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1. Aquamax (Etafilcon A) Daily Disposable Soft (Hydrophilic) Contact Lenses:
   Spherical and Aspherical
   Aquamax (Etafilcon A) SPHERE and ASPHERE Daily Disposable Soft (Hydrophilic) Contact Lenses 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 +20.00 diopters. The lenses may be worn by persons who exhibit astigmatism of 2.00 diopters or less that does not interfere with visual acuity.
   Toric
   Aquamax (Etafilcon A) Toric Daily Disposable Soft (Hydrophilic) Contact Lenses are indicated for daily wear for the correction of ametropia (myopia or hyperopia with astigmatism) in aphakic persons with non-diseased eyes in powers from -20.00 to +20.00 diopters and astigmatic corrections from -0.25 to -10.00 diopters.
   Multifocal
   Aquamax (Etafilcon A) Multifocal Daily Disposable Soft (Hydrophilic) Contact Lenses are indicated for daily wear for the correction of refractive ametropia (myopia and hyperopia) and presbyopia in aphakic persons with non-diseased eyes in powers from -20.00 to +20.00 diopters and with non-diseased eyes who may require a reading addition of up to +3.00D. 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 help protect against transmission of harmful UV radiation to the cornea and into the eye. The lenses are intended for single-use disposable wear.
2. Aquamax (Etafilcon A) Soft (Hydrophilic) Contact Lenses:
   Spherical and Aspherical
   Aquamax (Etafilcon A) SPHERE and ASPHERE Soft (Hydrophilic) Contact Lenses 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 +20.00 to -20.00 diopters. The lenses may be worn by persons who exhibit astigmatism of 2.00 diopters or less that does not interfere with visual acuity.
   Toric
   Aquamax (Etafilcon A) Toric Soft (Hydrophilic) Contact Lenses are indicated for daily wear for the correction of ametropia (myopia or hyperopia with astigmatism) in aphakic and/or non-aphakic persons with non-diseased eyes in powers from -20.00 to +20.00 diopters and astigmatic corrections from -0.25 to -10.00 diopters.
   Multifocal
   Aquamax (Etafilcon A) Multifocal Soft (Hydrophilic) Contact Lenses 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 -20.00 to +20.00 diopters and with non-diseased eyes who may require a reading addition of up to +3.00D. 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) Soft (Hydrophilic) Contact Lenses help protect against transmission of harmful UV radiation to the cornea and into the eye.
   The lenses are intended for frequent/planned replacement wear with cleaning, rinsing, disinfection 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.

Aquamax (Etafilcon A) Soft (Hydrophilic) Contact Lenses and Aquamax (Etafilcon A) Daily Disposable Soft (Hydrophilic) Contact Lenses are available as spherical, aspherical, toric and multifocal lenses. The model illuminated with high water (58 %). These hydrogel lens materials are random copolymer of 2-hydroxyethyl methacrylate (HEMA) and methacrylic acid (MAA), which were crosslinked with glycol dimethacrylate (EGDMA) and 1,1,1-trimethylolpropane ethylene e trimethacrylate (TMPTMA) via photo-polymerization. These lenses are tinted blue using C.I. reactive blue 19 to make them more visible for handling. These lenses contain UV blocker, a benzotriazole UV absorbing monomer to block UV radiation. 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 316-380nm. Lenses are supplied sterile in sealed blister package containing sterile isotonic borate buffered saline solution with Tween 80, Sodium Hyaluronate and Polyethylene Glycol.

Here's an analysis of the provided text regarding the acceptance criteria and study for the Aquamax (Etafilcon A) Soft (Hydrophilic) Contact Lenses.

It's important to note that this document is a 510(k) summary, which focuses on demonstrating substantial equivalence to predicate devices rather than providing a full, detailed study report with all raw data. Therefore, some information, especially regarding detailed sample sizes for specific tests (like each biocompatibility test), expert qualifications, and adjudication methods, is not explicitly provided in the summary.

