The Optical Tracking System (OTS) with Surface Matching Module is a graphical planning tool that allows for pre-operative and operative planning of cranial and spinal surgical procedures. The OTS with Surface Matching Module is indicated for use in cranial and spinal surgical procedures in which anatomical landmarks are not clearly visible or where a desired target is close to critical structures.

Device Description

The OTS with Surface Matching Module is a graphical planning tool that allows for preoperative and operative planning of cranial and spinal surgical procedures. The Surface Matching Module offers an alternate method of registering the patient to their scans. The OTS with Surface Matching Module, addressed in this premarket notification, has the same intended use and technological characteristics as the commercially available OTS, and Stealth Station Image-Guided Surgery System with SurfaceMerge registration option. Like the commercially available OTS, the OTS with Surface Matching Module offers the following functionality:

Ability to plan frameless stereotactic surgical procedures from scanned images;
Ability to plan stereotactic procedures performed with a Radionics CRW framed . system;
. Display of image slices in 3D reconstructed space;
Ability to display probe tip position in 2D and 3D displays;
Ability to display "real-time" position of the probe in 2D image space;
Ability to reconstruct oblique slices;
. Use of Pointer (probe) as a Mouse to operate program.

AI/ML Overview

The provided 510(k) summary for the "Optical Tracking System with Surface Matching Module" does not contain a detailed study proving the device meets specific acceptance criteria in the format requested. Modern 510(k) submissions typically include more explicit performance data.

Based on the available text, here's what can be extracted and inferred, along with what is explicitly stated as not present:

1. Table of Acceptance Criteria and Reported Device Performance:

The document states, "The RSA Surface Matching system testing rigorously tests the features of the software. The results of the testing indicate that the OTS with Surface Matching Module is safe and reliable for its intended use." However, specific numerical acceptance criteria (e.g., accuracy, precision thresholds) and the corresponding reported performance data are not provided in this summary.

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

Sample Size: Not specified.
Data Provenance: Not specified (e.g., country of origin, retrospective or prospective). The text only mentions "system testing."

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

This information is not provided. The summary does not detail how ground truth was established for "system testing."

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

This information is not provided.

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:

MRMC Study: No, an MRMC comparative effectiveness study is not mentioned. This device is an image-guided surgery system, not an AI for image interpretation by human readers. It's a tool for surgeons.
Effect size of human improvement: Not applicable given the type of device and lack of an MRMC study.

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

The device is an "Optical Tracking System with Surface Matching Module," which is inherently designed for human-in-the-loop surgical guidance. Therefore, a standalone (algorithm only) performance assessment in the context of interpretation AI is not applicable or described for this type of device. Its "standalone" function would be its ability to accurately track and register, but specific metrics are not detailed.

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

The specific type of ground truth used for the "system testing" is not provided. For a tracking and registration system, ground truth might involve physical phantoms with known fiducial locations or highly accurate alternative measurement systems, but this is not detailed.

8. The sample size for the training set:

The term "training set" in the context of machine learning (AI) is not used, and no such details are provided. It's unlikely this device, from 1998, utilized a machine learning approach that would necessitate a "training set" in the modern sense. The "Surface Matching Module" likely uses classical image processing and registration algorithms.

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

As no training set (in the machine learning sense) is mentioned, this information is not applicable.

Summary

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12983669 Optical Tracking System with Surface Matching Module 510(k)

Appendix A: Summary of Safety and Effectiveness

General Information

Classification:	Class II
Common Name:	Optical Frameless Planning System
Device Trade Name:	OTS with Surface Matching Module
Intended Use:	The Optical Tracking System (OTS) with SurfaceMatching Module is a graphical planning tool thatallows for pre-operative and operative planning ofcranial and spinal surgical procedures. The OTSwith Surface Matching Module is indicated for usein cranial and spinal surgical procedures in whichanatomical landmarks are not clearly visible orwhere a desired target is close to critical structures.
Predicate Devices:	Radionics Optical Tracking System (#K974602)Stealth Station Image-Guided Surgery System(K954276) with SurfaceMerge Registration option
Establishment Name and Address:	Radionics Software Applications, Inc.22 Terry AvenueBurlington, MA 01803
Contact Name and Phone	David Cromwick, (781) 272-1233
Date Summary was prepared	October 2, 1998
Establishment Registration Number:	1222895
Performance Standards:	None established under Section 514

Substantial Equivalence Determination

A summary of the information contained in this premarket notification that addresses safety and effectiveness follows.

Description of the Device and Basis for Substantial Equivalence

Ability to plan frameless stereotactic surgical procedures from scanned images; ●
Ability to plan stereotactic procedures performed with a Radionics CRW framed . system;
. Display of image slices in 3D reconstructed space;
Ability to display probe tip position in 2D and 3D displays; ●
Ability to display "real-time" position of the probe in 2D image space; .

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Optical Tracking System with Surface Matching Module 510(k)

Appendix A: Summary of Safety and Effectiveness

Description of the Device and Basis for Substantial Equivalence (Continued)

Ability to reconstruct oblique slices; .
. Use of Pointer (probe) as a Mouse to operate program.

Safety Summary

The RSA Surface Matching system testing rigorously tests the features of the software. The results of the testing indicate that the OTS with Surface Matching Module is safe and reliable for its intended use.

General Safety and Effectiveness Concerns

The device labeling contains Instructions for Use which include indications for use, cautions and warnings, as well as the general operating instructions required for proper use of the device. In addition, thorough training and support is provided to clinics that acquire and use the OTS. This information promotes safe and effective use of the device.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV 1 8 1998

Mr. David Cromwick Radionics, Inc. Director of Regulatory Affairs and Quality Assurance 22 Terry Avenue Burlington, Massachusetts 01803

Re: K983669

Trade Name: Optical Tracking System With Surface Matching Module, Model OTS Regulatory Class: II Product Code: HAW Dated: October 12, 1998 Received: October 19, 1998

Dear Mr. Cromwick:

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 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). 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 requirements, as set forth in the Quality System Regulation (QS) 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.

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Page 2 - Mr. David Cromwick

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.

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/dsma/dsmamain.html".

Sincerely yours.

signature

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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Optical Tracking System with Surface Matching Module 510(k)

Section II: Indications for Use

Indications for Use:

The Optical Tracking System (OTS) is a graphical planning tool that allows for pre-operative and operative planning of cranial and spinal surgical procedures. The OTS is indicated for use in cranial and spinal surgical procedures in which anatomical structures are not clearly visible or where a desired target is close to critical regions.

Prescription Use
(Per 21 CFR 801.109)

sedlo

(Division Sign-Off)
Division of General Restorative Devices
510(k) Number. 14983669

Optical Tracking System with Surface Matching Module 510(k) II-1

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).