The LEONARDO syngo Cardiology Workstation is a medical diagnostic workstation for viewing, manipulation, communication, and storage of medical images and data on exchange media.

The LEONARDO syngo Cardiology Workstation can be configured as a stand-alone diagnostic review and post-processing workstation with a variety of syngo or Windows based software options, which are intended to assist the physician in diagnosis or treatment planning. This includes commercially available post-processing techniques.

Device Description

This premarket notification covers Siemens LEONARDO syngo Cardiology Workstation syngo is a universal imaging platform based on Windows XP. LEONARDO syngo Cardiology offers a comprehensive cardiology solution to view, optimize, post-process diagnostic information and aid the doctors in the evaluation of digital cardiological and radiological examinations and patient information.

Due to special customer requirements based on the modality image type and the clinical focus, the LEONARDO syngo Cardiology Workstation can be configured with different combinations of clinical applications. syngo applications can be added to the LEONARDO syngo Cardiology Workstation either individually or as clinical focus packages.

The LEONARDO syngo Cardiology Workstation is a medical diagnostic workstation for viewing, manipulation, communication, and storage of medical images and data on exchange media.

The LEONARDO syngo Cardiology Workstation can be configured with a variety of syngo- or Windows based software options, which are intended to assist the physician in diagnosis or treatment planning. This includes commercially available post-processing techniques.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study proving the device meets them:

The provided document (K042203 for Siemens LEONARDO syngo Cardiology) is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device rather than outright performance against specific acceptance criteria for a new device.

Therefore, the information typically found in an acceptance criteria study (like detailed performance metrics, sample sizes for test/training sets, expert qualifications, and specific ground truth methodologies) is largely absent in this type of submission. The primary "study" is the comparison to the predicate device.

Let's address each point based on the available information:

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

Since this is a substantial equivalence submission, there are no explicit quantitative "acceptance criteria" presented in the document itself with corresponding "reported device performance" in the way a de novo or PMA submission would have for a novel device.

The acceptance criteria for a 510(k) is generally that the new device has the same intended use and similar technical characteristics to a legally marketed predicate device, and does not raise new questions of safety and effectiveness.

Acceptance Criteria (Implied for 510(k) Equivalence)	Reported Device Performance (Summary of Equivalence Claim)
Intended Use: Same as predicate device.	The LEONARDO syngo Cardiology Workstation has the same intended use as the predicate LEONARDO (K040970).
Technical Characteristics: Similar to predicate device, no new safety/effectiveness questions.	The LEONARDO syngo Cardiology Workstation has similar technical characteristics (Windows XP-based, DICOM support, software-only or complete workstation, post-processing techniques) as the predicate, and Siemens is of the opinion that it does not introduce any new potential safety risks.
Safety and Effectiveness: Does not raise new questions of safety and effectiveness.	Risk management (risk analysis, software development, verification and validation testing) is performed. Adheres to recognized industry practices and standards.

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 510(k) summary. A 510(k) for a workstation like this typically relies on predicate device equivalence and internal verification/validation, rather than a clinical "test set" in the sense of patient data used for performance comparison.

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 in the 510(k) summary.

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

This information is not provided in the 510(k) summary.

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

An MRMC study was not mentioned or performed as part of this 510(k) submission. This device is a workstation for viewing and post-processing, not an AI-powered diagnostic aid that would directly impact human reader performance through assistance.

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

This device is described as a "medical diagnostic workstation" with various "software options" and "commercially available post-processing techniques" intended to "assist the physician." It is not an algorithm performing a standalone diagnostic function without human involvement. Therefore, a standalone algorithm-only performance study as typically understood for AI-based devices was not applicable or performed.

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

The document does not detail specific "ground truth" establishment methods because it's focused on workstation functionality and equivalence rather than a diagnostic algorithm's accuracy against a clinical truth. Any internal verification and validation would be against functional specifications and existing image data, but not typically characterized as "ground truth" in this context.

8. The sample size for the training set

This workstation does not appear to employ machine learning or AI in a way that would require a "training set" in the context of deep learning models. It primarily provides tools for physicians. Therefore, a training set as understood for AI development was not applicable or mentioned.

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

As there's no mention of a training set for machine learning, this information is not applicable.

In summary:

This 510(k) pertains to a medical workstation that provides tools for viewing and post-processing cardiological and radiological examinations. Its clearance is based on substantial equivalence to an existing predicate device (LEONARDO K040970), meaning it has the same intended use and similar technological characteristics without raising new questions of safety and effectiveness. The document does not contain the detailed performance study information typically associated with novel diagnostic algorithms or AI-driven devices that would have specific acceptance criteria, test/training sets, or ground truth methodologies for performance evaluation.

Summary

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K04 2203

Siemens Medical Solutions, Inc 510(k) for LEONARDO syngo Cardiology

510(k) Summary

SEP 2 4 2004

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.

