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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.

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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.

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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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The MCP® is indicated for patients with MEDPOR® Ocular Implants, who desire improved prosthetic eye motility via direct coupling of the implant to the prosthetic eye. Primary placement of the-MGP® may occur during the initial … reconstruction procedure, following attachment of the extraocular muscles to the ocular implant but before closing the Tenon's capsule and the conjunctiva layer. Secondary placement of the MCP may occur typically 3-6 months post enucleation after the ocular implant has become vascularized.

Titanium Screw

The screw is intended for single patient use. The Titanium Screw is composed of #6A1-4V ELI titanium which meets ASTM Standard F136-92. Three head sizes of 4.6 mm, 3.5 mm, and 2.5 mm will be available. The screw head contains a square hole to mate with the driver. The screw shaft and thread pattern is the same for all three head sizes.
The ocular screw is supplied non-sterile.

Screwdriver

The Screwdriver is manufactured of 316 stainless steel. The screwdriver tip is designed to mate with the square hole in the head of the titanium screw. The screwdriver is supplied non-sterile and is intended to be re-usable.

Drill Bit

The Drill Bit is a 1 mm diameter, 316 stainless steel, twist drill bit to be used for drilling a pilot hole for the screw. The Drill Bit is supplied non-sterile, and is intended to be re-usable.

The provided text describes a 510(k) submission for the MEDPOR® Ocular Screw and Accessories (K971583). This submission is for a medical device that assists in attaching an ocular prosthesis to an orbital implant.

Crucially, the document does not contain information about acceptance criteria, device performance studies, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or training set details.

The submission is based on the device being substantially equivalent to a predicate device (an Ocular Screw and Accessories currently approved for sale by Porex Surgical). The only change is a revision in the timing of device use: the new version allows the device to be used at the time of enucleation, whereas the predicate device required the ocular implant to be vascularized first.

Therefore, I cannot provide the requested table and detailed information about a study proving acceptance criteria. The information is simply not present in the provided text.

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