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, fluoroscopy images, or digitized landmarks of the anatomy.

For the optical-based and EM-based system, 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 Pediatric Catheter Shunt Placement General Catheter Shunt Placement

Orthopaedic Procedures: Total Knee Arthroplasty (Primary and Revision) Unicompartmental Knee Arthroplasty

Spinal Procedures: Spinal Implant Procedures, such as Pedicle Screw Placement

ENT Procedures: Transphenoidal Procedures Intranasal Procedures Orbital Nerve Decompression Procedures Optic Nerve Decompression Procedures Polyposis Procedures Endoscopic Dacryocystorhinostomy Encephalocele Procedures Sinus procedures, such as Maxillary Antrostomies. Ethmoidectornies, Sphenoidotomies/Sphenoid Explorations, Turbinate Resections, and Frontal Sinusotomies

Additional example procedures for the optical-based system include, but are not limited to:

Total Knee Arthroplasty (Primary and Revision) Unicompartmental Knee Arthroplasty Minimally Invasive Orthopaedic Procedures Pediatric Orthopaedics Total Hip Replacement (Primary and Revision) Periacetabular Osteotomies Tumor Resection and Bone/Joint Reconstruction Femoral Revision Placement of Iliosacral Screws Stabilization and Repair of Pelvic Fractures (Including but not limited to Acetabular Fractures)

Device Description

This submission provides an update to the StealthStation® System, including a new computer hardware and operating system options, a passive-only optical digitizer option, new cranial reference frame and EM reference frame.

AI/ML Overview

I am sorry, but the provided text from K050438, "Summary of Safety and Effectiveness StealthStation® System Update," does not contain the specific details about acceptance criteria, device performance, or human study methodologies that you've requested.

This document primarily focuses on:

Device Identification: Naming the device, classification, and contact information.
Device Modification: Describing the updates to the StealthStation® System (new computer hardware, operating system, digitizer options, and reference frames).
Substantial Equivalence: Stating that the updated system was shown to be substantially equivalent to previously cleared versions and that verification and validation activities were performed.
Indications for Use: Reiterating the established indications for use for the StealthStation System, which remain unchanged by this update, and listing various cranial, spinal, ENT, and orthopaedic procedures for which it is indicated.
FDA Correspondence: The FDA's letter confirming the 510(k) clearance and substantial equivalence.

There is no information within this document about:

A table of acceptance criteria and reported device performance.
Sample sizes for test sets, data provenance, or the number/qualifications of experts.
Adjudication methods.
Multi-reader multi-case (MRMC) comparative effectiveness studies or effect sizes for human improvement with AI.
Standalone algorithm performance studies.
The type of ground truth used.
Sample size for the training set or how its ground truth was established.

This document describes a regulatory submission for a device update, asserting substantial equivalence rather than presenting detailed performance study data against specific acceptance criteria.

Summary

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KOSO438

Summary of Safety and Effectiveness StealthStation® System Update

Manufacturer Medtronic Navigation, Inc. 826 Coal Creek Circle

Louisville, Colorado 80027 USA Telephone Number: (720) 890-3217 Fax Number: (720) 890-3517

II. Contact Tina Dreiling Associate Regulatory Affairs Specialist Medtronic Navigation, Inc.

III. Product Name / Classification

Stereotaxic instrument Common Name: Instrument, Stereotaxic Classification Name: StealthStation® System Update Trade Name:

Stereotaxic instrument - Class II as described in 21 CFR § 882.4560 Product Code: HAW

IV. Date Summary Submitted February 18, 2005

V. Description of Device Modification

VI. Substantial Equivalence

The StealthStation® System Updates were shown to be substantially equivalent to the StealthStation® System cleared in previous 510(k) submissions. As required by risk analysis, all verification and validation activities were performed by designated individuals and the results demonstrated the substantial equivalence.

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Image /page/1/Figure/0 description: The image shows a sequence of alphanumeric characters. The characters are 'KOSOG38'. The characters are written in a handwritten style.

This submission does not change the indications for use for the StealthStation System.

For the optical-based and EM-based system, example procedures include, but are not limited to:

Cranial Procedures:	Spinal Procedures:
Cranial Biopsies	Spinal Implant Procedures, such as Pedicle
Tumor Resections	Screw Placement
Craniotomies/ Craniectomies
Skull Base procedures	ENT Procedures:
Thalamotomies/Pallidotomies	Transphenoidal Procedures
Pituitary Tumor Removal	Intranasal Procedures
CSF Leak Repair	Orbital Nerve Decompression Procedures
Pediatric Catheter Shunt Placement	Optic Nerve Decompression Procedures
General Catheter Shunt Placement	Polyposis Procedures
	Endoscopic Dacryocystorhinostomy
Orthopaedic Procedures:	Encephalocele Procedures
Total Knee Arthroplasty (Primary and Revision)	Sinus procedures, such as Maxillary
Unicompartmental Knee Arthroplasty	Antrostomies. Ethmoidectomies,
	Sphenoidotomies/Sphenoid Explorations

Turbinate Resections, and Frontal

Sinusotomies

Additional example procedures for the optical-based system include, but are not limited to:

Total Knee Arthroplasty (Primary and Revision) Unicompartmenta! Knee Arthroplasty Minimally Invasive Orthopaedic Procedures Pediatric Orthopaedics Total Hip Replacement (Primary and Revision) Periacetabular Osteotomies Tumor Resection and Bone/Joint Reconstruction Femoral Revision Placement of Iliosacral Screws Stabilization and Repair of Pelvic Fractures (Including but not limited to Acetabular Fractures)

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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health and Human Services (HHS). The seal features a stylized eagle with three stripes representing the three branches of government. The words "DEPARTMENT OF HEALTH AND HUMAN SERVICES USA" are arranged in a circle around the eagle.

JUN 2 - 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Tina Dreiling Associate Regulatory Affairs Specialist Medtronic Navigation Incorporated 826 Coal Creek Circle Louisville, Colorado 80027

Re: K050438

Trade/Device Name: StealthStation® System Update Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic instrument Regulatory Class: II Product Code: HAW Dated: May 16, 2005 Received: May 17, 2005

Dear Ms. Dreiling:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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) 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. Tina Dreiling

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), please contact the Office of Compliance at (240) 276-0115 . Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act 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/industry/support/index.html.

Sincerely yours,

Miriam C. Provost, Ph.D. Acting 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):

510(k) Number (if known): K050438

Device Name: StealthStation® System Update

Indications for Use

This submission does not change the indications for use for the StealthStation System.

For the optical-based and EM-based system, example procedures include, but are not limited to:

Orthopaedic Procedures: Total Knee Arthroplasty (Primary and Revision) Unicompartmental Knee Arthroplasty

Spinal Procedures: Spinal Implant Procedures, such as Pedicle Screw Placement

Additional example procedures for the optical-based system include, but are not limited to:

Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Z. le. le

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Medtronic Navigation, Inc.

Restorative
Devices CONFIDENTIAL

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).