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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. Du epair is supplied sterile in sheet form in a variety of sizes to be trimmed and sutu red by the surgeon to meet the individual patient's needs.

This 510(k) summary (K052211) for the Durepair® Dura Regeneration Matrix does not contain information about acceptance criteria or a study proving that the device meets such criteria. Instead, it focuses on demonstrating substantial equivalence to a previously cleared predicate device (Durepair® Dura Regeneration Matrix, K041000).

The summary explicitly states:
"Medtronic Neurosurgery submits that the collagen material, sourcing specification, fundamental scientific technological attributes, device labeling, and the intended use of the device are the same as the previously reviewed and cleared Durepair."

This indicates that the submission is based on the premise that the new device is essentially identical to the predicate, and therefore, its safety and effectiveness are established by the predicate's prior clearance. There is no mention of a new performance study or acceptance criteria.

Therefore, I cannot provide the requested information from the provided text.

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