(128 days)
This system is designed to drill hydroxyapatite orbital implants and place a motility peg for coupling to the artificial eye. It may also be used to replace a previous sleeve or a previous peg.
Not Found
I am sorry, but based on the provided text, there is no information about acceptance criteria or a study proving the device meets those criteria. The document is an FDA 510(k) clearance letter for the "Titanium Peg System," indicating that the device is substantially equivalent to legally marketed predicate devices.
The text does not include:
- A table of acceptance criteria and reported device performance.
- Details about sample sizes, data provenance, or ground truth establishment for any study.
- Information on expert reviews, adjudication methods, or MRMC studies.
- Results from standalone algorithm performance.
- Details about training sets.
§ 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.