(287 days)
As a primary implant for patients who present with eye disease or severe damage such that the eye must be enucleated or eviscerated.
An existing orbital implant that is malfunctioning or not satisfying the patient in terms of performance, may call for a secondary implant procedure to install a bio-ceramic orbital implant.
Bio-ceramic Orbital Implant
I am sorry, but the provided text does not contain information about the acceptance criteria or a study proving that a device meets such criteria. The document is a 510(k) clearance letter from the FDA for a Bioceramic Orbital Implant, indicating that the device is substantially equivalent to legally marketed predicate devices. It discusses regulatory matters, but not specific performance data or study results.
§ 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.