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The Eye Secret 38 UV Aspheric (polymacon) Soft (hydrophilic) Contact Lens for Daily Wear 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 38 UV Aspheric (polymacon) Soft (hydrophilic) Contact Lens for Daily Wear 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 38 UV Aspheric (polymacon) Soft (hydrophilic) Contact Lens for Daily Wear 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 sodium hyaluronate and trehalose wetting agents.

The provided document describes the predicate device "Eye Secret 38 UV Aspheric Color (polymacon) Soft (hydrophilic) Contact Lens for Daily Wear" (K143052) and the new device "Eye Secret 38 UV Aspheric (polymacon) Soft (hydrophilic) Contact Lens for Daily Wear." The acceptance criteria are based on demonstrating substantial equivalence to the predicate device through non-clinical testing.

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

1. Table of Acceptance Criteria and Reported Device Performance

The document presents a comparison to the predicate device, serving as the de-facto acceptance criteria. The subject device must match or perform equivalently to the predicate device across various parameters.

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

The document does not specify a distinct "test set" in the context of clinical trials or data for algorithm evaluation. Instead, it refers to non-clinical testing to demonstrate equivalence. For these non-clinical tests (e.g., toxicity, extractables, finished lens parameters), the sample sizes are not explicitly mentioned.

The data provenance for most tests is implied to be from the manufacturer, Yung Sheng Optical Co., Ltd., based in Taiwan. The tests are described as preclinical testing performed to demonstrate the safety and effectiveness. These are laboratory-based tests rather than data collected from human subjects.

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

Not applicable. The evaluation is based on non-clinical laboratory testing and comparison to an existing predicate device, not on expert-adjudicated images or clinical outcomes requiring ground truth establishment by experts in that manner.

4. Adjudication Method for the Test Set

Not applicable. There's no adjudication process described as the safety and effectiveness are determined by laboratory test results against established compliance standards (e.g., ISO 10993-5) and direct comparison to the predicate device's characteristics.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance

Not applicable. This is not an AI/software device. It is a soft contact lens, and its evaluation does not involve human readers or AI assistance.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Not applicable. This is not an AI/software device.

7. The Type of Ground Truth Used

The "ground truth" in this context is the established safety and performance characteristics of legally marketed predicate devices, along with compliance with international standards for medical device materials and product characteristics (e.g., ISO 10993-5 for cytotoxicity, FDA Premarket Notification 510(k) Guidance Document for Daily Wear Contact Lenses). The subject device demonstrates equivalence to these benchmarks through specific laboratory tests.

8. The Sample Size for the Training Set

Not applicable. This is not an AI/software device and therefore does not have a "training set."

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 38 UV Aspheric (polymacon) Soft (hydrophilic) Contact Lens for Daily Wear is 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 (polymacon) Soft (hydrophilic) Contact Lens for Daily Wear 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.

The provided document is a 510(k) premarket notification for a contact lens, the "Eye Secret 38 UV Aspheric (polymacon) Soft (hydrophilic) Contact Lens for Daily Wear." This type of submission focuses on demonstrating substantial equivalence to a predicate device rather than conducting extensive clinical studies typical for novel medical devices or AI algorithms. As such, the information you're requesting regarding AI-specific acceptance criteria, test sets, expert ground truth, MRMC studies, and training sets is not applicable to this document.

The "study that proves the device meets the acceptance criteria" in this context refers to a series of preclinical (non-clinical) tests and a comparison to a predicate device, rather than human clinical trials or AI performance evaluations.

Here's a breakdown based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

For this contact lens submission, the "acceptance criteria" are not framed as specific performance thresholds for an AI algorithm's metrics (like sensitivity, specificity, or AUC). Instead, they are demonstrated through equivalence to a legally marketed predicate device and through non-clinical testing that proves the device meets established standards for contact lens safety and function.

The table below summarizes the key comparative data provided for the subject device and its predicate, which implicitly defines the "acceptance criteria" through equivalence.

Summary of Non-Clinical Test Results (Meeting Implicit Acceptance Criteria):

The submission states that a series of preclinical tests were performed, and "The results of all testing demonstrated that the safety and effectiveness of the Eye Secret 38 UV Aspheric (polymacon) Soft (hydrophilic) Contact Lens for Daily Wear is equivalent to the BAUSCH & LOMB Soflens MultiFocal (polymacon) Visibility Tinted Contact Lens (K020927).". The tested areas include:

• Toxicity:
  • Acute Systemic Injection Study: Meets requirements, considered non-toxic.
  • White Rabbit Ocular Irritation Test: No ocular irritation.
  • Cytotoxicity Test: Meets ISO 10993-5 (non-cytotoxic).
• Extractables
• Finished Lens Parameters
• Light Transmittance
• Refractive Index
• Water Content
• pH and Osmolality
• Specific Gravity
• Physical Compatibility
• Oxygen Permeability
• Mechanical Comparative Testing
• Shelf-life test

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

• Sample Size: Not explicitly stated numerically for each non-clinical test, but implied to be sufficient to meet regulatory standards for each specific test (e.g., number of rabbits for ocular irritation, samples for physical/chemical characterization). These are laboratory-based tests, not human clinical trials or large image datasets.
• Data Provenance: The tests were conducted by the manufacturer, Yung Sheng Optical Co., Ltd., in Taiwan. There is no mention of retrospective or prospective data in the context of clinical studies, as none were performed.

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

• Not applicable. "Ground truth" in the AI sense (e.g., expert annotation of medical images) does not apply here. The "truth" for these tests is established by standardized laboratory methods and regulatory guidelines (e.g., ISO standards, FDA recommendations).

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

• Not applicable. There is no expert adjudication process over "test sets" as understood in AI/ML performance evaluation. Laboratory test results are interpreted against predefined specifications.

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 is a contact lens submission, not an AI-powered diagnostic device. No MRMC study was performed.

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

• Not applicable. This is a physical contact lens, not an algorithm.

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

• The "ground truth" for this device's safety and performance is based on established scientific and engineering principles, standardized laboratory testing methodologies (e.g., ISO, FDA guidance documents), and demonstrated equivalence to a legally marketed predicate device. It's primarily material characterization, biocompatibility testing, and physical performance metrics rather than clinical outcomes or expert consensus.

8. The sample size for the training set:

• Not applicable. This is not an AI/Machine Learning device. There is no "training set."

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

• Not applicable. There is no "training set" or AI model.

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