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.

The Hip Module for the StealthStation is intended to precisely position instruments and implants in example procedures such as but not limited to:

Orthopedic Procedures:

Minimally Invasive Orthopedic Procedures

Total Hip Replacement (Primary and Revision)

Tumor Resection and Bone/Joint Reconstruction

Placement of Iliosacral Screws

Femoral Revision

Stabilization and Repair of Pelvic Fractures (Including But Not Limited To Acetabular Fractures)

Device Description

This submission allows a surgeon to utilize a modified version of the FluoroNav™ Software to place hip implants and repair and/or stabilize trauma sustained to the pelvic area. The Hip Module for the StealthStation® System is technically equivalent to the StealthStation® System, and the FluoroNav™ Module for the StealthStation®. All systems use either active or passive infrared markers to track a reference frame attached to the anatomy and to track surgical instruments. This information is correlated to the patient's CT, MR or fluoroscopic images of the anatomy.

AI/ML Overview

This submission, K021980, pertains to the Hip Module Software for the StealthStation® System. The information provided is limited and focuses on establishing substantial equivalence to predicate devices rather than detailing specific performance studies with acceptance criteria for the new module. This is typical for a 510(k) submission where the primary goal is to demonstrate that a new device is as safe and effective as existing legally marketed devices.

Therefore, many of the requested details about acceptance criteria, specific performance metrics, sample sizes, and expert validation are not explicitly present in the provided document. The document primarily states that "all verification and validation activities were performed by designated individual(s) and the results demonstrated substantial equivalence." This is a high-level statement that doesn't provide the granular detail requested.

Here's a breakdown based on the available information and what we can infer:

1. Table of Acceptance Criteria and Reported Device Performance:

Based on the provided document, specific, quantitative acceptance criteria and detailed device performance metrics for the Hip Module software itself are not explicitly stated. The document focuses on demonstrating substantial equivalence to predicate devices. This implies that the performance of the Hip Module is considered acceptable if it is comparable to that of the predicate devices.

Acceptance Criteria	Reported Device Performance
Not explicitly defined for the Hip Module in this summary. The primary criteria is "Substantial Equivalence" to predicate devices.	The document states, "all verification and validation activities were performed by designated individual(s) and the results demonstrated substantial equivalence." This implies that the functional and safety performance of the Hip Module was deemed comparable to the predicate devices. No specific numerical performance metrics are provided.

2. Sample Size Used for the Test Set and Data Provenance:

Sample Size for Test Set: Not explicitly stated.
Data Provenance: Not explicitly stated. Given it's a 510(k) submission focused on equivalence, it's possible that internal testing data (e.g., in-house verification and validation) might have been used, but no details are provided about the nature or origin of this data.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications:

Number of Experts: Not explicitly stated.
Qualifications of Experts: Not explicitly stated. The document mentions "designated individual(s)" performed verification and validation, but their specific qualifications (e.g., surgeon experience, engineering expertise) are not detailed.

4. Adjudication Method for the Test Set:

Adjudication Method: Not explicitly stated.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

MRMC Study Conducted: Not stated and highly unlikely for this type of 510(k) submission focused on a software module's equivalence. MRMC studies are generally used for assessing the impact of new diagnostic tools on reader performance, which isn't the primary focus here.
Effect Size of Human Readers Improvement with AI vs. Without AI Assistance: Not applicable, as no such study is indicated. This device is a navigation aid, not an AI for image interpretation.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:

Standalone Study Conducted: Not explicitly detailed in terms of performance metrics. The submission focuses on device functionality and equivalence within the surgical navigation workflow. It's implied that the software's algorithms function correctly and accurately when used as intended, but no specific "standalone" performance study results (e.g., accuracy of algorithmic calculations against a ground truth without human intervention as a separate study) are provided. The "verification and validation activities" would likely have covered this in a general sense.

7. Type of Ground Truth Used:

Type of Ground Truth: Not explicitly stated. For a surgical navigation system, ground truth during verification and validation would typically involve:
- Phantom studies: Using precisely manufactured anatomical phantoms with known fiducial marker locations and instrument paths to assess accuracy.
- Cadaveric studies: Using cadavers to simulate surgical scenarios and verify instrument accuracy.
- Technical specifications: Comparing device output to known or expected engineering specifications and tolerances.
  The document only broadly refers to "verification and validation activities," implying these types of methods were used to confirm its function, but without specific details.

