The Stryker Navigation System – Knee Module is intended as a planning and intraoperative guidance system to enable open or percutaneous computer assisted surgery. The system is indicated for conditions of the knee joint in which the use of computer assisted surgery may be appropriate.

Device Description

The Knee Module is a part of the product series of the Stryker Navigation System. The system comprises a knee joint kinematics analysis module based on a wireless videooptical tracking localization device for the use in primary total knee arthroplasty.

The Stryker Navigation System provides precise stereotactic determination of surgical targets using a stereotactic methodology. The three principle features include computer calculation of stereotactic coordinates from the diagnostic images, measurement of stereotactic coordinates within the surgical field, high-resolution computer display of diagnostic images with stereotactic coordinates indicated. The system is comprised of hardware and software components.

AI/ML Overview

The provided text is a 510(k) summary for the Stryker Navigation System - Knee Module. This type of submission focuses on demonstrating substantial equivalence to a predicate device rather than providing extensive details on novel performance studies with acceptance criteria and detailed study designs.

Therefore, much of the requested information regarding specific acceptance criteria, detailed study designs (like sample sizes for test/training sets, expert qualifications, adjudication methods, MRMC studies, standalone performance), and ground truth establishment is not available in the provided document.

Here's a breakdown of what can be extracted and what is missing:

Acceptance Criteria and Device Performance

The document does not specify quantitative acceptance criteria or reported device performance metrics in a table format. The primary "acceptance criteria" for a 510(k) submission are typically demonstrating substantial equivalence to a predicate device in terms of intended use, safety, and effectiveness.

The document states:
"The Stryker Navigation System does not raise any new safety and efficacy concerns when compared to similar devices already legally marketed."

This general statement serves as the qualitative "performance" against the implicit "acceptance criteria" of being equally safe and effective as the predicate.

Study Details (Missing from document)

Given that this is a 510(k) submission focused on substantial equivalence, a full de novo clinical study with detailed performance metrics and acceptance criteria is typically not provided unless the device presents novel technology or significant new risks. The document does not describe such a study.

Sample size used for the test set and the data provenance: Not mentioned.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not mentioned.
Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not mentioned.
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: Not mentioned. This type of study would be more relevant for AI diagnostic tools, not a surgical navigation system of this era.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not explicitly mentioned as a formal standalone study. The system provides "precise stereotactic determination of surgical targets." Its effectiveness is implicitly tied to this precision, but specific quantitative standalone performance studies are not described.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not mentioned.
The sample size for the training set: Not mentioned.
How the ground truth for the training set was established: Not mentioned.

Key Information from the Document:

Device Type: Surgical Navigation System – Knee Module.
Intended Use: Planning and intraoperative guidance system for open or percutaneous computer-assisted surgery for knee joint conditions.
Substantial Equivalence: The document asserts substantial equivalence to existing image-guided surgery systems marketed by Stryker, Medtronic, Brainlab, and Aesculap. This is the primary "proof" for the 510(k) submission.
Safety and Efficacy: The system "does not raise any new safety and efficacy concerns" compared to predicate devices.
Features: Wireless video-optical tracking localization device, computer calculation of stereotactic coordinates from diagnostic images, measurement of stereotactic coordinates within the surgical field, high-resolution computer display of diagnostic images with stereotactic coordinates.

In summary, the provided 510(k) summary focuses on demonstrating equivalence to predicate devices, and therefore does not contain the detailed performance study information typically associated with a de novo or PMA submission, or more recent AI/software as a medical device (SaMD) submissions that often include such specific performance data.

Summary

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JUN - 2 2003

510(K) SUMMARY OF SAFETY AND EFFECTIVENESS: STRYKER NAVIGATION SYSTEM – KNEE MODULE TRADITIONAL 510(K)

K022579

General Information

Proprietary Name:	Stryker Navigation System -- KneeModule
Common Name:	Image Guided Surgery System
Classification Name(s):	Stereotaxic Instrument
Classification Code(s):	84 HAW
Submitter:	Stryker CorporationStryker Leibinger4100 East Milham AvenueKalamazoo, MI 49001800-253-7370
Submitter's Registration #:	1811755
Manufacturer's Registration #:	8010177
Contact Person:	Kelli J. BitterburgRegulatory Affairs AssociatePhone: 616-324-5346 x4026Fax: 616-323-4215
Summary Preparation Date:	August 2, 2002

Device Description

Intended Use

The Stryker Navigation System - Knee Module is intended as a planning and intraoperative guidance system to enable open or percutaneous computer assisted surgery. The system is indicated for conditions of the knee joint in which the use of computer assisted surgery may be appropriate.

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The surgeon has to determine whether the patient's conditions are appropriate for this kind of procedure or not. A pathological condition against the use of this system could be in some cases advanced osteoporosis or a displastic hip.

Substantial Equivalence

The Stryker Navigation System is equivalent in intended use, safety, and effectiveness to existing image guided surgery systems being marketed by companies such as Stryker, Medtronic, Brainlab and Aesculap.

The Stryker Navigation System does not raise any new safety and efficacy concerns when compared to similar devices already legally marketed. Therefore, the Stryker Navigation System is substantially equivalent to these existing devices.

Kell J. Bitterburg

Reculatory Affairs Associate

Dated: 6/2/03

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Image /page/2/Picture/1 description: The image is a black and white logo for the Department of Health & Human Services - USA. The logo is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter of the circle. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN = 2 2003

Kelli Bitterburg Regulatory Agent Stryker Leibinger 4100 E. Milham Ave. Kalamazoo, MI 49001

Re: K022579

Trade/Device Name: Stryker Navigation System-Knee Module Regulation Number: 21 CFR 882.4650 Regulation Name: Stereotaxic Instrument Regulatory Class: II Product Code: HAW Dated: March 3, 2003 Received: March 4, 2003

Dear Ms. Bitterburg:

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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Page 2 - Ms. Kelli Bitterburg

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 (301) 594-4659. 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.

Miriam C. Provost

for Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(K) Number (if known):

Device Name: Stryker Navigation System - Knee Module

Intended Use:

Contraindications:

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Miriam C. Provost

Division Sign-Off) Division of General, Restorative and Neurological Devices

KO22579 510(k) Number _

Prescription Use or (per 21 CFR 801.109)

Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________

(Optional Format 1-2-96)

Regulation Number and Section

§ 882.4560 Stereotaxic instrument.

(a)
Identification. A stereotaxic instrument is a device consisting of a rigid frame with a calibrated guide mechanism for precisely positioning probes or other devices within a patient's brain, spinal cord, or other part of the nervous system.(b)
Classification. Class II (performance standards).