(160 days)
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.
Not Found
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.
§ 886.3130 Ophthalmic conformer.
(a)
Identification. An ophthalmic conformer is a device usually made of molded plastic intended to be inserted temporarily between the eyeball and eyelid to maintain space in the orbital cavity and prevent closure or adhesions during the healing process following surgery. ](b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 886.9.