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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 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 surgery based on a fluoroscopy based model of the anatomy.

The provided text for K990214, the "StealthStation® System - FluoroNav™ Module," is a 510(k) summary and FDA clearance letter. It states:

• "The StealthStation® System with the FluoroNav™ Module was shown to be substantially equivalent to the original StealthStation® System."
• "Performance data was provided to support the claim of substantial equivalence."

However, the provided document does not include the specific acceptance criteria, detailed results of performance studies, or information regarding sample sizes, ground truth establishment, or expert involvement.

In a 510(k) submission, the "Summary of Safety and Effectiveness" usually provides a high-level overview. Detailed performance data, acceptance criteria, and study methodologies (including statistical methods, sample sizes, ground truth, etc.) are typically found in the full 510(k) submission not included in this document.

Therefore,Based on the provided text, I cannot complete your request. The document only states that performance data was provided to support substantial equivalence but does not detail the acceptance criteria, the study itself, or its results.

To fulfill your request, I would need access to the detailed performance study report that was submitted as part of the K990214 510(k) application.

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