The Navitrack™ System - Optical TKR CT-Less is indicated for use as a stereotaxic instrument to assist in the positioning of Total Knee Replacement components intra-operatively.

It is a computer controlled image-guidance system equipped with a three-dimensional tracking sub-system. It is intended to assist the surgeon in determining reference alignment axes in relation to anatomical landmarks, and in precisely positioning the alignment instruments relative to these axes by displaying their locations.

Device Description

The Navitrack™ System - Optical TKR CT-Less device consists of a computer workstation, an optical tracking system, surgical instruments, and tracking devices. It is designed to assist the surgeon in the placement of Total Knee Replacement (TKR) components. Intra-operatively, the tracking devices are attached to the femur and the tibia, and to the alignment and pointing instruments, in order to track and display their relative locations in real-time. The pointing instruments are used to digitize the relative locations of anatomical landmarks that are commonly used clinically for TKR alignment. In the case of the femoral head landmark, it is computed by the system as based on a motion analysis of the femur. From the landmarks the system then computes and displays the alignment axes. The alignment instrument is then navigated and positioned relative to these axes on each bone which in turn sets the placement of the cutting guides.

AI/ML Overview

This device, the Navitrack™ System - Optical TKR CT-Less, is a stereotaxic instrument for assisting in Total Knee Replacement (TKR) surgery. However, the provided text does not contain detailed acceptance criteria or a specific study proving the device meets them. Instead, it focuses on demonstrating substantial equivalence to predicate devices based on non-clinical performance data and technological comparisons.

Here's a breakdown of the information available and what is missing, structured as requested:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Not Explicitly Stated in Document: The document does not provide specific quantifiable acceptance criteria (e.g., accuracy thresholds in millimeters or degrees, success rates) for the device's performance in TKR procedures.	"Adequate to perform as intended." The document states: "Non-clinical tests were performed to assess that no new safety and efficacy issues were raised in the device. They consisted in verifying that the accuracy and performance of the system was adequate to perform as intended." This is a qualitative statement, not a quantitatively measured performance metric against a predefined criterion.

2. Sample Size Used for the Test Set and Data Provenance

This information is not provided in the document. The text mentions "non-clinical tests" but gives no details about sample size (e.g., number of cadaveric knees, number of in-vitro scenarios), country of origin, or whether the data was retrospective or prospective.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

This information is not provided in the document. The nature of "non-clinical tests" suggests an experimental setup, but there's no mention of expert involvement for ground truth establishment.

4. Adjudication Method for the Test Set

This information is not provided in the document. Since there's no mention of human experts establishing ground truth or evaluating device outputs in a comparative manner, an adjudication method is not described.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

This information is not provided in the document. The submission does not describe an MRMC study comparing human readers with and without AI assistance. The device is an intra-operative navigation system, not an AI-based diagnostic tool designed for human reader interpretation improvement.

6. Standalone (Algorithm Only) Performance Study

Yes, a form of standalone performance was assessed. The "non-clinical tests" focused on the "accuracy and performance of the system" itself to verify it was "adequate to perform as intended." This implies evaluating the algorithm's output (e.g., calculated alignment axes, instrument positioning) in a controlled setting without human-in-the-loop performance measurement. However, specific details of these tests (e.g., methodology, metrics, results) are not detailed beyond the general statement.

7. Type of Ground Truth Used

The document does not explicitly state the type of ground truth used for these "non-clinical tests." For a stereotaxic instrument assisting in TKR, ground truth would likely involve:

Physical measurements/Metrology: Highly accurate physical measurements of anatomical landmarks, cuts, and component positions using precision instruments in a controlled lab setting (e.g., based on CAD models, CMM measurements, or highly accurate pre-scans).
Simulated anatomical models: Using synthetic bones or cadaveric specimens where true anatomical axes and landmarks are known or can be precisely defined.

8. Sample Size for the Training Set

This information is not provided in the document. The device description does not explicitly mention a "training set" in the context of machine learning, as it appears to be a rule-based or model-based navigation system rather than a deep learning AI model requiring a large training dataset.

