(160 days)
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.
§ 886.3800 Scleral shell.
(a)
Identification. A scleral shell is a device made of glass or plastic that is intended to be inserted for short time periods over the cornea and proximal-cornea sclera for cosmetic or reconstructive purposes. An artificial eye is usually painted on the device. The device is not intended to be implanted.(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.