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The PERMASORB™ Disposable Fixation Device is indicated for the approximation of soft tissue and fixation of surgical mesh to tissues during open or laparoscopic surgical procedures, such as hernia repair.

PermaSorb™ is endoscopic or open surgical stapler composed of a disposable sterile single use delivery instrument and resorbable fixation devices.

The provided text is a 510(k) summary for the PERMASORB™ Disposable Fixation Device. It describes the device, its indications for use, and a comparison to predicate devices, but it explicitly states that "No clinical studies were performed."

Therefore, based on the provided text, there is no information available to construct a table of acceptance criteria or describe a study that proves the device meets those criteria. The submission relies solely on non-clinical testing summary (which states "No changes to product design specifications were made") and substantial equivalence to predicate devices (K060494 and K111153) to demonstrate safety and effectiveness.

Key takeaway from the document: The device approval is based on substantial equivalence, not a new study demonstrating performance against specific acceptance criteria.

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