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The PeriPatch™ Sleeve is intended for use as a surgical patch mesh material to reinforce surgical staples during stapling procedures and for reinforcing suture lines for cardiovascular and general procedures. Stapling is carried out according to the stapler manufacture's instructions. The sleeves are intended for a number of resection techniques including: lung volume reductions, biopsies, lobectomies, gastric banding, rectal and vaginal prolapse, and urethral sling.

PeriPatch™ Sleeve consists of one piece of The qlutaraldehyde fixed bovine pericardium that is sutured into a rectanqular shaped tube. It is intended for reinforcing surgical staples. These specially prepared sleeves are slipped over the forks of linear or endoscopic surgical staplers. Stapling is carried out according to the stapler manufacture's instructions. The suture is removed and the remaining pericardial tissue is withdrawn with the excised host tissue. The sleeves are intended for a number of resection techniques such as lung volume reductions, biopsies, lobectomies and other soft tissue repairs.

The provided document is a 510(k) Premarket Notification for the PM Devices Inc. PeriPatch™ Sleeve. It seeks substantial equivalence to existing predicate devices. However, this document does not contain any information about acceptance criteria or a study that specifically proves the device meets acceptance criteria.

The document focuses on:

• Device Description: What the PeriPatch™ Sleeve is, how it works, and its materials.
• Predicate Devices: Demonstrating similarity to other legally marketed devices (PeriPatch™ Sheet, Glycar Pericardial Patch, Supple Peri-Guard® Pericardium, Vascu-Guard, Supple Peri-Guard).
• Intended Use: Listing the medical conditions and procedures for which the device is intended.
• Technological Characteristics Comparison (Table 4.3): Comparing the PeriPatch™ Sleeve's characteristics (materials, processing, shape, sizes, packaging, tissue thickness, tensile strength, shrink temperature, suture retention, elongation, burst strength, storage solution, rinse instructions, sterility method) to those of the predicate devices. The table consistently lists "SE" (Substantial Equivalence) under the "Significance" column, indicating that these characteristics are considered substantially equivalent to the predicates.
• FDA Clearance Letter: Confirming that the FDA has reviewed the 510(k) and found the device substantially equivalent to legally marketed predicate devices.

Therefore, I cannot provide the requested information regarding acceptance criteria and a study proving their fulfillment because this data is not present in the provided text.

The document implies that the device meets acceptance criteria by demonstrating substantial equivalence to predicate devices, particularly through the comparison of physical and performance characteristics in Table 4.3. However, it does not explicitly state acceptance criteria or detail a specific study with sample sizes, expert ground truth establishment, or adjudication methods to "prove" these criteria were met.

Without this information, I cannot fill out the requested table or answer the specific questions about sample sizes, ground truth, MRMC studies, or standalone performance. The absence of this type of detail is common in 510(k) summary documents, which often focus on demonstrating equivalence rather than presenting full study reports.

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