syngo.via RT Image Suite is a 3D and 4D image visualization, multi-modality manipulation and contouring tool that helps the preparation 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 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 simple geometric treatment plans. Contours, images and treatment plans can subsequently be exported to a Treatment Planning System.

The software combines the following digital image processing and visualization tools:

. Multi-modality viewing and contouring of anatomical, and multi-parametric images such as but not limited to CT, PET, PET/CT, MRI, Linac CBCT images
Multiplanar reconstruction (MPR) thin/thick, minimum intensity projection (MIP), volume ● rendering technique (VRT)
. Freehand and semi-automatic contouring of regions-of-interest on any orientation including oblique
Automated Contouring on CT images
. Creation of contours on images supported by the application 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 multi-modality image fusion
. Visualization and contouring of moving tumors and organs
Management of points of interest including but not limited to the isocenter ●
Creation of simple geometric treatment plans ●
Generation of a synthetic CT based on multiple pre-define MR acquisitions ●

Device Description

The subject device with the current software version SOMARIS/8 VB60 is an image analysis software for viewing, manipulation, 3D and 4D visualization, comparison of medical images from multiple imaging modalities and for the segmentation of tumors and organs-at-risk, prior to dosimetric planning in radiation therapy. syngo.via RT Image Suite combines routine and advanced digital image processing and visualization tools for manual and software assisted contouring of volumes of interest, identification of points of interest, sending isocenter points to an external laser system, registering images and exporting final results. syngo.via RT Image Suite supports the medical professional with tools to use during different steps in radiation therapy case preparation.

For the current software version SOMARIS/8 VB60 the following already cleared features have been modified:

. Reference Point Management
Patient Marking ●
Contouring / Routine Contouring
Structure Set Management ●
Synthetic CT
Basic Feature of syngo,via RT Image Suite

AI/ML Overview

The provided documentation relates to the Siemens syngo.via RT Image Suite, specifically describing its 510(k) premarket notification for a new software version (SOMARIS/8 VB60) that includes an AI-based algorithm for synthetic CT generation.

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:

Acceptance Criteria and Reported Device Performance

The document describes performance criteria for the AI-based algorithm for generating synthetic CT images from MR images. While not presented in a formal table with specific thresholds, the text outlines the key metrics evaluated and the results.

Acceptance Criteria	Reported Device Performance
Geometric Fidelity (Body Outline Deviation)	Average deviations in the body outline were smaller than 1 mm.
HU Accuracy (Soft Tissue)	Within 50 HU.
HU Accuracy (Bone Tissue)	Within 200 HU.
Performance vs. Predicate Device	Equal performance in geometric accuracy and superior performance in HU accuracy.

The document states that the geometric deviation of < 1 mm is "below the voxel resolution and therefore not clinically relevant," implying this meets the clinical relevance standard.

Study Details

The document refers to "performance tests (Non-clinical test reports)" and a "Summary of the Performance Evaluation of the Algorithm" to demonstrate meeting acceptance criteria.

1. Sample Size Used for the Test Set and Data Provenance:

Sample Size: The document does not specify the exact sample size used for the test set for the AI algorithm. It only mentions "independent data."
Data Provenance: The document does not specify the country of origin or whether the data was retrospective or prospective. It only states the AI algorithm was "tested on independent data."

2. Number of Experts Used to Establish Ground Truth and Qualifications:

Number of Experts: Not specified.
Qualifications: Not specified.
- The ground truth methodology is not described in terms of expert consensus for the test set.

3. Adjudication Method for the Test Set:

Not specified. The document states "automated bench tests" were used for geometric and HU accuracy, implying an objective, quantitative comparison rather than reader adjudication.

4. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

No MRMC study appears to have been performed or reported in this document for the AI-based synthetic CT algorithm.
The evaluation focused on quantitative metrics (geometric and HU accuracy) of the algorithm's output, not on human reader performance with or without AI assistance.