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Sizes Used for Test Set and Data Provenance

• Sample Size for Test Set: Not explicitly stated for most tests in quantitative terms (e.g., number of lenses, number of animals). The document indicates "All tests were conducted" and "Studies were conducted to determine leachable materials," implying standard testing protocols were followed, which would inherently involve specific sample sizes per test type (e.g., for cytotoxicity, sensitization, ocular irritation, material property measurements) but these numbers are not detailed in this summary.
• Data Provenance: The studies were conducted by Pegavision Corporation (Taiwan). The report implies that these were internal studies to support the 510(k) submission. Therefore, it is retrospective in the sense that the data was generated to support the application, but the tests themselves would have been conducted prospectively on the device.

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

• This information is not provided in the summary. For non-clinical tests (biocompatibility, material characteristics, microbiology), "ground truth" is typically established by laboratory standards and validated methods rather than expert consensus on individual observations. For manufacturing verification, engineers and quality control personnel would assess against specifications.

4. Adjudication Method for the Test Set

• This information is not applicable in the context of these non-clinical, objective tests. Adjudication methods (like 2+1, 3+1) are typically used in clinical studies where subjective assessments (e.g., image interpretation, patient-reported outcomes) from multiple readers or clinicians require reconciliation for ground truth establishment.

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

• No, an MRMC comparative effectiveness study was not done.
• This device is a physical medical device (contact lenses), not an AI/software device that assists human readers. Therefore, this type of study is completely irrelevant to this submission.

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

• No, a standalone performance study was not done.
• As established above, this is a physical medical device, not an algorithm or AI.

7. The Type of Ground Truth Used

• For the non-clinical tests described:
  • Material properties: Measured values compared against established standards and values of predicate devices.
  • Biocompatibility: Negative responses (absence of toxicity, sensitization, irritation) based on standardized in vitro and in vivo models.
  • Microbiology/Sterility: Achievement of a specified Sterility Assurance Level (SAL) confirmed by validation studies using microbiological indicators and established protocols.
  • Leachability: Absence of detectable levels of specific substances using analytical chemistry methods.
  • Manufacturing Verification: Conformance to engineering specifications and tolerances for physical dimensions (diameter, power, base curve).

8. The Sample Size for the Training Set

• Not applicable. This device is a manufactured product, not an AI model requiring a training set. The term "training set" is typically associated with machine learning and AI algorithms.

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

• Not applicable. See point 8.

Summary of the Study per the Document:

The study presented in this 510(k) summary is a series of non-clinical, laboratory-based tests designed to demonstrate the safety and effectiveness of the Aquamax (Etafilcon A) contact lenses and their substantial equivalence to legally marketed predicate devices. The "study" encompasses:

• Technological Characteristics Comparison: Direct comparison of material properties and design specifications with three predicate devices (K120028, K962804, K991134). The current device largely matches the most relevant predicate (K120028) for key properties like oxygen permeability and percentage transmission, and is in acceptable ranges for others.
• Biocompatibility Testing: According to standard cytotoxicity, maximization sensitization, and ocular irritation tests.
• Microbiology and Sterilization Validation: Validation of the steam sterilization process to ensure a minimum SAL of 10⁻⁵ and demonstration of sterility throughout the shelf life.
• Bacteriostatic Validation: Testing of the steam sterilizer's effectiveness in killing microorganisms.
• Leachability Studies: To confirm the absence of leachable monomers and additive residues.
• Manufacturing Verification Studies: For the new toric and multifocal lens designs, ensuring they meet specified tolerances for key parameters like diameter, power, and base curve.

The overarching "study" proves adherence to the "Premarket Notification 510(K) Guidance Document for Class IV Contact Lenses" (May 1994) and establishes substantial equivalence based on these non-clinical tests. Clinical studies were deemed "not required" due to the well-documented safety and effectiveness of etafilcon A lenses and the similarity to predicate devices.

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