syngo via RT Image Suite is a 3D and 4D image visualization, multimodality 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 the body, such as but not limited to, skin outline, targets and organs-at-risk. Contours and images can subsequently be exported to a Treatment Planning System.

The software combines 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 Cone Beam CT (CBCT) images and dose distributions
· 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
· 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, 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

Device Description

syngo.via RT Image Suite 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 and response assessment in radiation therapy.

syngo.via RT Image Suite combine and advanced digital image processing and visualization tools for easy 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.

syngo.via RT Image Suite provides dedicated tools, which help the medical professional in contouring and evaluating volumes of interest, for example gross target volumes, or organs-at-risk.

The software application works in a similar fashion on any officially supported imaging modality, for example, native contouring is supported on CT but also on MR or PET images.

The following features have been modified:

Routine Annotation Functionality (modified) ●
Contouring Tools (modified)
Patient Marking (modified)
. Structure Set Management (modified)
Alignment Tools (modified)
Dose Evaluation (new)

AI/ML Overview

The provided text describes the "syngo.via RT Image Suite" and its 510(k) submission, comparing it to predicate devices. However, the document primarily focuses on demonstrating substantial equivalence through non-clinical testing (integration and functional tests, software verification and validation, risk analysis) and adherence to recognized standards. It does not present a detailed study with specific acceptance criteria and reported device performance metrics in the format requested, especially regarding clinical metrics, sample sizes for test sets, ground truth establishment, or comparative effectiveness studies with human readers.

The document states that "The testing results support that all the software specifications have met the acceptance criteria," but it does not specify what those acceptance criteria were or present the reported device performance against those criteria in a quantitative manner.

Therefore, much of the requested information cannot be extracted directly from this document.

Here's an attempt to answer based on the available information, with clear indications where information is missing:

1. A table of acceptance criteria and the reported device performance

The document states, "The testing results support that all the software specifications have met the acceptance criteria." However, it does not explicitly list the specific acceptance criteria or the quantitative reported device performance for the syngo.via RT Image Suite. The "Performance Data" section primarily describes the types of tests conducted (non-clinical integration and functional tests, software verification/validation, risk analysis) and a general conclusion that the device performs as intended and meets acceptance criteria.

2. Sample sizes used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This information is not provided in the document. The text mentions "non clinical tests (integration and functional)" and "verification/validation testing" but does not specify the sample size of cases, images, or data used for these tests, nor the provenance of any data (e.g., country of origin, retrospective/prospective). Given the non-clinical nature of the described tests, clinical "test sets" in the sense of patient data with ground truth might not have been the primary focus of the performance data presented here.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)

This information is not provided in the document. As the described performance data is related to non-clinical software testing, there is no mention of experts establishing ground truth for a clinical test set.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not provided in the document. No adjudication method is mentioned, likely because the performance data section focuses on software verification and validation rather than a clinical study requiring adjudicated ground truth.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

The document does not indicate that an MRMC comparative effectiveness study was performed or that human readers' performance with/without AI assistance was evaluated. The device is described as an "image visualization, multimodality manipulation and contouring tool" that helps preparation and response assessment, implying it supports human users, but no study on human performance improvement is detailed.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

The document does not explicitly present data from a "standalone" algorithm performance study in a clinical context. The performance data focuses on "non clinical tests (integration and functional)" along with "software verification and validation," which are evaluations of the software's functionality and adherence to specifications, not necessarily its autonomous clinical performance as an "algorithm only" device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

The document does not specify the type of ground truth used for any particular test set. Given the described non-clinical nature of the tests, ground truth likely refers to expected software behavior or outputs according to specifications rather than clinical benchmarks like pathology or expert consensus on medical images.

8. The sample size for the training set

This information is not provided in the document. The text does not refer to a "training set," which would typically be relevant for machine learning or AI-based devices. While the device has "semi-automatic contouring" and "manual and semi-automatic registration," the document describes these as features without detailing any machine learning training processes or associated datasets.

9. How the ground truth for the training set was established

This information is not provided in the document, as no training set is mentioned in the context of performance data.

