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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 a double-peel package, and is intended for single (one-time) use-only. Durepair is available in a variety of sizes intended to be cut by the surgeon to the desired shape.

The document describes the Durepair Dura Regeneration Matrix, a collagen implant for repairing dura mater defects. This is a 510(k) submission, meaning the device is seeking clearance by demonstrating substantial equivalence to a legally marketed predicate device, rather than proving de novo safety and effectiveness.

Here's an analysis of the acceptance criteria and supporting studies, based on the provided text:

Key Takeaway: The entire submission focuses on demonstrating that a manufacturing process change for the Proposed Durepair Device does not alter its fundamental technological characteristics, material, indications for use, or safety and effectiveness compared to the Predicate Durepair Device. Therefore, the "acceptance criteria" discussed are largely related to ensuring the proposed device performs comparably to the predicate across various physical, mechanical, and biological properties.

1. Table of Acceptance Criteria and Reported Device Performance

The document provides "Table 2 – Summary of Bench Top Testing" and "Table 3 – Summary of Biocompatibility Testing" which directly address acceptance criteria and the performance of the Proposed Durepair device.

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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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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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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.

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