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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.

Note on "Acceptance Criteria": For this type of device, the "acceptance criteria" effectively boil down to demonstrating that the device is as safe and effective as the predicate device(s) based on comparable technological characteristics and non-clinical and biocompatibility testing. The inclusion of color additives is a distinguishing feature, and the safety of these additives is addressed through biocompatibility testing and their listing in 21 CFR 73 subpart D and 74 subpart D.

2. Sample size used for the test set and the data provenance
Not applicable for this type of device (physical contact lens). The document describes non-clinical and biocompatibility tests, but not a "test set" for an algorithm.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
Not applicable. The "ground truth" here is the established safety and effectiveness of the predicate device, against which the new device's physical, chemical, and biocompatibility properties are compared.

8. The sample size for the training set
Not applicable.

9. How the ground truth for the training set was established
Not applicable.

Summary of the Study Proving Acceptance:

The device's acceptance is based on demonstrating substantial equivalence to legally marketed predicate devices (Largan U38 (Polymacon) Daily Wear Soft (hydrophilic) Contact Lens and Largan 55 UV Color (Ocufilcon D) Daily Wear Soft (hydrophilic) Contact Lens), as evidenced by:

• Identical Intended Use: Both the subject device and predicates are indicated for correction of refractive ametropia (myopia and hyperopia) in non-diseased eyes with limited astigmatism, for daily or frequent/planned replacement wear. The subject device adds the function of enhancing or altering eye color, which is already present in the secondary predicate (Largan 55 UV Color).
• Similar Technological Characteristics: The document provides a detailed comparison (Table 8) showing that the subject device shares many key physical and optical parameters (lens design, replacement schedule, chemical composition (with primary predicate), water content (with primary predicate), oxygen permeability (with primary predicate), base curve, diameter, center thickness, powers, refractive index (with primary predicate), light transmittance) with one or both predicate devices.
• Non-Clinical Testing: Various physical and optical properties were tested (Back Vertex Power, Radius of Curvature, Overall Diameter, Center Thickness, etc.) to ensure the device performs as expected.
• Biocompatibility Testing: Conducted in accordance with FDA guidance (Premarket Notification [510(k)] Guidance Document for Class II Daily Wear Contact Lenses (1994)), including:
  • In-Vitro Cytotoxicity (non-cytotoxic)
  • Ocular irritation testing (no ocular irritation)
  • Acute systemic toxicity (no acute systemic toxicity)
  • Skin Sensitization Study (no skin sensitization)
• Color Additives: The color additives used are listed in 21 CFR 73 subpart D and 74 subpart D, addressing the safety aspect of the color-enhancing feature.

The conclusion is that the "Largan U38 Color (Polymacon) Daily Wear Soft (hydrophilic) Contact Lens" is as safe, as effective, and performs as well as the predicate devices, thereby meeting the criteria for 510(k) clearance based on substantial equivalence.

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