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The S 42 UV Single Vision (hefilcon A) Soft (Hydrophilic) Contact Lens is indicated for daily wear for the correction of refractive ametropia (myopia and hyperopia) in aphakic or not-aphakic persons with non-diseased eyes that may exhibit refractive and/or corneal astigmatism up to 2.00 diopters that does not interfere with visual acuity.

The T 42 UV Toric (hefilcon A) Soft (Hydrophilic) Contact Lens is indicated for daily wear for the correction of refractive ametropia (myopia, hyperopia and astigmatism) in aphakic and/or not aphakic persons with non-diseased eyes that may exhibit refractive and/or corneal astigmatism up to 5.00 Diopters.

The M 42 UV Multifocal (hefilcon A) Soft (Hydrophilic) Contact Lens is indicated for daily wear for the correction of refractive ametropia (myopia and hyperopia) and presbyopia in aphakic or not-aphakic persons with non-diseased eyes that may exhibit refractive and/or corneal astigmatism up to 2.00 diopters that does not interfere with visual acuity.

The lenses may be disinfected using chemical (not heat) or hydrogen peroxide disinfecting systems. Eyecare practitioners may prescribe the lenses for daily wear and/or frequent replacement. When prescribed for a Frequent Replacement Program, the lenses may be disinfected using chemical (not heat), or hydrogen peroxide disinfecting systems.

S 42 UV Single Vision, T 42 UV Toric, and M 42 UV Multifocal (hefilcon A) Soft (Hydrophilic) Daily Wear Contact Lenses are hemispherical flexible shells that cover the cornea and a portion of the adjacent sclera. The 42 UV Contact Lens is available in a single vision lens design, the 42 UV Toric Contact Lens is available in a back surface design, and the 42 UV Multifocal lens is available in an aspheric lens design. The lens material (hefilcon A) is a hydrophilic polymer of 2-hydroxyethyl methacrylate (HEMA) and n-vinyl-2-pyrrolidone (NVP) cross-linked with ethyleneglycol dimethacrylate (EGDMA), using AIBN as the initiator. The lens contains 42% water by weight. 42 UV, 42 UV Toric, and 42 UV Multifocal (hefilcon A) Soft (Hydrophilic) Contact Lenses for Daily Wear are tinted using Piqment Blue 15, ([Phthalocyaninato(2-)] copper) which is approved for coloring contact lenses under 21 CFR 5 74.3045 and a UV absorbing compound, 2-(benzoyl-3-hydroxyphenoxy)ethyl acrylate, has been incorporated into the lens polymer.

Here's a breakdown of the acceptance criteria and study information based on the provided 510(k) summary for the "Optical Connection Inc." contact lenses.

It's important to note that this 510(k) submission is for contact lenses, a medical device in a different category than typical AI/ML-driven diagnostics. Therefore, many of the requested fields, particularly those related to "AI performance," "expert ground truth," "MRMC studies," "training set," and "adjudication methods" are not applicable or described in the context of this type of device. Medical devices like contact lenses primarily rely on physicochemical properties, biocompatibility, and clinical performance (in terms of vision correction and safety) which are established through different types of testing.

Acceptance Criteria and Device Performance for Optical Connection Inc. Contact Lenses (K040900)

1. Table of Acceptance Criteria and Reported Device Performance

For contact lenses, "acceptance criteria" and "performance" are typically related to the physical and chemical properties of the material and the lens design, as well as the safety of the materials. The summary does not provide specific numerical "acceptance criteria" against which a single "reported device performance" value is compared in a pass/fail manner for each characteristic. Instead, it demonstrates substantial equivalence to predicate devices by comparing their properties.

However, based on the comparative table, we can infer the target values (which act as de facto acceptance criteria by being "comparable to predicate devices") and the properties of the new device.

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