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Conformer, is fabricated for the needs of a specific patient. Each is uniquely designed, fabricated, and fitted past-enucleation surgery, to maintain correct eye lid/socket configuration. In the other cases, to correct deformities of the eyelids, and/or socket. They are also fitted in a necessarily, sequential, increasing size, for infants afflicted with anophthalmia, or micro-ophthalmia, or in infants previous to the trauma or other socket and eyelid anomalies. Proper expansion therapy, with the use of sequential, increasing size conformers, is essential in eyelid development in infants and children.

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This document is a 510(k) clearance letter from the FDA for an "Ocular Conformer" device, dated July 7, 1997. It explicitly states that the FDA has determined the device is "substantially equivalent" to predicate devices marketed prior to May 28, 1976.

Based on the content, this letter does not contain the information requested regarding acceptance criteria and a study proving the device meets those criteria. The 510(k) clearance process for this type of device typically focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than requiring extensive clinical trials with specific performance metrics and acceptance criteria as would be expected for novel devices or those undergoing PMA.

Therefore, I cannot provide the requested table and study details. This document simply indicates market clearance based on substantial equivalence.

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The Custom Scleral Cover Shell, is an ocular prosthesis, (artificial eye), fitted over a deformed, or disfigured blind eye, or over an eviscerated globe, for a specific patient. Scleral Cover Shells are also indicated for patients with Microphthalmia, Phthisis Bulbi, or other types of eye deformities.

In cases of infants and children with microphthalmia, and /or anophthalmia, the orbital fascia, bony orbit, and palpebral fissures, will be provided with the volume and surface area necessary to develop more normally, thus avoiding the complication of future deformities and possible corrective surgery.

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The provided text is a 510(k) clearance letter from the FDA for a device called "Scleral Shell." This document does not describe the acceptance criteria for a device or a study proving that the device meets those criteria. Instead, it states that the device is "substantially equivalent" to legally marketed predicate devices.

Therefore, I cannot extract the requested information from this document. If you have a different document that contains acceptance criteria and study details, please provide it.

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