Search Results

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.

Ask a specific question about this device