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 target 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 Truen in a complement to these standard procedures.

Device Description

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 (VOD structures in DICOM RT format for use in radiation therapy planning systems.

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

This 510(k) summary primarily focuses on the substantial equivalence of the "syngo™ TrueD Software" to existing predicate devices, rather than providing detailed acceptance criteria and a specific study demonstrating performance against those criteria. It's a submission for a software device used for image viewing, manipulation, and 3D visualization, targeting applications in oncology and radiation therapy planning.

Based on the provided text, the following information can be extracted:

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not specify quantitative acceptance criteria or report specific performance metrics for the syngo™ TrueD Software that would typically be found in a performance study (e.g., sensitivity, specificity, accuracy for a diagnostic task). The submission emphasizes substantial equivalence to predicate devices for its intended use and technical characteristics.

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

The document does not mention a specific test set, its sample size, or data provenance (e.g., country of origin, retrospective/prospective). This type of information is usually associated with performance studies assessing diagnostic accuracy or similar metrics.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:

The document does not describe any specific ground truth establishment process for a test set, nor does it mention the number or qualifications of experts involved.

4. Adjudication Method for the Test Set:

No adjudication method is mentioned as there is no described test set or ground truth establishment process.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:

No MRMC comparative effectiveness study is mentioned. The document primarily argues for substantial equivalence based on intended use and technological characteristics compared to predicate devices. The final "Note" 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 TrueD in a complement to these standard procedures." This suggests the device is an assistive tool and not designed to replace human interpretation in diagnostic decision-making, which is often the focus of MRMC studies.

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

The document does not describe a standalone performance study. The device is presented as an image viewing and manipulation tool to support clinicians.

7. The Type of Ground Truth Used:

No specific ground truth type is mentioned as no performance study with a defined test set is described.

8. The Sample Size for the Training Set:

The document does not mention any training set or its sample size. This suggests the device may not heavily rely on machine learning models that require extensive training data in the same way as some contemporary AI diagnostics. Its function is primarily visualization and analysis, with tools to help users assess changes.

9. How the Ground Truth for the Training Set was Established:

Not applicable, as no training set is mentioned.

Summary of what the document does provide regarding "proof":

The document argues for the device's substantial equivalence to existing legally marketed predicate devices, rather than providing direct "proof" of meeting novel acceptance criteria through a performance study. It emphasizes:

Identical Intended Use: The device's intended use is described as viewing, manipulation, 3D visualization, and comparison of medical images, similar to the functions of its predicate devices. It supports oncology workflows (lesion evaluation, quantification, follow-up, documentation) and radiation therapy planning (visualization/analysis of respiratory gated studies).
Similar Technological Characteristics: It is a software-only solution, supports DICOM images, and runs on Windows XP, implying comparable technology to its predicates.
Safety Information: A hazard analysis was conducted, and appropriate preventive measures were taken, resulting in a determination of "minor level of concern." It highlights that the device has no patient-contacting materials, is used by trained professionals, and device output is subject to review by these professionals. It also states the device "does not impact the quality or status of the original acquired data."

Conclusion:

This 510(k) submission for syngo™ TrueD software in 2009 is a premarket notification for substantial equivalence. It does not include a detailed study with quantitative acceptance criteria and performance data like those commonly seen for AI/ML diagnostic algorithms today. Instead, its "proof" is centered on demonstrating that it is as safe and effective as, and performs as well as, already legally marketed predicate devices with similar intended uses and technological features.

Summary

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510(k) Summary

KD91373

MAY 20 2009

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: March 30th, 2009

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

ﺔ ﺍﻟﻤﺴﺘﻘﻠﺔ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟ

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Technological Characteristics

Safety Information

A summary of the software design description, hazard analysis, and technical and safety information can be found in the attached submission. The results of the hazard analysis, 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 devices:

Predicate Device Name	'DA Clearance Number
TrueD	K071950
GE PET VCAR	K063324
MiMVista (Mim Contouring)	K071964
GE Advantage 4D Option	K032915
Siemens syngo Circulation	K063762

In summary, Siemens is of the opinion that the indicated change 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/2/Picture/0 description: The image shows a circular logo for the Department of Health & Human Services - USA. The logo features a stylized eagle or bird-like symbol with three curved lines representing its wings or body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" is arranged around the upper half of the circle, following its curvature. The logo is black and white and appears to be a scanned or printed image.

DEPARTMENT OF HEALTH & HUMAN SERVICES

20 2009 MAY

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Siemens Medical Solution USA, Inc. % Mr. Ned Devine Senior Staff Engineer Underwriters Laboratories, Inc. 333 Pfingsten Rd. NORTHBROOK IL 60062

Re: K091373 .

Trade/Device Name: Syngo™ TrueD Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ · Dated: April 28, 2009 Received: May 11, 2009

Dear Mr. Devine:

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 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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter.

21 CFR 876.xxx	(Gastroenterology/Renal/Urology)	(240) 276-0115
21 CFR 884.xxx	(Obstetrics/Gynecology)	(240) 276-0115
21 CFR 892.xxx	(Radiology)	(240) 276-0120
Other		(240) 276-0100

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 contact the CDRH/Office of Surveillance and Biometrics/Division of Postmarket Surveillance at 240-276-3464. For more information regarding the reporting of adverse events, please go to http://www.fda.gov/cdrh/mdr/.

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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

[signature]

Janine M. Morris Acting Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

ﺎ ﻟﻠﻌﺐ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺪﻳﻨﺔ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪ

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Indications for Use

510(k) Number (if known):	Not Known K091373
Device Name:	Syngo™ TrueD

Indications for Use:

Prescription Use (Part 21 CFR 801 Subpart D)

AND / OR

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

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)

Division of Reproductive, Abdominal an Radiological Devi 510(k) Number

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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).