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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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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.

Ask a specific question about this device