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The Eye Secret 38 UV Aspheric Color (polymacon) Soft (hydrophilic) Contact Lens for Daily Wear and Eye Secret 38 UV Aspheric Color (polymacon) 1-Day Soft (hydrophilic) Contact Lens are indicated for the correction of ametropia (myopia) in aphakic and not-aphakic persons with non-diseased eyes. The lenses may be worn by persons who exhibit astigmatism of 2.00 diopters or less that does not interfere with visual acuity.

The Eye Secret 38 UV Aspheric Color (polymacon) Soft (hydrophilic) Contact Lens for Daily Wear and Eye Secret 38 UV Aspheric Color (polymacon) 1-Day Soft (hydrophilic) Contact Lens help protect against transmission of harmful UV radiation to the cornea and into the eye.

For Eye Secret 38 UV Aspheric Color (polymacon) Soft (hydrophilic) Contact Lens for Daily Wear, the eye care professionals may prescribe the lens for single use 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 38 UV Aspheric Color (polymacon) Soft (hydrophilic) Contact Lens for Daily Wear and Eye Secret 38 UV Aspheric Color (polymacon) 1-Day Soft (hydrophilic) Contact Lens are manufactured by using cast molding method. The lens material, polymacon, is a random copolymer of 2-hydroxyethyl methacrylate (HEMA) 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 to 315 nm and less than 50 % in the UVA range of 316 to 380 nm.

The lenses are tinted from edge to edge for visibility purposes with the color additive C.I. Reactive Blue No. 4 and printed with an intermittent coating containing a combination of the following approved pigments: Copper Phthalocyanine, Reactive Black 5, Iron Oxide, Titanium Dioxide, Carbazole Violet and D&C Yellow No. 10. The Lenses are available as aspheric lenses. Each finished lens is supplied in a plastic blister container with a sterile isotonic phosphate buffered saline solution containing 0.01 % sodium hyaluronate and 0.1 % trehalose wetting agents.

The provided text details a 510(k) premarket notification for new contact lenses, asserting their substantial equivalence to a legally marketed predicate device. This type of submission focuses on demonstrating equivalence rather than establishing de novo safety and effectiveness through extensive clinical trials. Therefore, the information typically requested in your prompt regarding acceptance criteria, study details, expert involvement, and specific performance metrics like sensitivity, specificity, and reader studies is not explicitly available in this document.

However, I can extract the closest available information related to the device's characteristics and the non-clinical testing performed to support its substantial equivalence.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are implicitly based on demonstrating similar performance and characteristics to the predicate device (Eye Secret 38 UV Aspheric (polymacon) Soft (hydrophilic) Contact Lens for Daily Wear, K132854). The "reported device performance" are the characteristics of the new devices.

2. Sample size used for the test set and the data provenance

The document does not specify a "test set" in the context of clinical or AI performance evaluation. The "testing" referred to is primarily non-clinical bench testing. For these tests:

• Sample size: Not explicitly stated for each non-clinical test (e.g., how many lenses were used for extractables or mechanical properties).
• Data provenance: Taiwan (Yung Sheng Optical Co., Ltd., based in Taichung City, Taiwan). The tests were conducted to demonstrate equivalence to a predicate device already cleared by FDA, suggesting the data originates from the manufacturer's testing facilities or contracted labs. These are likely retrospective in the sense that they are conducted on manufactured samples, not as part of a prospective clinical trial.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This information is not applicable. The submission is for contact lenses, and the "ground truth" for non-clinical tests (e.g., material properties, toxicity) is established by standard scientific and regulatory methods, not by expert consensus in a diagnostic sense.

4. Adjudication method for the test set

Not applicable. There is no diagnostic "test set" requiring adjudication by experts.

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, not an AI diagnostic tool.

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

Not applicable. This is not an AI algorithm.

7. The type of ground truth used

For the non-clinical tests, the "ground truth" is based on:

• Standardized methods and accepted thresholds: For tests like toxicity (systemic injection, ocular irritation, cytotoxicity based on ISO 10993-5), accepted biological responses or lack thereof served as the ground truth.
• Physical and chemical specifications: For parameters like water content, refractive index, light transmittance, and dimensions, the ground truth is the measured value and its adherence to pre-defined specifications (often mirroring the predicate device's specifications).

8. The sample size for the training set

Not applicable. There is no AI component requiring a training set.

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

Not applicable.

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