syngo.via MI Workflows are medical diagnostic applications for viewing, manipulation, 3D- visualization and comparison of medical images from multiple imaging modalities and/or multiple time-points. The application supports functional data, such as PET or SPECT as well as anatomical datasets, such as CT or MR.

syngo.via MI Workflows enable visualization of information that would otherwise have to be visually compared disjointedly. syngo.via MI Workflows provide analytical tools to help the user assess, and document changes in morphological or functional activity at diagnostic and therapy follow-up examinations. syngo.via MI Workflows can perform harmonization of SUV (PET) across different PET systems or different reconstruction methods.

syngo.via MI workflows support the interpretation of examinations and follow up documentation of findings within healthcare institutions, for example, in Radiology, Nuclear Medicine and Cardiology envirents.

Note: The clinician retains the ultimate responsibility for making the pertinent diagnosis based on their standard practices and visual comparison of the separate unregistered images. syngo.via MI Workflows are a complement to these standard procedures.

Device Description

The syngo.via MI Workflows are software only medical devices which will be delivered on CD-ROM / DVD to be installed onto the commercially available Siemens syngo.via software platform by trained service personnel.

syngo.via MI Workflows is a medical diagnostic application for viewing, manipulation, 3Dvisualization and comparison of medical images from multiple imaqinq modalities and/or multiple time-points. The application supports functional data, such as PET or SPECT as well as anatomical datasets, such as CT or MR. The images can be viewed in a number of output formats including MIP and volume rendering.

syngo.via MI Workflows enable visualization of information that would otherwise have to be visually compared disjointedly. synqo.via MI Workflows provide analytical tools to help the user assess, and document changes in morphological or functional activity at diagnostic and therapy follow-up examinations. They additionally support the interpretation and evaluation of examinations and follow up documentation of findings within healthcare institutions, for example, in Radiology (Oncology), Nuclear Medicine and Cardiology environments.

AI/ML Overview

The provided text primarily focuses on the submission of a 510(k) premarket notification for syngo.via MI Workflows VB30A and its substantial equivalence to a predicate device (syngo.via MI Workflows VB20). It outlines the device's intended use, technological characteristics, and compliance with various regulatory standards.

However, the document does not contain the detailed information necessary to fully answer all parts of your request regarding acceptance criteria and a specific study proving the device meets those criteria. The text mentions that "Verification and Validation activities have been successfully performed on the software package," and "All testing has met the predetermined acceptance values," but it does not provide specific numerical acceptance criteria, reported performance values, sample sizes, ground truth establishment, or details of any comparative effectiveness studies.

Therefore, I cannot populate all sections of the table or provide detailed answers to items 2-9.

Here's what can be extracted and what is missing:

1. Table of acceptance criteria and the reported device performance

Criteria Category	Acceptance Criteria	Reported Device Performance
Functional Design	Functions work as designed	Successfully performed
Performance Requirements	Performance requirements met	Successfully performed
Specifications Met	Specifications met	Successfully performed
Hazard Mitigation	All hazard mitigations fully implemented	Successfully performed
Predetermined Values	Predetermined acceptance values met	All testing met

Missing Information: Specific numerical or qualitative acceptance criteria for particular features (e.g., accuracy of 3D visualization, quantification precision, speed of processing) and the actual reported performance values are not detailed in this document.

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

Missing Information: The document states "Verification and Validation activities have been successfully performed," but does not provide any specifics about the sample size of the test set, the provenance of the data used for testing, or whether it was retrospective or prospective.

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)

Missing Information: This information is not present in the provided text.

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

Missing Information: This information is not present in the provided text.

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

Missing Information: The document outlines the device as a "medical diagnostic application for viewing, manipulation, 3D-visualization and comparison of medical images" and explicitly states it is a "complement to these standard procedures." It does not describe any MRMC comparative effectiveness study, nor does it provide any effect size for human reader improvement with or without AI assistance. The device is software for image manipulation and viewing, not an AI for interpretation in the sense of directly assisting reader decisions, but rather providing tools.

