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The Igel 55 UV (methafilcon A) Soft (Hydrophilic) Contact Lens for Daily Wear is indicated for daily wear for the corrective ametropia (myopia and hyperopia) in aphakic or not-aphakic persons with non-diseased eyes that may exhibit refractive and/or corneal astigmatism up to 2.00 Diopters that does not interfere with visual acuity.

The Iqel 55 UV Multifocal (methafilcon A) Soft (Hydrophilic) Contact Lens for Daily Wear is indicated for the correction of presbyopia in myopic and hyperopic eyes in aphakic or not-aphakic persons with non-diseased eves who exhibit no more than 2.00 Diopters of astigmatism and can obtain satisfactory visual acuity, in a power range of +4.00 to -5.00 Diopters and have near add requirements up to 3.00 Diopters.

The Igel 55 UV Toric (methafilcon A) Soft (Hydrophilic) Contact Lens is indicated for daily wear for the correction of refractive ametropia (myopia, hyperopia and astigmatism) in aphakic and/or not aphakic persons with non-diseased eyes that may exhibit refractive and/or corneal astigmatism up to 7.00 Diopters.

The lenses may be disinfected using chemical or hydrogen peroxide disinfecting systems. Eyecare practitioners may prescribe the lenses for daily wear and/or frequent replacement. When prescribed for a Frequent Replacement Program, the lenses may be disinfected using chemical or hydrogen peroxide disinfecting systems.

The Igel 55 UV, the Igel 55 UV Multifocal, and the Igel 55 UV Toric Daily Wear Contact Lenses (methafilcon A) are hemispherical flexible shells which cover the cornea and a portion of the adjacent sclera. The Igel 55 UV Contact Lens is available in a single vision lens design, the Igel 55 UV Multifocal Contact Lens is available in an aspherical lens design, and the Igel 55 UV Toric Contact Lens is available in a back surface toric design. The lens material (methafilcon A) is a hydrophilic polymer of 2-hydroxyethyl methacrylate (HEMA) and methacrylic acid cross-linked with ethyleneglycol dimethacrylate (45.0%) and water (55.0%). A UV absorbing compound has been incorporated into the lens polymer. All lenses are tinted using the color additive Reactive Blue #19.

Here's an analysis of the provided text regarding the acceptance criteria and supporting study for the IGEL Visioncare contact lenses, formulated to answer your specific questions.

It's important to note that this document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device rather than presenting a full clinical trial report with detailed performance metrics and statistical analyses typically associated with novel device approvals. Therefore, some of your requested information (e.g., specific effect sizes, adjudication methods for clinical studies with human readers, specific training set details, or sample sizes for clinical trials if not explicitly mentioned) may not be present or directly inferable from this type of regulatory document.

Acceptance Criteria and Reported Device Performance

The acceptance criteria are implicitly defined by demonstrating substantial equivalence to the predicate devices. The performance criteria are the physicochemical properties that are compared directly to the predicate devices.

Study Details

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

   • The document primarily references pre-clinical tests for safety and effectiveness. It states, "A series of pre-clinical tests were performed to demonstrate the safety and effectiveness of the Igel 55 UV, the Igel UV Multifocal and the Igel 55 UV Toric (methafilcon A) Contact Lenses for Daily Wear."
   • The specific sample sizes for these pre-clinical tests (e.g., number of animals for Systemic Injection, Primary Ocular Irritation, Cytotoxicity; number of lenses for extractables, sterility, stability) are not specified in this summary document.
   • Data provenance: Not explicitly stated, but these types of tests are typically conducted in laboratories and are considered retrospective in the context of a 510(k) submission, meaning the data was collected prior to the submission date. There is no indication of country of origin for the test data itself, beyond the submitter being in Singapore.

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

   • Not applicable in the context of this 510(k) summary. "Ground truth" for the pre-clinical tests would be established by standard laboratory protocols and analyses, not typically by expert consensus in the way a clinical image review might be. The tests performed (Systemic Injection, Primary Ocular Irritation, Cytotoxicity, Extractables, Sterility, Stability) yield objective results (e.g., toxic/non-toxic, irritating/non-irritating, pass/fail for sterility) rather than requiring subjective expert interpretation for ground truth.

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

   • Not applicable. Adjudication methods are typically used in clinical studies involving interpretation of data (e.g., images, patient symptoms) by multiple human experts. The pre-clinical tests described are objective laboratory analyses with pre-defined pass/fail criteria.

4. 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:

   • No, an MRMC comparative effectiveness study was not done. This type of study is relevant for AI-powered diagnostic devices where human readers interpret medical images or data. The device in question is a contact lens, and its evaluation relies on physicochemical properties and pre-clinical biocompatibility/safety tests, not AI-assisted human reading.

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

   • Not applicable. This question pertains to the performance of an AI algorithm as a standalone diagnostic tool. The device here is a contact lens, not an AI algorithm.

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

   • For the physicochemical properties (water content, Dk, transmittance, etc.), the ground truth is established through standardized laboratory measurement methods and analytical chemistry.
   • For biocompatibility and safety tests (Systemic Injection, Primary Ocular Irritation, Cytotoxicity, Extractables, Sterility, Stability), the ground truth is based on the results of validated laboratory assays and compliance with established biological reactivity standards (e.g., ISO standards for medical devices). These results are objective (e.g., "non-toxic," "no detectables," "passed requirements").

7. The sample size for the training set:

   • Not applicable. This question is relevant for machine learning or AI models. The IGEL contact lenses are a manufactured medical device, not an AI system that requires a "training set."

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

   • Not applicable. As stated above, there is no "training set" in the context of this device.

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