The Stryker Navigation System - Hip Module is intended as a planning and intraoperative guidance system to enable open or percutaneous computer assisted surgery. The system is indicated for any medical condition in which the use of computer assisted surgery may be appropriate, and where a reference to a rigid anatomical structure such as but not limited to the pelvis, or femur, can be identified.

The system must be used within the operating theatre and should be operated only by trained personnel such as orthopedic surgeons and clinic staff.

The Stryker Navigation System - Hip Module supports, but is not limited to the following surgical procedures

Any form of Total Hip Athroplasty (THA), e.g. open of minimal-invasive ●
Precisely position instruments, implants and bony tissue during orthopedic . surgery, such as operations performed with Hip and bones in the upper extremities
Revisions .

Device Description

The Stryker Navigation System – Hip Module is intended as a planning and intraoperative guidance system to enable open or percutaneous computer assisted surgery.

AI/ML Overview

The provided 510(k) summary for Ko22365, the Stryker Navigation System - Hip Module, does not contain a study demonstrating acceptance criteria or specific device performance metrics in the way a contemporary AI/ML medical device submission would. This submission predates the widespread use of AI/ML in medical devices and the current emphasis on rigorous performance studies for such devices.

The document primarily focuses on establishing substantial equivalence to existing, legally marketed image-guided surgery systems. It asserts that the device does not raise new safety or efficacy concerns.

Therefore, many of the requested elements for describing a study proving the device meets acceptance criteria cannot be extracted from this document.

Here's an analysis based on the information available:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Implied)	Reported Device Performance
Safety and Efficacy (General)	"The Stryker Navigation System does not raise any new safety and efficacy concerns when compared to similar devices already legally marketed." This is a statement of substantial equivalence, implying that its safety and efficacy are considered comparable to predicate devices, rather than a quantifiable performance metric against a specific acceptance criterion. The document does not provide specific performance data to support this claim in a measurable way.
Intended Use Equivalence	"The Stryker Navigation System is equivalent in intended use... to existing image guided surgery systems being marketed by companies such as Stryker, Sofamor Danek, and BrainLab." This is a qualitative statement of equivalence.
Functional Capabilities (Implicit from Indications for Use)	Supports: - Any form of Total Hip Arthroplasty (THA) - Precisely position instruments, implants and bony tissue during orthopedic surgery (Hip and upper extremities) - Revisions

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

Not Applicable / Not Provided: The document does not describe a specific "test set" or a performance study with a defined sample size for evaluating acceptance criteria. The basis for clearance is substantial equivalence to predicate devices, not a direct performance study against objective criteria.

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

Not Applicable / Not Provided: As there is no described test set or ground truth establishment process, this information is not available.

4. Adjudication method for the test set

Not Applicable / Not Provided: No test set or adjudication method is described.

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

No: This is a navigation system, not an AI/ML diagnostic or assistive device in the context of "human readers" interpreting images. No MRMC study is mentioned.

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

Not Applicable: This device is a "planning and intraoperative guidance system" designed to be used with human operators (surgeons and staff) within the operating theatre. It is not an "algorithm only" device in the sense of an AI/ML standalone diagnostic. Its performance is intrinsically linked to its use in a clinical setting by trained personnel.

7. The type of ground truth used

Not Applicable / Not Provided: There is no mention of ground truth in the context of validating performance parameters against a specific dataset. The "ground truth" for a surgical navigation system, in a broader sense, would be the actual anatomical positions and planned trajectories, and the accuracy with which the system guides instruments to those positions. However, the document does not include performance data on this.

8. The sample size for the training set

Not Applicable: This is an image-guided navigation system, not an AI/ML algorithm that is "trained" on a dataset in the modern sense. It uses existing imaging data (likely CT or MRI) to create 3D models for surgical planning and guidance.

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

Not Applicable: As above, this device predates typical AI/ML training paradigms. Its "knowledge" is embedded in its engineering and software based on principles of image processing, registration, and spatial tracking, not "ground truth" from a labeled training set.

Summary

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Ko22365

510(K) SUMMARY OF SAFETY AND EFFECTIVENESS: STRYKER NAVIGATION - HIP MODULE

JAN 2 2 2003

General Information

Proprietary Name:	Stryker Navigation System - HipModuleHipTrac
Common Name:	Image Guided Surgery System
Classification Name(s):	Instrument, Stereotaxic
Classification Code(s):	84HAW
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: 616-324-5454
Summary Preparation Date:	July 19, 2002

Summary of Safety and Effectiveness:

The Stryker Navigation System – Hip Module is intended as a planning and intraoperative guidance system to enable open or percutaneous computer assisted surgery. The system is indicated for any medical condition in which the use of computer assisted surgery may be appropriate, and where a reference to a rigid anatomical structure such as but not limited to the pelvis, or femur, can be identified.

The system must be used within the operating theatre and should be operated only by trained personnel such as orthopedic surgeons and clinic staff.

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The Stryker Navigation System – Hip Module supports, but is not limited to the following surgical procedures

Any form of Total Hip Athroplasty (THA), e.g. open of minimal-O invasive
Precisely position instruments, implants and bony tissue during O orthopedic surgery, such as operations performed with Hip and bones in the upper extremities
o Revisions

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, Sofamor Danek, and BrainLab.

They 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.

Kelli J. Bitterburg

Regulatory Affairs Associate

Dated: 7/19/02

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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 text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing right, stacked on top of each other.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN 2 2 2003

Ms. Kelli Bitterburg Regulatory Affairs Associate Stryker Leibinger 4100 East Milham Avenue Kalamazoo, Michigan 49001

Re: K022365

Trade Name: Stryker Navigation System - Hip Module Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic Instrument Regulatory Class: II Product Code: HAW Dated: October 25, 2002 Received: October 28, 2002

Dear Ms. Bitterburg:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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. 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 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

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 - Hip Module

Intended Use:

Indications for Use:

The system must be used within the operating theatre and should be operated only by trained personnel such as orthopedic surgeons and clinic staff.

The Stryker Navigation System - Hip Module supports, but is not limited to the following surgical procedures

Any form of Total Hip Athroplasty (THA), e.g. open of minimal-invasive ●
Precisely position instruments, implants and bony tissue during orthopedic . surgery, such as operations performed with Hip and bones in the upper extremities
Revisions .

(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)

Over-The-Counter Use

Muriam C. Provost (Optional Format 1-2-96)

ivision Sign-Off) Jivision of General, Restorative and Neurological Devices

Number K022 365

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).