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The Eye Secret 55 UV Aspheric (Methafilcon A) Soft (hydrophilic) Contact Lens 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 55 UV Aspheric (Methafilcon A) Soft (hydrophilic) Contact Lens 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 55 UV Aspheric (Methafilcon A) Soft (hydrophilic) Contact Lens is manufactured by using cast molding method. The lens material, Methafilcon A, is a random copolymer of 2-hydroxyethyl methacrylate (HEMA) and Methacrylic acid (MAA) 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 text is related to the Eye Secret 55 UV Aspheric (Methafilcon A) Soft (hydrophilic) Contact Lens. It serves as a 510(k) summary for premarket notification to the FDA. The document focuses on demonstrating substantial equivalence to a predicate device (K133735) rather than acting as a traditional clinical study report for a new medical device where complex acceptance criteria related to diagnostic performance might be required.

Therefore, the requested information regarding acceptance criteria and studies (e.g., MRMC, expert ground truth, training set details) that are typical for AI/ML-driven devices with diagnostic or prognostic capabilities is not applicable to this document. This document describes a contact lens and focuses on bench testing and material safety.

However, I can extract the "acceptance criteria" through the lens of substantial equivalence and the reported device performance related to the physical and chemical properties of the contact lens, as well as the non-clinical tests performed to demonstrate its safety and effectiveness.

Here's an interpretation of the requested information based on the provided text for the Eye Secret 55 UV Aspheric (Methafilcon A) Soft (hydrophilic) Contact Lens:

1. Table of Acceptance Criteria and Reported Device Performance

For this medical device (contact lens), the "acceptance criteria" are implied by demonstrating substantial equivalence to the predicate device (K133735) across various physical, chemical, and safety characteristics. The reported device performance is compared directly to the predicate device.

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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 55 UV Aspheric (Methafilcon A) Soft (Hydrophilic) Contact lenses are indicated for the correction of ametropia (myopia) in aphakic and non-aphakic persons with non-diseased eyes in powers from 0.00 to -12.00 diopters. The lenses may be worn by persons who exhibit astigmatism of 2.00 diopters or less that does not interfere with visual acuity. Eye Care professionals may prescribe the lens for 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 55 UV Aspheric (methafilcon A) Soft (hydrophilic) contact lens is manufactured by using advanced cast molding method. The lens material, methafilcon A, is a random copolymer of 2-hydroxyethyl methacrylate (HEMA) and methacrylic acid (MAA) 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 280~315 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 510(k) summary (K133735) describes the "Eye Secret 55 UV Aspheric (methafilcon A) Soft (hydrophilic) Contact Lens." This device is a contact lens, and its acceptance criteria and the study proving it meets these criteria are established through a demonstration of substantial equivalence to a predicate device, the "SAUFLON 55 UV (methafilcon A) Soft (Hydrophilic) Visibility Tinted Contact Lens for Daily Wear" (K013649).

The approval is based on non-clinical testing rather than a clinical study or AI performance evaluation. The review relies on the inherent equivalence of the new device to a previously approved one.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are implicitly defined by the characteristics of the predicate device, K013649. The new device demonstrates performance that is either identical or within acceptable limits of the predicate.

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