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Aquamax (Etafilcon A) Daily Disposable Soft (Hydrophilic) Contact Lenses and Aquamax (Etafilcon A) Soft (Hydrophilic) Contact Lenses with Sphere designs are indicated for daily wear for the correction of ametropia (myopia and hyperopia) in aphakic and/or non-aphakic persons with non-diseased eyes in powers from +6.00 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.

Aquamax (Etafilcon A) Daily Disposable Soft (Hydrophilic) Contact Lenses and Aquamax (Etafilcon A) Soft (Hydrophilic) Contact Lenses with Toric designs are indicated for the correction of ametropia (myopia or hyperopia with astigmatism) in aphakic and/or non-aphakic persons with non-diseased eyes in powers from +6.00 to -12.25 diopters and astigmatic corrections from -0.25 to -3.50 diopters.

Aquamax (Etafilcon A) Daily Disposable Soft (Hydrophilic) Contact Lenses and Aquamax (Etafilcon A) Soft (Hydrophilic) Contact Lenses with Multifocal designs are indicated for daily wear for the correction of refractive ametropia (myopia and hyperopia) and presbyopia in aphakic and/or non-aphakic persons with non-diseased eyes in powers from +6.00 to -12.25 diopters and with non-diseased eyes who may require a reading addition form +0.25 to +3.00 diopters. The lenses may be worn by persons who exhibit astigmatism of 2.00 diopters or less that does not interfere with visual acuity.

Aquamax (Etafilcon A) Daily Disposable Soft (Hydrophilic) Contact Lenses and Aquamax (Etafilcon A) Soft (Hydrophilic) Contact Lenses with Multifocal-Toric designs are indicated for daily wear for the correction of refractive ametropia (myopia and hyperopia) in aphakic and/or non-aphakic persons with non-diseased eyes in powers from +6.00 to -12.25 diopters who may need up to +3.00 diopters of ADD power and have -3.50 diopters of astigmatism or less.

Aquamax (Etafilcon A) Daily Disposable Soft (Hydrophilic) Contact Lenses are intended for single-use disposable wear. Aquamax (Etafilcon A) Soft (Hydrophilic) Contact Lenses are intended for frequent/planned replacement wear with cleaning, disinfecting and scheduled replacement as prescribed by the eye care professional. When prescribed for frequent/planned replacement wear, the lens may be disinfected using a chemical (not heat) lens care system only.

The Aquamax (Etafilcon A) Daily Disposable Soft (Hydrophilic) Contact Lenses and Aquamax (Etafilcon A) Soft (Hydrophilic) Contact Lenses are clear, visibility-tinted, UV absorber-containing and are available in sphere, asphere, toric, multifocal and multifocal-toric designs. It is an ionic hydrogel lens derived from Etafilcon A material which is a co-polymer of 2-Hydroxyethyl Methacrylate (2-HEMA) and Methacrylic Acid (MAA), cross-linked with Ethylene Glycol Dimethacrylate (EGDMA) and 1,1,1-Trimethylolpropane Trimethacrylate (TMPTMA) and made by photo-polymerization. The lens consists of 42% Etafilcon A and 58% water by weight when immersed in buffered saline solution. The lens polymer further contains a benzotriazole, a UV absorbing monomer, thus is able to block the UV radiation to the ocular. The average transmittance characteristics of theses lenses are less than 5% in the UVB range of 280-315 nm and less than 50% in the UVA range of 315-380mm. The lens is visibly tined with "Reactive Blue19" color additive, 21 CFR part 73.3121. Lenses are supplied sterile in the sealed blister package containing sterile isotonic borate buffered saline solution with Tween 80, Sodium Hyaluronate and Polyethylene Glycol.

The provided document is a 510(k) premarket notification for Aquamax (Etafilcon A) soft contact lenses. It asserts substantial equivalence to existing predicate devices rather than presenting a novel device that requires a new clinical study with specific acceptance criteria and performance data. Therefore, the information typically requested regarding acceptance criteria, study design, and performance metrics for a new device's clinical efficacy is not present in this document.

Instead, the submission relies on the established safety and effectiveness of the predicate devices.

Here's an breakdown of the available information regarding testing:

1. A table of acceptance criteria and the reported device performance:

This document does not provide a table of acceptance criteria for a new clinical study. Instead, it performed non-clinical tests to demonstrate that the proposed device is comparable to the predicate devices. The "Technological characteristics studies" table (page 8) presents a comparison of the proposed device's physical properties with those of the predicate devices.

Non-clinical tests performed (page 7) and their relevance to acceptance criteria:

• Physicochemical Properties Test: The results of this test would demonstrate that the lenses meet the established finished product specifications. The specific acceptance criteria are not detailed but are implied to be within acceptable ranges for contact lens safety and performance.
• Biocompatibility Tests (according to ISO 10993 series):
  • Cytotoxicity Test (ISO 10993-5): Proves the materials (lenses, packaging solution, plastic container) are not toxic to cells. Acceptance criteria would be no significant cytotoxic effect.
  • Ocular Irritation Test (ISO 10993-10): Proves the materials are not irritating to the eye. Acceptance criteria would be a low or absent irritation score.
  • Acute Systemic Toxicity Test (ISO 10993-11): Proves the materials do not cause acute systemic toxic effects. Acceptance criteria would be no significant systemic toxic response.
• Extractable Test: Demonstrates that leachable substances from the device are within safe limits. Acceptance criteria would be that extractables are below specified toxicological thresholds.
• Shelf Life Test and Sterility Test: Confirm the device maintains its properties and sterility over its intended shelf life. Acceptance criteria would include maintaining physical integrity, water content, and remaining sterile.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

No specific sample size for a clinical "test set" is mentioned because a clinical study was not required for this 510(k) submission. The non-clinical tests (physicochemical, biocompatibility, extractable, shelf life, sterility) would have their own sample sizes for the materials tested, but these are not detailed in this summary. The data provenance is implied to be from internal testing by Pegavision Corporation, Taiwan, as they are the submitter. These appear to be laboratory-based tests.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):

Not applicable. As no clinical study was required for this 510(k), there was no "test set" in the context of human data requiring expert ground truth establishment. Non-clinical tests are evaluated against scientific standards and regulations (e.g., ISO standards).

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

Not applicable, as no clinical study and corresponding test set requiring adjudication was performed.

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, not an AI-powered diagnostic tool. Therefore, an MRMC study related to AI assistance is irrelevant.

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

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

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

For the non-clinical tests, the "ground truth" is based on established scientific principles, regulatory standards (like ISO 10993), and the performance characteristics of the predicate devices. For example, for biocompatibility, the ground truth is an absence of toxicity or irritation defined by the standards. For material properties, it's the measured values compared against established ranges and predicate device data.

8. The sample size for the training set:

Not applicable. There is no training set in the context of an algorithm or AI.

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

Not applicable. There is no training set in the context of an algorithm or AI.

In summary:

This 510(k) submission for Aquamax contact lenses relies on demonstrating substantial equivalence to existing, legally marketed predicate devices rather than proving the safety and effectiveness of a novel device through new clinical trials with defined acceptance criteria. The "study" referenced involves a series of non-clinical tests (physicochemical properties, biocompatibility, extractables, shelf life, sterility) to confirm that the new device's materials and manufacturing process yield a product with comparable characteristics and safety profiles to the predicates. The success of these non-clinical tests, along with the inherent similarity to established predicate devices, forms the basis for the FDA's substantial equivalence determination.

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