This submission describes the addition of the STERRAD®* Sterilization System as a sterilization option for certain components of the StealthStation™ System which was cleared in a previous 510(k) submission.

AI/ML Overview

This document is a 510(k) summary for the StealthStation™ System Sterilization, which describes the addition of the STERRAD®* Sterilization System as a sterilization option for certain components of the StealthStation™ System.

The provided text does not contain any information about acceptance criteria or a study proving device performance in the context of diagnostic accuracy, clinical outcomes, or AI/algorithm performance. It primarily focuses on the sterilization validation of a medical device.

Therefore, I cannot provide the requested information in the table or answer the specific questions related to acceptance criteria for device performance, sample sizes for test/training sets, expert qualifications, adjudication methods, MRMC studies, standalone algorithm performance, or ground truth types.

The only relevant information from the provided text is:

Study type: Sterilization validation.
Standard followed: AAMI TIR No. 12-1994, "Designing, Testing and Labeling Reusable Medical Devices for Reprocessing in Health Care Facilities: A Guide for Device Manufacturers."
Validation performed by: An independent laboratory.

Summary

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UCT 25 1996

SIO(K)

Summary of Safety and Effectiveness

StealthStation™ System Sterilization

】. Company: Surgical Navigation Technologies 530 Compton St. Broomfield, CO 80020 (303) 439-9709
Product Name: StealthStation™ System II.
III. This submission describes the addition of the STERRAD®* Sterilization System as a sterilization option for certain components of the StealthStation™ System which was cleared in a previous 510(k) submission. This sterilization option was validated by an independent laboratory in accordance with the AAMI TIR No. 12-1994, Designing, Testing and Labeling Reusable Medical Devices for Reprocessing in Health Care Facilities: A Guide for Device Manufacturers.

*STERRAD is a registered trademark of Advanced Sterilization Products, a Division of Johnson and Johnson Medical, Inc.

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).