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Aquamax (polymacon) Quarterly Disposable Soft (hydrophilic) Contact Lenses and Aquamax (polymacon) Monthly Disposable Soft (hydrophilic) Contact Lenses are indicated for daily wear for vision correction of refractive ametropia in aphakic or not-aphakic persons with non-diseased eyes that are myopic or hyperopic. The lens may be worn by persons who exhibit refractive astigmatism of 2.00 diopters (D) or less where the astigmatism does not interfere with visual acuity. The lens may be prescribed in spherical powers ranging from +20.00 D to -20.00 D. Eye practitioners may prescribe the lens for frequent/planned replacement wear with cleaning, rinsing, disinfection and scheduled replacement as prescribed by the eye care professional. When prescribed for frequent/planned replacement wear, the lens may be disinfected using a chemical (not heat) lens care system only. Lenses help protect against transmission of harmful UV radiation to the cornea and into the eve.

Aquamax (Polymacon) Ouarterly Disposable Soft (Hydrophilic) Contact Lenses and Aquamax (Polymacon) Monthly Disposable Soft (Hydrophilic) Contact Lenses are available as spherical lenses manufactured by cast molding method. The model illuminated with water content of 38%. These hydrogel lens materials are homo-polymer of 2-hydroxyethyl methacrylate (HEMA) crosslinked with ethylene glycol dimethacrylate (EGDMA) via photo-polymerization. These lenses are tinted blue using C.I. reactive blue 19 to make them more visible for handling. These lenses contain UV blocker, a benzotriazole UV absorbing monomer to block UV radiation. The average transmittance characteristics of theses lenses are less than 5 % in the UV range of 280-315 nm and less than 50% in the UVA range of 316-380nm. Lenses are supplied sterile in sealed blister package containing sterile isotonic borate buffered saline solution.

Here's an analysis of the provided text regarding the acceptance criteria and supporting studies for the Aquamax (Polymacon) Soft (Hydrophilic) Contact Lenses:

The submission K123973 refers to a 510(k) premarket notification for contact lenses, which are inherently different from typical medical devices that might involve AI, image analysis, or complex algorithms requiring extensive performance criteria like sensitivity, specificity, or reader studies. This document, therefore, focuses on demonstrating substantial equivalence to existing, legally marketed predicate devices rather than proving performance against specific acceptance criteria for a novel technology.

As such, many of the requested categories (like sample sizes for test sets, number of experts, adjudication methods, MRMC studies, standalone AI performance, and training set information) are not applicable to this type of regulatory submission for contact lenses, which relies on the established safety and effectiveness of the material and manufacturing process. The "acceptance criteria" here are implicitly about matching the characteristics of the predicate devices and fulfilling non-clinical testing requirements.

Acceptance Criteria and Reported Device Performance

The "acceptance criteria" for this device are largely defined by its resemblance and comparable performance to the predicate devices. The study demonstrates substantial equivalence through a comparison of technological characteristics and non-clinical testing.

1. Table of Acceptance Criteria and Reported Device Performance:

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