(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.
SCLERAL SHELL, an ocular prosthesis, (artificial eye)
I'm sorry, but this document contains a letter from the FDA regarding a medical device, but it does not contain the specific information you've requested about acceptance criteria, study details, sample sizes, expert qualifications, or ground truth establishment for a device study. The letter is a 510(k) clearance notification, which states that the "Scleral Shell" device is substantially equivalent to previously marketed devices and can therefore be marketed.
To provide the information you're looking for, I would need a different type of document, such as a summary of safety and effectiveness data (SSED), a clinical study report, or a 510(k) submission summary that details the performance testing.
§ 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.