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The FREQUENCY 38™ (polymacon) 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 Dlopters 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 heat, chemical or hydrogen peroxide disinfection systems.

Soft contact lenses are hemispherical shells manufactured of polymerized material of HEMA crosslinked with EGDMA which yield 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 conter 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.

This document is a 510(k) premarket notification for a contact lens, establishing substantial equivalence to a previously marketed device. It does not contain an acceptance criteria table or a study proving that the device meets specific acceptance criteria in the manner typically found in a clinical study report for an AI/medical device. The approval is based on equivalence to another contact lens already on the market.

Therefore, many of the requested elements for an AI device submission are not applicable to this document.

However, I can extract information related to the device and its intended use, and explain why other sections are not present:

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

This document does not contain explicit acceptance criteria and corresponding reported device performance in the format of a clinical study or AI performance evaluation. The "acceptance" is based on demonstrating substantial equivalence to a predicate device.

The closest equivalent to "performance" stated is that the physical, optical, and chemical properties of the FREQUENCY 38™ (polymacon) Hydrophilic Contact Lens for Daily Wear (clear and tinted) are equivalent to those of the LifeStyle 4 Vue (polymacon) Soft Contact Lens for Daily Wear (clear and tinted).

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

Not applicable. This is a 510(k) for a contact lens, not a study evaluating an AI algorithm on a test set. Substantial equivalence is primarily based on manufacturing information and previous approvals of predicate devices, not on a new clinical trial with a defined test set in the context of AI.

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. Ground truth establishment with experts for a test set is not relevant for this type of device submission.

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

Not applicable. This document does not describe a clinical study with adjudication for a test set.

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 is not an AI device, and therefore no MRMC study or assessment of human reader improvement with AI assistance would be present.

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

Not applicable. This is not an AI algorithm.

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

Not applicable. Ground truth for an AI algorithm is not relevant here. The ground truth for the safety and effectiveness of the contact lens is implicitly tied to its equivalence to previously approved, legally marketed predicate devices which have established safety and effectiveness through their own approval processes and market experience.

8. The sample size for the training set

Not applicable. This is not an AI algorithm, so there is no training set.

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

Not applicable. As there is no training set for an AI algorithm, ground truth establishment is not relevant.

Summary of Relevant Information from the Document:

While the document doesn't fit the typical structure of an AI device submission, here's what can be extracted regarding the device itself:

• Device Name: FREQUENCY 38™ (polymacon) Hydrophilic Contact Lens for Daily Wear (clear and tinted)
• Common Name: contact lens
• Predicate Device: The LifeStyle 4 Vue (polymacon) Hydrophilic Contact Lens for Daily Wear (clear and tinted)
• Basis for Substantial Equivalence: Aspect Vision Care, Ltd. received all manufacturing information (formulation, processes, QC/QA, shelf life) from the predicate device manufacturer and has the right to reference its premarket notifications (K950283 and K963001). They will also manufacture the devices at the same location as the predicate devices.
• Device Description: Soft contact lenses made of HEMA crosslinked with EGDMA, designed to fit over the corneal surface for corrective refraction.
• Indications for Use: For daily wear for the correction of refractive ametropia (myopia and hyperopia) in aphakic and non-aphakic persons with non-diseased eyes that may exhibit astigmatism up to 2.00 Diopters that does not interfere with visual acuity. Can be prescribed for daily wear in a Frequent Replacement Program and disinfected using heat, chemical, or hydrogen peroxide disinfection systems.
• Parameters Available:
  • Powers: +20.00 to -20.00D
  • Center Thickness: 0.07 mm
  • Diameter: 14.0 mm
  • Base Curve: 8.6 mm
• Regulatory Class: II
• Product Code: 86 LPL

This document is a regulatory submission demonstrating substantial equivalence for a medical device (contact lens), not a clinical study report for an AI-powered diagnostic or therapeutic device. Therefore, the requested information pertaining to acceptance criteria and study design for AI evaluation is not present.

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