feature	Cloud Deployment	Cloud
Deployment
and Server	On-premise/standalone
deployment
Organ Templates	Creating, editing and
deletion of organ
templates. Customize
predefined structure
database with mapping
to international
nomenclature schemes.	No information
publicly
available.	Creating, editing and
deletion of structure
templates. Customize
predefined structure
database with mapping to
international nomenclature
schemes.
Automated
workflow	AI-Rad Companion
Organs RT
automatically
processes input image
data and sends the
results as DICOM-RT
Structure Sets to a
user-configurable
target node.	AccuContour
automatically
processes input
image data	Rapid Results workflow
feature allows the
configuration of automatic
organ contouring and
optionally send DICOM-
RT files to a target
DICOM-Node for further
processing.
Contour
visualization and
editing feature	AI-Rad Companion
Organs RT provides
basic result preview of
automatic	AccuContour
provides basic
result preview
of automatic	syngo.via RT Image Suite
provides advanced contour
visualization feature of
	segmentation results,
and no editing feature
of the automatic
segmented contour.	segmentation
results. Manual
contouring is
possible.	contours and manual
editing feature
Segmentation
Performance	The target performance
was validated using
113 cases distributed to
two cohorts. Cohort
A-Clinical Routine
Treatment Planning
CT (Siemens; Head
and Neck, Thorax and
Abdomen Pelvis) and
Cohort B-Multi
Vendor Coverage (GE
and Phillips; Head and
Neck).
To objectively evaluate
the target performance.
the DICE coefficient,
the absolute symmetric
surface distance
(ASSD) and the fail
rate was evaluated.
The segmentation
performance of the
subject and reference
device were equivalent
as well as the overall
performance compared
to the predicate device.	The
segmentation
performance
was validated
using datasets
from China
and the USA
using three
major vendors
(GE, Siemens
and Phillips).
The
segmentation
accuracy is
evaluated
using DICE
coefficient.	The target performance was
validated using 32 cases
with various fields of view.
To objectively evaluate the
target performance, the
DICE coefficient & the
absolute symmetric surface
distance (ASSD) were
evaluated. The
segmentation performance
of the subject and predicate
device were equivalent.
User Interface -
Results Preview
(Confirmation)	Basic visualization
functionality of
original data and
generated contours	Basic result
preview of
automatic
segmentation
results. Manual
contouring is
possible.	Standard visualization tools
(window levels, MPR,
MIP, VRT). Manual
contouring is possible.
User Interface
Configuration	Configuration UI	Configuration
menu	syngo.via GUI
Human Factors	Design to be used by
trained clinicians.	Design to be
used by trained
clinicians.	Design to be used by
trained clinicians.

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Image /page/8/Picture/0 description: The image contains the logo for Siemens Healthineers. The word "SIEMENS" is written in teal, and the word "Healthineers" is written in orange below it. To the right of the words is a graphic of orange dots.

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Traditional 510(k) Submission: AI-Rad Companion Organs RT

Table 3: Indications for Use and Segmentation Feature Comparison

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8. Nonclinical Bench Testing

Non-clinical tests were conducted to assess the functionality of AI-Rad Companion Organs RT. Software validation and bench testing have been conducted to assess the performance claims as well as the claim of substantial equivalence to the predicate device.

AI-Rad Companion Organs RT has been tested to meet the requirements of conformity to multiple industry standards. Non-clinical performance testing demonstrates that AI-Rad Companion Organs RT complies with the FDA guidance document, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" (May 11, 2005) as well as with the following voluntary FDA recognized Consensus Standards listed in Table 4 below.

| Recognition
Number | Product
Area | Title of Standard | Reference
Number and
Date | Standards
Development
Organization |
|-----------------------|--------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------|------------------------------------------|
| 5-114 | General | Medical Devices –
Application of usability
engineering to medical
devices [including
Corrigendum 1 (2016)] | 62366-1:
2015-02 | IEC |
| 5-40 | General | Medical Devices –
application of risk
management to medical
devices | 14971:2007 | ISO |
| 13-79 | Software/
Informatics | Medical device software –
software life cycle
processes [Including
Amendment 1 (2016)] | 62304:
2006/A1:2016 | AAMI
ANSI
IEC |
| 12-300 | Radiology | Digital Imaging and
Communications in
Medicine (DICOM) Set | PS 3.1 – 3.20
(2016) | NEMA |
| 12-261 | Radiology | Information Technology –
Digital Compression and
coding of continuous -tone
still images: Requirements
and Guidelines [including:
Technical Corrigendum
1(2005)] | 10918-1 1994-
02-15 | ISO
IEC |

Table 4: Voluntary Consensus Standards

Verification and Validation

Software documentation for a Major Level of Concern software, per FDA's Guidance Document "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" issued on May 11, 2005, is also included as part of this submission. The performance data demonstrates continued conformance with special controls for medical devices containing software. Non-clinical tests were conducted on the subject device during product development.

