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Simultaneous use of GBR-membrane (BIO-GIDE®) and implants; augmentation around implants placed in immediate extraction sockets; 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; and guided tissue regeneration procedures in periodontal defects.

BIO-GIDE® resorbable bilayer membrane for guided tissue and bone regeneration. BIO-GIDE® is a pure collagen membrane obtained by a standardized controlled manufacturing process. The collagen is extracted from veterinary certified pigs and is carefully purified to avoid antigenic reactions. BIO-GIDE® is sterilized in double blisters by gamma irradiation. BIO-GIDE® has a bilayer structure. The porous surface facing the bone - allows the ingrowth of bone forming cells. The dense surface - facing the soft tissue - prevents the ingrowth of fibrous tissue into the bone defect. The membrane is made of collagen type I and type III without further cross-linking or chemical treatment.

The provided text does not contain information about acceptance criteria or a study demonstrating device performance against such criteria. The document is a 510(k) summary for the BIO-GIDE® resorbable bilayer membrane, which focuses on demonstrating substantial equivalence to previously cleared predicate devices (K960724 and K042197).

The key point of this 510(k) summary is the addition of a heating step (70℃ for at least 30 minutes) to the manufacturing process for assurance that organisms causing Transmissible Spongiform Encephalopathies Disease have been destroyed. The document explicitly states: "The revised manufacturing process has been validated and tests have been done that confirm that the additional heating step does not affect the final product and that, as such, there were no changes that would render the product not substantially equivalent to the previously cleared predicate product."

Therefore, the requested information cannot be extracted from this document, as it does not describe a study proving the device meets specific performance acceptance criteria. It focuses on validating a manufacturing process change and demonstrating substantial equivalence.

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