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The AQUASPLASH (Polymacon) Soft (Hydrophilic) Daily Wear Contact Lens is indicated for daily wear for the correction of visual acuity in aphakic and non-aphakic persons with non-diseased eyes with myopia and hyperopia. The lens may be worn by persons who exhibit refractive astigmatism of 3.00 diopters or less. The lens is available clear or colored and may be used to enhance or alter the apparent color of the eye.

Eye care practitioners may prescribe the lens for frequent/planned replacement wear, with cleaning disinfection and scheduled replacement. When prescribed for frequent/planned replacement wear, the lens may be disinfected using a chemical disinfecting system. Eye care practitioners may prescribe the lens for single use daily disposable wear. When prescribed for daily disposable wear the lens is to be discarded after each removal.

The AQUASPLASH (Polymacon) Soft (Hydrophilic) Daily Wear Contact Lens is a hydrophilic polymer of 2-hydroximethyl methacrylate (HEMA) cross-linked with Ethylene glycol dimethylacrylate (EGDMA) and water. When hydrated the lens consists of 62.0% polymacon and 38.0% water by weight when immersed in saline solution. The (polymacon) name has been adopted by the United States Adopted Names Council (USAN).

The AQUASPLASH (Polymacon) Soft (Hydrophilic) Daily Wear Contact Lenses are available tinted for visibility or color printed to enhance or alter the apparent color of the eye. The lenses are processed to incorporate the 'listed' color additives and contain only the amount of the additive needed to accomplish the intended coloring effect.

When producing the color lenses, the manufacturing process changes the specifications to the clear contact lens by pad-printing the color pigment(s)-entrapping the colorants in the interpenetrating network of the contact lens material in a location that corresponds to the iris. The color pigments used are not removed by lens handling and cleaning/disinfecting procedures. Except for affecting the amount of light transmittance through the lens, the coloring process does not alter the original characteristics of the pre-tinted lens.

The AQUASPLASH (Polymacon) Soft (Hydrophilic) Daily Wear Contact Lens is manufactured in sphere and toric design configurations.

This document is a 510(k) Premarket Notification for a contact lens, the AQUASPLASH (Polymacon) Soft (Hydrophilic) Daily Wear Contact Lens. It does NOT involve an AI/ML device for which the requested information (acceptance criteria, study details, expert involvement, and ground truth establishment) would be applicable.

The document primarily focuses on demonstrating substantial equivalence to a predicate contact lens through:

• Comparison of technological characteristics: This involves comparing material properties, manufacturing methods, and intended use with the predicate device.
• Non-clinical performance testing: This includes bench testing to verify manufacturing capabilities within specified tolerances.

The document explicitly states: "Clinical testing is not required. The clinical performance of soft (hydrophilic) contact lenses manufactured from polymacon materials has been demonstrated previously." This reinforces that the evaluation is not based on a clinical study where AI/ML performance metrics would be assessed against ground truth established by experts.

Therefore, I cannot provide the requested information (table of acceptance criteria, sample sizes, expert details, adjudication methods, MRMC studies, standalone performance, or ground truth establishment) because this submission type and the nature of the device do not involve the type of evaluation described in your prompt for AI/ML medical devices.

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