syngo TrueD is a medical diagnostic application 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. The images can be viewed in a number of output formats including MIP and volume rendering.

syngo TrueD enables visualization of information that would otherwise have to be visually compared disjointedly. syngo TrueD provides analytical tools to help the user assess, and document changes in morphological or functional activity at diagnostic and therapy follow-up examinations.

syngo TrueD is designed to support the oncological workflow by helping the user to confirm the absence or presence of lesions, including evaluation, quantification, follow-up and documentation of any such lesions. The application allows to store and export volume of interest (VOI) structures in DICOM RT format for use in radiation therapy planning systems.

syngo TrueD allows visualization and analysis of respiratory gated studies to support accurate delineation of the farget or treatment volume over a defined phase of the respiratory cycle and thus provide information for radiation therapy planning.

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 TrueD is a complement to these standard procedures.

Device Description

syngo TrueD allows visualization and analysis of respiratory gated studies to support accurate delineation of the target or treatment volume over a defined phase of the respiratory cycle and thus provide information for radiation therapy planning.

TrueD will be marketed as a software only solution for the end-user (with recommended hardware requirements) .It will be installed by Siemens service engineers. The TrueD described supports DICOM formatted images and information. It is based on the Windows XP operating system.

AI/ML Overview

The provided 510(k) summary for syngo™ TrueD Software (K101749) describes an update to an existing medical image viewing and analysis software. However, it does not contain acceptance criteria for specific device performance metrics or a detailed study proving the device meets such criteria.

The document primarily focuses on demonstrating substantial equivalence to a predicate device (TrueD VC60A, K091373) by describing new features and stating that these new functionalities do not introduce unmitigated risks or functionality that would affect its safe and effective use. The "Safety Information / Nonclinical Testing" section refers to software validation but does not provide specific performance outcomes.

Therefore, many of the requested details cannot be extracted from this document. I will highlight what information is present and explicitly state what is missing.

Description of Acceptance Criteria and Study to Prove Device Meets Acceptance Criteria

1. Table of Acceptance Criteria and Reported Device Performance

Feature/Metric	Acceptance Criteria	Reported Device Performance
General Device Performance	Not explicitly stated as quantifiable performance metrics for new features. The overarching "acceptance criteria" is that the new functionalities do not introduce additional unmitigated risk or affect safe and effective use compared to the predicate device.	The submission asserts that the new features (dynamic PET support, multi-bed respiratory gated data, PERCIST workflow) are fully validated and technically equivalent or extensions of previously cleared technology. No specific quantitative performance data is provided in this summary.
Risk Management	Compliance with ISO 14971:2007 (Medical Devices Application of risk management to medical devices).	Hazard analysis and validation completed, indicating the device is of "minor level of concern."
DICOM Compliance	Compliance with DICOM Standard:2003.	Nonclinical testing completed in compliance with DICOM Standard:2003.
Software Validation	The software design description, hazard analysis, validation testing, and technical and safety information were summarized and attached to the submission (not provided in this excerpt).	Results of hazard analysis and validation, combined with preventive measures, indicate the device is of minor level of concern.

2. Sample Size Used for the Test Set and Data Provenance

Sample Size for Test Set: Not specified in this document.
Data Provenance: Not specified in this document. The document refers to "validation testing" but provides no details about the datasets used.

3. Number of Experts Used to Establish Ground Truth and Qualifications of Experts

Number of Experts: Not specified.
Qualifications of Experts: Not specified.
The document states: "The output of the device is evaluated by trained professionals allowing sufficient review for identification and intervention in the event of a malfunction." and "The clinician retains the ultimate responsibility for making the pertinent diagnosis based on their standard practices and visual comparison of the separate unregistered images." This implies physician involvement in interpreting results but does not describe their role in establishing ground truth for testing.

