The software comprising the syngo.MR post-processing applications are postprocessing software / applications to be used for viewing and evaluating the designated images provided by a magnetic resonance diagnostic device. All of the software applications comprising the syngo.MR post-processing applications have their own indications for use.

syngo.MR Neurology is a syngo based post-processing software for viewing, manipulating, and evaluating MR neurological images.

syngo.MR Oncology is a syngo based post-processing software for viewing. manipulating, and evaluating MR oncological images.

syngo.mMR General is a syngo based post-processing software for viewing. manipulating, and evaluating MR, PET and MR-PET images.

syngo.MR BreVis is a software package intended for use in viewing and analyzing magnetic resonance imaging (MRI) studies. syngo.MR BreVis supports evaluation of dynamic MR data. Depending on the region of interest, contrast agents may or may not be used.

syngo.MR BreVis automatically registers serial patient motion to minimize the impact of patient motion and visualizes different enhancement characteristics in those areas that are within the scope of the indications for use of MRI FDA approved contrast agents (parametric image maps). Furthermore, it performs other user-defined postprocessing functions such as image subtractions, multiplanar reformats and maximum intensity projections. The resulting information can be displayed in a variety of formats. including a parametric image overlaid onto the source image, syngo.MR BreVis can also be used to provide measurements of the diameters, areas and volumes.

Furthermore syngo.MR BreVis can evaluate the uptake characteristics of segmented tissues that are within the scope of the indications for use of MRI FDA approved contrast agents. syngo.MR BreVis is optimized for viewing breast MR studies, and it also displays images from a number of other imaging modalities, like digitized mammographic images.

The images by other imaging modalities displayed with syngo.MR BreVis must not be used for primary diagnostic interpretation. syngo.MR BreVis also includes the option to add annotations based on the American College of Radiology's BI-RADS (Breast Imaging Reporting and Data System). When interpreted by a skilled physician, syngo.MR BreVis provides information that may be useful in diagnosis. Patient management decisions should not be made based solely on the results of syngo.MR BreVis analysis.

Device Description

syngo.MR Neurology, syngo.MR Oncology, syngo.MR BreVis and syngo.mMR General are post-processing software / applications to be used for viewing and evaluating MR images provided by a magnetic resonance diagnostic device, syngo.MR Neurology, syngo.MR Oncology, syngo.MR BreVis and synqo.mMR General are syngo.via-based software that enable structured evaluation of MR images.

AI/ML Overview

The provided text is a 510(k) summary for the syngo.MR post-processing software (Version SMRVA16B). This type of submission focuses on demonstrating "substantial equivalence" to a legally marketed predicate device rather than presenting an extensive study proving performance against specific acceptance criteria.

Therefore, the document does not contain the detailed information required to fully answer all points of your request, such as specific acceptance criteria for a new clinical study, the reported device performance against those criteria, sample sizes for test sets, number/qualifications of experts for ground truth, adjudication methods, MRMC studies, standalone performance details, training set information, or how ground truth for training was established.

Instead, the submission argues that the new device has "same technological characteristics and functionalities as the predicate device, and do not introduce any new issues of safety or effectiveness." The "study" here is essentially a comparison to the predicate device.

However, I can extract the following based on the available information:

1. Table of Acceptance Criteria and Reported Device Performance:

This information is not provided in the document as a new clinical study with specific acceptance criteria was not conducted for this 510(k) submission. The entire submission is built on the premise of substantial equivalence to a predicate device.

2. Sample size used for the test set and the data provenance:

Sample Size for Test Set: Not applicable. No new clinical test set was used to establish performance against new acceptance criteria. The submission relies on the predicate device's clearance.
Data Provenance: Not applicable.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not applicable. Ground truth for a new test set was not established for this submission.

4. Adjudication method for the test set:

Not applicable.

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:

No MRMC comparative effectiveness study was done for this submission. The device is a post-processing software, not specifically an AI-driven diagnostic aid in the context of an MRMC study to compare reader performance with and without AI assistance.

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

Not explicitly stated as a standalone performance study with specific metrics. The software's functionality is described as "post-processing software for viewing, manipulating, and evaluating" images, implying it's a tool for human readers rather than making independent diagnostic decisions. The document states, "Patient management decisions should not be made based solely on the results of syngo.MR BreVis analysis."

