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The Aquaflex 2 Contact Lens is indicated for daily wear for the correction of refractive ametropia (myopia and hyperopia) and astigmatism up to 1.50 diopters or less in aphakic and/or not-aphakic persons with non-diseased eyes. The lens may be disinfected using either a heat or chemical disinfection system.

The Aquaflex 2 (tefilcon) Soft (hydrophilic) Contact Lens is available as a spherical lens. The lens material, tefilcon, is a hydrophilic polymer of 2-hydroxyethyl methacrylate crosslinked with ethylene glycol dimethacrylate. The Aquaflex 2 Contact Lens is a hemispherical shell.

Here's an analysis of the provided text regarding the acceptance criteria and study for the Aquaflex 2 (tefilcon) Soft (hydrophilic) Contact Lens, structured to address your specific points:

Note: The provided document is a 510(k) summary for a contact lens, which primarily focuses on demonstrating substantial equivalence to a predicate device rather than presenting a novel device's performance against specific acceptance criteria in a detailed clinical study report. Therefore, some of your requested information, particularly around detailed study methodology (sample sizes, expert qualifications, adjudication, MRMC, training sets), is not present in this type of regulatory submission. The information provided heavily relies on the equivalence to a previously cleared device.

Acceptance Criteria and Device Performance Study for Aquaflex 2 (tefilcon) Soft (hydrophilic) Contact Lens

1. Table of Acceptance Criteria and Reported Device Performance

As this is a 510(k) submission based on substantial equivalence, explicit "acceptance criteria" for novel performance metrics are not typically presented in this format. Instead, the document asserts equivalence to a predicate device across several key characteristics. The performance of the Aquaflex 2 is described by its physical/optical properties, which are implicitly accepted if they are comparable to the predicate and meet established safety and effectiveness profiles for contact lenses.

2. Sample Size Used for the Test Set and Data Provenance

The document does not explicitly state a sample size for a test set or provide details about prospective/retrospective studies or country of origin for clinical data. This is because a 510(k) submission for substantial equivalence primarily relies on benchmarking against a predicate device and established safety profiles of similar materials, rather than a de novo clinical trial with a "test set" in the context of diagnostic AI. The "study" here is demonstrating the equivalence of the new device's material and design to already approved devices.

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

This information is not applicable/not provided in this 510(k) summary. The evaluation relies on comparing the device's characteristics against known and accepted properties of predicate devices and materials, not on establishing a "ground truth" via expert consensus for a new diagnostic claim.

4. Adjudication Method for the Test Set

This information is not applicable/not provided for the same reasons as (3).

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done, What was the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance

This information is not applicable. This is a contact lens, not an AI-powered diagnostic device, and therefore no MRMC study or AI assistance is involved.

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

This information is not applicable, as it is a physical medical device (contact lens), not an algorithm.

7. The Type of Ground Truth Used

The "ground truth" used in this submission is the established safety, efficacy, and material properties of the predicate device (BayVue polymacon) and a previously cleared lens of the same material (LL-Bifocal tefilcon, K971647). The submission aims to show that the Aquaflex 2 device is substantially equivalent to these established benchmarks.

8. The Sample Size for the Training Set

This information is not applicable/not provided. There is no "training set" in the context of an AI algorithm for this device. The development and testing of a contact lens involve material science, engineering, and clinical trials (if required for novel claims, but not for this 510(k) based on equivalence).

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

This information is not applicable/not provided for the same reasons as (8).

Summary of the Study Proving Acceptance Criteria:

The study proving the device meets acceptance criteria (defined as demonstrating substantial equivalence to a predicate device) is the 510(k) premarket notification process itself. This process does not involve a traditional clinical study with a defined test set, ground truth experts, or AI performance metrics.

Instead, the submission for the Aquaflex 2 (tefilcon) Soft (hydrophilic) Contact Lens demonstrates its acceptance by:

• Identifying a Predicate Device: The BayVue (polymacon) Soft (hydrophilic) Contact Lens.
• Demonstrating Material Equivalence: The Aquaflex 2 uses tefilcon, a hydrophilic polymer whose safety profile is explicitly stated as equivalent to the LL-Bifocal (tefilcon) Contact Lens (K971647).
• Comparing Physical and Optical Properties: Listing key properties (specific gravity, refractive index, light transmittance, water content, oxygen permeability) to show they fall within accepted ranges for contact lenses and are comparable to safe and effective lenses on the market.
• Matching Intended Use: Showing the indications for use are identical to the predicate device.
• Asserting Similar Manufacturing and Quality Systems: Stating that manufacturing, packaging, and sterilization procedures are similar to currently marketed devices and that a quality management system is in place.

The FDA's review of this comparison, culminating in the "substantially equivalent" determination in the provided letter (K050743), serves as the "proof" that the device meets the implicit acceptance criteria for market clearance under the 510(k) pathway.

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