4. Adjudication Method for the Test Set

Not specified.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

Was a MRMC study done? This document does not mention an MRMC comparative effectiveness study. The focus is on demonstrating technical equivalence and safety rather than comparative clinical effectiveness with human readers.
Effect Size: Not applicable, as no MRMC study is reported.

6. Standalone (i.e., algorithm only without human-in-the-loop performance) Study

Was a standalone study done? This document describes a "software only solution" and mentions "validation testing." However, it does not provide details about a standalone performance study with specific metrics like sensitivity, specificity, or accuracy for the new features (e.g., PERCIST quantification, lesion detection). The device is positioned as an "analytical tool to help the user" and a "complement to standard procedures," suggesting it's intended for human-in-the-loop use.

7. Type of Ground Truth Used

Not specified. Given the nature of the device as an image viewing and analysis tool for oncology, potential ground truths could include expert consensus, pathology, or clinical outcomes, but the document does not elaborate on how ground truth was established for any validation activities.

8. Sample Size for the Training Set

Not applicable. This is a software update to an existing device (syngo TrueD), and the features described appear to be based on algorithmic implementations of established clinical criteria (e.g., PERCIST) and technical extensions for handling image data types, rather than a learning algorithm that requires a "training set" in the context of machine learning. The document describes "validation testing" but not "training."

9. How the Ground Truth for the Training Set Was Established

Not applicable, as no training set for a learning algorithm is mentioned.

Summary

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510(k) Summary

AUG 1 6 2010

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

Date Prepared; May 20th, 2010

General Information

Manufacturer Facility (Developer/manufacturer) Siemens Medical Solutions USA, Inc. 20 Valley Stream Pkwy Malvern, PA 19355 Establishment Registration Number: 3002329443

Contact Person

James E. Kuhn Jr. Senior Regulatory Submissions Manager Phone: (610) 448-3006 Fax: (610) 448-4274

Device Name and Classification

Trade Name: Classification Name: CFR Section: Device Class: Product Code:

syngo™ TrueD Software Picture Archiving and Communications System 21 CFR §892.2050 Class II LLZ

Safety and Effectiveness Information Supporting the Substantial Equivalence Determination

Device Description and Intended Use

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Technological Characteristics

Safety Information / Nonclinical Testing

The following nonclinical testing has been completed in compliance to the following;

· DICOM (Digital Imaging and Communications in Medicine) Standard:2003 Developed by the American College of Radiology and the National Electrical Manufacturers Association. Specifies the format for the communication of digital images between individual devices and over networks.
· ISO 14971:2007 Medical Devices Application of risk management to medical devices

A summary of the software design description, hazard analysis, validation testing, and technical and safety information can be found in the attached submission. The results of the hazard analysis and validation, combined with the appropriate preventive measures taken indicate the device is of minor level of concern, as per Guidance for the Content of Premarket Submission for Software Contained in Medical Devices, May 2005

The device has no patient contacting materials and is utilized only by trained professionals. The output of the device is evaluated by trained professionals allowing sufficient review for identification and intervention in the event of a malfunction. Device output and analysis is used to indicate the appropriateness of a referral. The device does not impact the quality or status of the original acquired data.

Substantial Equivalence:

The syngo TrueD Software is substantially equivalent, both in intended use and technically, to the following device:

