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The EyeYon (hioxifilcon D) Spherical soft contact lenses for daily wear are indicated for the correction of visual acuity in aphakic and not aphakic persons with non-diseased eyes with myopia or hyperopia. The lens may be worn by persons who exhibit refractive astigmatism of 0.75 diopters or less where the astigmatism does not interfere with visual acuity.

The EyeYon (hioxifilcon D) Toric soft contact lenses for daily wear are indicated for the optical correction of refractive ametropia (myopia and hyperopia) in phakic persons with non-diseased eyes with 4.00 diopters (D) or less of astigmatism.

The EyeYon (hioxifilcon D) Multifocal soft contact lenses for daily wear are indicated for the optical correction of refractive ametropia (myopia, and/or presbyopia) in phakic or aphakic persons with non-diseased eyes who may require a reading addition of +3.00 diopters (D) or less and who may have up to approximately 0.75 diopters of astigmatism.

The EyeYon (hioxifilcon D) Multifocal Toric soft contact lenses for daily wear are indicated for the optical correction of refractive ametropia (myopia, astigmatism and presbyopia) in phakic or aphakic persons with non-diseased eyes. The lenses may be worn by persons who have 4.00 diopters (D) or less of refractive and/or corneal astigmatism.

The Hyper-CL™ (hioxifilcon D) Therapeutic soft contact lenses for daily wear are indicated for the optical correction of refractive ametropia in phakic persons with non-diseased eyes. The lenses may be prescribed for therapeutic use to promote corneal healing and relieve corneal pain by protecting the treatment of acute or chronic pathologies, such as corneal edema, corneal erosions, entropion, bullous keratopathy, and corneal dystrophies as well as post-surgical conditions resulting from cataract extraction and corneal surgery.

Eyecare practitioners may prescribe the lenses for frequent/planned replacement wear, with cleaning, disinfection and scheduled replacement. When prescribed for frequent wear, the lens may be cleaned and disinfected using a chemical (not heat) lens care system.

The EveYon (hioxifilcon D) Soft (hydrophilic) Contact Lenses & Hyper-CL™ (hioxifilcon D) Therapeutic Soft (hydrophilic) Contact Lenses for Daily Wear are fabricated from hioxifilcon D, which in the dry (unhydrated) state may be machined and polished. The hydrophilic nature of this material allows the lens to become soft and pliable when immersed in an aqueous solution. The EveYon (hioxifilcon D) Soft (hydrophilic) Contact Lenses & Hyper-CL™ (hioxifilcon D) Therapeutic Soft (hydrophilic) Contact Lenses are manufactured from CONTAFLEX 54 optical blanks, supplied by Contamac Ltd (cleared under K150590).

The non-ionic lens material, (hioxifilcon D) is a co-polymer of 2-Hydroxyethylmethacrylate (2-HEMA) and 2,3- Dihydroxypropyl Methacrylate (Glycerol Methacrylate), cross-linked with ethylene glycol dimethacrylate (EGDMA), plus an initiator. The co-polymer consists of 46% hioxifilcon D and 54% water by weight when immersed in normal buffered saline solution. The hioxifilcon D name has been adopted by the United States Adopted Names Council (USAN).

In the hydrated state, the lens conforms to the curvature of the eye covering the cornea and extending slightly beyond the limbus forming a colorless, transparent optical surface. The (hioxifilcon D) soft hydrophilic contact lens has a spherical back surface. The hydrophilic properties of the lens require that it be maintained in a fully hydrated state in a solution compatible with the eye. If the lens dries out, it will become hard and appear somewhat warped however, it will return to its proper configuration when completely rehydrated in the proper storage solution.

The Hyper-CL™ (hioxifilcon D) Therapeutic Soft (hydrophilic) Contact Lens design includes two (2) different base curves, and a peripheral groove including 4-16 fenestrations. When worn on the eve the Hyper-CL™ lens design creates a tear film reservoir between the corneal surface and the back surface of the contact lens. The fenestrations improve tear mixing efficiency.

The provided document is a 510(k) summary for EyeYon (hioxifilcon D) Soft (hydrophilic) Contact Lenses and Hyper-CL™ (hioxifilcon D) Therapeutic Soft (hydrophilic) Contact Lenses. This document describes the device, its intended use, and its substantial equivalence to predicate devices, focusing on non-clinical performance data and material properties. However, it does not contain a detailed study proving that the device meets specific acceptance criteria related to clinical performance metrics like accuracy, sensitivity, or specificity for a diagnostic or AI device.

Therefore, many of the requested information points, particularly those related to clinical studies, expert adjudication, and AI performance, cannot be extracted from this document.

Here's a breakdown of what can be inferred or directly stated from the document, and what cannot:

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

The document does not provide specific acceptance criteria or performance metrics in terms of accuracy, sensitivity, or specificity. Instead, it focuses on the material properties and manufacturing consistency.

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

This information is not provided in a way that relates to a "test set" for clinical performance. The manufacturing verification involved "all lenses" from manufacturing runs to check specifications, but this isn't a clinical test set. The shelf-life studies involved samples for sterility, stability, and package integrity, but specific numbers are not given.

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)

This information is not applicable and not provided. The substantial equivalence is based on material properties and non-clinical bench testing, not on interpretation by experts.

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

This information is not applicable and not provided.

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

There is no mention of an MRMC study or AI assistance. This document describes contact lenses, not an AI diagnostic or assistance device.

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

This information is not applicable as the device is a contact lens and not an algorithm.

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

For the material properties and manufacturing verification, the "ground truth" would be the established chemical and physical standards for contact lens materials (e.g., ISO, ANSI standards) and the specifications of the predicate device (CONTAFLEX 54). For shelf-life studies, the ground truth would be accepted methods for assessing sterility, stability, and package integrity. There is no expert consensus or pathology data mentioned in this context.

8. The sample size for the training set

This information is not applicable as this is not an AI device with a "training set."

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

This information is not applicable.

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