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The Eye Secret 55 UV Aspheric (Methafilcon A) Soft (hydrophilic) Contact Lens is indicated for the correction of refractive ametropia (myopia) in aphakic and not-aphakic persons with non-diseased eyes. The lenses may be worn by person who exhibit astigmatism of 2.00 diopters or less that does not interfere with visual acuity.

The Eye Secret 55 UV Aspheric (Methafilcon A) Soft (hydrophilic) Contact Lens helps protect against transmission of harmful UV radiation to the cornea and into the eye.

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 55 UV Aspheric (Methafilcon A) Soft (hydrophilic) Contact Lens is manufactured by using 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 to 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. Each finished lens is supplied in a plastic blister container with a sterile isotonic phosphate buffered saline solution containing sodium hyaluronate and trehalose wetting agents.

The provided text is related to the Eye Secret 55 UV Aspheric (Methafilcon A) Soft (hydrophilic) Contact Lens. It serves as a 510(k) summary for premarket notification to the FDA. The document focuses on demonstrating substantial equivalence to a predicate device (K133735) rather than acting as a traditional clinical study report for a new medical device where complex acceptance criteria related to diagnostic performance might be required.

Therefore, the requested information regarding acceptance criteria and studies (e.g., MRMC, expert ground truth, training set details) that are typical for AI/ML-driven devices with diagnostic or prognostic capabilities is not applicable to this document. This document describes a contact lens and focuses on bench testing and material safety.

However, I can extract the "acceptance criteria" through the lens of substantial equivalence and the reported device performance related to the physical and chemical properties of the contact lens, as well as the non-clinical tests performed to demonstrate its safety and effectiveness.

Here's an interpretation of the requested information based on the provided text for the Eye Secret 55 UV Aspheric (Methafilcon A) Soft (hydrophilic) Contact Lens:

1. Table of Acceptance Criteria and Reported Device Performance

For this medical device (contact lens), the "acceptance criteria" are implied by demonstrating substantial equivalence to the predicate device (K133735) across various physical, chemical, and safety characteristics. The reported device performance is compared directly to the predicate device.

Note: For properties like "Powers", "Base Curve", and "Diameter", the subject device offers a broader range, which is typically acceptable if the safety and performance for the new range are demonstrated, often through bridging data or established manufacturing controls, and the material and fundamental design remain equivalent.
The packaging solution for the subject device is more specific but still within the expected range of saline solutions for contact lenses.

2. Sample size used for the test set and the data provenance
The document states: "A series of preclinical testing were performed to demonstrate the safety and effectiveness of the Eye Secret 55 UV Aspheric (Methafilcon A) Soft (hydrophilic) Contact Lens." However, it does not specify the exact sample sizes for each non-clinical test (e.g., number of lenses, animals tested).

• Data Provenance: The tests were conducted by Yung Sheng Optical Co., Ltd. (Taiwan). The nature of the tests (e.g., in-vitro, animal studies) means they are primarily lab-based and not derived from human patient data in the clinical trial sense. The status is "preclinical testing".

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This type of information is not applicable to this premarket notification for a contact lens. The "ground truth" for contact lens performance is established through standardized non-clinical (bench) testing, material characterization, and established clinical performance of the material. Expert consensus, in the diagnostic sense, is not typically used here. The assessment is based on physical and chemical measurements against industry standards and comparisons to a legally marketed predicate device.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
Not applicable. Adjudication methods like 2+1 or 3+1 are used in clinical trials involving human readers assessing medical imaging or other diagnostic outputs to establish ground truth or resolve discrepancies. This document describes non-clinical testing of a physical device.

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. MRMC studies are specific to evaluating diagnostic systems, particularly those involving AI assistance with human interpretation. This document pertains to a contact lens and its physical/chemical properties.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. This question relates to AI/ML software performance. The device is a contact lens.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for the non-clinical tests is established by:

• Standardized Test Methods: Adherence to established standards (e.g., ISO 10993-5 for cytotoxicity, FDA Premarket Notification 510(k) Guidance Document for Daily Wear Contact Lenses, 1994).
• Material Specifications: Chemical and physical properties of the Methafilcon A material and the finished lens parameters (e.g., water content, light transmittance, refractive index).
• Predicate Device Equivalence: The primary "ground truth" or benchmark is the performance and safety profile of the legally marketed predicate device (K133735), which has already been deemed safe and effective.

8. The sample size for the training set
Not applicable. There is no "training set" in the context of this device. Training sets are relevant for machine learning algorithms.

9. How the ground truth for the training set was established
Not applicable. There is no "training set" for this device.

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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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