syngo plaza is a Picture Archiving and Communication System (PACS) intended to display, process, read, report, communicate, distribute, store and archive digital medical images. It supports the physician in diagnosis and treatment planning. syngo.plaza also supports storage and archiving of DICOM Structured Reports. In a comprehensive imaging suite syngo.plaza integrates Hospital/Radiology Information Systems (HIS/RIS) to enable customer specific workflows. syngo.plaza optionally uses a variety of advanced postprocessing applications. Note: Web-based image distribution is not intended for reporting. In the U.S.A., syngo.plaza is not intended for the reporting of digital mammography images.

Device Description

syngo. plaza is a Picture Archiving and Communication System (PACS) intended to display, process, read, report, communicate, distribute, store and archive digital medical images. It supports the physician in diagnosis and treatment planning. syngo.plaza also supports storage and archiving of DICOM Structured Reports. In a comprehensive imaging suite syngo.plaza integrates Hospital/Radiology Information Systems (HIS/RIS) to enable customer specific workflows. syngo. plaza optionally uses a variety of advanced post processing applications. syngo.plaza is a "software only"-system, which will be delivered on CD-ROM / DVD or also preconfigured on hardware. syngo.plaza will be installed by Siemens service engineers. Defined Hardware requirements are to be met. The herewith described syngo.plaza supports DICOM formatted images and objects.

AI/ML Overview

This 510(k) summary for syngo.plaza is quite brief and primarily focuses on establishing substantial equivalence to a predicate device rather than detailing specific performance studies with acceptance criteria for a new or significantly modified feature. It is a PACS system, and the submission emphasizes its functionality as a medical diagnostic and viewing workstation, along with its integration capabilities.

Therefore, much of the requested information regarding acceptance criteria and performance studies for a device meeting specific quantitative performance metrics is not explicitly stated in this document. The submission focuses on verification and validation (V&V) against established standards for software development and medical devices.

Here's an analysis of the provided text in relation to your request:

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

The document does not provide a table of acceptance criteria with reported device performance in the manner typically seen for devices that perform a specific diagnostic measurement or AI-driven analysis. The "acceptance criteria" here refer to the successful completion of software verification and validation (V&V) activities and the demonstration of substantial equivalence.

The closest statement to an acceptance criterion is:

"After completion of the system test and comparison of the test results with the software release acceptance criteria, Siemens is of the opinion, that syngo.plaza is substantially equivalent to and performs as well as the predicate device."

This implies that the overall system performance as a PACS met internal "software release acceptance criteria" to demonstrate substantial equivalence to the predicate device. However, these criteria are not detailed in terms of specific quantitative metrics (e.g., sensitivity, specificity, processing time).

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

This information is not provided in the document. The non-clinical testing discussion focuses on software V&V against standards, not on clinical performance testing with a specific test set of medical images from patients.

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)

This information is not provided. As there's no mention of a clinical test set with ground truth, there's no information about experts.

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

This information is 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

There is no mention of an MRMC study or any study evaluating human reader improvement with or without AI assistance. This submission describes a PACS system, not an AI-assisted diagnostic tool in the sense of a standalone algorithm for interpretation.

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

There is no mention of a standalone algorithm performance study. The device is a PACS system, which is inherently a human-in-the-loop system for image display, processing, reading, and reporting.

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

This information is not provided. Given the nature of the device (PACS), the "ground truth" for V&V would likely involve ensuring accurate image display, processing functions, data integrity, and compliance with standards, rather than diagnostic accuracy against a clinical ground truth.

8. The sample size for the training set

This information is not provided. There is no mention of a "training set" as would be relevant for machine learning or AI models with learned parameters. The software V&V process for a PACS does not typically involve a training set.

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

This information is not provided.

Summary of what is present:

Acceptance Criteria (Implicit): Substantial equivalence to the predicate device and successful completion of software V&V against specified standards (DICOM, JPEG, SMPTE, ISO 14971, IEC 60601-1-4, IEC 60601-1-6, HL7, IEC 62304). The "reported device performance" is that it "performs as well as the predicate device" and successfully passed these V&V activities.
Study: The "study" referenced is the non-clinical testing which comprises "software verification and validation (Unit Test Level, Integration Test Level and System Test Level)." This is a demonstration of adherence to quality systems and regulatory standards, not a comparative clinical performance study.
Key focus: The submission's primary goal is to demonstrate substantial equivalence to an existing PACS device (Siemens VO 1190). It is a "software only"-system delivered on CD-ROM/DVD or preconfigured hardware, meeting defined hardware requirements, and supporting DICOM formatted images and objects.

In conclusion, the provided document describes a PACS system and its regulatory submission focused on substantial equivalence based on software V&V. It does not contain the detailed quantitative performance metrics, test set characteristics, or AI-specific study designs that are typically requested when evaluating advanced diagnostic algorithms or AI-powered devices.

Summary

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510(k) Summary

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

GENERAL INFORMATION I.
MAR - 4 2010

Establishment:

Siemens AG. Medical Solutions Address: . Henkestrasse 127 D-91052 Erlangen Germany
Registration Number: 3002808157 ●

Sabine Schroedel Contact Person: . Regulatory Affairs Manager Telephone: +49 (9131) 84-8285 +49 (9131) 84-2792 Telefax:

Device Name and Classification:

• Trade Name:	syngo.plaza
	Classification Name: Picture Archiving andCommunications System
• Classification Panel:	Radiology
• CFR Section:	21 CFR §892.2050
• Device Class:	Class II
• Product Code:	LLZ

Date of Submission:

November 06, 2009

II. SAFETY AND EFFECTIVENESS INFORMATION SUPPORTING THE SUBSTANTIAL EQUIVALENCE DETERMINATION

Device Description and Intended Use: .

