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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, fluoroscopy images, or digitized landmarks of the anatomy.

The AxiEM™ Imageless Hip Module for the StealthStation® is intended to precisely position instruments and implants in example procedures such as but not limited to:

Orthopedic Procedures: Minimally Invasive Orthopedic Procedures Total Hip Replacement (Primary and Revision)

The AxiEM™ Imageless Hip Module for the StealthStation® System provides a mechanism for the establishment of stereotactic coordinates without the use of a pre-operative or intra-operative image using electromagnetic navigation

The provided text does NOT include acceptance criteria or a study proving that the device meets acceptance criteria. The document is a 510(k) summary for the AxiEM™ Imageless Hip Module for the StealthStation® System, which is a premarket notification to the FDA to demonstrate substantial equivalence to a legally marketed predicate device.

The document discusses:

• Manufacturer and Contact Information
• Product Name and Classification
• Date Summary Submitted
• Description of Device Modification: States that the AxiEM™ Imageless Hip Module uses electromagnetic navigation instead of optical tracking (the primary difference from its predicate).
• Substantial Equivalence: Claims substantial equivalence to the Imageless Hip Module for the StealthStation® System (K052623) and highlights the difference from the AxiEM™ Imageless Knee Module (hip vs. knee procedures). It vaguely mentions that "all verification and validation activities will be performed... and will demonstrate the safety and effectiveness of the device," but does not provide details about these activities, specific acceptance criteria, or study results.
• Indications for Use
• FDA Letter of Substantial Equivalence: This letter confirms that the FDA reviewed the 510(k) and determined the device is substantially equivalent to predicate devices, thus allowing it to be marketed. It reiterates that substantial equivalence does not mean the device complies with all other requirements of the Act, such as GPM, labeling, etc.

Therefore, I cannot populate the requested table or provide information on the study, sample sizes, ground truth establishment, expert qualifications, or comparative effectiveness, as this information is not present in the provided text.

The document only serves as a regulatory submission for market clearance based on substantial equivalence, not a detailed technical report of performance testing against specific acceptance criteria.

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