The Navitrack™ System is a stereotaxic instrument indicated for use in precisely positioning instruments or implants during orthopedic surgery, such as operation perform within spinal structures.

Device Description

The main components of the Navitrack™ system are: Computer Workstation and device display, Localization System, and Tools and instruments. The computer workstation runs the software and is linked to position sensors fixed on surgical tools. The localization system consists of a Position Sensor Unit (Magnetic Field Digitizer) and the Navitrack™ Software, using electromagnetic transmitters and receivers to measure six degrees of freedom for tool position and attitude. Electromagnetic receivers are fixed to surgical tools, and a positioning sensor on a reference clamp is attached to the bone to be instrumented to follow bone structure movements.

AI/ML Overview

The provided text describes the Navitrack™ Computer-Assisted Surgery System and its 510(k) submission. However, it does not contain specific details about acceptance criteria, the study design, sample sizes, ground truth establishment, or expert qualifications as requested. The document states that "Performance tests were done on the Navitrack™ System. These tests along with clinical studies demonstrate that the Navitrack™ System is safe and accurate in performing the stated intended use. The results of those tests and studies are attached to this submission," but the attached results are not included in the provided text.

Therefore, I cannot provide the detailed information requested in the format of a table or specific answers to most of the questions using only the provided text.

Based on the available text, here's what can be inferred:

1. A table of acceptance criteria and the reported device performance:

This information is not explicitly provided in the given text. The document states that "Performance tests were done on the Navitrack™ System" and that these tests "demonstrate that the Navitrack™ System is safe and accurate in performing the stated intended use," but no specific criteria or quantitative performance metrics are listed.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

This information is not provided in the given text.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):

This information is not provided in the given text. The study mentions "clinical studies" but no details on expert involvement or ground truth establishment.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

This information is not provided in the given text.

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:

The document describes the Navitrack™ System as a "Computer-Assisted Surgery System" and a "stereotaxic instrument" that "enables the surgeon to review radiology images... This system also enables the surgeon to virtually manipulate bone structures... in order to perform pre-operative planning." While it's a computer-assisted system, there is no mention of an MRMC study, "human readers," or "AI" in the context of the requested comparative effectiveness study. The term "AI" itself was not commonly used in regulatory submissions in 1998 in the same way it is today for specific performance evaluations.

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

The device is described as assisting the surgeon by "virtually displaying simultaneously the surgical tools and the structure of interest." This implies a human-in-the-loop system. The text doesn't specify if a standalone performance evaluation of the "algorithm only" was conducted. Given the nature of a computer-assisted surgery system, standalone performance without a surgeon would likely be irrelevant or not the primary evaluation metric.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

This information is not provided in the given text. The document refers to "clinical studies" but does not detail how ground truth was established within those studies.

8. The sample size for the training set:

This information is not provided in the given text. The document does not discuss a "training set" in the context of "AI" or machine learning algorithms, which is generally associated with such terminology.

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

This information is not provided in the given text.

Summary

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વે JUL

ORIGINAL 510K SUBMISSION NAVITRACK™ COMPUTER-ASSISTED SURGERY SYSTEM

SECTION 2 : 510(K) SUMMARY

K98/315

This summary of 510(k) safety and effectiveness information is submitted in accordance with the requirements of SMDA 1990 and CFR § 807.92.

A. SUBMITTER INFORMATION

1. Company Name :	ORTHOsoft Inc.
2. Company Address :	40, Bates Road, suite 240
	Outremont, Quebec
	Canada, H2V 1A8
3. Company Phone :	(514)-276-4074
4. Contact Person :	Nicole Landreville, Eng.I.T.
	Quality Manager
	ORTHOsoft Inc.
5. Date Summary Prepared :	April 8th, 1998

B. DEVICE IDENTIFICATION

1. Proprietary Name :	Navitrack™ System
2. Classification Name :	Stereotaxic Instrument (84 HAW)21 CFR § 882.4560

C. IDENTIFICATION OF PREDICATE DEVICES

The Navitrack™ System is substantially equivalent to the following legally marketed devices :

The Regulus™ Navigator from COMPASS International Inc. (K964229), determined . to be substantially equivalent to a legally marketed device on August 19, 1997.
. The Surgical Microscope Navigator System from Zeiss (K965139), determined to be substantially equivalent to a legally marketed device on April 23, 1997.

