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Sphere and Aspheric: (omafilcon A) Soft (hydrophilic) Contact Lenses are indicated for daily wear for the correction of visual acuity in not aphakic persons with non-diseased eves that are myopic or hyperopic and exhibit astigmatism of 2.00D or less that does not interfere with visual acuity.

Toric: (omafilcon A) Soft (hydrophilic) Contact Lenses are indicated for daily wear for the correction of visual acuity in not aphakic persons with non-diseased eyes that are myopic or hyperopic. The lens may be worn by persons who have astigmatism of 5.00D or less.

Multifocal: (omafilcon A) Soft (hydrophilic) Contact Lenses are indicated for daily wear for the correction of refractive ametropia (myopia, hyperopia, and astigmatism) and presbyopia in not aphakic persons with non-diseased eves. The lens may be worn by persons who have astigmatism of 2.00D or less that does not interfere with visual acuity.

Multifocal Toric: (omafilcon A) Soft (hydrophilic) Contact Lenses are indicated for daily wear for the correction of visual acuity in not aphakic persons with non-diseased eyes that are myopic or hyperopic, possess astigmatism of 10.00 diopters or less, and are presbyopic.

Proclear XC and Proclear 1 Day (omafilcon A) Soft (hydrophilic) Contact lenses may provide improved comfort for contact lens wearers who experience mild discomfort or symptoms related to dryness during lens wear associated with Evaporative Tear Deficiency or from Aqueous Tear Deficiency (non-Sjogren's only).

Daily wear replacement schedules may vary from patient and should be decided by eyecare practitioners in consultation with their patients.

FREQUENT/PLANNED REPLACEMENT WEAR

When prescribed for Frequent/Planned replacement the lenses are to be cleaned, rinsed and disinfected each time they are removed from the patient's eye and discarded after the recommended wearing period prescribed by the eye care practitioner. The lens may be disinfected using a chemical disinfection system.

DISPOSABLE WEAR

When prescribed for Daily Disposable Wear the lens is to be discarded after each removal.

The Proclear (omafilcon A) are Daily Wear soft contact lenses intended for single use daily disposable wear or Scheduled Replacement wear. The Proclear (omafilcon A) Soft (hydrophilic) contact lenses are a hemispherical shell. The Proclear lens is available in several designs. Spherical or aspherical soft contact lens; Toric is a back surface toric; Multifocal has multiple curves with complementary reverse geometry (N and D) which allows for correction of presbyopia in persons who are myopic or hyperopic; Multifocal Toric has an aspheric front surface with anterior having two multifocal zones with a toric generated surface for the purpose of correcting vision in an eye that is astigmatic. The omafilcon A lens material is equivalent to other omafilcon A daily wear hydrophilic contact lenses cleared under several 510(k) notifications. Omafilcon A is composed of polymer of 2-hydroxy-ethylmethacylate and 2-metacryloloyoxyethyl phosphoryIcholine cross linked with ethylmethacrylate. The lenses are tinted from edge to edge for visibility purposes with the color additive Vat Blue 6.

This document is a 510(k) premarket notification for contact lenses, which primarily focuses on demonstrating substantial equivalence to previously cleared devices rather than extensive new clinical studies with acceptance criteria for device performance. Therefore, many of the requested elements for describing acceptance criteria and a study proving device adherence are either not applicable, not explicitly detailed as a separate "study" in the traditional sense, or are referred to through equivalence to predicate devices.

Here's an attempt to answer the questions based on the provided text, highlighting where information is not present or not directly applicable:

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

The document does not explicitly present a table of "acceptance criteria" against which "reported device performance" is measured in a comparative fashion, as it is a substantial equivalence submission. Instead, the device's physical and material properties are compared to predicate devices for equivalency. The implied acceptance criterion for the subject device is that its characteristics fall within ranges considered equivalent and safe, as demonstrated by the predicate devices.

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

The document states, "The technical characteristics, formulation, manufacturing, and sterilization processes of this lens are equivalent to omafilcon A soft contact lenses currently marketed by CooperVision, therefore no clinical data is required." This indicates that a separate, formal "test set" and a clinical study to prove the device meets acceptance criteria in a new cohort were not performed for this submission. The "test set" implicitly refers to the data and studies associated with the predicate devices which established their safety and effectiveness.

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, as no new clinical study with a "test set" requiring ground truth establishment by experts was conducted for this 510(k) submission.

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

Not applicable, for the same reason as 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 is a contact lens submission, not an AI or imaging device, and no MRMC study was performed.

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

Not applicable. This is a contact lens submission, not an AI or algorithm-based device.

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

Not applicable, as no new clinical study with a "test set" requiring ground truth establishment was conducted for this 510(k) submission. The "ground truth" for demonstrating safety and effectiveness relies on the previously established regulatory clearances of the predicate devices based on their initial studies (which presumably included clinical trials and robust testing at the time).

8. The sample size for the training set

Not applicable. This is a contact lens submission and does not involve a training set for an algorithm. The "training" in this context refers to the accumulated knowledge and testing performed on the predicate devices over time.

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

Not applicable, for the same reason as point 8. The "ground truth" for the predicate devices' safety and efficacy would have been established through a combination of physical/chemical testing, toxicology studies, and likely clinical trials performed at the time of their original submissions.

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