STEALTHSTATION SYSTEM by SURGICAL NAVIGATION TECHNOLOGIES, INC.

The StealthStation™ System with the Universal Attachment is intended as an aid for precisely locating anatomical locations 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 a 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 of the anatomy. The StealthStation™ System is also indicated for intranasal or sinus use.

Device Description

This submission describes a Universal Attachment with infrared markers that allows a StealthStation® System user to image guide rigid surgical instruments.

AI/ML Overview

The provided text does not contain detailed information about specific acceptance criteria or a dedicated study proving the device met those criteria. It is a 510(k) summary and an FDA clearance letter for a "Universal Attachment for the StealthStation® System."

The submission focuses primarily on demonstrating substantial equivalence to previously cleared devices (the original StealthStation® System and the BrainLAB VectorVision™ System), rather than presenting a performance study with detailed acceptance criteria. Substantial equivalence is a regulatory standard, not a performance metric defined by specific numerical criteria.

Therefore, many of the requested details, such as specific performance metrics, sample sizes, expert qualifications, and adjudication methods for a standalone study, are not present in the provided documents.

Here's an attempt to answer based only on the information provided, with the understanding that much requested information is missing:

Acceptance Criteria and Device Performance Study (Based on Provided Text)

The provided documents describe a 510(k) premarket notification for a "Universal Attachment for the StealthStation® System." The primary "acceptance criteria" discussed implicitly within the context of a 510(k) submission is substantial equivalence to predicate devices. The study conducted to meet this regulatory requirement is a comparison against those predicates.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Implicit from 510(k))	Reported Device Performance (as stated in 510(k) Summary)
Pertains to: Aid for precisely locating anatomical locations in either open or percutaneous procedures. Indicated for any medical condition where stereotactic surgery is appropriate and a reference to a rigid anatomical structure can be identified relative to a CT or MR based model. Also indicated for intranasal or sinus use.	Substantially Equivalent to the previously cleared StealthStation® System and the BrainLAB VectorVision™ System.
Functional Equivalence: Ability to image guide rigid surgical instruments.	The Universal Attachment described "allows a StealthStation® System user to image guide rigid surgical instruments."

Explanation: The "acceptance criteria" here are not numerical performance targets but rather the regulatory standard of being sufficiently similar in intended use, technology, and performance characteristics to a legally marketed predicate device such that it can be considered equally safe and effective. The "reported device performance" is the statement of substantial equivalence.

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

Sample Size for the Test Set: Not specified in the provided documents. It is highly likely that comparisons were made based on design specifications, functional testing, and potentially some limited performance data, but specific sample sizes for a "test set" in the context of a clinical or performance study are not mentioned.
Data Provenance: Not specified. Given the regulatory submission, any data would typically be generated by the manufacturer (Surgical Navigation Technologies). The documents do not specify if it was retrospective or prospective.

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

Number of Experts: Not specified.
Qualifications of Experts: Not specified. Given the nature of a 510(k) submission focused on substantial equivalence, the "ground truth" would likely relate to engineering specifications, functional tests, and comparisons to predicate device specifications, rather than a clinical expert consensus on complex diagnostic or interventional outcomes.

4. Adjudication Method for the Test Set

Adjudication Method: Not specified. This level of detail is typically not included in a 510(k) summary focused on substantial equivalence where clinical adjudication might not be the primary evaluation method.

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

MRMC Study: No, there is no mention of a Multi-Reader Multi-Case (MRMC) comparative effectiveness study, nor any evaluation of how human readers improve with AI vs. without AI assistance. The device in question is a surgical navigation attachment, not an AI-powered diagnostic or interpretive tool.

6. Standalone Performance Study (Algorithm Only)

Standalone Study: No, there is no mention of a standalone (algorithm only) performance study. The device is a physical attachment for a surgical navigation system, not a standalone algorithm.

7. Type of Ground Truth Used

Type of Ground Truth: Not explicitly stated, but based on the nature of a 510(k) for a surgical attachment, the "ground truth" for demonstrating substantial equivalence would likely involve:
- Engineering Specifications: Comparing the design, materials, and mechanical properties to predicate devices.
- Functional Testing: Verifying the attachment's ability to hold instruments and integrate with the StealthStation® system for image-guided navigation, likely measured against established engineering tolerances and specifications.
- Performance Metrics (potentially): Could include accuracy, precision, or stability measurements, but these are not detailed.

8. Sample Size for the Training Set

Sample Size for Training Set: Not applicable. This device is a mechanical attachment and is not described as involving machine learning or algorithms that require a "training set" of data in the typical sense.

9. How the Ground Truth for the Training Set was Established

Ground Truth for Training Set: Not applicable, as there is no mention of a training set or machine learning algorithm.

Summary

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JAN 1 4 1999

K983670

510(k) Summary

Universal Attachment for the StealthStation® System

I. Company: Surgical Navigation Technologies 530 Compton St. Broomfield, CO 80020 (303) 439-9709
Universal Attachment II. Product Name:
This submission describes a Universal Attachment with infrared markers that III. allows a StealthStation® System user to image guide rigid surgical instruments.
The StealthStation® System with the Universal Attachment is intended as an aid IV. for precisely locating anatomical locations 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 a 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 of the anatomy. The StealthStation™ System is also indicated for intranasal or sinus use.
V. The Universal Attachment for the StealthStation@ System was shown to be substantially equivalent to the previously cleared StealthStation® System and the BrainLAB VectorVision™ System.

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JAN 1 4 1999

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Roger White Group Director Quality Systems and Regulatory Affairs Surgical Navigation Technologies 530 Compton Street Broomfield, Colorado 80020

Re: K983670

Trade Name: StealthStation™ System Universal Attachment Regulatory Class:II Product Code: HAW Dated: October 15, 1998 Received: October 19, 1998

Dear Mr. White:

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.

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Page 2 - Mr. Roger White

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

Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Page __ 1__ of_ 1

510(k) Number (if known):

Device Name: __ Universal Attachment

Indications For Use:

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

Concurrence of CDRH, Office Of Device Evaluation (ODE)

(Divisign St
Division of General Restorative Devices 12983670
510(k) Number

Prescription Use
(Per 21 CFR 801.109)

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).