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SIEMENS Healthineers

Software bench testing in the form of Unit, System and Integration tests were performed to evaluate the performance and functionality of the new features and software updates. All testable requirements in the Requirement Specifications and the Risk Analysis have been successfully verified and traced in accordance with the Siemens Healthineers DH product development process. Human factor usability validation is addressed in system testing and usability validation test records. Software verification and regression testing have been performed successfully to meet their previously determined acceptance criteria as stated in the test plans.

Siemens Healthineers adheres to the cybersecurity requirements as defined the FDA Guidance "Content of Premarket Submissions for Management for Cybersecurity in Medical Devices," issued October 2, 2014 by implementing a process of preventing unauthorized access, modifications, misuse or denial of use, or the unauthorized use of information that is stored, accessed, or transferred from a medical device to an external recipient.

Performance Software Validation

To validate the AI-Rad Companion Organs RT software from clinical perspective, the autocontouring algorithm underwent a scientific evaluation. The results of clinical data-based software validation for the subject device AI-Rad Companion Organs RT demonstrated equivalent performance in comparison to the predicate device. A complete scientific evaluation report is provided in support of the device modifications.

The performance of the AI-Rad Companion Organs RT has been validated in a retrospective performance study on CT data previously acquired for RT treatment planning (N= 113, data from multiple clinical sites across the North American and Europe). Ground truth annotations were established following RTOG and clinical guidelines using manual annotation. The subject device achieved a median DICE score > 80% across all automatically contoured organs at risk with a median 95% Hausdorff (HD) value of 2.0 mm. In a subcohort analysis performance results were found to be consistent on CT data across multiple vendors. In comparison to the predicate device, AccuContour, both the DICE score and HD value were similar in nature and achieves appropriate quality not only for the unmodified organs but also for the newly supported automatically contoured organs and structures. The results of both devices are shown in the following Table. As we can see, the performance of the subject device and predicate device are comparable in DICE and Hausdorff Distance.

	DICE	95% Hausdorff Distance (HD)
AccuContour (K191928)	0.85 – 0.95	$≤$ 3.5 mm
AI-Rad Companion Organs RT
VA20	MED: 0.85	MED: 2.0 mm

Table5. Performance comparison between subject device and predicate device

9. Clinical Tests

No clinical tests were conducted to test the performance and functionality of the features introduced within AI-Rad Companion Organs RT. Verification and validation of the algorithm enhancements and improvements have been performed and these modifications have been validated for their intended use. The data from these activities were used to support the subject device and the substantial equivalence argument. No animal testing has been performed on the subject device.

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10. Safety and Effectiveness

The device labeling contains instructions for use and any necessary cautions and warnings to ensure safe and effective use of the device.

Risk management is ensured via ISO 14971:2007 compliance to identify and provide mitigation of potential hazards in a risk analysis early in the design phase and continuously throughout the development of the product. These risks are controlled via measures realized during software development, testing and product labeling.

Furthermore, the device is intended for healthcare professionals familiar with the post processing of computed tomography images in the context of radiation oncology.

11. Substantial Equivalence and Conclusion

AI-Rad Companion Organs RT is substantially equivalent to the following predicate device:

Predicate Device	FDA Clearance Number	FDA Clearance Date	Main Product Code
AccuContour	K191928	February 28, 2020	QKB

Table 6: Predicate for AI-Rad Companion Organs RT

The intended use of the predicate device and the subject device are equivalent. The two devices process the same form of CT DICOM data, are agnostic with respect to the CT machine and Treatment Planning System. The main difference is that AI-Rad Companion Organs RT is a dedicated solution for auto-contouring while AccuContour (K191928), additionally provides (among other features) manual contouring capabilities and image registration. AccuContour is used additionally for treatment evaluation and treatment adaption. From a performance perspective both devices provide automatic organ-at-risk contouring using deep learning method in head and neck, thorax, abdomen and pelvis (for both male and female) regions. Both devices are able to contour organ-at-risk using GE, Siemens and Philips scanners. Additionally, both devices have comparable DICE and HD values when compared to the ground truth. Due to the above-mentioned attributes, AI-Rad Companion Organs RT is substantially equivalent to the predicate device, AccuContour, and does not raise any additional concerns to the safety or effectiveness of the subject device.