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Concert™ Cranioplast is a resinous material for repair of cranial defects.

Concert™ Cranioplast is a resinous material for repair of cranial defects.

The provided text is a 510(k) summary for a medical device called "Concert™ Cranioplast," which is a methyl methacrylate material for cranioplasty. The document states that the device is substantially equivalent to a predicate device, Codman Cranioplastic™, Acrylic Cranioplasty Material (K873689).

However, the provided text does not contain any information regarding acceptance criteria, specific device performance metrics, clinical study details, sample sizes, expert involvement, ground truth establishment, or any of the other specific items you requested in your prompt.

The 510(k) summary focuses on demonstrating substantial equivalence through non-clinical performance testing. It simply states:

"Performance testing demonstrated that Concert™ Cranioplast is substantially equivalent to Cranioplastic with regard to functional characteristics."

Without further documentation, it is impossible to fulfill your request for detailed information about acceptance criteria, study design, and results. This summary is at a very high level and indicates that detailed performance data was submitted, but it is not publicly available in this document.

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