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Frequency 55, Frequency 55 UV, Frequency 55 Aspheric, Encore, CooperFlex a 1. Onevue are indicated for daily wear for the correction of refractive ametropia (myopia and hyperopia) 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 usual acuity.
Frequency 55 lenses with UV absorbing monomer helps protect against transmission of harmful UV radiation to the cornea and into the eye.

2. Encore Toric lenses are indicated for daily for the correction of refractive (myopia, hyperopia, and astigmatism) in aphakic and not-aphakic persons with nondiseased eyes. The lenses may be worn by persons who have astigmatism of 12.00 diopters or less.

Frequency 55, Frequency 55 Aspheric, Encore, CooperFlex and Onevue (methafilcon A) Soft (hydrophilic) Contact Lenses are available as spherical lenses. Encore Toric (methafilicon A) Soft (hydrophilic) Contact Lenses are available as astigmatic (toric) lenses. The lens material, methafilcon A, is a random copolymer of hydroxyethylmethacrylic acid. The lenses are tinted from edge to edge for visibility purposes with the color additive, Reactive Blue No. 4.

Frequency 55 UV (methafilcon A) Soft (hydrophilic) Contact Lenses are available as spherical lenses. The lens material, methafilcon A, is a random copolymer of hydroxyethylmethacrylate and methacrylic acid. A benzotriazole UV absorbing monomer is used to block UV radiation. the average transmittance characteristics are less than 10% in the UVB range if 280 to 315 nm and less than 10% in the UVA range of 315 to 380 nm. The lenses are tinted aqua from edge to edge for visibility purposes with the color additives, C.I. Reactive Blue No. 4 and C.I. Reactive Yellow 86.

I am sorry, but based on the provided text, there is no information about acceptance criteria, device performance, sample sizes for test or training sets, data provenance, expert involvement, adjudication methods, or MRMC studies.

The document is a 510(k) premarket notification for contact lenses. It states explicitly:

"No Non-Clinical or Clinical tests were performed. The lenses are the same as those cleared in the above premarket notifications."

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them, as no such study was conducted for this specific submission. The approval is based on substantial equivalence to previously cleared devices.

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