Search Results

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.

Ask a specific question about this device

Not Found

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.

Therefore, I cannot generate the table or answer the questions related to acceptance criteria and study details.

Ask a specific question about this device