9. How Ground Truth for the Training Set Was Established

This information is not provided in the document. As mentioned above, a "training set" in the modern AI sense is not explicitly discussed. If there were calibration or model development data, the method for establishing their ground truth is not described.

Summary

{0}------------------------------------------------

KO21760

SECTION 2: 510(K) SUMMARY OF SAFETY AND EFFECTIVENESS

Applicant: ORTHOsoft Inc. 75 Queen Street, suite 3300 Montreal, Quebec Canada, H3C 2N6 Tel .: 514 861 4074 Fax: 514 866 2197

Contact Person: Christopher McLean

Date Summary Prepared: May 27, 2002

Device Trade Name: Navitrack™ System - Optical TKR CT-Less

Device Classification Name: Stereotaxic Instrument (84 HAW); 21 CFR § 882.4560

Reason for 510(k) Notification: Modifications of indications and technology to a currently cleared device from Orthosoft Inc.

Susbtantial Equivalence Claimed To:

The Navitrack System™ - Optical Option, from Orthosoft Inc. (K002053) The Orthopilot®, from Kinamed Inc. (K003347)

Device Description:

Indications for Use / Intended Use:

The Navitrack™ System - Optical TKR CT-Less is indicated for use as a stereotaxic instrument to assist in the positioning of Total Knee Replacement components intraoperatively.

It is a computer controlled image-guidance system equipped with a three-dimensional tracking sub-system. It is intended to assist the surgeon in determining reference

{1}------------------------------------------------

alignment axes in relation to anatomical landmarks, and in precisely positioning the alignment instruments relative to these axes by displaying their locations.

♥ ♥ U U ▲ !

Technological Comparisons to Substantial Equivalent Devices:

The comparisons showed that the proposed product is equivalent to both the Navitrack and the Orthopilot predicates in terms of the workstation and the tracking technology. The main departures of the proposed product relative to the Navitrack predicate related to its intended use in TKR procedures, and to the technology change of navigating relative to knee alignment axes instead of 3D bone models reconstructed pre-operatively. These new elements were however found to be equivalent to the Orthopilot predicate.

Performance Data:

Non-clinical tests were performed to assess that no new safety and efficacy issues were raised in the device. They consisted in verifying that the accuracy and performance of the system was adequate to perform as intended.

Conclusion:

The information and data provided in this 510(k) Premarket Notification established that the Navitrack "1" System - Optical TKR CT-Less device is substantially equivalent to the legally marketed predicates: the Navitrack System™ - Optical Option, and the Orthopilot®.

{2}------------------------------------------------

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 border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized emblem featuring a symbol that resembles a bird or a person with outstretched arms, composed of three curved lines.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 2 7 2002

ORTHOsoft Inc. Christopher McLean Regulatory Affairs & Quality Assurance Manager 75, Queen Street, suite 3300 Montreal, Quebec Canada H3C 2N6

Re: K021760

Trade/Device Name: Navitrack™ System Optical TKR CT-Less Regulation Number: 882.4560 Regulation Name: Stereotaxic instrument Regulatory Class: Class II Product Code: HAW Dated: May 27, 2002 Received: May 29, 2002

Dear Mr. McLean:

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.

{3}------------------------------------------------

Page 2 - Mr. Christopher McLean

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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of vour device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). 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

ncerely vours 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

{4}------------------------------------------------

KOZI760 510(k) Number:

Device Name: Navitrack™ System - Optical TKR CT-Less

Indications for Use:

The Navitrack™ System - Optical TKR CT-Less is indicated for use as a stereotaxic instrument to assist in the positioning of Total Knee Replacement components intra-operatively.

It is a computer controlled image-guidance system equipped with a threedimensional tracking sub-system. It is intended to assist the surgeon in determining reference alignment axes in relation to anatomical landmarks, and in precisely positioning the alignment instruments relative to these axes by displaying their locations.

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (per 21CFR 801.109)

Over-the-Counter Use

Stupt Plurdu

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

510(k) Number K021760

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).