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The Eye Secret 59 UV Aspheric (Omafilcon A) Soft (hydrophilic) Contact Lens for Daily Wear is indicated for daily wear for the correction of refractive ametropia (myopia or hyperopia) in aphakic and not-aphakic persons with nondiseased eyes. The lens may be worn by person who exhibit astigmatism of 2.00 diopters or less that does not interfere with visual acuity.

The eye care professionals may prescribe the lens for single use daily disposable or daily wear in a Frequent Replacement Program. When prescribed for frequent/planned replacement, the lens should be disinfected using a chemical or hydrogen peroxide disinfecting systems.

The Eye Secret 59 UV Aspheric (Omafilcon A) Soft (hydrophilic) Contact Lens for Daily Wear is hydrophilic available with aspheric design manufactured by using Cast Molding method. The soft contact lens material, Omafilcon A, is a random copolymer of 2-hydroxyethyl methacrylate (HEMA) and 2-Methacryloyloxyethyl phosphoryIcholine (MPC) crosslinked with ethylene glycol dimethacrylate (EDGMA), and has 59% water by weight. These lenses contain UV blocker, a benzotriazole UV absorbing monomer to block UV radiation. Thus, the lens helps protect against the transmission of harmful UV radiation to the cornea and into the eye. The transmittance characteristics are less than 5 % in the UVB range of 280 nm to 315 nm and less than 50 % in the UVA range of 316 nm to 380 nm. The lenses are tinted from edge to edge for visibility purposes with the color additive Reactive Blue 246.

The Eye Secret 59 UV Aspheric (Omafilcon A) Soft (hydrophilic) Contact Lens for Daily Wear helps protect against transmission of harmful UV radiation to the cornea and into the eye.

The lenses are available as aspheric lenses. Each finished lens is supplied in a plastic blister container with a sterile isotonic phosphate buffered saline solution containing 2-(Methacryloyloxy) ethyl 2-(trimethylammonio) ethyl phosphate-n-butylmethacrylate copolymer (PMB) wetting agent.

This document is a 510(k) Premarket Notification for a soft contact lens, not an AI-powered medical device. Therefore, much of the requested information regarding acceptance criteria for AI models, such as detailed clinical study designs for AI performance, expert adjudication, MRMC studies, and separate training/test sets for AI, is not applicable to this submission.

The "acceptance criteria" and "study that proves the device meets the acceptance criteria" in this context refer to the non-clinical testing performed to demonstrate the safety and effectiveness of the contact lens itself, primarily through physiochemical and toxicology studies, and by demonstrating substantial equivalence to legally marketed predicate devices.

Here's an attempt to answer the questions based on the provided document, interpreting "acceptance criteria" through the lens of contact lens regulatory submission:

1. A table of acceptance criteria and the reported device performance

The document doesn't present a single formal "acceptance criteria" table in the way one might see for an AI model. Instead, acceptance is demonstrated by meeting established specifications for physical, optical, and chemical properties, and by demonstrating biocompatibility. The performance is compared against predicate devices and relevant ISO standards.

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