I. GENERAL INFORMATION

Establishment:Address:	Siemens Medical Systems, Inc.51 Valley Stream ParkwayMalvern, PA 19355
----------------------------	--------------------------------------------------------------------------------

2240869 Registration Number: .
Ana Ladino . Contact Person: Technical Specialist Regulatory Submissions Telephone: (610) 448-1785 (610) 448-1787 Telefax: ---------------------------------------------------------------------------------------------------------------------------------------------------------------------

Device Name:

LEONARDO syngo Cardiology Workstation Trade Name: .
Picture Archiving and Communications System (PACS) Classification: ●
Radiology Classification Panel: .
21 CFR 8892.2050 CFR Section: .
Class II . Device Class:
LLZ . Product Code:

Date of Preparation of Summary: August 5th, 2004

II. SAFETY AND EFFECTIVENESS INFORMATION SUPPORTING THE SUBSTANTIAL EQUIVALENCE DETERMINATION

Device Description and Intended Use: .

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added to the LEONARDO syngo Cardiology Workstation either individually or as clinical focus packages.

The LEONARDO syngo Cardiology Workstation is a medical diagnostic workstation for viewing, manipulation, communication, and storage of medical images and data on exchange media.

. Technological Characteristics:

The LEONARDO syngo Cardiology Workstation will be marketed as a software only solution for the end-user (with recommended hardware requirements) or as a complete work station for the end-user (hardware and software package). It will be installed by Siemens service engineers. The LEONARDO syngo Cardiology Workstation described supports DICOM formatted images and information. The workstation is based on the Windows XP operating system.

General Safety and Effectiveness Concerns: .

The device labeling 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. To minimize electrical, mechanical, and radiation hazards, Siemens adheres to recognized and established industry practice and standards.

Substantial Equivalence: .

The LEONARDO syngo Cardiology Workstation, addressed in this premarket notification, is substantially equivalent to the following commercially available device:

LEONARDO (K040970)

The LEONARDO syngo Cardiology Workstation described in this premarket notification has the same intended use and similar technical characteristics as the device listed above.

In summary, Siemens is of the opinion that LEONARDO syngo Cardiology Workstation does not introduce any new potential safety risks and is substantially equivalent to and performs as well as the predicate device.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird in flight. The symbol is composed of three curved lines that form the wings and body of the bird.

SEP 2 4 2004

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Ana Ladino Technical Specialist, Regulatory Submission Siemens Medical Systems, Inc. 51 Valley Stream Parkway MALVERN PA 19355 -

Re: K042203 Trade/Device Name: LEONARDO syngo Cardiology Workstation Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II

Product Code: 90 LLZ Dated: August 5, 2004 Received: August 16, 2004

Dear Ms. Ladino:

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 either class II (Special Controls) or class III (PMA), it may be subject to such 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); 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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This letter will allow you to begin marketing your device as described in your Section 510(k) I his letter will anow you to ought haling of substantial equivalence of your device to a legally premarket nothcation: "The PPF annums to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please If you desire specific advice at one of the following numbers, based on the regulation number at the top of the letter:

8xx. 1xxx	(301) 594-4591
876.2xxx, 3xxx, 4xxx, 5xxx	(301) 594-4616
884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx	(301) 594-4616
892.2xxx, 3xxx, 4xxx, 5xxx	(301) 594-4654
Other	(301) 594-4692

Additionally, for questions on the promotion and advertising of your device, please contact the Additionally, for questions on any -4639. Also, please note the regulation entitled, "Misbranding Other of Othphanos at ( notification" (21CFR Part 807.97) you may obtain. Other general of releveloc to premanted non-on-er the Act may be obtained from the Division of Small miormation on your respensional Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.

Sincerely yours,

Nancy C. Brogdon

Nancy C. Brogdon Director, Division of Reproductive, Abdominal and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Intended Use

510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________ Device Name: _________________________________________________________________________________________________________________________________________________________________

Indications for Use

The LEONARDO syngo Cardiology Workstation is a medical diagnostic workstation for The LEONARDO bylgo conmunication, and storage of medical images and data on exchange media.

The LEONARDO syngo Cardiology Workstation can be configured as a stand-alone diagnostic review and post-processing workstation with a variety of syngo or Windows agnoste forfow and possible intended to assist the physician in diagnosis or treatment planning. This includes commercially available post-processing techniques.

(Please do not write below this line - continue on another page if needed) ( 1 loabo do 110 v 1120 v 11210 - 314
----------------------------------------------------------------------------------------------------------------------------------------Concurrence of the CDRH, Office of Device Evaluation (ODE)

V Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________ OR Prescription Use _ (Per 21 CFR 801.109)

David R. Ingram

(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devices 510(k) Number __

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).