Summary of what can be inferred or is explicitly stated regarding the "study":

Type of Study: Non-clinical (integration and functional tests, software verification and validation).
Purpose: To demonstrate conformance with special controls for medical devices containing software, mitigate identified hazards (risk analysis), and support the claim of substantial equivalence to predicate devices.
Acceptance Criteria (General): "all the software specifications have met the acceptance criteria." (Specific criteria not detailed).
Reported Device Performance (General): The device "performs as intended" and "performance is comparable to the predicate devices." (Specific quantitative performance metrics not detailed).
Standards Conformed To: DICOM Set (PS 3.1 - 3.20), IEC 62304 (Medical device software - Software life cycle processes), ISO 14971 (Application of risk management to medical devices), IEC 60601-1-6 (Usability), IEC 60601-1-4 (Programmable electrical medical systems).
Support for Claims: Six scientific articles are mentioned as used to support marketing claims in the product brochure, but these are not described as part of the core performance data reported for this 510(k) submission.

In conclusion, the document focuses on regulatory compliance through non-clinical software testing and comparison to predicates, rather than providing a detailed clinical study with the specific criteria and performance metrics requested.

Summary

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

October 25, 2016

Siemens Medical Solutions USA, Inc. % Ms. Kimberly Mangum Regulatory Affairs Specialist 40 Liberty Blvd., Mail Code 65-1A MALVERN PA 19355

Re: K162370

Trade/Device Name: syngo.via RT Image Suite Regulation Number: 21 CFR 892.5050 Regulation Name: Medical charged-particle radiation therapy system Regulatory Class: II Product Code: MUJ, LLZ Dated: August 12, 2016 Received: August 24, 2016

Dear Ms. Mangum:

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. 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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. 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

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours.

Michael D'Hara

For

Robert Ochs, Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K162370

Device Name syngo.via RT Image Suite

Indications for Use (Describe)

The software combines 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 Cone Beam CT (CBCT) images and dose distributions
· 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
· 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, 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

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

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510(K) SUMMARY FOR SYNGO.VIA RT IMAGE SUITE

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

Date Prepared: August 12, 2016

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

I. Submitter

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

Contact Person

Kimberly Mangum Regulatory Affairs Specialist Siemens Medical Solutions USA, Inc. 40 Liberty Boulevard Malvern, PA 19355 Phone: (610) 448-6477 Fax: (610) 640-4481 Email: kimberly.mangum@siemens.com

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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
Subsequent CFR Section:	21 CFR §892.2050
Device Class:	Class II
Product Code:	MUJ
Subsequent Product Code:	LLZ

III. Predicate Device

Primary Predicate Device:

Trade Name:	syngo.via RT Image Suite
510(k) Number:	K151380
Clearance Date:	August 13, 2015
Classification Name:	System, Planning, Radiation Therapy Treatment
Classification Panel:	Radiology
CFR Section:	21 CFR §892.5050
Subsequent CFR Section:	21 CFR §892.2050
Device Class:	Class II
Product Code:	MUJ
Subsequent Product Code:	LLZ
Recall:	There have been no recalls for this device

Secondary Predicate Device:

Trade Name:	syngo Dosimetrist Workspace v2.7
510(k) Number:	K101119
Clearance Date:	October 9, 2010
Classification Name:	System, Planning, Radiation Therapy Treatment
Classification Panel:	Radiology
CFR Section:	21 CFR § 892.5050
Device Class:	Class II
Product Code:	MUJ
Recall:	68395

IV. Device Description

syngo.via RT Image Suite provides dedicated tools, which help the medical professional in contouring and evaluating volumes of interest, for example gross target volumes, or organs-at-risk.

The software application works in a similar fashion on any officially supported imaging modality, for example, native contouring is supported on CT but also on MR or PET images.

The following features have been modified:

Routine Annotation Functionality (modified) ●
Contouring Tools (modified)
Patient Marking (modified)
. Structure Set Management (modified)

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Image /page/5/Picture/0 description: The image shows the word "SIEMENS" in a sans-serif font. The letters are a light blue color. The word is displayed horizontally and is the main focus of the image.

Alignment Tools (modified)
Dose Evaluation (new)

V. Indications for Use

syngo.via RT Image Suite is a 3D and 4D image visualization, multimodality 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).

. Multi-modality viewing and contouring of anatomical, functional, and multi-parametric images such as but not limited to CT, PET, PET/CT, MRI, Linac Cone Beam CT (CBCT) images and dose distributions
. 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
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 .

VI. Comparison of Technological Characteristics with the Predicate Device

syngo.via RT Image Suite has the same intended use, operating principle as well as the image visualization and manipulation technological characteristics as the predicate devices. Evaluation and post-processing are the technological principles for both the subject and predicate devices. The fundamental features of this subject device are: viewing, manipulation, 3D and 4D visualization, comparison of medical images from multiple imaging modalities and the segmentation of tumors and organs-at-risk, prior to dosimetric planning and response assessment in radiation therapy. The indications for use are similar.

