STRYKERWARE SYSTEM by Stryker Endoscopy

The Strykerware™ PACS System is a system designed to provide licensed medical professionals access to medical images. This product is intended to be used for reviewing and storing images from a variety of modalities. Strykerware™ is the system with software installed on a computer configured with connections to image acquisition devices, image storage locations and the internet. The system facilitates the transferal of images between local and remote locations (including but not limited to a licensed medical professional's operating suite).

Device Description

The Stryker Strykerware™ PACS System is a medical system that is designed to allow access to medical images and related data for physicians and other licensed professionals. The system receives images and medical data from image acquisition devices or other PACS (Picture Archive and Communication System) networks. The system's software includes an integrated web-based viewing and storage archival applications. The Strykerware™ System allows for the transfer of medical images and data between locations such as but not limited to a physicians operating suite.

AI/ML Overview

This 510(k) summary document for the Strykerware™ PACS System does not contain the specific information required to complete all sections of your request regarding acceptance criteria and study details. The document is primarily a declaration of substantial equivalence to predicate devices and outlines the device's intended use and regulatory compliance.

Here's what can be extracted and what is missing:

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

This information is not provided in the document. The document states that the device is "substantially equivalent in safety and efficacy as the currently marketed Remotelmage™ System and AMICAS Web/Intranet Image Server." This implies that the acceptance criteria are met by virtue of being comparable to these predicate devices, but no explicit performance metrics or criteria are listed for the Strykerware™ system itself.

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. As this is a 510(k) for a PACS system, not a diagnostic AI device, there isn't typically a "test set" in the sense of clinical images for diagnostic accuracy evaluation. The evaluation would have been focused on functionality, connectivity, and image integrity, which are not detailed here.

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. This type of detail is typically associated with clinical performance studies for diagnostic algorithms, which is not the primary focus of a PACS system's 510(k).

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

This information is not provided. This is not relevant for a PACS system's 510(k).

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

This information is not provided. An MRMC study is relevant for evaluating the impact of AI on human reader performance, which is not applicable to a PACS system like the Strykerware™.

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

This information is not provided. This question is typically for AI algorithms that perform a diagnostic or analytical function. The Strykerware™ is an image management and viewing system, not a standalone diagnostic algorithm.

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

This information is not provided. As explained above, for a PACS system, the "ground truth" would relate to the accuracy of image storage, retrieval, display, and transfer, rather than diagnostic accuracy. These functional tests are typically performed during product development and verification but are not usually detailed in a 510(k) summary in this manner.

8. The sample size for the training set

This information is not provided. The Strykerware™ PACS system is not an AI/ML diagnostic algorithm that would have a "training set" of medical images in the traditional sense. Its development would involve software engineering principles, testing against functional requirements, and adherence to standards like DICOM.

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

This information is not provided. Similar to point 8, this question is not applicable to the type of device described.

Summary of what can be inferred or explicitly stated from the document:

Device Name: Strykerware™ PACS System (formerly Strykerware™ Office Portal/Media Archive)
Classification Name: System, Image Processing (21 CFR 892.2050)
Predicate Devices: Remotelmage™ System (K994228) and AMICAS Web/Intranet Image Server (K970064).
Acceptance Criteria (Implied): The device meets acceptance criteria by demonstrating "substantial equivalence in safety and efficacy" to the predicate devices. The specific performance metrics or thresholds for this equivalence are not listed.
Study Proving Acceptance Criteria: The document mentions a "510(k) summary and effectiveness" but does not detail a specific study or test results. The primary "proof" is the declaration of substantial equivalence based on technological similarities and adherence to voluntary standards (ACR/NEMA DICOM, ANSI/AAMI SW68, IEC 60601). The lack of "new issues of safety and efficacy" compared to predicates is the core argument.
Device Performance Reported: The document does not report specific performance metrics for the Strykerware™ system. It rather asserts its performance is substantially equivalent to the predicate devices. The function is described as allowing access, viewing, storage, and transfer of medical images and data.

Summary

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K02 4159

MAR 1 0 2003

stryker
ENDOSCOPY

5900 Ontical Cour an Jose CA 9513 x (408) 754-2505

510(k) SUMMARY OF SAFETY AND EFFECTIVENESS

Device Name

Classification Name:	System, Image Processing
Common and Usual Name:	StrykerwareTM Office Portal/Media Archive

Strykerware™ System Proprietary Name:

This 510(k) summary and effectiveness is being submitted in accordance with requirements of SMDA 1990.

The Strykerware™ PACS System is substantially equivalent in safety and efficacy as the currently marketed Remotelmage™ System and AMICAS Web/Intranet Image Server which were cleared under 510K#'s K994228 and K970064 respectively.

The intent of the Strykerware™ System is to allow an office-based practice to convert from a paper to paperless environment and to create a flow of medical images and information between the office and the operating suites of the physicians belonging to that practice.

The Strykerware™ System conforms to the following voluntary standards: ACR/NEMA DICOM, ANSI/AAMI SW68 - "Medical device software - Software life cycle processes", and IEC 60601 -"Medical Electrical Equipment."

The technological differences between the Strykerware™ System and the predicate Remotelmage™ and AMICAS devices do not raise new issues of safety and efficacy of the predicate devices. Therefore, the Strykerware™ System is substantially equivalent to the currently marketed Remotelmage™ and AMICAS Web/Intranet Image Server.

Lee Rich

Jerry Dickerson Senior Project Engineer Stryker Endoscopy

Date: 12-13-02

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Image /page/1/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an image of an eagle with its wings spread.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Evan Norton Product Manager Stryker Endoscopy 5900 Optical Court SAN JOSE CA 95138 Re: K024159

MAR 1 0 2003

Trade/Device Name: Strykerware PACS System Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: 90 LLZ Dated: December 13, 2002 Received: December 17, 2002

Dear Mr. Norton:

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 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) 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 Part 801), please contact the Office of Compliance 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 Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97) you may obtain. Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and 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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December 12, 2002

KO2 4154 510(k) Number (if known):

Device Name

Indications for Use:

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use
(Per 21 CFR 801.109)

510(k) Number

Over-The-Counter-Use_

Marcye brogdon

(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Dai

Stryker Endoscopy Strykerware™ PACS System SHUIKTSUOMISSION

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Regulation Number and Section

N/A