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The Largan U38 Color (Polymacon) Daily Wear Soft (hydrophilic) Contact Lens is a daily wear soft contact lens indicated for daily wear to enhance or alter the apparent color of the eye and/or for the correction of refractive ametropia (myopia and hyperopia) in phakic or non-aphakic persons with non-diseased eyes who exhibit refractive astigmatism of 1.00D or less where the astigmatism does not interfere with visual acuity.

Eye care practitioners may prescribe the lens for either single-use disposable wear, or for frequentl planned replacement wear, with cleaning, disinfection, and scheduled replacement. When prescribed for single-use disposable wear, the lens is to be discarded after each removal. therefore no cleaning or disinfecting is required. When prescribed for frequent replacement, the lens may be disinfected using a chemical disinfection system only.

The Largan U38 Color (Polymacon) Daily Wear Soft (hydrophilic) Contact Lens is available in hemispherical flexible shells for myopia. The Largan U38 Color (Polymacon) Daily Wear Soft (hydrophilic) Contact Lens is an aspherical design contact lens. The lens material (Polymacon) is a hydrophilic co-polymer by crosslinking 2-Hydroxyethyl methacrylate (HEMA). and Ethylene Glycol Dimethacrylate (EGDMA). The hydrated lens consists of 62.0% (Polymacon) and 38.0% water by weight of saline immersed in normal saline. A light blue color tinted with "reactive Blue 247" is for handling visibility purpose. A benzophenone UV absorbing monomer is used to block UV radiation. The average transmittance characteristics are less than 5% in the UVB range of 280 to 315nm and less than 50% in the UVA range of 315 to 380 nm. The lenses contain a combination of the following color additives: Phthalocyanine green, Carbazole violet, [Phthalocyaninato (2-)] copper, Titanium dioxide, Iron oxides (Red, Yellow and Black),and Mica-based pearlscent pigment (Gold, Silver and Red). All color additives used are listed in 21 CFR 73 subpart D and 74 subpart D. It is supplied in a sterile package with buffered saline solution.

This document describes the premarket notification (510(k)) clearance for the Largan U38 Color (Polymacon) Daily Wear Soft (hydrophilic) Contact Lens. However, it does not contain information typically associated with acceptance criteria and a study that proves a device meets them in the context of an AI/ML medical device.

This type of FDA clearance (510(k)) is for a physical medical device (a contact lens) and relies on demonstrating substantial equivalence to a previously cleared predicate device, rather than a clinical study with quantifiable performance metrics against specific acceptance criteria for an algorithm.

Therefore, many of the requested elements for an AI/ML device (like sample size for test/training sets, ground truth establishment methods, expert qualifications, MRMC studies, or standalone performance) are not applicable or not provided in this document.

Here's the breakdown of what can be extracted and what cannot:

1. A table of acceptance criteria and the reported device performance

The document provides a comparative table (Table 8) against predicate devices, focusing on physical and chemical characteristics. It does not present a formal "acceptance criteria" table with reported performance in the way one would for an AI/ML algorithm. Instead, it demonstrates similarity to predicate devices.

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