(120 days)
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 fluoroscope images of the anatomy. The StealthStation® System with the ENT option is also indicated for intranasal or sinus use.
This submission describes a modification to the StealthStation® System to provide for image-guided tracking of a motorized instrument placement tool.
This document is a 510(k) premarket notification for the StealthStation® System - NATREX™ Device. It declares substantial equivalence to a predicate device and does not contain detailed information about specific acceptance criteria or an analytical study proving device performance against such criteria. The document focuses on regulatory approval based on demonstrating equivalence, rather than providing a performance study report with the requested details.
Therefore, I cannot provide a table of acceptance criteria and device performance, nor details about sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or training set information based on the provided text.
The provided text only states:
- The device is a modification to the StealthStation® System to provide image-guided tracking of a motorized instrument placement tool.
- The device was shown to be substantially equivalent to the StealthStation® System with the SNT Image Guided Biopsy Needle and the Compass Stereotactic Positioning System.
- "Performance data was provided to support the claim of substantial equivalence," but these data are not presented in the provided text.
To answer your specific questions, a detailed performance study report would be required, which is not present in this 510(k) submission document.
§ 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).