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Sphere and Asphere
Pegavision (Hioxifilcon A) Daily Disposable Soft Contact Lenses with Sphere designs are indicated for daily wear for the correction of refractive ametropia (myopia and hyperopia) in aphakic and/or non-aphakic persons with nondiseased eyes in powers from +6.00 diopters. The lenses may be worn by persons who exhibit astigmatism of 1.00 diopters or less that does not interfere with visual acuity.

Toric
Pegavision (Hioxifilcon A) Daily Disposable Soft Contact Lenses with Toric designs are indicated for the correction of refractive ametropia with astigmatism) in aphakic and/or non-aphakic persons with non-diseased eyes in powers from +6.00 to -12.00 diopters and astigmatic corrections from -0.50 to -3.50 diopters.

Multifocal
Pegavision (Hioxifilcon A) Daily Disposable Soft Contact Lenses with Multifocal designs are indicated for daily wear for the correction of refractive ametropia (myopia and hyperopia) and presbyopia in aphakic persons with non-diseased eyes in powers from +6.00 to -12.00 diopters and with non-diseased eyes who may require a reading addition from +0.25D to +3.00D. The lenses may be worn by persons who exhibit astigmatism of 1.00 diopters or less that does not interfere with visual acuity.

The lenses are intended for single-use disposable wear.

The Pegavision (Hioxifilcon A) Daily Disposable Soft Contact Lenses are visibility-tinted and include UV blocker-containing. The lens is available in sphere, asphere, toric and multifocal designs. It is a non-ionic hydrogel lens derived from Hioxifilcon A material which is a co-polymer of 2-Hydroxyethyl methacrylate (HEMA) and 2,3-Dihydroxypropyl methacrylate (Glycerol methacrylate, GMA), cross-linked with Ethylene glycol dimethacrylate (EGDMA) and made by photo-polymerization. It consists of 41% Hioxifilcon A and 59% water by weight when immersed in buffered solution. There are two types of buffer solution, one is borate solution another one is borate solution with Tween 80, Hyaluronic Acid and Polyethylene Glycol. The lens further contains a benzotriazole UV absorbing monomer and thus is able to block UV radiation. The lens is visibly tinted with "Reactive Blue 19" and "Reactive Red 180" color additive, 21 CFR part 73.3121. Besides, Reactive Yellow 15, 21 CFR part 73.3121, is also used to reduce light in the range from 380 nm to 450 mm. The UV Blocking averages 95% in the UVB range of 280 nm to 315 nm and 50% in the UVA range of 315 nm to 380 nm. The lens reduces transmittance by less than or equal to 35% in the light range from 380 nm to 450 nm.

The provided text describes a 510(k) submission for Pegavision (Hioxifilcon A) Daily Disposable Soft Contact Lenses. It outlines the device's characteristics and compares it to a predicate device to establish substantial equivalence. However, the document does not contain information about acceptance criteria and a study that proves the device meets those criteria in the context of a diagnostic or AI-powered medical device.

This submission is for soft contact lenses, which are regulated differently from diagnostic software/AI. The "studies" mentioned are non-clinical performance and biocompatibility tests, not clinical performance studies with acceptance criteria for diagnostic accuracy metrics (e.g., sensitivity, specificity, AUC).

Therefore, I cannot fulfill your request to provide a table of acceptance criteria and reported device performance, nor details about sample sizes, ground truth establishment, expert qualifications, adjudication methods, or MRMC/standalone studies, because this information is not present in the provided FDA 510(k) summary for a contact lens.

The document mainly focuses on:

• Technological characteristics comparison to a predicate device (K222885).
• Non-clinical testing (physicochemical properties, biocompatibility, shelf life, sterility) to demonstrate safety and effectiveness for a contact lens.
• Substantial equivalence based on material, design, intended use, and performance claims to the predicate device, with differences in dye and light transmittance being compared to another reference device (ACUVUE® OASYS MAX 1-DAY K210930).

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