7. The type of ground truth used:

Not applicable for a new study. The safety and effectiveness are based on demonstrating substantial equivalence to a previously cleared device. For the predicate device, the regulatory clearance would have been based on appropriate clinical data and ground truth (which could be expert consensus, pathology, or outcomes data depending on the device).

8. The sample size for the training set:

Not applicable. This document describes a 510(k) submission for new versions/modules of existing software, relying on substantial equivalence, not a de novo clearance requiring a new AI model with a training set.

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

Not applicable.

Explanation of the "Study" and "Acceptance Criteria" in this Context:

In a 510(k) submission based on "substantial equivalence," the "study" is less about generating new performance data against novel acceptance criteria and more about demonstrating that the new device is as safe and effective as a legally marketed predicate device.

The "acceptance criteria" here implicitly refer to the regulatory standards and performance of the predicate device, K130749 (syngo.MR Post-Processing Software Version SMRVA16A), which was cleared on August 20, 2013. The manufacturer's claim is that the updated software "do not raise new questions of safety or effectiveness" and has "same technological characteristics and functionalities as the predicate device" despite having "greater capabilities."

Therefore, the "proof" the device meets acceptance criteria is the argument that it is substantially equivalent to a device that has already met the FDA's safety and effectiveness requirements.

Summary

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K133401
Page 1 of 6

SEEMENS

Traditional 510(k) Submission / Bundling 510(k) for: syngo.MR Post-Processing Software (Version SMRVA16B)

510(k) Summary: syngo.MR Neurology, syngo.MR Oncology, syngo.MR BreVis and syngo.mMR General

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

Date of Summary Preparation: November 5, 2013

l. General Information

Importer / DistributorRegistration Number:	Siemens Medical Solutions USA, Inc.51 Valley Stream PkwyMail Code D02Malvern, PA 19355, USA2240869
Manufacturer	Siemens AGMedical SolutionsHenkestrasse 127D-91052 Erlangen, Germany
Registration Number:	3002808157
Contact Person	Nadia SookdeoRegulatory Affairs Technical SpecialistSiemens Medical Solutions USA, Inc.51 Valley Stream PkwyMail Code D02Malvern, PA 19355, USAPhone: (610) 448-4918Fax: (610) 448-1787Email: nadia.sookdeo@siemens.com

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SEMENS

Traditional 510(k) Submission / Bundling 510(k) for:
syngo.MR Post-Processing Software (Version SMRVA16B)

Device Name and Classification
Data	Details
Trade name /Device ProprietaryName:	syngo.MR Neurology
	syngo.MR Neurology covers single and engine applications:• syngo.MR Neuro Perfusion• syngo.MR Neuro Perfusion Mismatch• syngo.MR Neuro fMRI• syngo.MR Tractography• syngo.MR Neuro Perfusion Engine• syngo. MR Neuro 3D Engine
	syngo.MR Oncology
	syngo.MR Oncology covers single and engine applications:• syngo.MR Onco• syngo.MR 3D Lesion Segmentation• syngo.MR Tissue4D• syngo.MR Onco Engine
	syngo.MR BreVis
	syngo.MR BreVis is available as single application.
	syngo.mMR General
	syngo.mMR General is available as singleapplication.
ClassificationName:	Regulation Description:Picture Archiving and Communication System (PACS)
ClassificationPanel:	Radiology
DeviceClassification:	Class II devices
Regulation number:	21 CFR § 892.2050
Product Code:	Primary: LLZ, Secondary: LNH

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Image /page/2/Picture/0 description: The image shows the word "SOUVENIRS" in a stylized font. The letters are large and bold, and they appear to be slightly distressed or textured. The word is the main focus of the image, and it is likely used to indicate a place where souvenirs are sold.

SIKENS S S S S S Staditions Story Software (Version Software (Version SMR) Story (Version SMR) Ander (Version SMR) Ander

II. Safety and Effectiveness Information Supporting Substantial Equivalence

Intended Use

syngo.MR Neurology is a syngo based post-processing software for viewing, manipulating, and evaluating MR neurological images.

syngo.MR Oncology is a syngo based post-processing software for viewing. manipulating, and evaluating MR oncological images.

syngo.mMR General is a syngo based post-processing software for viewing. manipulating, and evaluating MR, PET and MR-PET images.