5. Standalone (Algorithm Only) Performance:

Yes, a standalone performance evaluation was conducted. The "Summary of the Performance Evaluation of the Algorithm" specifically details the AI-based algorithm's performance on "geometric fidelity and HU accuracy using automated bench tests." This implies an algorithm-only evaluation without human intervention in the performance measurement.

6. Type of Ground Truth Used:

The ground truth for the synthetic CT evaluation appears to have been measured/reference CT images against which the synthetic CTs were compared for geometric and Hounsfield Unit (HU) accuracy. This falls under reference standard/objective measurement data, implying accuracy was determined by comparing the AI's output to a known, accurate CT.

7. Sample Size for the Training Set:

Not specified. The document does not provide details about the training set size for the deep-learning algorithm.

8. How the Ground Truth for the Training Set Was Established:

Not specified. The document indicates that the "algorithm for brain and pelvis synthetic CTs has been changed from Atlas based to a deep-learning algorithm." However, it does not describe how the ground truth for training this deep-learning algorithm was established (e.g., source of data, annotation methods, expert review, etc.).

Summary

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July 30, 2021

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 & Human Services logo. To the right of that is the FDA logo, which consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, and then the word "ADMINISTRATION" in a smaller font size below that.

Siemens Medical Solutions USA Inc. % Clayton Ginn Regulatory Affairs Specialist 810 Innovation Drive KNOXVILLE TN 37932

Re: K211379

Trade/Device Name: syngo.via RT Image Suite Regulation Number: 21 CFR 892.5050 Regulation Name: Medical charged-particle radiation therapy system Regulatory Class: Class II Product Code: MUJ Dated: May 3, 2021 Received: May 4, 2021

Dear Clayton Ginn:

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 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

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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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Indications for Use

510(k) Number (if known)

K211379

Device Name syngo.via RT Image Suite

Indications for Use (Describe)

syngo.via RT Image Suite is a 3D and 4D image visualization, multimodality manipulation and contouring tool that helps the preparation 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 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 simple geometric treatment plans. Contours, images and treatment plans can subsequently be exported to a Treatment Planning System.

The software combines the following digital image processing and visualization tools:

· Multi-modality viewing and contouring of anatomical, and multiparametric images such as but not limited to CT, PET, PET/CT, MRI, Linac CBCT images
· Multiplanar reconstruction (MPR) thick, minimum intensity projection (MIP), volume rendering technique (VRT)
· Freehand and semi-automatic contouring of regions-of-interest on any orientation including oblique
· Automated Contouring on CT images
· Creation of contours on images supported by the application without prior assignment of a planning CT
Manual and semi-automatic registration using rigid and deformable registration
· Supports the user in comparing, and adapting contours based on datasets acquired with different imaging modalities and at different time points
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
· Creation of simple geometric treatment plans
· Generation of a synthetic CT based on multiple pre-define MR acquisitions

Type of Use (Select one or both, as applicable)
-------------------------------------------------	--

X Prescription Use (Part 21 CFR 801 Subpart D)

| Over-The-Counter Use (21 CFR 801 Subpart C)

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Image /page/3/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.

Traditional: 510(k): syngo.via RT Image Suite

K211379

Section 5 510(k) Summary

Identification of the Submitter I.

Importer/Distributor

Siemens Medical Solutions USA, Inc. 40 Liberty Boulevard Malvern, PA 19355

Establishment Registration Number

2240869

Manufacturing Site

Siemens Healthcare GmbH Siemensstr 1 D-91301 Forchheim, Germany

Establishment Registration Number

3004977335

Submitter Contact Person:

Clayton Ginn Regulatory Affairs Specialist 810 Innovation Drive Knoxville, TN 37932 Phone: (865) 898-2692 Email: clayton.ginn@siemens-healthineers.com

II. Device Name and Classification

Product Name:	syngo.via RT Image Suite
Propriety Trade Name:	syngo.via RT Image Suite
Classification Name:	System, Planning, Radiation Therapy Treatment
Classification Panel:	Radiology
CFR Section:	21 CFR §892.5050
Device Class:	Class II
Product Code:	MUJ