This premarket notification covers Siemens' enhanced PACS system syngo.plaza.

syngo. plaza is a Picture Archiving and Communication System (PACS) intended to display, process, read, report, communicate, distribute, store and archive digital medical images.

It supports the physician in diagnosis and treatment planning.

syngo.plaza also supports storage and archiving of DICOM Structured Reports.

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In a comprehensive imaging suite syngo.plaza integrates Hospital/Radiology Information Systems (HIS/RIS) to enable customer specific workflows. syngo. plaza optionally uses a variety of advanced post processing applications.

Note:

Web-based image distribution is not intended for reporting.

In the U.S.A., syngo.plaza is not intended for the reporting of digital mammography images.

syngo.plaza Workplaces

The three syngo.plaza workplace deployments ...

a) syngo.plaza Cluster Client
b) syngo.plaza Web Client
c) syngo.plaza Standalone Workstation

... are medical diagnostic and viewing workstations intended for post processing, reading, reporting, viewing and communicating / distributing of radiological softcopy images and so allow radiologists and radiological technicians to receive and process all data needed.

By usage of only specific FDA approved monitors validated together with the software, diagnosis on digital mammography images is possible, but it is not supported in the U.S.A. as disclaimed in the Intended Use.

Integration

The integration of syngo.plaza shall be applied at different levels and by using technologies like sharing the same HW/SW platform, using common Siemens Medical components (e.g. OPENLink), offering an open interface for other vendors to connect with other DICOM nodes and especially the DICOM Archive functionality, with other information systems (mainly RIS).

. Technological Characteristics:

syngo.plaza is a "software only"-system, which will be delivered on CD-ROM / DVD or also preconfigured on hardware. syngo.plaza will be installed by Siemens service engineers.

Defined Hardware requirements are to be met.

The herewith described syngo.plaza supports DICOM formatted images and objects.

. Summary of Non-Clinical Testing:

The software verification and validation (Unit Test Level, Integration Test Level and System Test Level) was performed for all newly developed components and the complete system according the following standards: . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

DICOM Standard [2008]
JPEG/JPEG 2000 Standard [1992, 2002]
SMPTE Test Pattern [1995]
ISO 14971:2007
IEC 60601-1-4 + A1 [1999]
IEC 60601-1-6 [2006]

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HL7 [2006]
IEC 62304 [2006]

After completion of the system test and comparison of the test results with the software release acceptance criteria, Siemens is of the opinion, that syngo.plaza is substantially equivalent to and performs as well as the predicate device.

General Safety and Effectiveness Concerns: .

The device labelling contains instructions for use and any necessary cautions and warning, to provide for safe and effective use of the device.

Risk management is ensured via a risk analysis, which is used to identify potential hazards. These potential hazards are controlled via software development, verification and validation testing.

Substantial Equivalence: .

The syngo.plaza, addressed in this special premarket notification, is substantially equivalent to the following commercially available device:

Siemens	VO 1190magingSUNOO	17000100AU024------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
.

The syngo.plaza described in this 510(k) has the same intended use and similar technical characteristics as the device listed above in regard to the specific functionalities. In summary. Siemens is of the opinion that syngo.plaza does not introduce any new potential safety risks and is substantially equivalent to and performs as well as the predicate devices.

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Image /page/3/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized depiction of an eagle or bird-like figure with three curved lines forming its body and wings. The logo is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" in a circular arrangement.

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 AG Medical Solutions . % Mr. Stefan Preiss Responsible Third Party Official TÜV SÜD America 1775 Old Hwy 8 NW, Ste 104 NEW BRIGHTON MN 55112-1891

MAR - 4 2010

Re: K093612

Trade/Device Name: syngo, plaza Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: February 10, 2010

Received: February 16, 2010

Dear Mr. Preiss:

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 Amendmouts, 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 (DMA). 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 firther. 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. Your must comply with 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.

Amlt

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

Image /page/5/Picture/19 description: The image shows a simple line drawing of a rectangular shape. The rectangle is slightly tilted, giving it a dynamic appearance. The lines are clean and create a clear outline of the shape, set against a plain white background.

510(k) Number (if known):
Device Name:	syngo plaza

Indications For Use:

syngo plaza is a Picture Archiving and Communication System (PACS) intended to display, process, read, report, communicate, distribute, store and archive digital medical images.

It supports the physician in diagnosis and treatment planning.

syngo.plaza also supports storage and archiving of DICOM Structured Reports.

In a comprehensive imaging suite syngo.plaza integrates Hospital/Radiology Information Systems (HIS/RIS) to enable customer specific workflows. syngo.plaza optionally uses a variety of advanced postprocessing applications.

Note:

Web-based image distribution is not intended for reporting.

In the U.S.A., syngo.plaza is not intended for the reporting of digital mammography images.

X Prescription Use (Part 21 CFR 801 Subpart D)

AND / OR

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

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Concurrence of the CDRH, Office of Device-Evaluation (ODE) ODVD

(Division Sign-Off)
Division of Radiological Devices
Office of In Vitro Diagnostic Device Evaluation and Safety

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).