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The Kensey Nash Fibrillar Collagen Dental Membrane is indicated for:

• . Simultaneous use of Guided Bone Regeneration (GBR)-membrane and implants.
• Augmentation around implants placed in immediate extraction sites. .
• . Augmentation around implants placed in delayed extraction sockets.
• Localized ridge augmentation for later implantation. .
• . Alveolar ridge reconstruction for prosthetic treatment.
• Filling of bone defects after root resection, cystectomy, removal of retained teeth. .
• Guided bone regeneration in dehiscence defects. .
• . Guided tissue regeneration procedures in periodontal defects

The Kensey Nash (KN) Fibrillar Collagen Dental Membrane is a translucent, resorbable, non-friable, rectangular collagen membrane sheet derived from bovine tissue. The KN Fibrillar Collagen Dental Membrane is intended for single-use and is sterilized by Ethylene Oxide.

The provided text is a 510(k) summary for the Kensey Nash Fibrillar Collagen Dental Membrane. It describes the device, its intended use, and claims substantial equivalence to predicate devices. However, it does not contain any information about specific acceptance criteria or a study demonstrating the device meets those criteria.

The document states: "Performance Testing has confirmed that the Kensey Nash Fibrillar Collagen Dental Membrane is substantially equivalent to the predicate devices with regard to materials, intended use, and technological characteristics, pursuant to section 510(k)." This is a general statement and does not provide details of acceptance criteria or performance results.

Therefore, I cannot populate the requested table or answer the specific questions about sample size, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth, or training set details because this information is not present in the provided text.

The closest information provided is the list of predicate devices, implying that the new device's performance is compared to theirs for substantial equivalence, but the specific metrics and comparison results are absent.

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