Device Description

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SIEMENS

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syngo.MR Neurology, syngo.MR Oncology, syngo.MR BreVis and syngo.mMR General comprise the following (please refer to Table 1).

Table 1: syngo.MR General, syngo.MR Cardiology and syngo.MR Vascular and their content

Medical device /post-processingapplication	covered single and engines applications
syngo.MR Neurology	syngo.MR Neuro Perfusionallows the visualization of temporal variations in the dynamicsusceptibility time series of MR datasets.
	syngo.MR Neuro Perfusion Mismatchcalculates the difference between the DWI lesion (diffusionROI) and the PWI lesion (perfusion ROI) areas.
	syngo.MR Neuro fMRIis a workflow-oriented visualization package for BOLD fMRI. Itenables the visualization of task-related areas of activationoverlaid onto 2D or 3D anatomical datasets, providing thespatial correspondence of BOLD results.
	syngo.MR Tractography (NEW)allows assessment of central nervous system structuresthrough utilitzing 3D tractographic data derived from DiffusionTensor Imaging.
	syngo.MR Neuro Perfusion EngineContains:- syngo.MR Neuro Perfusion- syngo.MR Neuro Perfusion Mismatch
	syngo.MR Neuro 3D EngineContains:- syngo.MR Neuro fMRI- syngo.MR Tractography
syngo.MR Oncology	syngo.MR Oncois a image viewing, processing and reading software thatallows for oncological MR image evaluation in a structuredway.
	syngo.MR 3D Lesion Segmentationprovides convenient volumetric evaluation of lesions and/orother structure of interest as well as a particularly useful toolfor oncology applications

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SIEMENS

Traditional 510(k) Submission / Bundling 510(k) for: syngo.MR Post-Processing Software (Version SMRVA16B)

Medical device /post-processingapplication	covered single and engines applications
application
	syngo.MR Tissue4D (NEW)is a postprocessing workflow which supports the physician inthe reading of dynamic contrast-enhanced MR data sets.
	syngo.MR Onco Engine
	contains:
	- syngo.MR Onco- syngo.MR 3D Lesion Segmentation
syngo.MR BreVis	syngo.MR BreVis (NEW)is a software package intended for use in viewing andanalyzing magnetic resonance imaging (MRI) studies.
syngo.mMRGeneral	syngo.mMR General (NEW)is a syngo based post-processing software for viewing,manipulating and evaluating MR, PET and MR-PET images.

General Safety and Effectiveness Concerns

Instructions for use are included within the device labeling, and the information provided will enable the user to operate the device in a safe and effective manner.

Product risk management is accomplished through a process in compliance with ISO 14971:2009 to identify and provide mitigation to potential hazards in a risk analysis beginning early in the design phase and continuing throughout the development of the product. These risks are controlled via measures realized in software development. SW testing and product labeling. To minimize risks, Siemens adheres to recognized and established industry practices and standards. Furthermore, the operators are healthcare professionals familiar with and responsible for the evaluating and post-processing of magnetic resonance images.

syngo.MR Neurology, syngo.MR Oncology, syngo.MR BreVis and syngo.mMR General conform to the applicable FDA recognized and international IEC, ISO and NEMA standards with regards to performance and safety as recommended by the respective MR FDA Guidance Document.

Substantial Equivalence

syngo.MR Neurology, syngo.MR Oncology, syngo.MR BreVis and syngo.mMR General are substantially equivalent to the following current legally marketed devices (please refer to Table 2):

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K133401
Page 6 of 6

SERVENS

Traditional 510(k) Submission / Bundling 510(k) for: Traditional STOR) Submission / Bunding 310(x) 16.
Syngo.MR Post-Processing Software (Version SMRVA16B)

Predicate devices for syngo.MR Neurology, syngo.MR Oncology, syngo.MR Table 2: BreVis and syngo.mMR General

Predicate Device Name	FDAClearanceNumber	FDA ClearanceDate	Product Code
syngo.MR Post-ProcessingSoftware Version SMRVA16A	K130749	August 20, 2013	LLZLNH

Conclusion as to Substantial Equivalence

The syngo.MR post-processing applications are intended for similar indications as cleared in the predicate devices, as previously noted.