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

Missing Information: This document does not detail any standalone performance studies. The device is described as an application for viewing and manipulation, implying human interaction.

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

Missing Information: This information is not present in the provided text.

8. The sample size for the training set

Missing Information: The document describes the device as a software platform with new features added to a predicate device. It does not mention any "training set" in the context of machine learning, suggesting this is not a machine learning device that requires a training set in the typical sense.

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

Missing Information: As no training set is mentioned in the context of machine learning, there is no information on how its ground truth would be established.

Summary of what the document does convey:

The device (syngo.via MI Workflows VB30A) is a software-only medical device for medical image viewing, manipulation, 3D-visualization, and comparison from multiple modalities and time-points.
It is an updated version of a predicate device (syngo.via MI Workflows VB20) with new features in specific workflows (MM Oncology, MI Neurology, MI Cardiology, MI Reading / SPECT Processing).
It is intended to run on the Siemens syngo.via software platform.
Siemens claims substantial equivalence to the predicate device and states that "no changes that raise any new issues of safety and effectiveness."
Verification and validation activities were successfully performed, and all testing met predetermined acceptance values.
The device complies with various recognized industry standards (ISO 14971, IEC 62304, NEMA PS 3.1 - 3.20, IEC 62366, ISO 15223-1).

Summary

{0}------------------------------------------------

Image /page/0/Picture/0 description: The image shows the logos of the Department of Health and Human Services and the Food and Drug Administration (FDA). The Department of Health and Human Services logo is on the left, and the FDA logo is on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.

Siemens Medical Solutions USA, Inc. Veronica Padharia Regulatory Affairs Specialist 810 Innovation Drive Knoxville, Tennessee 37932

April 5, 2018

Re: K173897

Trade/Device Name: syngo.via MI Workflows Regulation Number: 21 CFR 21CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: Class II Product Code: LLZ Dated: December 21, 2017 Received: December 22, 2017

Dear Veronica Padharia:

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 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);

{1}------------------------------------------------

Page 2 - Veronica Padharia

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

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Michael D. O'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

{2}------------------------------------------------

Indications for Use

510(k) Number (if known)

K173897

Device Name syngo.via MI Workflows VB30A

Indications for Use (Describe)

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

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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

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

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

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

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

{3}------------------------------------------------

510(k) Summary

as required by 21 CFR Part 807.87(h)

Identification of the Submitter

	Primary Contact:	Alternate Contact:
Submitter:	Veronica PadhariaRegulatory Affairs SpecialistSiemens Medical SolutionsUSA, Inc.Molecular Imaging810 Innovation DriveKnoxville, TN 37932	Alaine MedioPET and PCS RegulatoryProjects ManagerSiemens Medical SolutionsUSA, Inc.Molecular Imaging810 Innovation DriveKnoxville, TN 37932
Telephone Number:	(630) 877 - 5761	(865) 218 - 2703
Fax Number:	(865) 218 - 3019	(865) 218 - 3019
Name / Address ofManufacturer	Siemens Medical Solutions USA, IncMolecular Imaging2501 N. Barrington RoadHoffman Estates, IL 60192USA
Date of Submission:	December 21st, 2017
Identification of the product
Device Proprietary Name:	syngo.via MI Workflows VB30A
Common Name:	Image Processing Software
Classification Name:	Picture Archiving and Communication System per 21 CFR892.2050
Product Code:	LLZ
Classification Panel:	Radiology
Device Class:	Class II

{4}------------------------------------------------

Marketed Devices to which Equivalence is claimed

Device	Manufacturer	510(k) Number
syngo.via MIWorkflows VB20	Siemens Medical Solutions USA, Inc	K163421 (January 2017)

Device Description

{5}------------------------------------------------

The modifications to the syngo.via MI Workflows (K163421) include the following new features:

