STELTHSTATION WIRELESS SURGEON MOUSE by MEDTRONIC SURGICAL NAVIGATION

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 a 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, 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), 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

Modification to the StealthStation® System to allow for the use of a wireless Bluetooth mouse.

AI/ML Overview

This submission describes the StealthStation® Wireless Surgeon Mouse, a modification to the existing StealthStation® System to allow for the use of a wireless Bluetooth mouse. The 510(k) summary does not include detailed acceptance criteria or a dedicated study proving the device meets specific performance metrics in the way one might expect for a diagnostic or AI device. Instead, the focus is on demonstrating "substantial equivalence" to a legally marketed predicate device through risk analysis and verification/validation activities.

Here's an analysis based on the provided document:

Acceptance Criteria and Device Performance for StealthStation® Wireless Surgeon Mouse

The provided document does not specify quantitative acceptance criteria for the StealthStation® Wireless Surgeon Mouse. Instead, it relies on demonstrating substantial equivalence to a predicate device through risk analysis and verification/validation activities. The core claim is that the modification (the addition of a wireless mouse) does not change the indications for use or the fundamental safety and effectiveness of the existing StealthStation® System.

Therefore, the "acceptance criteria" can be inferred as:

Maintaining the safety and effectiveness of the predicate device.
Not introducing new safety concerns or raising new questions of effectiveness.
The wireless mouse functionality performs as expected within the integrated system.

No specific device performance metrics (e.g., accuracy, precision, latency) are reported in this summary.

Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria (Inferred from Substantial Equivalence Goal)	Reported Device Performance
No new safety concerns introduced.	Verified through risk analysis and verification/validation activities.
No new questions of effectiveness raised.	Verified through risk analysis and verification/validation activities.
Wireless mouse functions as intended within the StealthStation® System.	Verified through risk analysis and verification/validation activities.
Clinical indications for use remain unchanged.	Explicitly stated: "This submission does not change the indications for use for the StealthStation System."

Study Details (Based on available information in the 510(k) summary)

The document refers to "all verification and validation activities were performed by required by risk analysis, and the results demonstrated the substantial equivalence." However, it does not provide details about a specific clinical study or technical performance study in the traditional sense, particularly not one involving AI or diagnostic performance metrics.

Sample size used for the test set and the data provenance:
- Test Set Sample Size: Not specified.
- Data Provenance: Not specified. The document outlines a regulatory submission process based on risk analysis and verification/validation, rather than a clinical trial with a specific data set. The evaluation is for a device modification (adding a wireless mouse) to an existing, cleared system.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. This is a 510(k) submission for a device modification (wireless mouse), not a diagnostic or AI device requiring expert-established ground truth for a test set.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. This type of adjudication method is relevant for studies involving human interpretation or diagnostic accuracy assessments, which are not detailed in this submission.
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:
- No MRMC comparative effectiveness study was done or reported. This device is not an AI diagnostic tool and does not involve human readers in this context.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- No standalone algorithm performance study was done or reported. This device is a hardware accessory (wireless mouse) for an existing surgical navigation system.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- "Ground truth" as typically defined for diagnostic or AI studies is not applicable here. The "truth" for this device modification would relate to the functional operation of the wireless mouse and its integration into the StealthStation® System, ensuring it performs its intended control functions reliably and safely without degrading the core system's performance.
The sample size for the training set:
- Not applicable. This device is a hardware accessory and not an AI or machine learning algorithm that requires a training set.
How the ground truth for the training set was established:
- Not applicable, as there is no training set for an AI algorithm.

Summary

{0}------------------------------------------------

221029

Summary of Safety and Effectiveness StealthStation® Wireless Surgeon Mouse

Manufacturer l. Medtronic Navigation, Inc. 826 Coal Creek Circle Louisville, Colorado 80027 USA Telephone Number: (720) 890-3217 Fax Number: (720) 890-3517
Contact 11. Tina Dreiling Associate Regulatory Affairs Specialist Medtronic Navigation, Inc.

Product Name / Classification III.

Common Name:	Stereotaxic instrument
Classification Name:	Instrument, Stereotaxic
Trade Name:	StealthStation® Wireless Surgeon Mouse

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

IV. Date Summary Submitted April 20, 2005
Description of Device Modification V. Description of Device Modification® System to allow for the use of a wireless Bluetooth mouse.
VI. Substantial Equivalence Substantial Lqurvalenoo The use of the StealthStation® Wirenton ourgressions 510(K) submissions. As equired by risk analysis, all verification and validation activities were performed by required by nok analyons, and the results demonstrated the substantial equivalence.

{1}------------------------------------------------

VII. Indications for Use

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

The StealthStation® System is intended as an aid for precisely locating anatomical The StealthStation® Oystem is Intended as an and an and StealthStation® System is structures in enner open of persulanced in which the use of stereotactic surgery may be Indicated for any medical condition in which the aconcel structure, such as the skull, a long appropriate, and where references to a nigra that 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:	Spinal
Cranial Biopsies	Spinal
Tumor Resections	Screw
Craniotomies/ Craniectomies
Skull Base procedures	ENT P
Thalamotomies/Pallidotomies	Trans
Pituitary Tumor Removal	Intrana
CSF Leak Repair	Orbital
Pediatric Catheter Shunt Placement	Optic
General Catheter Shunt Placement	Polyp
	Endos

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

Spinal Procedures: Implant Procedures, such as Pedicle Placement

rocedures: henoidal Procedures asal Procedures Nerve Decompression Procedures Nerve Decompression Procedures sis Procedures copic Dacryocystorhinostomy Encephalocele Procedures Sinus procedures, such as Maxillary 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) 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)

{2}------------------------------------------------

DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three lines representing its body and wings. The eagle is enclosed in a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter.

Public Health Service

JUN 8 - 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

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

Re: K051029

Trade/Device Name: StealthStation® Wireless Surgeon Mouse Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic instrument Regulatory Class: II Product Code: HAW Dated: May 31, 2005 Received: June 1, 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.

{3}------------------------------------------------

Page 2 - Ms. Tina Dreiling

This letter will allow you to begin marketing your device as described in your Section 510(k) remarket 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 other general mixernational and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrb/industry/support/index.html.

Sincerely yours,

Signature

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

{4}------------------------------------------------

INDICATIONS FOR USE

510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Device Name: StealthStation® Wireless Surgeon Mouse

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

The StealthStation® System is intended as an aid for precisely locating anatomical structures in rite ofcalthorions operations of the StealthStation® System is indicated for any medical condition in which the use of stereotactic surgery may be appropriate, and where reference to a Condition in which the doe of etersetablications of 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 Turnor 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, 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) 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 Piacement of Iliosacral Screws r labornent of Medarer of Pelvic Fractures (Including but not limited to Acetabular Fractures)

× 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)

Page 1 of 1
(Division Sign-Off)
Division of General, Restorative
and Neurological Devices

K05/029
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).