(99 days)
Durepair® is indicated as a dura substitute for the repair of the dura mater.
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 of sizes to be trimmed and; sutured or onlayed 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 collagen implant for dura mater repair. It outlines the device's description, indications for use, and a statement of substantial equivalence to predicate devices (Dura-Guard® and DuraGen™).
However, the document does not contain information about:
- Acceptance criteria in terms of specific performance metrics or thresholds.
- A "study" describing device performance against such criteria.
- Sample sizes for test sets or training sets.
- Data provenance, expert qualifications, adjudication methods, MRMC studies, standalone performance, or type of ground truth.
The document states that "Safety of the Durepair® device to the predicate products was demonstrated in biocompatibility studies in accordance with ISO 10993, in vitro testing, animal studies, and clinical data." This vaguely mentions "clinical data" but provides no details about the design, results, or specific metrics from these studies that would allow for an evaluation of acceptance criteria or performance.
Therefore, I cannot fulfill the request for a table of acceptance criteria, reported device performance, or detailed study information based solely on the provided text. The document focuses on demonstrating substantial equivalence to predicate devices rather than providing detailed performance study results that would typically include such metrics.
§ 882.5910 Dura substitute.
(a)
Identification. A dura substitute is a sheet or material that is used to repair the dura mater (the membrane surrounding the brain).(b)
Classification. Class II (performance standards).