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VERZA™ High Speed Drills are indicated for drilling, burring, removing, and otherwise manipulating hard tissue, bone, bone cement, prosthesis, implant, and other bone related tissue during spinal and orthopedic procedures.

ExcelsiusGPS® is intended for use as an aid for precisely locating anatomical structures and for the spatial positioning and orientation of an instrument holder or guide to be used by surgeons for navigating and/or guiding compatible surgical instruments in open or percutaneous procedures provided that the required fiducial markers and rigid patient anatomy can be identified on CT scans or fluoroscopy. The system is indicated for the placement of spinal and orthopedic bone screws and interbody fusion devices.

ExcelsiusHub™ is intended for use as an aid for precisely locating anatomical structures to be used by surgeons for navigating compatible surgical instruments in open or percutaneous procedures provided that the required fiducial markers and rigid patient anatomy can be identified on CT scans or fluoroscopy. The system is indicated for the placement of spinal and orthopedic bone screws and interbody fusion devices.

VERZA™ High Speed Drills are electrical drill handpieces/attachments powered by a motor with a control unit and foot pedal, and may be navigated using ExcelsiusGPS® or ExcelsiusHub™. The navigated components are provided nonsterile and are reusable. Burs are provided sterile and are single-use.

I am sorry, but the provided text is a 510(k) Premarket Notification from the FDA regarding a medical device called "VERZA™ High Speed Drills". This document primarily focuses on demonstrating substantial equivalence to predicate devices for regulatory clearance. It does not contain the detailed information necessary to answer your specific questions about acceptance criteria, performance studies, sample sizes, expert qualifications, or ground truth establishment for an AI/ML-based medical device.

The document mentions that "The navigation and guidance accuracy of VERZA™ High Speed Drills was evaluated using intra-operative imaging and accuracy verification testing. Testing confirmed that accuracy values meet the product requirement specification." However, it does not provide:

• A table of acceptance criteria and reported device performance.
• Sample size used for the test set or data provenance.
• Number of experts or their qualifications for establishing ground truth.
• Adjudication method.
• Information about multi-reader multi-case (MRMC) comparative effectiveness studies or effect sizes.
• Details about standalone (algorithm-only) performance.
• The type of ground truth used (beyond "accuracy verification testing" and meeting "product requirement specification").
• Sample size for the training set.
• How ground truth for the training set was established.

This device appears to be a surgical tool (drills) that may be navigated using existing systems (ExcelsiusGPS® or ExcelsiusHub™), rather than a new AI/ML software device that diagnoses or predicts outcomes based on data. Therefore, the types of studies and information you are requesting are not typically found in a 510(k) for this kind of physical medical device.

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