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The Perry-Kolberg Titanium Motility/Support System is intended to provide a direct mechanical coupling of an ocular prosthesis to an orbital implant (eye sphere implant) in order to enhance motility of the prosthesis over that of a prosthesis used without a direct coupling to the implant. It also reduces the weight of the ocular prosthesis on the lower eyelid. It may be placed in a secondary operation that occurs after the ocular implant has become vascularized, approximately three to six months after implant placement. Alternatively, it may be placed during the initial implantation procedure before closing the Tenon's capsule and the conjunctiva.

The Perry-Kolberg (PK) Titanium Motility/Support System consists of the PK Titanium Threaded Sleeve, the PK Titanium Flat Peg for Sleeve, the PK Titanium Locking Socket Peg for Sleeve, the PK Titanium Motility Ball Peg for Sleeve, the PK Titanium Threaded Sleeve Wrench and a scries of PK Titanium Needle Drill Handles. The latter two devices are Class I, exempt devices, and are included in this submission only for reference and to explain the use of the PK Titanium Motility/Support System. The Threaded Sleeve is an excernally threaded cylinder with an internal drilled hole designed to receive a peg. It is placed in the Bioeye® Hydroxyapatite Implant with the use of the PK Titanium Threaded Sleeve Wrench after a hole is prepared in the implant by drilling with a series of hypodermic needles of gradually increasing size, from 21-gauge to 14 gauge. The needles are held with the PK Titanium Needle Drill Handle.

After the Threaded Slecve is placed in the implant, any of the PK Motility Pegs can be inserted. The PK Titanium Flat Peg for Sleeve can be used as a temporary device to maintain the integrity of the drilling hole or can, in some cases, be used to directly attach to the ocular prosthesis. The PK Titanium Locking Socket Peg for Sleeve is designed to aid in retention of a prosthesis even in extreme gazes by locking into the ocular prosthesis and avoiding the loss of engagement of the peg and the motility hole. It is manufactured with a shaft length that is adjustable in one millimeter increments by the ocularist, to mect each patient's individual requirements. A non-adjustable ball and socket peg, the PK Titanium Motility Ball Peg for Sleeve, is also included in the system.

The provided text is a 510(k) summary for the Perry-Kolberg Titanium Motility/Support System. It discusses the device's substantial equivalence to previously marketed devices and does not describe a study involving specific acceptance criteria, device performance metrics, sample sizes, expert involvement, or any form of AI for performance evaluation.

Therefore, I cannot provide the requested information from the given text. This document is a regulatory submission for market clearance based on substantial equivalence, not a clinical or performance study report.

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