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The CranioClamp™ - Bioabsobable Cranial Bone Flap Fixation System is intended for use in covering burr holes and for fixation of cranial bone flaps after craniotomy

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The provided text is a 510(k) clearance letter from the FDA for a medical device called "CranioClamp™ - Bioabsorbable Cranial Bone Flap Fixation System." This type of document does not contain the detailed information required to describe acceptance criteria and a study proving those criteria are met.

Here's why and what kind of information is missing based on your request:

• Focus of a 510(k) letter: The letter primarily states that the device has been found substantially equivalent to a predicate device, allowing it to be marketed. It confirms regulatory class, product codes, and general controls. It does not delve into the specific details of the performance testing or clinical studies conducted by the manufacturer.
• Missing information: All the points you've asked for (acceptance criteria table, sample sizes, expert qualifications, adjudication, MRMC studies, standalone performance, ground truth types, training set details) are typically found in the manufacturer's 510(k) summary document or the full 510(k) submission, not in the FDA's clearance letter itself.

Therefore, based only on the provided text, I cannot answer your request.

To provide the information you're seeking, I would need access to the full 510(k) submission document or the publicly available 510(k) summary for K071138, which would detail the performance data and the studies conducted.

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