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The FREQUENCY 55™ (methafilcon A ) Hydrophilic Contact Lens (clear and tinted ) is indicated for daily wear for the correction of refractive ametropia (myopia and hyperopia) in aphakic and not-aphakic persons with non-diseased eyes that may exhibit astigmatism up to 2.00 Diopters that does not interfere with visual acuity.

Eyecare practitioners may prescribe the lens for daily wear in a Frequent Replacement Program. The lenses may be disinfected using chemical or hydrogen peroxide disinfection svstems.

Soft contact lenses are hemispherical shells manufactured of polymerized material of HEMA crosslinked with EGDMA. which vield the appearance of lenses which are designed to fit over the comeal surface of the eye. These lenses are designed with varying base curves which conform to the shape of the radius of the cornea and center over the apex of the cornea to provide corrective refraction for functional conditions of the eye including myopia (nearsightedness), hyperopia (farsightedness) and astigmatism (multiple foci). Each lens provides corrective power. which is to correspond to the refractive power of the eye to which it is being treated. Each lens is designed with a base curve on the internal side of the lens and an optical zone in the center of the lens which is generally of a diameter greater than 6mm. Secondary and tertiary curves as well as beveled edge configurations are built into the lens for aiding in lens centration and comfort.

The provided text is a 510(k) summary for a contact lens. It describes the device, its indications for use, and its substantial equivalence to a predicate device. However, it does not contain information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, expert qualifications, or comparative effectiveness studies. The document is a regulatory submission, not a scientific study report.

Therefore, I cannot fulfill the request to describe the acceptance criteria and the study that proves the device meets them from the provided text. The requested information is absent.

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