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Synthes Rapid Resorbable Cranial Clamp is indicated for covering burr holes and for fixation of cranial bone flaps in adult and pediatric populations.

Synthes Rapid Resorbable Cranial Clamp consists of two disks connected by a tensioned ratcheting shaft. The clamps fit a range of burr holes and craniotomy gap sizes.

The provided text is a 510(k) summary for the Synthes Rapid Resorbable Cranial Clamp, which seeks to demonstrate substantial equivalence to previously marketed devices. This type of submission generally does not include detailed studies with acceptance criteria, sample sizes for test/training sets, expert ground truth establishment, or multi-reader multi-case studies, as it's not a de novo device requiring extensive clinical validation for novel performance claims.

Instead, the submission focuses on mechanical and material properties that establish equivalence to predicate devices, and the document explicitly states: "Documentation was provided which demonstrated the Synthes Rapid Resorbable Cranial Clamp to be substantially equivalent to other legally marketed devices."

Therefore, I cannot extract the requested information from the provided text because it is not present in a 510(k) summary focused on substantial equivalence. The document doesn't describe a study with performance targets or acceptance criteria as one would find for a novel device making specific diagnostic performance claims.

If this were a device requiring such performance criteria, the information would typically be presented in a dedicated section on performance studies.

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