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The Eye Secret 38 UV Aspheric (polymacon) 1-Day Soft (hydrophilic) Contact Lens is indicated for daily wear single use only 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 care professional should prescribe the lenses for daily wear single use only. The lenses are to be discarded upon removal: Therefore no cleaning or disinfecting is required. The Eye Secret 38 UV Aspheric (polymacon) 1-Day Soft (hydrophilic) Contact Lenses help protect against transmission of harmful UV radiation to the cornea and into the eye.

The Eye Secret 38 UV Aspheric (polymacon) 1-Day Soft (hydrophilic) Contact Lens is 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 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 0.01 % sodium hyaluronate and 0.1 % trehalose wetting agents.

The document provided describes the Eye Secret 38 UV Aspheric (polymacon) 1-Day Soft (hydrophilic) Contact Lens and its substantial equivalence to a predicate device, K132854. The submission focuses on non-clinical testing to demonstrate safety and effectiveness.

Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for the "Eye Secret 38 UV Aspheric (polymacon) 1-Day Soft (hydrophilic) Contact Lens" are established by demonstrating equivalence to the predicate device, "Eye Secret 38 UV Aspheric (polymacon) Soft (hydrophilic) Contact Lens for Daily Wear (K132854)." Performance is shown through comparative testing against the predicate's established characteristics.

Note: For the test items without specific numerical acceptance criteria in the predicate column, the acceptance criterion is that the new device's performance is demonstrated to be equivalent or safe and effective, as required for a 510(k) submission.

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

The document does not specify exact sample sizes for each non-clinical test. It states that "A series of preclinical testing were performed" and lists the types of tests. These tests are generally conducted on a representative sample of the devices.

The data provenance is Taiwan, as the manufacturer is based in Taichung City, Taiwan, and the tests were performed to support the 510(k) submission for the US market. The study is considered prospective for the new device's testing, as samples of the new device were specifically tested according to recommended FDA guidelines.

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

This information is not provided in the document. The studies performed are non-clinical (bench testing and biological safety tests) and do not typically involve human experts establishing a "ground truth" in the same way clinical studies for AI models do. Compliance with standards and regulatory requirements is typically assessed by designated test personnel and internal/external auditors.

4. Adjudication Method for the Test Set

This information is not applicable as the studies are non-clinical tests measuring physical parameters and biological responses, not expert review or diagnostic performance.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size

No, an MRMC comparative effectiveness study was not done. This document describes the submission of a contact lens, which is a physical medical device, not an AI-powered diagnostic tool requiring MRMC studies.

6. If a Standalone Study (Algorithm Only Without Human-in-the-Loop Performance) Was Done

This question is not applicable as the device is a contact lens and does not involve an algorithm or AI. All the testing performed can be considered "standalone" in the sense that it's the performance of the device itself being measured, without human-in-the-loop interaction in the context of an AI system.

7. The Type of Ground Truth Used

For the non-clinical tests, the "ground truth" is established by:

• Established Test Methods and Standards: e.g., ISO 10993-5 for cytotoxicity.
• Predicate Device Specifications: physical parameters are compared directly to the known specifications of the legally marketed predicate device.
• Regulatory Guidance: The tests were conducted as recommended by the FDA Premarket Notification 510(k) Guidance Document for Daily Wear Contact Lenses.

8. The Sample Size for the Training Set

This question is not applicable. The device is a physical contact lens, not an AI model, so there is no concept of a "training set" in this context.

9. How the Ground Truth for the Training Set Was Established

This question is not applicable for the same reasons as #8.

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