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The Stryker Universal Drill Attachments and Accessories are intended for use in the cutting, drilling, reaming, decorticating, and smoothing of bone and other bone related tissue in a variety of surgical procedures including: ENT, orthopedic, maxillofacial, neuro, and plastics.

The Stryker Universal Drill Attachments are used in conjunction with the previously 510(k) cleared Stryker 75K Drill. The 75K drill motor is powered by DC electric current via the Total Performance System Console. The Extra Long Attachments are up to 400 mm in length. The Hudson Chuck reduces the speed of the 75K drill from 75,000 rom to 700 - 1200 rpm. This chuck with Hudson fitting holds cranial perforators with a standard Hudson shank fitting.

This document is a 510(k) premarket notification for a surgical drill and its attachments. It describes the device's intended use and claims substantial equivalence to predicate devices already on the market.

However, the provided text does not contain any information about acceptance criteria, a study proving the device meets those criteria, or any statistical performance metrics that would be relevant to the questions asked. The document is strictly a regulatory submission stating the device's characteristics and its equivalence to existing products.

Therefore, I cannot populate the table or answer the specific questions regarding acceptance criteria, study details, sample sizes, ground truth, or expert involvement. The document primarily focuses on establishing substantial equivalence based on intended use, technology, and materials, rather than presenting a performance study against predefined acceptance criteria.

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