The Navitrack™ System – Total Hip Replacement is indicated for use as a stereotaxic instrument to assist in the positioning of hip replacement components. It is a computer controlled image-guidance system that integrates a threedimensional tracking sub-system and image-processing software. It is intended to assist in precisely positioning hip replacement components intra-operatively by displaying their positions relative to the bone structures of interest that are modeled pre-operatively from radiology images.

Device Description

The Navitrack™ System - Total Hip Replacement device consists of a software-driven workstation, an optical tracking system, surgical instruments, and tracking accessories. It is designed to assist the surgeon in the placement of Total Hip Replacement (THR) components. Tracking devices are incorporated with given surgical instruments, as well as onto fixation bases that attach to the pelvis, such to allow the ability to track and display to the user their respective positions intra-operatively. The bones of interest are displayed to the user as three-dimensional (3D) surface models, while the instruments are schematically represented. Models of the implant are also represented in order to visualize their placement using the instruments. The 3D models of the pelvis are reconstructed pre-operatively from given CT-images using image processing tools provided with the software. The software also provides planning features by allowing the user to determine pre-operatively an ideal location for the implants as based on the models.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study for the Navitrack™ System - Total Hip Replacement:

1. Table of Acceptance Criteria and Reported Device Performance:

The document mentions that "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." However, it does not provide specific quantitative acceptance criteria or detailed reported device performance metrics. It broadly states that the system's "accuracy and performance...was adequate."

Performance Metric	Acceptance Criteria	Reported Device Performance
Accuracy	Not explicitly stated in the document	"adequate to perform as intended"
Performance	Not explicitly stated in the document	"adequate to perform as intended"

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

The document does not specify the sample size used for the test set. It also does not provide information on the data provenance (e.g., country of origin, retrospective or prospective). The testing appears to be non-clinical, implying it was likely conducted in a lab environment rather than with patient data.

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

The document does not mention the use of experts to establish ground truth for a test set. This is consistent with the nature of the "non-clinical tests" described, which likely involved technical verification rather than medical interpretation.

4. Adjudication Method for the Test Set:

Since there's no mention of experts or a test set requiring interpretation, there's no information on any adjudication method.

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

The document does not describe a multi-reader multi-case (MRMC) comparative effectiveness study. The focus is on the device's standalone performance and its equivalence to predicate devices, not on how human readers perform with or without AI assistance.

6. Standalone (Algorithm Only) Performance:

Yes, a standalone performance assessment was done. 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 indicates that the device, as an "algorithm only without human-in-the loop performance" component, was tested.

7. Type of Ground Truth Used:

The document does not explicitly state the type of ground truth used. Given the nature of the device (a stereotaxic instrument for hip replacement component positioning) and the "non-clinical tests," the ground truth was likely based on engineering specifications, physical measurements, and known geometric truths obtained in a controlled laboratory setting (e.g., using phantoms or precise physical models). It was not based on expert consensus, pathology, or outcomes data in a clinical sense.

8. Sample Size for the Training Set:

The document does not mention a training set sample size. The "non-clinical tests" seem to refer to verification and validation of the completed system, not a machine learning model that would require a separate training set. The device uses "models of the pelvis... reconstructed pre-operatively from given CT-images using image processing tools provided with the software," implying rule-based or traditional image processing rather than data-driven machine learning that typically requires a training set.

9. How Ground Truth for the Training Set Was Established:

Since a training set is not explicitly mentioned as being used for a machine learning model, there's no information on how its ground truth would have been established. The device relies on "image processing tools" and 3D surface model reconstruction from CT images, suggesting a deterministic approach rather than one requiring labeled training data for an AI model.

Summary

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FEB 0 4 2003

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

ORTHOsoft Inc. Applicant: 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: July 19, 2002

Device Trade Name: Navitrack™ System - Total Hip Replacement

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 VectorVision® Hip, from BrainLAB AG (K010602)

Device Description:

Indications for Use / Intended Use:

The Navitrack™ System - Total Hip Replacement is indicated for use as a stereotaxic instrument to assist in the positioning of hip replacement components. It is a computer controlled image-guidance system that integrates a three-dimensional tracking sub-system and image-processing software. It is intended to assist in precisely

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positioning hip replacement components intra-operatively by displaying their positions relative to the bone structures of interest that are modeled pre-operatively from radiology images.

Technological Comparisons to Substantial Equivalent Devices:

The comparisons showed that the proposed product is equivalent to both the Navitrack and the VectorVision Hip predicates in terms of the workstation and the tracking technology. The only significant departures of the proposed product relative to the predicates consisted in the intended use of the proposed device in THR procedures unlike in the Navitrack predicate. However, the VectorVision Hip predicate includes this intended use as well as also being otherwise equivalent.

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™ System - Total Hip Replacement device is substantially equivalent to the legally marketed predicates: the Navitrack System™ - Optical Option, and the VectorVision® Hip.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

FEB 0 4 2003

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

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

Re: K022364

Trade/Device Name: Navitrack System Total Hip Replacement, Model 900.200 Regulation Number: 882.4560 Regulation Name: Stereotaxic Instrument Regulatory Class: Class II Product Code: HAW Dated: November 5, 2002 Received: November 6, 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 lisung (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 - 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), 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). 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,

Mark N Mebena

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:

Device Name: Navitrack™ System - Total Hip Replacement

Indications for Use:

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (per 21CFR 801.109) OR

Over-the-Counter Use

Mark A. Millman

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

510(k) Number K022364

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).