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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, and astigmatism) and presbyopia in not aphakic persons with non-diseased eyes. 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 lens is composed of polymer of 2-hydroxy-ethylmethacylate and 2-metacrylolovoxvethyl phosphorylcholine cross linked with ethylmethacrylate. The lenses are tinted blue from edge to edge for visibility purposes. The Proclear (omafilcon A) Soft (hydrophilic) contact lenses are a hemispherical shell. The physical properties and available dimensions are unchanged from predicate 510ks.

The modifications to the stability - shelf life protocol include alternate test method for package integrity and adjusted storage temperatures for the packaged products that will be tested using alternate package integrity test method.

The provided document describes CooperVision's Proclear (omafilcon A) Soft (hydrophilic) Contact Lenses and a 510(k) submission (K111966) for a modification to its shelf-life protocol. This submission does not contain acceptance criteria for device performance or a study demonstrating the device meets such criteria.

Instead, the submission argues for substantial equivalence to predicate devices based on the following:

• No change in material, manufacturing methods, lens parameters, or indicated use.
• The modification is specifically to the stability-shelf life protocol, including an alternate test method for package integrity and adjusted storage temperatures.

Therefore, the sections of your request related to device performance, clinical studies, sample sizes, expert ground truth, adjudication methods, MRMC studies, or standalone algorithm performance cannot be answered from the provided text, as these concepts are not applicable to this type of submission.

Here's what can be extracted from the provided text:

1. Table of Acceptance Criteria and Reported Device Performance
This information is not provided in the document. The submission is for a modification to a shelf-life protocol, not for initial device performance evaluation. The document explicitly states: "Results from physical, optical and chemical properties were not required as support for this modification to shelf life protocol. Change will not affect physicochemical properties of the lenses." and "Results from in-vivo and in-vitro studies were not required as support for this modification to shelf life protocol."

2. Sample size used for the test set and the data provenance
Not applicable/Not provided. This document does not describe a test set or data provenance for device performance. It is a submission for a modification to a shelf-life protocol.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable/Not provided. This document does not describe a test set, ground truth establishment, or human experts.

4. Adjudication method for the test set
Not applicable/Not provided. This document does not describe a test set or adjudication method.

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/Not provided. This document pertains to contact lenses and changes in shelf-life testing, not AI or MRMC studies.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable/Not provided. This document pertains to contact lenses, not algorithms or standalone performance studies.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
Not applicable/Not provided. This document does not describe a study involving ground truth for device performance.

8. The sample size for the training set
Not applicable/Not provided. This document does not describe a training set for an algorithm or device performance study.

9. How the ground truth for the training set was established
Not applicable/Not provided. This document does not describe a training set or ground truth establishment.

Summary of what the document does state regarding acceptance and substantial equivalence:

The core of this 510(k) submission is to assert substantial equivalence to previously cleared predicate devices, not to prove new performance criteria. The "acceptance criteria" here are implicitly that the modified shelf-life protocol does not negatively impact the established characteristics of the contact lenses, and that the lens properties remain within previously established specifications.

The "study" demonstrating this involves:

• Stating that the physical, optical, and chemical properties remain unchanged and within established specifications. This implies that prior testing for the original predicate devices did establish these specifications.
• Stating that toxicology results from original in-vivo and in-vitro studies remain valid, verifying non-toxicity and biocompatibility.
• Introducing an alternate test method for package integrity and adjusted storage temperatures. While not detailed, the implication is that this new method is still capable of ensuring package integrity over the stated shelf-life.

Conclusion stated in the document:
"Based on no change to material, no change to manufacturing methods, no change to lens parameters and no change to indicated use, the omafilcon A soft contact lens described in this document is substantially equivalent with the predicate devices." (Section 12)

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