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Aquamax (polymacon) Quarterly Disposable Soft (hydrophilic) Contact Lenses and Aquamax (polymacon) Monthly Disposable Soft (hydrophilic) Contact Lenses are indicated for daily wear for vision correction of refractive ametropia in aphakic or not-aphakic persons with non-diseased eyes that are myopic or hyperopic. The lens may be worn by persons who exhibit refractive astigmatism of 2.00 diopters (D) or less where the astigmatism does not interfere with visual acuity. The lens may be prescribed in spherical powers ranging from +20.00 D to -20.00 D. Eye practitioners may prescribe the lens 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. Lenses help protect against transmission of harmful UV radiation to the cornea and into the eve.

Aquamax (Polymacon) Ouarterly Disposable Soft (Hydrophilic) Contact Lenses and Aquamax (Polymacon) Monthly Disposable Soft (Hydrophilic) Contact Lenses are available as spherical lenses manufactured by cast molding method. The model illuminated with water content of 38%. These hydrogel lens materials are homo-polymer of 2-hydroxyethyl methacrylate (HEMA) crosslinked with ethylene glycol dimethacrylate (EGDMA) 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 UV 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.

Here's an analysis of the provided text regarding the acceptance criteria and supporting studies for the Aquamax (Polymacon) Soft (Hydrophilic) Contact Lenses:

The submission K123973 refers to a 510(k) premarket notification for contact lenses, which are inherently different from typical medical devices that might involve AI, image analysis, or complex algorithms requiring extensive performance criteria like sensitivity, specificity, or reader studies. This document, therefore, focuses on demonstrating substantial equivalence to existing, legally marketed predicate devices rather than proving performance against specific acceptance criteria for a novel technology.

As such, many of the requested categories (like sample sizes for test sets, number of experts, adjudication methods, MRMC studies, standalone AI performance, and training set information) are not applicable to this type of regulatory submission for contact lenses, which relies on the established safety and effectiveness of the material and manufacturing process. The "acceptance criteria" here are implicitly about matching the characteristics of the predicate devices and fulfilling non-clinical testing requirements.

Acceptance Criteria and Reported Device Performance

The "acceptance criteria" for this device are largely defined by its resemblance and comparable performance to the predicate devices. The study demonstrates substantial equivalence through a comparison of technological characteristics and non-clinical testing.

1. Table of Acceptance Criteria and Reported Device Performance:

Study Details

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

• Sample size for test set: Not explicitly specified in terms of number of lenses or subjects. The document refers to "tests" conducted, implying a certain number of samples for each non-clinical test (e.g., biocompatibility, sterilization, leachability).
• Data provenance: Not specified, but generally refers to in-house laboratory testing based on FDA guidelines for non-clinical performance.

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

• Not Applicable. This is a non-clinical evaluation comparing material properties and safety characteristics, not a diagnostic device requiring expert interpretation for ground truth.

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

• Not Applicable. See point 3.

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. No reader studies were conducted.

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:

• The "ground truth" here is based on established testing methodologies and standards for contact lens materials and safety. For instance:
  • Technological characteristics: Measured physical properties (e.g., water content, refractive index, oxygen permeability) against known values for the material (Polymacon) and predicate devices.
  • Biocompatibility: Results from standardized in vitro and in vivo animal model tests (cytotoxicity, sensitization, ocular irritation).
  • Microbiology/Sterilization: Validation against a sterility assurance level (SAL) of 10⁻⁶ using standard methods.
  • Leachability: Chemical analysis to detect leachable substances.

8. The sample size for the training set:

• Not Applicable. This device is a contact lens, not an AI-powered system that requires a "training set."

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

• Not Applicable. See point 8.

Summary of the Study:

The study presented in K123973 is a non-clinical study designed to demonstrate substantial equivalence of the Aquamax (Polymacon) Quarterly and Monthly Disposable Soft (Hydrophilic) Contact Lenses to two predicate devices: Soflens Multifocal (Polymacon) Visibility Tinted Contact lens (K020927) and Frequency 38 (Polymacon) Soft (hydrophilic) Contact Lens (K042824).

The study followed the May 1994 FDA guideline titled "Premarket Notification 510(K) Guidance Document for Class IV Contact Lenses."

The proof of meeting "acceptance criteria" (i.e., substantial equivalence) is established by showing that the Aquamax lenses:

1. Share the same technological characteristics with the predicate devices (same FDA Group, USAN name (Polymacon), production method, water content, refractive index, power range, and comparable oxygen permeability and % T at 593 nm). The new lenses also include UV blocking properties.
2. Pass a series of non-clinical safety tests:
   • Biocompatibility: Negative responses for cytotoxicity, maximization sensitization, and ocular irritation.
   • Microbiology/Sterilization: Validation of steam sterilization process to achieve a minimum SAL of 10⁻⁶ and shelf-life stability.
   • Bacteriostatic Validation: Demonstration that microorganisms were killed and lens packages maintained sterility and integrity for a 5-year accelerated period.
   • Leachability: No detectable leachable monomers or additive residues.

The document explicitly states that clinical studies were "not required" because the USAN name (Polymacon) and manufacturing process are the same as the predicate devices, whose safety and effectiveness are "well documented." This approach is typical for 510(k) submissions of devices that are very similar to already cleared devices.

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