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Synthes Cerclage Positioning Pin is intended for use with cerclage monofilament wire and multifilament cable to augment fracture stabilization with plates used in long bone fixation when the use of screws is contraindicated, as in the presence of intramedullary implants.

The Cerclage Positioning Pin is designed for use in dynamic compression screw holes that accept a 4.5 mm bone screw. The Cerclage Positioning Pin (and cerclage wire or cable) can be used with a variety of Synthes plates.

The design of the cerclage positioning pin is an oval body with a hole running perpendicular to the long axis (for use in compression holes), and has a stud protruding from the bottom. By placing the post through the top of the dynamic compression screw hole into a pre-drilled hole in cortical bone a stable structure is created for cerclage wire or cable fixation. The wire or cable is passed around the bone, through the Cerclage Positioning Pin hole above the outer plate surface, and then the wire is twisted or cable is crimped for final securement.

I am sorry, but based on the provided document, there is no information about acceptance criteria or a study that proves the device meets specific performance metrics.

The document is a 510(k) summary for the "Synthes Cerclage Positioning Pin" and primarily focuses on:

• Device identification and classification: Name, common name, classification, and predicate device.
• Description and intended use: How the device works and for what purpose.
• FDA's substantial equivalence determination: The FDA's letter stating that the device is substantially equivalent to a legally marketed predicate device.
• Indications for Use statement.

This type of submission to the FDA (510(k)) aims to demonstrate that a new device is as safe and effective as a legally marketed predicate device. It typically relies on comparison to the predicate rather than on new, extensive performance studies with acceptance criteria as one might see for novel devices or PMAs.

Therefore, I cannot provide the requested table or details about a study, sample sizes, experts, adjudication methods, MRMC studies, standalone performance, or ground truth establishment based on the information given.

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