The StealthStation® System is intended as an aid for precisely locating anatomical structures in either open or percutaneous procedures. The StealthStation® System is indicated for any medical condition in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure, such as the skull, a long bone, or vertebra, can be identified relative to a CT or MR based model or fluoroscopy images of the anatomy.

Example procedures include, but are not limited to:

Cranial Procedures:

Cranial biopsies Tumor resections Craniotomies/ Craniectomies Skull base procedures Thalamotomies/Pallidotomies Pituitary Tumor Removal CSF Leak Repair

ENT Procedures:

Transphenoidal procedures Intranasal procedures Orbital Decompression Procedures Optic Nerve Decompression Procedures Polyposis Procedures Endoscopic Dacryocystorhinostomy Encephalocele Procedures Sinus procedures, such as Maxillary antrostomies, Ethmoidectomies, Sphenoidotomies/Sphenoid explorations, Turbinate resections, and Frontal sinusotomies Orthopedic Procedures:

pedicle screw placement.

Spinal Procedures:

Total Knee Arthroplasty (Primary and Revision) Unicompartmental Knee Arthroplasty

Spinal implant procedures, such as

Device Description

This submission describes a modification to the StealthStation® System FluoroNav™ III. Module to provide for image guided knee surgery and orthopedic indications.

AI/ML Overview

The provided text is a summary of safety and effectiveness for the Knee Module for the StealthStation® System, focusing on its substantial equivalence to predicate devices rather than a detailed study report with specific acceptance criteria or performance metrics. Therefore, much of the requested information cannot be extracted directly from this document.

Here's a breakdown of what can and cannot be answered based on the provided text:

1. Table of acceptance criteria and the reported device performance

This document does not specify quantitative acceptance criteria or detailed performance metrics from a study. It states that "Performance data was provided to support the claim of substantial equivalence," but the data itself is not presented.

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

This information is not available in the provided 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 available in the provided text.

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

This information is not available in the provided 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

This is a navigation system for surgery, not an AI-assisted diagnostic tool for "human readers." Therefore, an MRMC comparative effectiveness study involving human readers with or without AI assistance is not applicable in this context. The document does not mention any studies in this vein.

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

The device is a "Knee Module for the StealthStation® System," described as an "aid for precisely locating anatomical structures in either open or percutaneous procedures." This strongly implies human-in-the-loop performance during surgical navigation. The document does not describe a standalone performance study of an algorithm without human interaction.

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

This information is not available in the provided text. For a surgical navigation system, "ground truth" would typically relate to the accuracy of anatomical localization compared to actual anatomical structures, but the method of establishing this is not detailed here.

8. The sample size for the training set

This information is not available in the provided text.

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

This information is not available in the provided text.

In summary, the provided document focuses on the regulatory submission and FDA's determination of substantial equivalence for the Knee Module for the StealthStation® System. It does not contain the detailed study information regarding acceptance criteria, performance data, sample sizes, or ground truth establishment that would typically be found in a comprehensive clinical study report.

Summary

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JAN 2 5 2002

Summary of Safety and Effectiveness

Knee Module for the StealthStation® System

Medtronic Surgical Navigation Technologies I. Company: 826 Coal Creek Circle Louisville, CO 80027 (720) 890-3200
Product Name: Knee Module for the StealthStation® System II.
This submission describes a modification to the StealthStation® System FluoroNav™ III. Module to provide for image guided knee surgery and orthopedic indications.
The indications for use for the Knee Module for the StealthStation® System are as IV. follows:

Example procedures include, but are not limited to:

Cranial Procedures:

Cranial biopsies Tumor resections Craniotomies/ Craniectomies Skull base procedures Thalamotomies/Pallidotomies Pituitary Tumor Removal CSF Leak Repair

ENT Procedures:

pedicle screw placement.

Spinal Procedures:

Total Knee Arthroplasty (Primary and Revision) Unicompartmental Knee Arthroplasty

Spinal implant procedures, such as

The Knee Module for the StealthStation® System was shown to be substantially equivalent V. 1110 Knoor inoade 101 Ris Brown. System, the FluoroNav™ Module for the StealthStation® System and the Orthopilot® System. Performance data was provided to support the claim of substantial equivalence.

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Image /page/1/Picture/1 description: The image is a black and white circular seal for the Department of Health & Human Services - USA. The seal features the department's name in a circular pattern around the edge. In the center of the seal is an abstract image of a bird or eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN 2 5 2002

Victoria G. Rendon Clinical and Regulatory Affairs Associate Medtronic Surgical Navigation Technologies 826 Coal Creek Circle Louisville, Colorado 80027

Re: K012937

Trade Name: Knee Module for the Stealthstation® System Regulation Number: 882.4560 Regulation Name: Stereotaxic instrument Regulatory Class: II Product Code: HAW Dated: November 26, 2001 Received: November 27, 2001

Dear Ms. Rendon:

We have reviewed your Section 510(k) premarket 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) 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 - Ms. Victoria Rendon

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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), 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). 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,

bo Mich n Millerson

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 (if known):

Device Name: Knee Module for the StealthStation® System

Indications For Use:

The StealthStation® System is intended as an aid for precisely locating anatomical structures in I he Steallinstation® System is an are for processor System is indicated for any medical entified of perculaneous proceants. The creating be appropriate, and where reference to a condition in wincil the use of stereoucate only of your sprestebra, can be identified relative to a CT or MR based model or fluoroscopy images of the anatomy.

Example procedures include, but are not limited to:

Cranial Procedures:

Cranial biopsies

Tumor resections

Craniotomies/ Craniectomies

Skull base procedures

Thalamotomies/Pallidotomies

Pituitary Tumor Removal

CSF Leak Repair

ENT Procedures:

Transphenoidal procedures

Intranasal procedures

Orbital Decompression Procedures

Optic Nerve Decompression Procedures

Polyposis Procedures

Endoscopic Dacryocystorhinostomy

Encephalocele Procedures

Sinus procedures, such as Maxillary antrostomies, Ethmoidectomies, Sphenoidotomies/Sphenoid explorations, Turbinate resections, and Frontal sinusotomies

Spinal Procedures:

Spinal implant procedures, such as pedicle screw placement.

Orthopedic Procedures:

Total Knee Arthroplasty (Primary and Revision)

Unicompartmental Knee Arthroplasty

Mark McNemar

Restorative and Neurologic

510(k) Number

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

Concurrence of CDRH, Office Of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109) OR

Over-The-Counter Use

(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).