8. Sample Size for the Training Set:

Sample Size for Training Set: Not applicable in the context of this document. This is not an AI/machine learning model where a separate training set is typically discussed in this manner. The software is a navigation aid that processes imaging data (CT, MR, fluoroscopy) and tracks instruments. Its functionality is based on established geometric algorithms and image processing, not on learning from a "training set" of cases in the AI sense.

9. How the Ground Truth for the Training Set Was Established:

Ground Truth for Training Set Establishment: Not applicable for the reasons stated above.

In summary: The provided document is a 510(k) summary for a software module, primarily focusing on demonstrating substantial equivalence to predicate devices. It does not contain the detailed performance study results, acceptance criteria, sample sizes, or expert validation methods that would be expected for a comprehensive clinical effectiveness or AI algorithm validation study. The statement "all verification and validation activities were performed by designated individual(s) and the results demonstrated substantial equivalence" serves as the overarching conclusion regarding its safety and effectiveness.

Summary

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Koz19Ao

Summary of Safety and Effectiveness Hip Module Software for the StealthStation® System

I. Manufacture:

Medtronic Surgical Navigation Technologies 826 Coal Creek Circle Louisville, CO 80027 USA Telephone Number: (720) 890-3200 Fax Number: (720) 890-3500

NOV 1 9 2002

II. Contact:

Victoria G. Rendon Clinical and Regulatory Affairs Associate Medtronic Surgical Navigation Technologies

III. Product Name/ Classification Name:

Product Name: Hip Module for the StealthStation® System Classification Name: Stereotaxic Instrument (21 CFR 882.4560) Classification Panel: 84 HAW

IV. Date Summary Submitted

June 13, 2002

V. Description of Device Modification:

This submission provides new orthopedic indications that are substantially equivalent to the named predicate devices' indications statement.

VI. Substantial Equivalence:

The Hip Module for the StealthStation® System was substantially equivalent to the StealthStation System cleared in previous 510(k)'s. Additionally, the Hip Module was determined to be substantially equivalent to the BrainLAB Vector Vision Hip, and the Stryker Navigation System -Spine & Fluoroscopy Module. As required by risk analysis, all verification and validation activities were performed by designated individual(s) and the results demonstrated substantial equivalence.

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VII. Indications For Use:

The indications for use for the Hip Module for the StealthStation® Software are identical to the indications for use for the named predicate devices. The indications for use are as follows:

The Hip Module for the StealthStation is intended to precisely position instruments and implants in example procedures such as but not limited to:

Orthopedic Procedures:

Minimally Invasive Orthopedic Procedures

Total Hip Replacement (Primary and Revision)

Tumor Resection and Bone/Joint Reconstruction

Placement of Iliosacral Screws

Femoral Revision

Stabilization and Repair of Pelvic Fractures (Including But Not Limited To Acetabular Fractures)

2 of 2

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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 is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

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

Re: K021980

Trade/Device Name: Hip Module for the Stealthstation System Regulation Number: 882.4560 Regulation Name: Stereotaxic instrument Regulatory Class: Class II Product Code: HAW Dated: October 25, 2002 Received: October 28, 2002

Dear Ms. Rendon:

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. Victoria G. 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" (21 CFR 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,

Miriam C. Purvet

fol 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

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510(k) Number (if known):

Device Name: Hip Module for the StealthStation® System

Indications For Use:

The Hip Module for the StealthStation is intended to precisely position instruments and implants in example procedures such as but not limited to:

Orthopedic Procedures:

Minimally Invasive Orthopedic Procedures

Total Hip Replacement (Primary and Revision)

Tumor Resection and Bone/Joint Reconstruction

Placement of Iliosacral Screws

Femoral Revision

Stabilization and Repair of Pelvic Fractures (Including But Not Limited To Acetabular Fractures)

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

Concurrence of CDRH, Office Of Device Evaluation (ODE)

Prescription Use O (Per 21 CFR 801.109)

Over-The-Counter Use

(Optional Format 1-2-96)

Miriam C. Provost

Division Sign-Off Division of General. Restorative

Number __

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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).