OPTICAL TRACKING SYSTEM MICROSCOPE MODULE II, MODEL OTS MMII by RADIONICS SOFTWARE APPLICATIONS, INC.

Interactive, image-guided means of localizing targets in surgical procedures. OTS 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 above device consists of a software module that allows a variable focused microscope to be used with OTS. The position and trajectory of the microscope's focal point is tracked using light emitting diodes (LEDs) attached to the microscope and viewed by a camera array in conjunction with digital communications with the microscope.

AI/ML Overview

The provided text is a 510(k) summary for the Radionics OTS Microscope Module II. This document primarily focuses on establishing substantial equivalence to predicate devices and does not contain information about acceptance criteria, detailed study designs, or performance metrics that would typically be found in a clinical study report.

Therefore, I cannot fulfill your request for:

A table of acceptance criteria and the reported device performance: This information is not present.
Sample size used for the test set and the data provenance: Not mentioned.
Number of experts used to establish the ground truth for the test set and their qualifications: Not mentioned.
Adjudication method for the test set: Not mentioned.
If a multi-reader multi-case (MRMC) comparative effectiveness study was done, the effect size: Not mentioned.
If a standalone performance (i.e., algorithm only without human-in-the-loop performance) was done: Not mentioned, and this device is an accessory for an optical tracking system, not a standalone diagnostic algorithm.
The type of ground truth used: Not mentioned.
The sample size for the training set: Not mentioned.
How the ground truth for the training set was established: Not mentioned.

Based on the provided text, the device is an accessory (software module) that allows a variable-focused microscope to be used with Radionics Optical Tracking System (OTS). Its clearance is based on substantial equivalence to previously cleared devices (Radionics Microscope Module I and Zeiss Surgical Microscope Navigator System), rather than a detailed clinical performance study with acceptance criteria.

The 510(k) summary focuses on:

Device Name: Radionics OTS Microscope Module II
Common Name: Intraoperative Guidance Device
Classification Name: Stereotaxic instrument (accessory)
Intended Use: Interactive, image-guided means of localizing targets in surgical procedures. Indicated for use in cranial and spinal surgical procedures where anatomical landmarks are not clearly visible or where a desired target is close to critical structures.
Substantial Equivalence: To Radionics Microscope Module I (K981213) and Zeiss Surgical Microscope Navigator System (K965139).
Technological Characteristics: The device consists of a software module that allows a variable focused microscope to be used with OTS. The position and trajectory of the microscope's focal point are tracked using LEDs attached to the microscope, viewed by a camera array, and communicated digitally with the microscope. The technological characteristics are stated to be the same or similar to those found with the predicate device.

To obtain the detailed study information you are asking for, you would typically need to review the full 510(k) submission, which is not provided, or associated clinical trial documentation if any were required for clearance.

Summary

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3/4/99
7.0 510(k) Summary:

/C990326

This summary of the 510(k) safety and effectiveness information is submitted in accordance with the requirements of the Safe Medical Devices Act of 1990 and 21 C.F.R. 807.92.

1.0 The submitter of this premarket notification is:

Kevin J. O'Connell Regulatory Engineer Radionics Software Applications, Inc, 22 Terry Avenue Burlington, MA 01803 Tel .: (781) 272-1233 Fax: (781) 272-2428

This summary was prepared on January 29, 1999.

2.0 The name of the device is the Radionics OTS Microscope Module II for use with Radionics Optical Tracking System (OTS). The common name is an Intraoperative Guidance Device, and its classification name is a Stereotaxic instrument (accessory).
3.0 The above device is substantial equivalent to the Radionics Microscope Module I cleared via 510(k) K981213 and Zeiss Surgical Microscope Navigator System cleared via 510(k) K965139.
4.0 The above device consists of a software module that allows a variable focused microscope to be used with OTS. The position and trajectory of the microscope's focal point is tracked using light emitting diodes (LEDs) attached to the microscope and viewed by a camera array in conjunction with digital communications with the microscope.
5.0 The device like its predicates is intended for cranial and spinal surgical procedures.
6.0 The technological characteristics are the same or similar to those found with the predicate device.

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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of an eagle or bird-like figure with three stylized wing segments.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR - 4 1999

Mr. Kevin J. O'Connell Regulatory Engineer Radionics Software Applications, Inc. 22 Terry Avenue Burlington, Massachusetts 01803

Re: K990326

Trade Name: Optional Tracking System (OTS) Microscope Module II Regulatory Class: II Product Code: HAW Dated: February 1, 1999 Received: February 2, 1999

Dear Mr. O'Connell:

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 (OS) 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. Kevin J. O'Connell

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/dsmamain.html".

Sincerely yours,

Stpt Rhodes

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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11:48

510(k) Number (if known):
K990326

Device Name: Optical Tracking System (OTS) Microscope Module II

Indications for use:

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Hok Elurch

15990326

PRESCRIPTION USE _X

Over-The-Counter Use

(Per 21 CFR 801.109

(Optional Format 1-2-96)

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).