Workflow	Workflow-specific Features	CommonFeatures
MM Oncology	Hybrid VRT/MIP display which allows the fusion ofanatomical VRT with functional MIPDeauville Evaluation scale for staging and assessingtreatment response in Hodgkin/non-Hodgkinlymphomas.Visualization and Quantification of Parametric PETdatasetsBariatric SUV provides quantification for bariatricpatientsTotal Activity for SPECT to indicate the amount ofactivity within a segmentation boundaryImprovements to already existent features / toolswithin the MM Oncology workflow.	DoD ATO(Authorization toOperate)Readiness
MI Neurology	Usability ImprovementsIntegrating the latest Scenium VE20 software (510kpending; K173597)
MI Cardiology	Updates to 3rd party software
MI Reading /SPECT Processing	Gastric Enhancement tools and fixes

{6}------------------------------------------------

Technological Characteristics

The syngo.via MI Workflows VB30A software modifications are based on the commercially available syngo.via MI Workflows VB20 software (K163421). The features introduced into syngo.via VB30A had no impact on the technological characteristics already present in the commercially available predicate system.

syngo.via MI Workflows is intended to be run on the Siemens syngo.via software platform (K150843) either alone or with other advanced commercially cleared applications.

Performance Testing / Safety and Effectiveness

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 has been ensured via risk analyses in compliance with ISO 14971 to identify and provide mitigation to potential hazards beginning early in the design cycle and continuing throughout the development of the product. Siemens Medical Solutions, USA Inc. adheres to recognized and established industry standards for development including EN ISO 13485 and IEC 62304.

Verification and Validation activities have been successfully performed on the software packaqe, including assurance that functions work as designed, performance requirements and specifications have been met, and that all hazard mitigations have been fully implemented. All testing has met the predetermined acceptance values. Traceability of the requirements specified in the requirement specifications and functional specifications is ensured during component integration, software validation and system testing.

The device is designed and manufactured in accordance with Quality System Requlations as outlined in 21 CFR 820. The FDA recognized standards are listed as follows:

Recognition Number 13-32: IEC 62304:2006
Recognition Number 13-79: IEC 62304 Edition 1.1 2015-06 ●
Recognition Number 12-300: NEMA PS 3.1 - 3.20 (2016)
o Recognition Number 5-70: AAMI ANSI ISO 14971:2007|(R)2010 (Corrected 4 October 2007)
Recognition Number 5-67: IEC 62366:2007/(R) 2013
Recognition Number 5-96: IEC 62366-1:2015
Recognition Number 5-118: AAMI ANSI ISO 15223-1:2016

Indications for Use

syngo.via MI Workflows are medical diaqnostic applications for viewing, manipulation, 3Dvisualization and comparison of medical images from multiple imaqinq modalities and/or multiple time-points. The application supports functional data, such as PET or SPECT as well as anatomical datasets, such as CT or MR.

{7}------------------------------------------------

syngo.via MI Workflows enable visualization of information that would otherwise have to be visually compared disiointedly. syngo.via MI Workflows provide analytical tools to help the user assess, and document changes in morphological or functional activity at diagnostic and therapy follow-up examinations. syngo.via MI Workflows can perform harmonization of SUV (PET) across different PET systems or different reconstruction methods.

syngo.via MI Workflows support the interpretation and evaluation of examinations and follow up documentation of findings within healthcare institutions, for example, in Radiology, Nuclear Medicine and Cardiology environments.

Note: The clinician retains the ultimate responsibility for making the pertinent diagnosis based on their standard practices and visual comparison of the separate unreqistered images. syngo.via MI Workflows are a complement to these standard procedures.

Statement Regarding Substantial Equivalence:

There are no differences in the Indications for Use or Fundamental Technological Characteristics of the synqo.via MI Workflows as compared to the currently commercially available software (K163421). Both devices are used for viewing, manipulation, 3Dvisualization and comparison of medical images from multiple imaqinq modalities and/or multiple time-points

Additionally, there have been no changes that raise any new issues of safety and effectiveness as compared to the predicate device. Based on this information, as well as the documentation in support of the modifications, it is Siemens opinion that the syngo.via MI Workflows software with the modifications outlined in this application is substantially equivalent to the predicate device.

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).