(317 days)
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.
§ 886.3320 Eye sphere implant.
(a)
Identification. An eye sphere implant is a device intended to be implanted in the eyeball to occupy space following the removal of the contents of the eyeball with the sclera left intact.(b)
Classification. Class II (special controls). The device, when it is an ocular peg which is supplied sterile only, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 886.9.