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Biopor Porous Polyethylene Implants in block, sheet, and anatomical shapes are intended for the augmentation or reconstruction of the maxillofacial skeleton.

Biopor Porous Polyethylene Implants are manufactured of porous high-density polyethylene, a biomaterial that is easily contoured or carved to suit the anatomical and functional requirements of the patient. The interconnecting pores of the Porous HDPE material permits fibrovascular ingrowth into the implant. The implants are manufactured with the option of a coating with a water-soluble alkylene oxide copolymer blend and/or the option of embedded titanium mesh. AOC™ Porous Polyethylene Surgical Implants are provided STERILE and should not be resterilized.

The provided text describes a 510(k) premarket notification for a medical device (Biopor Porous Polyethylene Implants) and does not contain information about acceptance criteria for device performance in the context of a study that proves the device meets those criteria.

The document is a regulatory submission to the FDA, demonstrating substantial equivalence to predicate devices, focusing on:

• Device Description: Porous high-density polyethylene implants for maxillofacial skeleton augmentation/reconstruction.
• Intended Use: Augmentation or reconstruction of the maxillofacial skeleton.
• Substantial Equivalence: Claiming substantial equivalence to predicate devices (Ceremed Biopor K141880, Poriferous Su-Por K140437, Stryker Medpor K922489) based on similar intended use, additional shapes and sizes, material properties, and biocompatibility.
• Biocompatibility and Performance Testing: Listing various ISO 10993-compliant tests performed (e.g., Cytotoxicity, Implantation studies, Genotoxicity, Pyrogen test).

Therefore, I cannot provide the requested information, as the input does not contain a study outlining specific performance acceptance criteria, device performance results against those criteria, or details regarding test sets, expert ground truth, adjudication methods, or MRMC studies.

The "performance testing" mentioned refers to a list of standard biocompatibility and material tests (e.g., Cytotoxicity, Implantation studies) rather than a study evaluating diagnostic performance or algorithm effectiveness as might be implied by "acceptance criteria and the study that proves the device meets the acceptance criteria" in an AI/software context.

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