STEALTHSTATION SYSTEM by SURGICAL NAVIGATION TECHNOLOGIES, INC.

The StealthStation™ System 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 considered to be safe and effective, 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 with the ENT option is also indicated for intranasal or sinus use.

Device Description

This submission describes a revised indications statement for the StealthStation System to provide specifically for the ENT application of intranasal or sinus use.

AI/ML Overview

I'm sorry, but based on the provided text, I cannot extract the detailed information required to fill out the table and answer all the questions about acceptance criteria and a study proving device performance. The document is a 510(k) summary for a revised indication (ENT application) of an existing device, the StealthStation System. It primarily focuses on demonstrating substantial equivalence to the original device.

Here's what I can and cannot infer:

Information I can provide (partially):

1. A table of acceptance criteria and the reported device performance: The document states, "The StealthStation System ENT Application was shown to be substantially equivalent to the original StealthStation System. Clinical data was provided to support the claim of substantial equivalence." This is the core "acceptance criteria" (substantial equivalence to a predicate device) and the "reported device performance" (it met this criteria). However, it does not provide specific quantitative performance metrics (like accuracy, precision, sensitivity, specificity, etc.) that would typically be found in an acceptance criteria table alongside numerical results.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: The device is described as "an aid for precisely locating anatomical locations in either open or percutaneous procedures." This strongly implies it's a tool used by a human surgeon. The concept of "standalone" performance without human interaction doesn't directly apply here as it's a surgical navigation system, not an autonomous diagnostic algorithm.
7. The type of ground truth used: The system identifies anatomical structures relative to a "CT or MR based model of the anatomy." This strongly suggests the ground truth for positioning would be based on these imaging modalities.

Information I cannot provide from the given text:

2. Sample sized used for the test set and the data provenance: The document mentions "clinical data was provided" but does not specify the sample size, number of cases, or the origin (country, retrospective/prospective nature) of this data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: This information is completely absent.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: No details on adjudication are provided.
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 type of study is not mentioned, and the device is a navigation system, not a diagnostic AI intended to assist "readers."
8. The sample size for the training set: This information is not provided.
9. How the ground truth for the training set was established: This information is not provided.

Summary of available information:

Acceptance Criteria & Performance	Details
Acceptance Criteria	Substantial equivalence to the original StealthStation System for its intended use as an aid for precisely locating anatomical locations, specifically for intranasal or sinus use.
Reported Device Performance	The StealthStation System ENT Application was shown to be substantially equivalent to the original StealthStation System. "Clinical data was provided to support the claim of substantial equivalence." (Specific quantitative performance metrics are not provided in this summary.)

Study Details:

Sample size for the test set & data provenance: Not specified. "Clinical data was provided."
Number of experts for ground truth & qualifications: Not specified.
Adjudication method for the test set: Not specified.
MRMC comparative effectiveness study: Not applicable/not mentioned. This is a surgical navigation aid, not a diagnostic AI for human reader improvement studies.
Standalone algorithm performance: Not applicable. The device is an aid for human surgeons.
Type of ground truth used: Likely based on CT or MR imaging models of the anatomy, given the description "reference to a rigid anatomical structure... identified relative to a CT or MR based model of the anatomy."
Sample size for the training set: Not specified.
How ground truth for training set was established: Not specified.

Summary

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

Ki 14,51

JAN 2 1 1998

510(k) Summary

StealthStation™ System - ENT Application

Surgical Navigation Technologies I. Company: 530 Compton Street Broomfield, CO 80020 (303) 439-9709

Product Name: StealthStation System ENT Application II.
})
This submission describes a revised indications statement for the III. StealthStation System to provide specifically for the ENT application of intranasal or sinus use.
The indications for use for the StealthStation System are as follows: IV.

The StealthStation System 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 considered to be safe and effective, 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 with the ENT option is also indicated for intranasal or sinus use.

The StealthStation System ENT Application was shown to be V. substantially equivalent to the original StealthStation System. Clinical data was provided to support the claim of substantial equivalence.

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

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN 2 1 1998

Roger White Group Director Quality Systems and Regulatory Affaris Surgical Navigation Technologies 530 Compton Street Broomfield, CO 80020

Re:

K974187 StealthStation™ System - ENT Application Dated: December 15, 1997 Received: December 16, 1997 Regulatory class: II 21 CFR 882.4560/Procode: 84 HAW

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 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 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 OS 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 does not affect any obligation you might have under sections 531 through 542 of the Act for devices under Radiation Control provisions, or other Federal laws or regulations. ... . . . . . . . . . .

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) 594-4613. 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/cdrb/dsmamain.html":---------------------------------------------------------------------------------------------

Sincerely yours,

hìàu Yu

Lillian Yin, Ph.D. Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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

510(k) Number (if known): K974187 ____________________________________________________________________________________________________________________________________________

Device Name: StealthStation System - ENT Application

Indications For Use:

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

Concurrence of CDRH, Office Of Device Evaluation (ODE)

	David C. Seymour
	(Division Sign-Off)
	Division of Reproductive, Abdominal, ENT, and Radiological Devices
510(k) Number	K974187

Prescription Use	X	OR	Over-The-Counter Use ______
(Per 21 CFR 801.109)			(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).