syngo.via MI Workflows are medical diagnostic applications for viewing, manipulation, 3Dvisualization 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 data sets. 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 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 followup 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 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 are medical diagnostic applications for viewing, manipulation, 3Dvisualization 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. 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. 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. 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.

The modifications to the syngo.via MI Workflows (K123577) is adding a new feature allowing the physician to harmonize SUV data based on a standard reference value, allowing comparison of scans acquired over multiple timepoints or using different scan parameters or equipment. This change is based on current commercially available software features and does not change the technological characteristics of the device.

syngo via MI Workflows are intended to be run on the Siemens syngo.via software platform (K123375) either alone or with other advanced commercially cleared applications.

AI/ML Overview

The provided text (K133644, Siemens Medical Solutions USA, Inc., syngo.via MI Workflows) is a 510(k) summary and FDA clearance letter, which describes the device and its intended use but** does not contain information about acceptance criteria, specific studies, or performance metrics in the way requested.**

The document states that the modification to the previously cleared syngo.via MI Workflows (K123577) is "adding a new feature allowing the physician to harmonize SUV data based on a standard reference value, allowing comparison of scans acquired over multiple timepoints or using different scan parameters or equipment." It also notes that this change "does not change the technological characteristics of the device" and that "no changes that raise any new issues of safety and effectiveness as compared to the predicate device."

Therefore, based solely on the provided text, I cannot complete the table or answer most of the questions relating to specific acceptance criteria, study details, and performance results.

However, I can extract information related to the device and its general validation:

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

Acceptance Criteria	Reported Device Performance
Specific performance metrics for SUV harmonization	Not provided in the document. The document states that "Verification and Validation activities have been successfully performed on the software package, including assurance that functions work as designed and that all hazard mitigations have been fully implemented." However, no quantitative performance metrics for the SUV harmonization feature are presented.
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 14971:2012... Siemens Medical Solutions, USA Inc. adheres to recognized and established industry standards for development including ISO 13485 and IEC 62304."
No new issues of safety and effectiveness compared to predicate device	"There are no differences in the Fundamental Technological Characteristics of the syngo.via MI Workflows as compared to the currently commercially available software (K123577). Additionally, there have been no changes that raise any new issues of safety and effectiveness as compared to the predicate device."

No specific study is described in detail within these documents. The information provided discusses verification and validation activities generally, but not a specific clinical or performance study with defined acceptance criteria and performance results directly linked to the SUV harmonization feature.

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

Not provided. The document states "Verification and Validation activities have been successfully performed" but does not detail sample sizes, data provenance, or whether the testing 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)

Not provided.

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

Not provided.

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

Not provided. The document focuses on the software's functional capabilities (SUV harmonization) and its substantial equivalence, not on comparative effectiveness studies involving human readers.

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

Given the nature of the device as "Image Processing Software" that "provide analytical tools to help the user assess, and document changes," it is inherently a human-in-the-loop device. No standalone performance metrics are provided or implied for automated decision-making without a clinician. The "Note" in the Indications for Use explicitly states: "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."

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

Not provided. The document does not describe the specific ground truth methodologies used for its "Verification and Validation activities."

8. The sample size for the training set

Not provided. The document describes a software modification to an existing product and does not indicate details about machine learning model training.

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

Not applicable / Not provided. As no training set details are mentioned, the method for establishing its ground truth is also not provided.

Summary

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K133644
Page 1 of 3

. ..

510(k) Summary

as required by 21 CFR Part 807.87(h)

FEB 2 5 2014

« «

Identification of the Submitter

Submitter:	M. Alaine Medio, RACPET and PCS Regulatory Projects ManagerSiemens Medical Solutions USA, Inc.Molecular Imaging810 Innovation DriveKnoxville, TN 37932
Telephone Number:	(865)218-2703
Fax Number:	(865)218-3019
Name / Address of Manufacturer	Siemens Medical Solutions USA, IncMolecular Imaging2501 N. Barrington RoadHoffman Estates, IL 60192USA
Date of Submission:	November 25, 2013
Identification of the product
Device Proprietary Name:	syngo.via MI Workflows
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

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Marketed Devices to which Equivalence is claimed

Device	Manufacturer	510(k) Number
syngo.via MIWorkflows	Siemens Medical Solutions USA, Inc	K123577 (January 22, 2013)

Device Description:

syngo. via MI Workflows are medical diagnostic applications for viewing, manipulation, 3Dvisualization 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. The images can be viewed in a number of output formats including MIP and volume rendering.

syngo via MI Workflows are intended to be run on the Siemens syngo.via software platform (K123375) either alone or with other advanced commercially cleared applications.

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 14971:2012 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 ISO 13485 and IEC 62304.

Verification and Validation activities have been successfully performed on the software package, including assurance that functions work as designed and that all hazard mitigations have been fully implemented.

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K133644
Page 3 of 3

Indications for Use:

syngo.via MI Workflows are medical diagnostic applications for viewing, manipulation, 3Dvisualization 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 M1 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 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 unregistered images. syngo. via MI Workflows are a complement to these standard procedures.

Conclusions:

There are no differences in the Fundamental Technological Characteristics of the syngo.via MI Workflows as compared to the currently commercially available software (K123577). 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.

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Image /page/3/Picture/0 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three stripes forming its body and wings. The eagle is enclosed in a circle of text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES USA".

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

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

February 25, 2014

Siemens Medical Solutions USA, Inc. % Alaine Medio, RAC PET and PCS Regulatory Projects Manager 810 Innovation Drive KNOXVILLE TN 37932-2571

Re: K133644

Trade/Device Name: syngo.via MI Workflows Regulation Number: 21 CFR 892.2050 Regulation Name: Picture Archiving and Communications System Regulatory Class: II Product Code: 1.L.Z Dated: November 26, 2013 Received: November 27. 2013

Dear Ms. Medio:

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. Iisting 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 (2) CFR Part 820); and if applicable, the electronic form in and quinn control provisions (Sections 531-542 of the Act): 21 CFR 1000-1050.

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Page 2-Ms. Medio

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

hup://www.fda.gov/MedicalDevices/Resources/or You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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/deliault.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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industrv/default.htm.

Sincerely yours,

Michael D. O'Hara

for

Janine M. Morris 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): K133644

Device Name: syngo.via MI Workflows

Indications for Use:

Prescription Use x (Part 21 CFR 801 Subpart D) AND/OR

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

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)

Richard D. O'Hara

(Division Sign-Off Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health

રે । O(k) K133644

Page 1 of 1

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).