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For use as a prosthesis for the surgical repair of soft tissue deficiencies which include: defects of the abdominal and thoracic wall, gastric banding, muscle flap reinforcement, and hernias (diaphragmatic, femoral, incisional, inguinal, lumbar, paracolostomy, scrotal and umbilical).

Supple Peri-Guard® is prepared from bovine pericardium which is crosslinked with glutaraldehyde. The pericardium is procured from cattle originating in the United States. Supple Peri-Guard is chemically sterilized using ethanol and propylene oxide. Supple Peri-Guard has been treated with 1 molar sodium hydroxide for 60-75 minutes at 20-25°C. Supple Peri-Guard is packaged in a container filled with sterile, nonpyrogenic water containing propylene oxide. The contents of the unopened, undamaged container are sterile.

This document presents a 510(k) Summary for the Supple Peri-Guard Pericardium device. However, it does not contain specific acceptance criteria, performance data, or details of a study that proves the device meets acceptance criteria in the format typically requested for AI/diagnostic studies.

Instead, this document is a regulatory submission demonstrating the substantial equivalence of the Supple Peri-Guard Pericardium to a predicate device (which is itself) for purposes of market clearance. The "Technology/Device Testing" section explicitly states: "Supple Peri-Guard is identical to the predicate device, clarification of labeling only." This indicates that no new performance testing was conducted for this specific 510(k) submission because the device itself, and its performance, are considered the same as the already cleared predicate.

Therefore, I cannot populate the table and answer the questions as requested based on the provided text, as the information simply isn't present in this type of regulatory document. This submission relies on the prior clearance of the predicate device (K921895 and K923657) and asserts sameness, rather than presenting new performance data against specific acceptance criteria.

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Peri-Guard is intended for use as a prosthesis for the surgical repair of soft tissue deficiencies which include: defects of the abdominal and thoracic wall, gastric binding, muscle flap reinforcement, and hernias (including diaphragmatic, femoral, incisional, inguinal, lumbar, paracolostomy, scrotal, and umbilical hernias).

Peri-Guard® Repair Patch (Peri-Guard) is a biologic tissue prepared from bovine pericardium cross-linked with glutaraldehyde. The pericardium is procured from cattle originating in the United States. Peri-Guard is chemically sterilized using ethanol and propylene oxide. Peri-Guard is treated with 1 molar sodium hydroxide for 60-75 minutes at 20-25°C. Peri-Guard is virtually identical to Supple Perl-Guard, differing only in elasticity (i.e., suppleness).

The provided text is a 510(k) summary for a surgical mesh device called "Peri-Guard Repair Patch." It does not contain any information about acceptance criteria, device performance metrics, or study details such as sample sizes, ground truth establishment, or expert qualifications.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them based on the provided text. The document is primarily focused on the administrative aspects of a 510(k) submission, including device description, intended use, and substantial equivalence to predicate devices, rather than detailed performance testing.

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