III. Predicate Device

Trade Name:	syngo.via RT Image Suite
510(k) Number:	K201444
Clearance Date:	08/13/2020
Classification Name:	System, Planning, Radiation Therapy Treatment
Classification Panel:	Radiology
CFR Section:	21 CFR §892.5050
Device Class:	Class II
Product Code:	MUJ

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Healt

IV. Device Description

For the current software version SOMARIS/8 VB60 the following already cleared features have been modified:

. Reference Point Management
Patient Marking ●
Contouring / Routine Contouring
Structure Set Management ●
Synthetic CT
Basic Feature of syngo,via RT Image Suite

V. Indications for Use

The software combines the following digital image processing and visualization tools:

. Multi-modality viewing and contouring of anatomical, and multi-parametric images such as but not limited to CT, PET, PET/CT, MRI, Linac CBCT images
Multiplanar reconstruction (MPR) thin/thick, minimum intensity projection (MIP), volume ● rendering technique (VRT)
. Freehand and semi-automatic contouring of regions-of-interest on any orientation including oblique
Automated Contouring on CT images
. Creation of contours on images supported by the application 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 multi-modality image fusion
. Visualization and contouring of moving tumors and organs
Management of points of interest including but not limited to the isocenter ●
Creation of simple geometric treatment plans ●
Generation of a synthetic CT based on multiple pre-define MR acquisitions ●

The Indications for Use is unchanged from that of the predicate device.

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VI. Comparison of Technological Characteristics with the Predicate Device

As with the predicate device syngo.via RT Image Suite SOMARIS/8 VB50, the subject device supports viewing, manipulation, 3D and 4D visualization, comparison of medical images from multiple imaging modalities and the segmentation of turnors and organs-at-risk, prior to dosimetric planning and response assessment in radiation therapy.

At a high-level a tabular summary of the subject and predicate device's technological differences is provided as Table 4 below for the software version SOMARIS/8 VB60:

Feature	Description and Comparison of the Subject Device to the Predicate Device
ReferencePointManagement	Reference Point Management allows to edit the position, color, and typeof Points of Interest (POI).Modification:The workflow for POI creation and editing has been slightly adapted to improveusability without modification of the functionality.
PatientMarking	Transmission of reference points with the offset details to a movable laser systemfor patient marking.Modification:• Saving of sent POIs• Removal of default value for laser calibration offset• Consistency checks for laser calibration offset (only for integrated laser)• Minor usability improvements
Contouring(RoutineContouring)	With Contouring, the user can create, delete, and edit Volumes of Interest (VOIs).Modification:The routine contouring feature has been enhanced for the subject device toinclude a tool to cut a structure at a user-defined axial level.
Structure SetManagement	• Loading and storing of DICOM RT structure sets, creating, editing and deletionof structures and POIs.• Creating, editing and deletion of structure templates.• Customize predefined structure database with mapping to internationalnomenclature schemes.Modifications:The Structure Set Management provides a set of improvements to optimize theworkflow including:• Structure Set approval• Enhanced color picker• Structure sorting by type• Manual and automated merging of structure sets• Streamlined rapid results configuration• Filter for auto-contourable structures• Merge / expand structure via structure templates
Synthetic CT	The synthetic CT feature provides functionality to create a CT-density equivalentimage series out of multiple MR-image-series.Modification:The algorithm for brain and pelvis synthetic CTs has been changed from Atlasbased to a deep-learning algorithm.
Basic Featureof syngo.viaRT Image Suite	The set provides basic feature of the subject device.Modification:For the subject device the Parallel Image Display feature as well as the generalworkflow have been improved.

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Image /page/6/Picture/1 description: The image contains the logo for Siemens Healthineers. The word "SIEMENS" is in teal, and the word "Healthineers" is in orange. There are also some orange dots to the right of the word "SIEMENS".