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D. DEVICE DESCRIPTION

The main components of the Navitrack™ system are:

D.1. Computer Workstation and device display

All the software implemented by ORTHOsoft and part of the Navitrack™ system resides and runs on a computer workstation. The computer is installed inside the device chassis and is linked to position sensors fixed on the surgical tools via cable, in order to follow surgeon movements.

D.2. Localization System

The localization system is made of a Position Sensor Unit (Magnetic Field Digitizer) and the Navitrack™ Software. Since the positioning sensors have the ability to measure six degrees of freedom, only one of these sensors will be required to monitor the 3 dimensional position and the attitude of each tool.

The electromagnetic transmitter and receivers are connected to electronic units, which perform position computations and relay information to the workstation.

D.3. Tools and instruments

The computer software is adapted to the surgical equipment. Electromagnetic receivers are fixed to the surgical tools. In order to follow the bone structure movements, a positioning sensor mounted onto a reference clamp is attached to the bone to be instrumented.

E. INTENDED USE

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

The Navitrack™ System enables the surgeon to review radiology images from different modalities in two-dimensional and three-dimensional display. This system also enables the surgeon to virtually manipulate bone structures as reconstructed from these modalities in order to perform pre-operative planning.

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ORIGINAL 510K SUBMISSION NAVITRACK™ COMPUTER-ASSISTED SURGERY SYSTEM

F. COMPARISON WITH SUBSTANTIALLY EQUIVALENT DEVICES

The Navitrack™ is substantially equivalent to the following legally marketed predicate devices :

The Navitrack™ System is substantially equivalent to the Zeiss Surgical Microscope . Navigator (SMN) System with regard to its intended use which is navigational support during surgery. Both systems are indicated for use in orthopedic surgery.
The Navitrack™ System is substantially equivalent to the Compass Regulus™ . Navigator with regard to its basic functions as a computer-assisted surgery system that incorporates a reconstruction software module intended to visualize the structure orientation within the anatomy of the human body

The Navitrack™ System, the Zeiss Surgical Microscope Navigator System and the Regulus™ Navigator are stereotaxic instruments intended to provide the surgeon with navigational support during surgery. Basically, these systems assist surgery by virtually displaying simultaneously the surgical tools and the structure of interest.

Differences that exist between these systems and Navitrack ™ relate to physical appearance and materials, options and accessories, and control systems. They do not affect the relative safety or effectiveness of the Navitrack™ System.

G. TECHNOLOGICAL CHARACTERISTICS

The fundamental technical characteristics of the Navitrack™ are similar or identical to those of the predicate devices and are listed on the comparison table provided in this submission. Technical differences that exist between these systems do not affect the relative safety or effectiveness of the Navitrack device.

H. PERFORMANCE DATA

Performance tests were done on the Navitrack™ System.

These tests along with clinical studies demonstrate that the Navitrack™ System is safe and accurate in performing the stated intended use.

The results of those tests and studies are attached to this submission.

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I. PREMARKET NOTIFICATION 510(k) CHECKLIST

This notification contains all information required by 21 CFR 807.87. A completed copy of the Premarket Notification 510(k) Reviewer's Checklist is provided at the beginning of this submission.

J. CONCLUSION

The information and data provided in this 510(k) Notification establish that the Navitrack™ System is substantially equivalent to the legally marketed predicate devices.

.. ***

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Image /page/4/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. In the center of the seal is an abstract image of an eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

d 1698 JUL

Ms. Nicole Landreville, Eng.I.T. · Quality Manager Orthosoft, Inc. 40 Bates Road, Suite 240 Outremont. Quebec Canada, H2V 1A8

Re: K981315 Trade Name: Navitrack Regulatory Class: II Product Code: HAW Dated: April 8, 1998 Received: April 10, 1998

Dear Ms. Landreville:

We have reviewed your Section 510(k) 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (OS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

This letter will allow you to begin marketing your device as described in your 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.

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Page 2 - Ms. Nicole Landreville

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4595. 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" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

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

Enclosure

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1900010

April 8th, 1998

510(k) Number :

Device Name : Navitrack™ System

Indications for Use : The Navitrack™ System is a stereotaxic instrument indicated for use in precisely positioning instruments or implants during orthopedic surgery, such as operation perform within spinal structures.

(Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)
Division of General Restorative Devices
510(k) Number	K981315

Prescription Use(Per 21 CFR 801.109)	OR	Over-the-Counter Use __________
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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).