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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.

Example procedures include, but are not limited to:

Cranial Procedures: Cranial biopsies Tumor resections Craniotomies/ Craniectomies Skull base procedures Thalamotomies/Pallidotomies Pituitary Tumor Removal CSF Leak Repair

Spinal Procedures: Spinal Implant, such as pedicle screw procedures

ENT Procedures: Transphenoidal procedures Intranasal procedures Sinus procedures, such as Maxillary antrostomies, Ethmoidectomies, Sphenoidotomies/Sphenoid explorations, Turbinate resections, and Frontal sinusotomies Orbital Decompression Procedures Optic Nerve Decompression Procedures Polyposis Procedures Endoscopic Dacryocystorhinostomy Encephalocele Procedures

Orthopedic Indications: Total Knee Arthroplasty (Primary and Revision) Unicompartmental Knee Arthroplasty

This submission describes updates made to the StealthStation® System to include an optional software package that enables a user to merge a patient's pre-operative dataset with a patient's intra-operative dataset.

The provided text is a 510(k) summary for the StealthStation® with FluoroMerge™ Software. It describes updates to an existing device, focusing on substantial equivalence rather than presenting new clinical study data with specific acceptance criteria and performance metrics against them.

Therefore, the requested information regarding acceptance criteria, reported device performance, sample sizes for test and training sets, expert qualifications, and adjudication methods cannot be extracted from this document, as it falls outside the scope of a 510(k) summary for a device modification establishing substantial equivalence to a predicate. The document states:

• "As required by risk analysis, all verification and validation activities were performed by designated individual(s) and the results demonstrated substantial equivalence." This implies internal testing was done, but specific details or results are not provided for public review in this summary.
• The focus is on the "Description of Device Modification" and "Substantial Equivalence" to previously cleared StealthStation Systems. This suggests that the primary method of demonstrating safety and effectiveness was by showing that the modified device performs as intended and is no less safe or effective than the predicate.

Without specific performance studies and acceptance criteria detailed in the document, it's impossible to fill out the table and answer the subsequent questions.

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