The METRx™ Microscope is indicated for visualization of the surgical field in any area of the body cut open during a surgical procedure. When used in the cervial, thoracic, or lumbar spine either from an anterior or posterior direction, for example, the METRx Microscope and accessories are intended to aid the surgeon's visualization of the surgical area and allow him/her to perform any type of surgical spinal procedure such as herniated disc repair, visualization of the circumferential decompression of the nerve roots, aiding in the search and removal of nucleus material, spinal fusion, or insertion of spinal implants. Other examples of generic surgical use of the METRx Microscope would be for use in the knee, ankle, shoulder, hand, wrist, and temporomandibular joint (TMJ).

Device Description

Not Found

AI/ML Overview

This 510(k) summary for the METRx Microscope and Accessories (K002931) does not contain the information requested to describe acceptance criteria and associated study results for a device that relies on an algorithm or AI.

The document is a traditional 510(k) premarket notification for a medical device (a microscope and its accessories) and focuses on demonstrating substantial equivalence to a predicate device based on technological characteristics and intended use. This type of submission predates the widespread use of AI/ML in medical devices and therefore does not include the detailed performance evaluation against predefined criteria that would be required for such a device today.

Therefore, I cannot extract the following information from the provided text:

A table of acceptance criteria and the reported device performance: This document does not define specific performance metrics or acceptance criteria in the way an AI/ML device submission would.
Sample size used for the test set and the data provenance: Not applicable as there is no mention of a "test set" in the context of algorithm performance.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
Adjudication method for the test set: Not applicable.
If a multi reader multi case (MRMC) comparative effectiveness study was done: Not applicable.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
The type of ground truth used: Not applicable.
The sample size for the training set: Not applicable.
How the ground truth for the training set was established: Not applicable.

Summary of what the document does provide:

Device Name: METRx™ System (Microscope and Accessories)
510(k) Number: K002931
Submission Date: September 2000
Clearance Date: November 24, 2000
Indications for Use: Visualization of the surgical field in any area of the body cut open during a surgical procedure, with specific examples for cervical, thoracic, or lumbar spine procedures (herniated disc repair, nerve root decompression, nucleus material removal, spinal fusion, implant insertion) and other generic surgical uses (knee, ankle, shoulder, hand, wrist, TMJ).
Basis for Clearance: Substantial equivalence to predicate devices based on technological characteristics.

To obtain the requested information, a document describing the validation of an AI/ML medical device would be needed.

Summary

510(k) Summary - METRx Microscope and Accessories

Page 1

NOV 24 2000

510(k) Summary
METRx Microscope and Accessories
September 2000

K002931

I. Company:

Medtronic Sofamor Danek
1800 Pyramid Place
Memphis, TN 38120
901-396-3133
Richard W. Treharne, Ph.D.

II. Product Trade Name:

METRx™ System
Common or usual name: Microscope
Classification name: Microscope and Accessories (FSO and EPT as described in 21 CFR 878.4700)

III. The labeled indications for use for the METRx™ System are as follows:

The METRx™ Microscope is indicated for visualization of the surgical field in any area of the body cut open during a surgical procedure. When used in the cervial, thoracic, or lumbar spine either from an anterior or posterior direction, for example; the METRx Microscope and accessories are intended to aid the surgeon's visualization of the surgical area and allow him/her to perform any type of surgical spinal procedure such as herniated disc repair, visualization of the circumferential decompression of the nerve roots, aiding in the search and removal of nucleus material, spinal fusion, or insertion of spinal implants. Other examples of generic surgical use of the METRx Microscope would be for use in the knee, ankle, shoulder, hand, wrist, and temporomandibular joint (TMJ).

VI. The technological characteristics of the device were claimed be the same as or substantially equivalent to those of predicate devices.

Page 2

DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration
9200 Corporate Boulevard
Rockville MD 20850

NOV 24 2000

Richard W. Treharne, Ph.D.
Senior Vice President, Regulatory Affairs
Medtronic Sofamor Danek
1800 Pyramid Place
Memphis, Tennessee 38132

Re: K002931
Trade Name: METRx™ System
Regulatory Class: II
Product Code: HRX
Dated: September 18, 2000
Received: September 20, 2000

Dear Dr. Treharne:

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 (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.

Page 3

Page 2 - Richard W. Treharne, Ph.D.

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,

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

Page 4

Page 1 of 1

510(k) Number (if known): K002931

Device Name: METRx™ Microscope - Indications Modification

Indications For Use:

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

Concurrence of CDRH, Office Of Device Evaluation (ODE)

Prescription Use ✓ OR Over-The-Counter Use____
(Per 21 CFR 801.109) (Optional Format 1-2-96)

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

510(k) Number K002931

Regulation Number and Section

§ 888.1100 Arthroscope.

(a)
Identification. An arthroscope is an electrically powered endoscope intended to make visible the interior of a joint. The arthroscope and accessories also is intended to perform surgery within a joint.(b)
Classification. (1) Class II (performance standards).(2) Class I for the following manual arthroscopic instruments: cannulas, currettes, drill guides, forceps, gouges, graspers, knives, obturators, osteotomes, probes, punches, rasps, retractors, rongeurs, suture passers, suture knotpushers, suture punches, switching rods, and trocars. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 888.9.