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The Eye Secret 38 UV Aspheric (polymacon) Soft (hydrophilic) Contact Lens for Daily Wear is indicated for the correction of refractive ametropia (myopia) in aphakic and not-aphakic persons with non-diseased eyes. The lenses may be worn by person who exhibit astigmatism of 2.00 diopters or less that does not interfere with visual acuity.

The Eye Secret 38 UV Aspheric (polymacon) Soft (hydrophilic) Contact Lens for Daily Wear helps protect against transmission of harmful UV radiation to the cornea and into the eye.

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

The Eye Secret 38 UV Aspheric (polymacon) Soft (hydrophilic) Contact Lens for Daily Wear is manufactured by using cast molding method. The lens material, polymacon, is a random copolymer of 2-hydroxyethyl methacrylate (HEMA) crosslinked with ethylene glycol dimethacrylate (EGDMA). A UV absorbing monomer is used to block UV radiation. The average transmittance characteristics are less than 5% in the UVB range of 280 to 315 nm and less than 50% in the UVA range of 316 to 380 nm. The lenses are tinted blue for visibility purposes with the color additives, C.I. Reactive Blue No.4.

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 sodium hyaluronate and trehalose wetting agents.

The provided document describes the predicate device "Eye Secret 38 UV Aspheric Color (polymacon) Soft (hydrophilic) Contact Lens for Daily Wear" (K143052) and the new device "Eye Secret 38 UV Aspheric (polymacon) Soft (hydrophilic) Contact Lens for Daily Wear." The acceptance criteria are based on demonstrating substantial equivalence to the predicate device through non-clinical testing.

Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document presents a comparison to the predicate device, serving as the de-facto acceptance criteria. The subject device must match or perform equivalently to the predicate device across various parameters.

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The Eye Secret 38 UV Aspheric (polymacon) Soft (hydrophilic) Contact Lens for Daily Wear is indicated for the correction of ametropia (myopia) in aphakic and not-aphakic persons with non-diseased eyes. The lenses may be worn by persons who exhibit astigmatism of 2.00 diopters or less that does not interfere with visual acuity.

The Eye Secret 38 UV Aspheric (polymacon) Soft (hydrophilic) Contact Lens for Daily Wear is manufactured by using cast molding method. The lens material, polymacon, is a random copolymer of 2-hydroxyethyl methacrylate (HEMA) crosslinked with ethylene glycol dimethacrylate (EGDMA). A UV absorbing monomer is used to block UV radiation. The average transmittance characteristics are less than 5% in the UVB range of 280 to 315 nm and less than 50% in the UVA range of 316 to 380 nm. The lenses are tinted blue for visibility purposes with the color additives, C.I. Reactive Blue No.4. The Lenses are available as aspheric lenses.

The provided document is a 510(k) premarket notification for a contact lens, the "Eye Secret 38 UV Aspheric (polymacon) Soft (hydrophilic) Contact Lens for Daily Wear." This type of submission focuses on demonstrating substantial equivalence to a predicate device rather than conducting extensive clinical studies typical for novel medical devices or AI algorithms. As such, the information you're requesting regarding AI-specific acceptance criteria, test sets, expert ground truth, MRMC studies, and training sets is not applicable to this document.

The "study that proves the device meets the acceptance criteria" in this context refers to a series of preclinical (non-clinical) tests and a comparison to a predicate device, rather than human clinical trials or AI performance evaluations.

Here's a breakdown based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

For this contact lens submission, the "acceptance criteria" are not framed as specific performance thresholds for an AI algorithm's metrics (like sensitivity, specificity, or AUC). Instead, they are demonstrated through equivalence to a legally marketed predicate device and through non-clinical testing that proves the device meets established standards for contact lens safety and function.

The table below summarizes the key comparative data provided for the subject device and its predicate, which implicitly defines the "acceptance criteria" through equivalence.

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