The product is intended for use by trained professionals. The Clinician retains the ultimate responsibility for making the pertinent assessment based on their standard practices and visual comparison of the information.

Device Description

Siemens syngoCirculation DynamicPET is a software product intended for visualization, assessment and quantification of medical images. The application supports dynamic Rubidium - PET and Ammonia - PET images.

The application provides visualization and measurement tools, for qualitative and quantitative visualization and assessment of the input data. It provides automatic and manual tools to orient and segment the myocardium. The software calculates measures of myocardial perfusion over time, and provides tools for the Clinician to assess these results. The user may save the results.

The application is intended for use by trained professionals. The Clinician retains the ultimate responsibility for making the pertinent assessment based on their standard practices and visual assessment of the myocardial perfusion PET images. The quantitative assessment is to be used in conjunction with traditional visual assessment of myocardial perfusion PET images for the assessment of coronary artery disease.

AI/ML Overview

The provided text details the 510(k) summary for the syngoCirculation DynamicPET device but does not contain information about specific acceptance criteria or an explicit study proving the device meets those criteria.

The document primarily focuses on:

Device identification and classification.
Claim of substantial equivalence to predicate devices (ImagenMD with ImagenQ, and Syngo® Circulation).
A general device description and its intended use for visualization, assessment, and quantification of dynamic Rubidium-PET and Ammonia-PET images, with a focus on myocardial perfusion.
A statement on safety and effectiveness, mentioning risk management in compliance with IEC/ISO 14971 and arguing that the device introduces no new safety concerns and is substantially the same as predicates.

Therefore, most of the requested information cannot be extracted from the given text.

However, I can provide a summary based on the available information and highlight what is missing.

Acceptance Criteria and Device Performance Study for syngoCirculation DynamicPET

The provided 510(k) summary for the syngoCirculation DynamicPET device does not explicitly state specific acceptance criteria or provide details of a study designed to prove the device meets such criteria. The document focuses on demonstrating substantial equivalence to predicate devices, rather than presenting a detailed performance study with defined metrics.

Given the information provided, specific performance metrics, sample sizes, ground truth establishment, or expert involvement for a dedicated performance study are not available. The safety and effectiveness statement relies on risk analysis (IEC/ISO 14971) and a claim of substantial equivalence to predicate devices, implying that its performance is considered comparable to already cleared devices.

Missing Information:

No specific acceptance criteria are listed.
No quantitative device performance metrics (e.g., accuracy, sensitivity, specificity for specific tasks) are reported.
No details of a specific device performance study are provided (e.g., study design, objective, outcomes).

Summary of Available Information (and what's missing):

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria: Not explicitly stated.
Reported Device Performance: Not explicitly stated in quantitative terms. The document implies performance is substantially equivalent to predicate devices.

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

Sample Size (Test Set): Not provided.
Data Provenance: Not provided.

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

Number of Experts: Not provided.
Expert Qualifications: Not provided.

4. Adjudication method for the test set

Adjudication Method: 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

MRMC Study: Not mentioned or detailed. The device is a "Picture archiving and communications system" and performs "quantitative measurements of tracer uptake over time." It's likely intended as a tool to aid clinicians, but an MRMC study demonstrating human reader improvement with the software is not described in this document.
Effect Size of Improvement: Not applicable, as no MRMC study is detailed.

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

Standalone Performance: Not mentioned or detailed. The device is described as "a software product intended for visualization, assessment and quantification" that "provides automatic and manual tools" for clinicians, suggesting it's a tool for human review rather than solely relying on standalone algorithmic output presented without human intervention in terms of performance evaluation.

7. The type of ground truth used

Type of Ground Truth: Not specified, as no particular performance study with ground truth is described.

8. The sample size for the training set

Sample Size (Training Set): Not provided.

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

Ground Truth Establishment (Training Set): Not provided.

Summary

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KC83227

Template, Summary of Safety and Effectiveness (510(k)) Page 1 of 2

510(k) Summary

as required by 21 CFR Part 807.87(h)

ldentification of the Submitter

18 2009 MAY

Submitter:	Gunhild Paulsen
Telephone Number:	847-304-7516
Fax Number:	847-304-6023
Date of Submission:	10-31-2008

ldentification of the product

Device Proprietary Name:	syngoCirculation DynamicPET
Common Name:	Picture archiving and communications system
Classification Name:	System, Image Processing, Radiological
Product Code:	LLZ
Classification Panel:	Radiology
Device Class:	Class II

Marketed Devices to which Equivalence is claimed

Device	Manufacturer	510(k) Number
ImagenMD™ with ImagenQ™	Cardiovascular Imaging Technologies	K080770
Syngo® Circulation	Siemens AG Medical Solutions	K063762, K052029

\ : : :

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KC83227

Template, Summary of Safety and Effectiveness (510(k)) Page 2 of 2

Device Description:

Safety and Effectiveness:

Risk Management is ensured via a risk analysis in compliance with IEC/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 considers that the proposed device does not introduce new safety concerns, and is substantially the same in indications for use, design, materials, energy sources and technology as the predicate devices. Siemens believes that the syngoCirculation DynamicPET software application is substantially equivalent to the predicate devices.

Indications for Use:

Siemens syngoCirculation DynamicPET is a software product intended for visualization, assessment and quantification of PET images.

The application performs quantitative measurements of tracer uptake over time to aid in the interpretation of myocardial perfusion PET images.

QRMI0097-T-01

Reference: QRM10080-M

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features a stylized eagle with its wings spread, symbolizing the department's mission to protect and promote the health and well-being of all Americans. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the eagle, indicating the department's name and national affiliation. The seal is presented in black and white.

Public Health Service

18 2009 MAY

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Gunhild Paulson · Senior Regulatory Affairs Specialist Siemens Medical Solutions USA, Inc. 2501 N. Barrington Road HOFFMAN ESTATES IL 60192

Re: K083327

Trade/Device Name: syngoCirculation DynamicPET Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: · II Product Code: LLZ Dated: April 17, 2009 Received: April 21, 2009

Dear Mr. Paulson:

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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Page 2

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

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INDICATIONS FOR USE

510(k) Number (if known): K083327

Device Name: syngoCirculation DynamicPET

Indications for Use:

Siemens syngoCirculation DynamicPET is a software product intended for visualization, assessment and quantification of PET images.

The application performs quantitative measurements of tracer uptake over time to aid in the interpretation of myocardial perfusion PET images.

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 ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

tonie Mthan

(Division Sign-Off)

luctive, Abdominal, 510/k) Number

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).