(89 days)
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The MEDPOR® Ocular Peg and Sleeve and Accessories consist of two HDPE (High Density Polyethylene) Pegs, and an HDPE Sleeve with the necessary associated manual surgical instruments. The pegs and sleeve will be sold as a package, supplied sterile. All other components will be supplied separately, non-sterile.
The associated surgical instruments include an Ocular Implant Clamp for holding the implant during the procedure, a sleeve driver for screwing the sleeve into the implant, and three drill bits for drilling the hole for the peg or peg and sleeve.
I am sorry, but the provided text does not contain the information needed to answer your request. The document describes a medical device (MEDPOR® Ocular Peg System and Accessories) and its components, sterilization methods, biocompatibility, and comparison to predicate devices for 510(k) submission. However, it does not include any acceptance criteria, performance data, or details of a study that proves the device meets specific criteria as you've requested.
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§ 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.