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Durepair® is indicated as a dura substitute for the repair of the dura mater.

The Durepair Dura Regeneration Matrix is a collagen implant for the repair of defects in the dura mater. Durepair is supplied sterile in sheet form in a variety ropal. of act and sutured by the surgeon to meet the individual patient's needs.

The provided text is a 510(k) summary for the Durepair® Dura Regeneration Matrix, a dura substitute device. This document does not contain information about acceptance criteria, device performance studies, sample sizes, expert qualifications, or ground truth establishment relevant to the provided questions.

The 510(k) summary focuses on establishing substantial equivalence to a predicate device based on:

• Technological Comparison: Stating that the collagen material, fundamental scientific attributes, device labeling, and the device's familiar material are the same as the previously reviewed and cleared Durepair® Dura Regeneration Matrix (K041000 and K052211).
• Intended Use: Both the current device and the predicate device are intended as a dura substitute for the repair of the dura mater.

Therefore, I cannot provide a table of acceptance criteria and reported device performance or answer questions 2 through 9 based on the provided text. The submission relies on the prior clearance of the predicate device and does not present new performance data from clinical studies for the submitted device.

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