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Mesh wrapped Bioceramic orbital implants are designed to fill in the orbital cavity following enucleation, evisceration or during secondary implantation.

Mesh Wrapped Bioceramic Orbital Implant

I apologize, but this document is not a study that proves the device meets the acceptance criteria. This is a 510(k) clearance letter from the FDA, indicating that the device, "FCI Mesh Wrapped Bioceramic Orbital Implant", is substantially equivalent to legally marketed predicate devices.

A 510(k) clearance does not typically include a detailed study proving performance against specific acceptance criteria in the way a clinical trial report would. Instead, it demonstrates substantial equivalence, often through comparisons of design, materials, and intended use to a previously cleared device, along with preclinical testing (e.g., biocompatibility, mechanical testing) rather than a clinical study focused on performance metrics like sensitivity or specificity.

Therefore, I cannot provide the information requested in your prompt based on the provided document. The document primarily focuses on regulatory clearance rather than a detailed performance study with acceptance criteria.

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