Search Results

Eye Spheres are permanent implants that occupy the eye cavity when it has become necessary to surgically remove the eye (enucleation) or the contents of the eye sac (evisceration)

Conformers are temporary devices which maintain the shape of the eye and prevent closure or adhesion during the healing process

When an eye is severely damaged by trauma or disease, it may be necessary to remove it surgically. The most common procedures are evisceration (removal of the contents of the eye) or enucleation (removal of the eye itself). Eye spheres are permanent implants to occupy the cavity that results from surgery. Conformers are temporary devices, which maintain the shape of the eye and prevent closure or adhesion during the healing process. When healing is complete, conformers are replaced with prosthesis. Eye Spheres and Conformers are made of polymethylmethacrylate (PMMA), a hard, clear plastic that is lightweight, inert and virtually unbreakable. Eye spheres are available in even diameters from 10mm through 22mm. Conformers are available in three sizes: small, medium, large. Conformers may be ordered with or without holes. Eye spheres and Conformers are FDA Class II products.

The provided text is a 510(k) summary for Product and Educational Services LLC's Eye Spheres and Conformers. This document describes the device, its intended use, and its substantial equivalence to legally marketed predicate devices. It does not contain information about acceptance criteria or a study proving that the device meets such criteria.

The core of this submission is demonstrating "substantial equivalence" to existing devices, not presenting novel performance data against pre-defined acceptance criteria. The document states:

• "Product and Educational Services LLC (PES) Eye Spheres and Conformers are the same Eye Spheres and Conformers manufactured and marketed by Gulden Ophthalmics as 'non sterile'."
• "The only difference is that PES will be providing the same Eye Spheres and Conformers as sterile, single use devices."
• "Gulden Ophthalmics Eye Spheres and Conformers are 'preamendment' devices."

Therefore, the submission relies on the established safety and effectiveness of the predicate Gulden Ophthalmics devices, with the primary "non-clinical test" being a comparison of technological characteristics as shown in the table on page 2, and the change in sterilization method.

Regarding the specific questions you asked, the document does not provide the requested information because it describes a 510(k) submission based on substantial equivalence, not a performance study against acceptance criteria.

Here's a breakdown of why each point cannot be answered from the provided text:

1. A table of acceptance criteria and the reported device performance: Not present. The submission focuses on technological characteristics comparison with predicate devices.
2. Sample size used for the test set and the data provenance: No test set data is provided. The document implies no new performance testing (beyond sterilization validation, which is not detailed here) was conducted to demonstrate equivalence for the device itself, as it's the "same" as the predicate.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, as there's no test set described for performance evaluation.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
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 applicable. This device is an ophthalmic implant/conformer, not a diagnostic AI system involving human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an AI algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable, as no performance study data is presented.
8. The sample size for the training set: Not applicable, as there is no mention of a training set for an AI model.
9. How the ground truth for the training set was established: Not applicable.

Ask a specific question about this device