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VII. Performance Data

The following performance data were provided in support of the substantial equivalence determination.

Software 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. The Risk Analysis was completed, and risk control implemented to mitigate identified hazards. The testing supports that all software specifications have met the acceptance criteria. Testing for verification and validation support the claim of substantial equivalence.

Non-Clinical Testing

This submission contains performance tests (Non-clincal test reports) to demonstrate continued conformance with special controls for medical devices containing software. Non-clinical tests (integration and functional) were conducted for syngo.via RT Image Suite during product development. These tests have been performed to test the ability of the included features of the subject device. The results of these tests demonstrate that the subject device performs as intended. The result of all conducted testing was found acceptable to support the claim of substantial equivalence.

Summary of the Performance Evaluation of the Algorithm

The subject device syngo.via RT Image Suite VB60 includes an Al-based algorithm for the creation of synthetic CT images from MR images to be used in the preparation of radiation therapy treatment planning.

The Al-based algorithm was tested on independent data for geometric fidelity and HU accuracy using automated bench tests.

The subject device algorithm demonstrated very good geometric accuracy with average deviations in the body outline smaller than 1 mm, which is below the voxel resolution and therefore not clinically relevant. The HU accuracy of the subject device algorithm was well within 50 HU (200 HU) for soft (bone) tissue.

In comparison to the predicate device, the subject device algorithm showed equal performance in geometric accuracy and superior performance in HU accuracy.

Risk Analysis

The risk analysis was completed, and risk control implemented to mitigate identified hazards. The testing results support that all the software specifications have met the acceptance criteria. Testing for verification and validation of the device was found acceptable to support the claims of substantial equivalence.

Siemens hereby certifies that syngo.via RT Image Suite meets the following voluntary standards covering electrical and mechanical safety listed below:

RecognitionNumber	ProductArea	Title of Standard	Date ofRecognition	StandardsDevelopmentOrganization
12-300	Radiology	Digital Imaging and Communications inMedicine (DICOM) Set; PS 3.1 ">– 3.20	06/27/2016	NEMA
13-79	Software	Medical Device Software ">– Software Life CycleProcesses; 62304:2015-06 (Edition 1.1)	01/14/2019	AAMI, ANSI,IEC
5-40	Software/Informatics	Medical devices ">– Application of riskmanagement to medical devices; 14971 SecondEdition 2007-03-01	06/27/2016	ISO

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Image /page/8/Picture/0 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 words is a graphic of several orange dots arranged in a circular pattern.

RecognitionNumber	ProductArea	Title of Standard	Date ofRecognition	StandardsDevelopmentOrganization
5-114	General I(QS/RM)	Medical devices - Part 1: Application ofusability engineering to medical devicesIEC 62366-1:2015	12/23/2016	IEC

VIII. Conclusion

syngo.via RT Image Suite (software version SOMARIS/8 VB60) has the same intended use and same indication for use as the predicate device (software version SOMARIS/8 VB50). The fundamental technological characteristics are the same as the predicate device. The result of all testing conducted was found acceptable to support the claim of substantial equivalence. The comparison of technological characteristics, non-clinical performance data, and software validation demonstrates that the subject device is as safe and effective when compared to the predicate device that is currently marketed for the same intended use. For the subject device, syngo.via RT Image Suite, Siemens used the same testing with the same workflows as used to clear the predicate device. Siemens considers syngo.via RT Image Suite to be as safe, as effective and with performance substantially equivalent to the commercially available predicate devices.

Regulation Number and Section

§ 892.5050 Medical charged-particle radiation therapy system.

(a)
Identification. A medical charged-particle radiation therapy system is a device that produces by acceleration high energy charged particles (e.g., electrons and protons) intended for use in radiation therapy. This generic type of device may include signal analysis and display equipment, patient and equipment supports, treatment planning computer programs, component parts, and accessories.(b)
Classification. Class II. When intended for use as a quality control system, the film dosimetry system (film scanning system) included as an accessory to the device described in paragraph (a) of this section, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.