The Navitrack™ System - FluoroSpine is a stereotaxic instrument indicated for use in precisely positioning instruments or implants during orthopaedic surgery, such as operations performed within spinal structures.

The Navitrack™ System enables the surgeon to review radiology images from different modalities in 2D and 3D display. This system also enables the surgeon to virtually manipulate bone structures as reconstructed from these modalities in order to perform preoperative planning.

Device Description

The Navitrack "10 System - FluoroSpine 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 spine reconstruction components relative to the vertebrae. Tracking devices are incorporated with given surgical instruments, as well as on to bases that attach to the vertebrae, such to allow the ability to track and display to the user their respective positions intra-operatively. The vertebrae are displayed to the user as based on a fluoroscopic image obtained at the beginning of the procedure. Given instrument and implant components that need to be positioned are schematically represented superimposed on the vertebrae image to depict their relative locations.

AI/ML Overview

The provided text describes the Navitrack™ System - FluoroSpine, a stereotaxic instrument for orthopedic surgery, and its 510(k) submission (K031156). However, the document does not explicitly state specific acceptance criteria or report detailed performance metrics with numerical values in a table format.

Instead, the submission focuses on demonstrating substantial equivalence to a predicate device (Navitrack System™ - Optical Option). The performance data section vaguely 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 as compared to the predicate." This indicates that the performance criteria were implicitly tied to matching or not degrading from the predicate's performance.

Given the information provided, here's an attempt to outline the requested details, with significant parts indicating where information is not available in the given text:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Implied/Referenced)	Reported Device Performance (Implied)
Accuracy of system adequate (compared to predicate)	The system's accuracy was found to be "adequate as compared to the predicate." The specific numerical accuracy values or metrics (e.g., in millimeters, degrees) or the defined threshold for "adequate" are not detailed in this document.
Performance of system adequate (compared to predicate)	The system's performance was found to be "adequate as compared to the predicate." The specific performance metrics (e.g., speed, reliability, precision) or the defined threshold for "adequate" are not detailed in this document.
No new safety and efficacy issues raised	Non-clinical tests were performed to "assess that no new safety and efficacy issues were raised." No specific issues were identified.
Substantial equivalence to predicate	The device was found to be substantially equivalent to the Navitrack System™ - Optical Option predicate, implying it meets similar safety and efficacy profiles.

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

Sample Size for Test Set: Not specified in the provided document. The text only mentions "Non-clinical tests were performed." It does not detail specific cases, images, or scenarios used in testing.
Data Provenance: Not specified. There is no mention of country of origin, or whether the data was retrospective or prospective. Given the non-clinical nature mentioned, it's likely referring to bench testing or simulations rather than patient data.

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

Number of Experts: Not specified.
Qualifications of Experts: Not specified.
The document focuses on "non-clinical tests" and comparison to a predicate, not on a study involving expert-established ground truth for a test set of clinical images.

4. Adjudication Method for the Test Set

Adjudication Method: Not specified/Not applicable. As no expert review or ground truth establishment based on clinical data is detailed, an adjudication method is not described.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

MRMC Study: No, an MRMC comparative effectiveness study involving human readers with and without AI assistance was not mentioned in the provided document. The evaluation focused on the device's functional equivalence to a predicate.
Effect Size of Human Readers with AI vs. without AI Assistance: Not applicable as no MRMC study was reported.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study Was Done

Standalone Study: The document describes "non-clinical tests" to verify "accuracy and performance of the system." While not explicitly called a "standalone study," the nature of these tests, comparing the system's output to that of the predicate, suggests an evaluation of the algorithm/system's inherent performance rather than human-in-the-loop performance. However, the exact methodology and metrics are not detailed.

7. The Type of Ground Truth Used

Type of Ground Truth: The document implies that the ground truth for "accuracy and performance" verification was likely established by the performance of the predicate device (Navitrack System™ - Optical Option) or by known engineering specifications/measurements for the new system's components and overall function during non-clinical testing. It is not based on expert consensus, pathology, or outcomes data as would be typical for image analysis AI.

8. The Sample Size for the Training Set

Sample Size for Training Set: Not applicable/Not specified. The Navitrack™ System - FluoroSpine is described as a software-driven workstation that assists surgeons by superimposing schematic representations on fluoroscopic images. It is not an AI/ML algorithm that learns from a training set in the typical sense (e.g., for image classification or segmentation). Its functionality involves processing real-time fluoroscopic images and tracking instruments. The document describes "changes to the software" and new accessories, implying engineering and software development, but not a machine learning training phase with a specific dataset.

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

Ground Truth for Training Set: Not applicable/Not specified. As the device is not presented as an AI/ML system trained on a dataset requiring labeled ground truth in the traditional sense, this information is not relevant or provided in the context of this 510(k) summary. The "ground truth" for its development would be based on engineering principles, physics of imaging, and surgical requirements for accuracy and usability.

Summary

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K031156

510(K) SUMMARY OF SAFETY AND EFFECTIVENESS Navitrack™ System - FluoroSpine

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: April 9, 2003

Device Trade Name: Navitrack™ System – FluoroSpine

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

Predicate Device:

Navitrack System™ - Optical Option, from Orthosoft Inc, 510(k) # K002053

Device Description:

Indications for Use / Intended Use:

This is identical to the Navitrack System™ - Optical Option predicate.

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11 Ko31156

Technological Comparisons to the Predicates:

The comparisons showed that the proposed device is substantially equivalent to the Navitrack System - Optical Option. It is a modification to the predicate. The fundamental scientific technology of the Navitrack predicate is unchanged. It utilizes the same workstation, tracking technology, and instruments. The modification consists in using images obtained from a fluoroscope to depict the tracked vertebrae, as compared to using model depictions reconstructed from CT-scans as in the Navitrack. This involved changes to the software and the inclusion of accessories. The new accessories involve a device to calibrate and correct the distortion of the source x-ray image and correct the image projection plane during navigation, and an x-ray detector device to trigger the system to record the image when the user activates the fluoroscope. In addition, changes to the ergonomics of the software user interface were incorporated to improve userfriendliness.

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 as compared to the predicate.

Conclusion:

The information and data provided in this 510(k) Premarket Notification established that the proposed Navitrack™ System - FluoroSpine device is substantially equivalent to the Navitrack System™ - Optical Option predicate.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of an eagle.

Public Health Service

MAY - 9 2003

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Christopher McLean, Eng. Regulatory Affairs and Quality Assurance Manager ORTHOsoft, Inc. 75, Queen Street, Suite 3300 Montréal, Quebec Canada H3C2N6

Re: K031156

Trade/Device Name: Navitrak™ System-FluoroSpine Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic instrument Regulatory Class: II Product Code: HAW Dated: April 10, 2003 Received: April 14, 2003

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.

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Page 2 - Mr. Christopher McLean, Eng.

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:

Device Name: Navitrack™ System – FluoroSpine

Indications for Use:

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (per 21CFR 801.109)

Over-the-Counter Use__________________________________________________________________________________________________________________________________________________________

Miriam C. Provost

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

KO31156 510(k) Number -

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).