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The Prosthetic (hefilcon A) Soft Contact Lens is indicated for daily wear to enhance or alter the appearance of the eve. including ocular masking, in sighted or non-sighted eyes, that may require a prosthetic contact lens for the cosmetic management of corneal, iris, scleral or lens abnormalities; or for persons wishing to change the appearance of their eyes without eye abnormalities. The lens may also be prescribed for the correction of refractive ametropia (myopia, hyperopia or astigmatism) in aphakic or non-aphakic persons or for occlusive therapy for conditions such as diplopia, amblyopia or extreme photophobia. The lens may be disinfected with a chemical disinfection system.

The Prosthetic (hefilcon A)Soft Lens is a partially or totally white opaque lens that is painted or printed with an iris or other pattern to mask a disfiguring or unsightly eye condition. The lens may be totally opaque for a non-sighted eye or clear in the center for a sighted eye. The approved pigment, titanium dioxide, is incorporated into the lens matrix as the white opaquing agent. Lenses are printed or painted by skilled artists to a eye care practitioners specifications with approved reactive dyes. The opaquing agent and colorants are permanent and are not leached from a lens.

The provided text is a 510(k) summary for a contact lens, focusing on its substantial equivalence to previously cleared devices. It does not contain information about acceptance criteria or a study proving device performance against such criteria in the manner requested. Specifically:

1. A table of acceptance criteria and the reported device performance: This information is not present. The document focuses on regulatory clearance based on substantial equivalence, not on specific performance metrics or acceptance criteria.
2. Sample size used for the test set and the data provenance: Not applicable, as no performance study is described.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
4. Adjudication method: 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 document is about a contact lens and does not involve AI or human readers for diagnostic interpretation.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable.
7. The type of ground truth used: Not applicable.
8. The sample size for the training set: Not applicable.
9. How the ground truth for the training set was established: Not applicable.

The document states that the device is "substantially equivalent" to predicate devices, which implies that it meets similar safety and effectiveness standards, but it does not detail specific performance studies of the Prosthetic (hefilcon A) Soft Lens itself against defined acceptance criteria.

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