#	New Feature	Comparison	Predicate
1	Support Dynamic PET dataFeatures:- Dynamic PET in oneof the three time-points- Rotating MIP of atimeslice in dynamicstudy	The new version is extending thefunctionality of syngo TrueD fromloading static as well as respiratorygated PET data to loading dynamicPET data.Dynamic PET data are technicallyequivalent to static PET data with theonly difference that dynamic PETdatasets consist of multiple time-slices,	TrueD VC60AK091373
	Cine of dynamic PETstudiesCopy VOI to anothertime-slice of thesame dynamic dataDisplay dynamicdata informationTime activity curvefor dynamic studiesAdd time activitytable and table datato report	which is similar to respiratory gatedPET studies which have been clearedin TrueD (K071950)Similar to static and respiratory-gatedPET, TrueD can perform a rotating MIPfor each time-slice.Similar to respiratory-gated PET data,TrueD can perform cine for dynamicPET data.Similar to creating VOIs in onerespiratory gate and copying VOIsacross respiratory gates, TrueD allowscreating VOIs in one time-slice andcopying to other time-slices.This new feature has been fullyvalidated and adds no additionalunmitigated risk or functionality thatwould affect the safe and effective useof this device in comparison to itspredicate
2	Respiratory gated datawith multiple bedpositions.	The VE10A version of TrueD isextended to allow respiratory gatedstudies with multiple bed positions tobe loaded into the application, ratherthan single bed positions as in TrueDVC60A (K091373).The respiratory gating functionalityremains otherwise unchanged.	TrueD VC60AK091373
3	Enabling PERCISTworkflow:Features:- Peak sphere- Peak spherediameter- Provide SUV peakquantification- Peak value- PERCIST ReferenceVOI- PERCIST threshold- Peak trending- Highest peaktrending	TrueD VE10A is extending the volumeof interest (VOI) quantificationfunctionality previously cleared inK091373 by enabling the user to applythe PERCIST (PET Response Criteriain Solid Tumors). The interpretation ofthe quantification results according tothe PERCIST criteria remains theresponsibility of the physician.The peak sphere is a 3D sphere VOIwhich is placed inside a larger 3D VOIat the location of the highest averageSUV value in the VOI which is calledthe 'peak SUV value'. This is anextension to previously clearedtechnology where TrueD is searchingfor the highest SUV value in a VOI.	TrueD VC60AK091373

	For each peak sphere, the applicationdisplays a peak sphere diameter whichis technically the same as a spherediameter.
	The application is extended to allowusers to create PERCIST referenceVOIs in the liver or blood pool: a 3 cmspherical ROI (VOI) should bemanually placed by the user in thenormal right lobe of the liver (if the liveris abnormal a 1 cm diameter ROIshould be positioned in the descendingthoracic aorta extending 2 cm along z-axis). The VOI technology used forPERCIST reference VOIs is equivalentto existing VOIs in TrueD.
	In addition to the usual quantificationparameters, the PERCIST ReferenceVOIs provide a PERCIST thresholdvalue which is calculated based on adefined mathematical formula which isprovided to the user in the userdocumentation of the application.
	The application provides peakquantification trending in the samemanner as for other quantificationparameters.
	The trending is extended to allow usersto see trending values between thehighest values for each time point forPeak, which may not be the samelesions in each time-point.

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Summary

In summary, Siemens is of the opinion that the indicated changes to the syngo TrueD software, as described within this submission does not introduce any new potential safety risks and is substantially equivalent to and performs as well as the predicate device.

REV B

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Image /page/4/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three bars representing its wings. The eagle is positioned to the right of the text, which is arranged in a circular pattern around the logo. The text 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 Room - WO66-G609 Silver Spring, MD 20993-0002

Siemens Medical Solutions USA, Inc. % Mr. Casey Conry Senior Project Engineer Underwriters Laboratories, Inc. 1285 Walt Whitman Rd. MELVILLE NY 11747

AUG 1 6 2010

Re: K101749

Trade/Device Name: syngo™ TrueD Regulation Number: 21 CFR 892.5050 Regulation Name: Medical charged-particle radiation therapy system Regulatory Class: II Product Code: LLZ Dated: July 29, 2010 Received: August 2, 2010

Dear Mr. Conry:

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.

If your device is classified (see above) into class II (Special Controls), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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 or mry reith all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); medical device reporting (reporting of

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medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Parts 801 and 809), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. 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 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/cdrh/industry/support/index.html.

Sincerely yours,

Donald J. Trump

Donald J. St.Pierre Acting Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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Indications for Use Form

510(k) Number (if known): K101749

Device Name: Syngo™ TrueD

Indications for Use:

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

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

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

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) K101749

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).