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Synthes 6.5 mm Cannulated Screw is intended for fracture fixation of large bones and large bone fragments, such as femoral neck fractures; slipped capital femoral epiphyses; an adjunct to DHS in basilar neck fractures; tibial plateau fractures; ankle arthrodeses; pediatric femoral neck fractures; intercondylar femur fractures; SI joint disruptions; and subtalar arthrodeses.

Synthes 6.5 mm Cannulated Screw is a self-tapping and self-drilling screw with a cancellous thread that can be guided into a position via a guidewire. Screws are available partially or fully threaded, in thread / screw lengths of 16 mm / 30 - 200 mm, 32 mm / 45 - 200 mm and full / 20 - 200 mm. Synthes 2.8 mm guidewires in 300 and 450 mm lengths are used for precise placement in bone.

This document is a 510(k) summary for a medical device (Synthes 6.5 mm Cannulated Screw) and does not contain information about acceptance criteria or a study proving that the device meets such criteria in terms of performance metrics like accuracy, sensitivity, or specificity. These types of performance metrics and studies are typically associated with devices that involve algorithms, diagnostics, or other measurable outputs that require validation against a ground truth.

The Synthes 6.5 mm Cannulated Screw is a bone fixation fastener, a type of mechanical implant. The "acceptance criteria" for such a device are typically related to its mechanical properties (e.g., strength, fatigue resistance), biocompatibility, and manufacturing quality, which are assessed through engineering tests, material characterization, and quality control processes. The 510(k) summary focuses on demonstrating substantial equivalence to predicate devices based on intended use, technology, and safety/effectiveness, rather than providing a performance study with acceptance criteria in the context you've outlined.

Therefore, I cannot extract the requested information (table of acceptance criteria, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, training set sizes, or ground truth establishment for training set) from the provided text, as it describes a different type of device and regulatory submission.

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