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The DuraSoft 2 FreshLook Colors (phemfilcon A) Soft (hydrophilic) Contact Lenses and the DuraSoft 2 FreshLook LiteTint (phemfilcon A) Soft (hydrophilic) Contact Lenses are indicated for daily wear in the correction of visual acuity in aphakic and not-aphakic persons with non-diseased eves that are revopic (nearsighted) or hyperopic (farsighted) and may exhibit astigmatism of 0.75 diopters (D) or less that does not interfere with visual acuity.

The lenses indicated are for Daily Wear (for available powers see Lens Description Section). Eve care practitioner may prescribe the lens for either single-use disposable daily wear or for frequent replacement wear for daily use, with cleaning, rinsing, disinfection and scheduled replacement from one to 14 days of use. (See Wear Schedule Section for additional information.) When prescribed for frequent replacement wear, the lens must be disinfected using either chemical or heat disinfection systems.

The DuraSoft 2 FreshLook Colors (phemfilcon A) Soft (hydrophilic) Contact Lenses and DuraSoft 2 FreshLook LiteTint (phemfilcon A) Soft (hydrophilic) Contact Lenses are hemispherical shells of the following dimensions:

Chord Diameter: 12.0 to 15.0 mm
Center Thickness: 0.08 to 0.56 mm (Varies with power)
Base Curves: 7.80 to 9.00 mm
Powers: -20.00 Diopters to +20.00 Diopters

The lens material (phemfilcon A) is a hydrophilic copolymer of 2-hydroxyethy) methylcrylate and 2ethoxyethyl methacrylate. The DuraSoft 2 FreshLook Colors (phemfilcon A) Soft (hydrophilic) Contact Lenses are made by modifying the clear lens by affixing a colored pigment on that portion of the front surface of the lens which corresponds to the iris. The colored pigments consist of the following color additives listed in the Color Additive Provisions of the Code of Federal Requilations 21 CFR Section 706. All colored lenses contain iron oxides, titanium dioxide and [phthalocyaninato (2-1)] copper. In addition, the green lens contains chromium oxide and the violet lens contains carbazole violet. The DuraSoft 2 FreshLook Colors (phemfilcon A) Soft (hydrophilic) Contact Lenses are available in the following opaque colors: Blue, Green, Hazel and Violet. The DuraSoft 2 FreshLook LiteTint (phemfilcon A) Soft (hydrophilic) Contact Lenses is tinted green with the color additive, phthalocyanine green for easy visibility for handling.

The physical properties of the lenses are:

Specific Gravity: 1.176
Refractive Index: 1.440
Light Transmittance:
FreshLook LiteTint: 95% minimum
FreshLook Colors: 97% minimum
Surface Characteristics: Hydrophilic
Water Content: 38%
Optical Zone (FreshLook Colors): 5 mm
(FreshLook LiteTint): 5 mm to 9 mm (Varies with power)
Oxygen Transmissibility: Dk/L = 12.9 x 10-9 ml O2 cm@ 35°C sec ml mm Hg

The provided text describes a medical device (contact lenses) and its properties but does not contain any information about acceptance criteria or a study designed to prove the device meets such criteria in the context of an AI/ML algorithm or a comparative effectiveness study involving human readers.

The document is a "Summary of Safety & Effectiveness" for a contact lens submission (K962957), which is a regulatory document for medical devices. It focuses on:

• General Information: Device generic and trade names, manufacturer, contact person, common name.
• Indications for Use: What the contact lenses are for (correcting visual acuity for aphakic/non-aphakic persons with nearsightedness/farsightedness and minor astigmatism).
• Substantial Equivalence: How this device is similar to previously marketed devices, citing physical, optical, and chemical characteristics, and preclinical testing (cytotoxicity, systemic toxicity, ocular irritation).
• Device Description: Physical dimensions, material composition (phemfilcon A), color pigments, and physical properties (specific gravity, refractive index, light transmittance, water content, optical zone, oxygen transmissibility).
• General Use Instructions: Wearing schedules (disposable daily wear or frequent replacement wear).

Therefore, I cannot fulfill your request to describe acceptance criteria and a study proving device performance for an AI/ML algorithm, as this document does not discuss such a device or study.

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