Search Results

Conformer, is fabricated for the needs of a The Custom specific patient. Each is uniquely designed, fabricated, and t fitted post-enucleation/evisceration 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, as well as patients with trauma or other socket and eyelid anomalies. Proper expansion therapy, with the sential anomaries proper expansion chocariers, is essential in sequential, increasing Stac Controlmose), and eyelid development in infants and children.

Not Found

The provided text is a 510(k) premarket notification letter from the FDA regarding an "Ocular Conformer" device. This document primarily focuses on regulatory approval and does not contain information about a study that would establish acceptance criteria or demonstrate device performance as typically expected for medical device software or AI.

Therefore, I cannot extract the requested information points because they are not present in the provided text. The document is a clearance letter, not a study report.

Here's why each point cannot be addressed based on the provided text:

1. A table of acceptance criteria and the reported device performance: Not present. The letter states the device is "substantially equivalent" to a predicate device, which is a regulatory standard, not a performance metric for this type of detailed analysis.
2. Sample size used for the test set and the data provenance: Not present. There is no mention of a test set or data for a study.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not present. No test set or ground truth establishment is described.
4. Adjudication method: Not present. No study or adjudication process is detailed.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not present. This device ("Ocular Conformer") is a physical medical device (an ocular prosthetic), not an AI or software device that would typically undergo such a study.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not present. This is not an algorithm.
7. The type of ground truth used: Not present.
8. The sample size for the training set: Not present.
9. How the ground truth for the training set was established: Not present.

Ask a specific question about this device

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