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Using a high-level comparison, the subject and predicate devices are based on the following same technological elements respectively have the following differences:

	Subject Device	Primary Predicate Device	Secondary Predicate Device	Comparison
Feature	syngo.via RT ImageSuite	syngo.via RT ImageSuite	syngo DosimetristWorkspace v2.7
BasicFeatures	Routine ReadingFunctionality; ParallelImage Display; RoutineAnnotation Functionality	Routine ReadingFunctionality; ParallelImage Display; RoutineAnnotation Functionality	Routine ReadingFunctionality; ParallelImage Display	Routine AnnotationFunctionalitysupports now afinding feature
Contouring	Routine Contouring;Advanced Contouring;Contouring on 4D ImageData; Routine StructureOperations; Duplicationof Structures and POIs	Routine Contouring;Advanced Contouring;Contouring on 4D ImageData; Routine StructureOperations: Duplicationof Structures and POIs	Routine Contouring:Advanced Contouring:Routine StructureOperations	Routine &Contouring Toolsand Contouring on4D Image Datahave beenimproved
PatientMarking	Transmission of POIs oftype isocenter to anexternal laser system	n/a	Transmission of POIs oftype isocenter to anexternal laser system	New feature in thesubject device butis similar to thesecondary one
AlignmentTools	Rigid Alignment andDeformable Alignment	Rigid Alignment andDeformable Alignment	Rigid Alignment	Rigid andDeformableAlignment toolshave beenimproved toprovide a betterworkflow
DoseEvaluation	Loading of any existingdose files: Addition orSubtraction of two dosefiles	n/a	n/a	new feature

Table 4 Differences and Similarities in Technical Characteristics

VII. Performance Data

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

This submission contains performance data to demonstrate 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. The modifications described in this Premarket Notification were supported with verification/validation testing.

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

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.

Non-Clinical Testing Summary

Performance tests were conducted to test the functionality of the syngo.via RT Image Suite. 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.

General Safety and Effectiveness Concerns:

The device labeling contains instructions for use and any necessary cautions and warnings to provide for safe and effective use of the device. Risk management is ensured via a hazard analysis, which is

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used to identify potential hazards. These potential hazards are controlled during development, verification and validation testing.

syngo.via RT Image Suite is designed to fulfill the requirements of the following safety and performance standards:

RecognitionNumber	ProductArea	Title of Standard	ReferenceNumber and Date	PublicationDate	StandardsDevelopmentOrganization
12-300	Radiology	Digital Imaging and Communications inMedicine (DICOM) Set	PS 3.1 - 3.20	06/27/2016	NEMA
N/A	Software	Medical device software - Software lifecycle processes	62304 First edition2006-05	08/20/2012	IEC
5-40	General	Medical devices – Application of riskmanagement to medical devices	14971 SecondEdition 2007-03-01	06/27/2016	ISO
5-85	General	Medical electrical equipment - Part 1-6:General requirements for basic safetyand essential performance - CollateralStandard: Usability	60601-1-6 Edition3.0	07/09/2014	IEC
N/A	General	Medical electrical equipment - Part 1-4:General requirements for safety -Collateral standard Programmableelectrical medical systems, Edition 1.1	60601-1-4:2000,Consol. Ed. 1.1	09/08/2009	IEC

In this subject device six scientific articles are used to support the marketing claims provided in the product brochure.

VIII. Conclusions

The predicate devices were cleared based on non-clinical supportive information. The subject device was tested using the same non-clinical methods. The subject device non-clinical data supports the safety of the software with verification and validation testing. Verification and Validation testing also demonstrates that syngo.via RT Image Suite performs as intended. The non-clinical test data demonstrates that syngo.via RT Image Suite device performance is comparable to the predicate devices that are currently marketed for the same intended use. Furthermore, for the subject device, syngo.via RT Image Suite, Siemens used the same testing with the same workflows as was used to clear the predicate devices. Since both devices were tested using the same methods. Siemens believes that the data generated from the syngo.via RT Image Suite testing supports a finding of substantial equivalence.

In summary, Siemens is of the opinion that the syngo.via RT Image Suite does not introduce any new potential safety risk and is substantially equivalent to and performs as well as the 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.