In summary, Siemens is of the opinion that the syngo.MR post-processing applications do not raise new questions of safety or effectiveness and are substantially equivalent to the currently marketed device syngo.MR Post-Processing Software Version SMRVA16A (K130749 cleared on August 20, 2013).

There are minor changes to the indications for use for the subject devices, compared to that of the predicate device syngo.MR Post-Processing Software Version SMRVA16A. The differences between the subject devices and the predicate device include the aforementioned improved changes, adaption to the updated syngo.via basis platform and other enhancements. The differences give the device greater capabilities than the predicate device, but have same technological characteristics and functionalities as the predicate device, and do not introduce any new issues of safety or effectiveness.

Therefore, Siemens believes that the subject devices, the syngo.MR post-processing applications, are substantially equivalent to the predicate device listed above.

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Image /page/6/Picture/0 description: The image shows the logo for the Department of Health & Human Services USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is an abstract image of an eagle.

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

March 11, 2014

Siemens Medical Solutions USA, Inc. % Ms. Nadia Sookdeo Regulatory Affairs Technical Specialist 51 Valley Stream Parkway MALVERN PA 19355

Re: K133401

Trade/Device Name: syngo.MR Neurology, syngo.MR Oncology, syngo.MR BreVis, syngo.mMR General Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: Il Product Code: LLZ, LNH Dated: February 12, 2014 Received: February 18, 2014

Dear Ms. Sookdeo:

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 (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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

Page 2-Ms. Sookdeo

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

http://www.lda.gov/MedicalDevices/ResourcesforYou/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/McdicalDevices/Safety/ReportaProblem/dcfault.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.goy/MedicalDevices/ResourcesforYou/Industry/default.hum.

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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510{k} Number (if known)

K133401

Device Name

syngo.MR Neurology, syngo.MR Oncology, syngo.MR BreVis and syngo.mMR General

Indications for Use (Describe)

The software comprising the syngo.MR post-processing applications are post-processing software to be used for viewing and evaluating the designated images provided by a magnetic resonance diagnostic device. All of the software applications comprising the syngo.MR post-processing applications have their own indications for use.

syngo.MR Neurology is a syngo based post-processing software for viewing, and evaluating MR neurological images.

syngo.MR Oncology is a syngo based post-processing software for viewing, and evaluating MR oncological images.

syngo.mMR General is a syngo based post-processing software for viewing, manipulating MR, PET and MR-PET images.

syngo.MR BreVis is a software package intended for use in viewing and analyzing magnetic resonance imaging (MR) studies. syngo.MR BreVis supports evaluation of dynamic MR data. Depending on the region of interest, contrast agents may or may not be used.

syngo.MR BreVis automatically registers serial patient motion to minimize the impact of patient motion and visualizes different enhancement characteristics in those areas that are within the scope of the indications for use of MRI FDA approved contrast agents (parametric image maps). Furthermore, it performs other user-defined post-processing functions, multiplanar reformats and maximum intensity projections. The resulting information can be displayed in a variety of formats, including a parametric image overlaid onlo the source image. syngo.MR BreVis can also be used to provide measurements of the diameters, areas and volumes.

Furthermore syngo.MR BreVis can evaluate the uplake characteristics of segmented tissues that are within the scope of the indications for use of MRI FDA approved contrast agents. syngo.MR BreVis is oplimized for viewing breast MR studies, and it also displays images from a number of other imaging modalities, like digitized mammographic images.

The images by other imaging modalities displayed with syngo.MR BreVis must not be used for primary diagnostic interpretation. syngo.MR BreVis also includes the option to add annotations based on the American College of Radiology's Bl+RADS (Breast Imaging Reporting and Data System). When interpreted by a skilled physician, syngo.MR BreVis provides information that may be useful in diagnosis. Patient management decisions should not be made based solely on the results of syngo.MR BreVis analysis.

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)

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

Mechal D. O'Hara

FORM FDA 3881 (9/13)

PSK' Publishing New York (101) 443-6741 EF

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).