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The FREQUENCY 55™ (methafilcon A ) Hydrophilic Contact Lens (clear and tinted ) is indicated for daily wear for the correction of refractive ametropia (myopia and hyperopia) in aphakic and not-aphakic persons with non-diseased eyes that may exhibit astigmatism up to 2.00 Diopters that does not interfere with visual acuity.

Eyecare practitioners may prescribe the lens for daily wear in a Frequent Replacement Program. The lenses may be disinfected using chemical or hydrogen peroxide disinfection systems.

Soft contact lenses are hemispherical shells manufactured of polymerized material of HEMA crosslinked with EGDMA which vield the appearance of lenses which are designed to fit over the comeal surface of the eye. These lenses are designed with varying base curves which conform to the shape of the radius of the comea and center over the apex of the cornea to provide corrective refraction for functional conditions of the eye including myopia (nearsightedness), hyperopia (farsightedness) and astigmatism (multiple foci). Each lens provides corrective power which is to correspond to the refractive power of the eye to which it is being treated. Each lens is designed with a base curve on the internal side of the lens and an optical zone in the center of the lens which is generally of a diameter greater than 8mm. Secondary and tertiary curves as well as beveled edge configurations are built into the lens for the purpose of aiding in lens centration and comfort.

The provided 510(k) summary (K971164) describes a contact lens and focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study with specific acceptance criteria and detailed device performance data. Therefore, many of the requested fields cannot be directly extracted from this document.

Here's an analysis based on the available information:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state quantitative acceptance criteria or detailed device performance metrics in a format suitable for such a table. It primarily asserts that the physical, optical, and chemical properties of the FREQUENCY 55™ lens are equivalent to its predicate device, The LifeStyle FREQUENCY™ Progressive (methafilcon A) Soft Contact Lens for Daily Wear.

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

The document does not mention a specific "test set" in the context of a clinical performance study. The submission relies on demonstrating equivalence through manufacturing information and the inherent properties of the material and design, presumed to be identical to the predicate device. Therefore, no sample size or data provenance for a test set is provided.

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

Not applicable. As no clinical test set is described, there's no mention of experts establishing a ground truth for such a set.

4. Adjudication Method for the Test Set

Not applicable. No test set involving human review or adjudication is described.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size

No MRMC comparative effectiveness study is mentioned. This is a 510(k) submission for a contact lens, which typically focuses on material safety, manufacturing equivalence, and performance characteristics rather than reader studies of diagnostic accuracy.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

Not applicable. The device is a physical contact lens, not an algorithm or AI system.

7. The Type of Ground Truth Used

The "ground truth" in this context is the established performance and safety profile of the predicate device (The LifeStyle FREQUENCY™ Progressive (methafilcon A) Hydrophilic Multifocal Contact Lens for Daily Wear). The submission aims to establish that the new device is sufficiently similar to the predicate that its safety and effectiveness can be inferred. This "ground truth" is based on the previously cleared device's regulatory approval and presumed successful market history.

8. The Sample Size for the Training Set

Not applicable. There is no mention of a "training set" as this is not an AI/ML device.

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

Not applicable. As there's no training set, there's no establishment of ground truth for it.

In summary:

This 510(k) submission is for a contact lens and follows a "substantial equivalence" pathway. Its primary focus is on demonstrating that the new device is functionally and materially the same as a legally marketed predicate device, leveraging the predicate's established safety and effectiveness. It does not contain information about clinical studies with specific acceptance criteria, test sets, or expert review panels typically found in submissions for AI-powered diagnostic devices.

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