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The Eye Secret 55 UV Aspheric (Methafilcon A) Soft (Hydrophilic) Contact lenses are indicated for the correction of ametropia (myopia) in aphakic and non-aphakic persons with non-diseased eyes in powers from 0.00 to -12.00 diopters. The lenses may be worn by persons who exhibit astigmatism of 2.00 diopters or less that does not interfere with visual acuity. Eye Care professionals may prescribe the lens for daily disposable or daily wear in a Frequent Replacement Program. As prescribed for planned replacement, the lens should be disinfected using a chemical or hydrogen peroxide disinfecting systems.

The Eye Secret 55 UV Aspheric (methafilcon A) Soft (hydrophilic) contact lens is manufactured by using advanced cast molding method. The lens material, methafilcon A, is a random copolymer of 2-hydroxyethyl methacrylate (HEMA) and methacrylic acid (MAA) crosslinked with ethylene glycol dimethacrylate (EGDMA). A UV absorbing monomer is used to block UV radiation. The average transmittance characteristics are less than 5% in the UVB range of 280~315 nm and less than 50% in the UVA range of 316 to 380 nm. The lenses are tinted blue for visibility purposes with the color additives, C.I. Reactive Blue No.4. The Lenses are available as aspheric lenses.

The provided 510(k) summary (K133735) describes the "Eye Secret 55 UV Aspheric (methafilcon A) Soft (hydrophilic) Contact Lens." This device is a contact lens, and its acceptance criteria and the study proving it meets these criteria are established through a demonstration of substantial equivalence to a predicate device, the "SAUFLON 55 UV (methafilcon A) Soft (Hydrophilic) Visibility Tinted Contact Lens for Daily Wear" (K013649).

The approval is based on non-clinical testing rather than a clinical study or AI performance evaluation. The review relies on the inherent equivalence of the new device to a previously approved one.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are implicitly defined by the characteristics of the predicate device, K013649. The new device demonstrates performance that is either identical or within acceptable limits of the predicate.

Note: The differences in 'Powers', 'Light Transmittance', 'UV-A', 'UV-B', 'Refractive Index', 'Base Curve', and 'Diameter' were deemed acceptable for substantial equivalence. For instance, the new device specifies '<5%' for UV-B blockage, while the predicate is 9.41%. This indicates the new device has better UV-B blocking, which is not a safety concern.

2. Sample Size Used for the Test Set and Data Provenance

No specific "test set" in the context of clinical data for AI evaluation is mentioned. The device's substantial equivalence is established through non-clinical testing, which included:

• Toxicity (Acute Systemic Injection Study, White Rabbit Ocular Irritation Test, Cytotoxicity Test)
• Extractables (Leachability)
• Finished Lens Parameters
• Light Transmittance
• Refractive Index
• Water Content
• Oxygen Permeability
• pH and Osmolality Test
• Shelf-life
• Mechanical Comparative Testing

No details are provided on the sample sizes for these specific non-clinical tests (e.g., number of lenses tested for parameters, number of animals in toxicity studies), nor is there information on data provenance in terms of country of origin or whether it was retrospective/prospective, as this is typically not relevant for bench testing.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts

Not applicable. The ground truth for proving the device meets acceptance criteria is based on established scientific and engineering principles for material characterization and biocompatibility, as outlined in FDA guidance for contact lenses. There were no human experts establishing ground truth for a test set in the context of AI or clinical evaluation.

4. Adjudication Method for the Test Set

Not applicable, as no human-adjudicated test set was used.

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. This device is a contact lens and does not involve AI or human readers for diagnostic interpretation. The evaluation is for physical, chemical, and biological compatibility properties.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done

Not applicable. This device does not involve an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

The ground truth for the non-clinical tests is based on:

• Established ASTM/ISO standards and validated testing methodologies for material properties (e.g., water content, Dk, light transmittance, refractive index, pH, osmolality, mechanical properties).
• Biocompatibility standards (e.g., ISO 10993-5 for cytotoxicity, and standard animal models for systemic injection and ocular irritation) to demonstrate safety.
• Comparison to the legally marketed predicate device (K013649), which has already established its safety and effectiveness based on similar ground truths.

8. The sample size for the training set

Not applicable. This device does not involve a training set as it is not an AI or machine learning device.

9. How the ground truth for the training set was established

Not applicable, as there is no training set for this device.

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