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The QUASAR® (hybufocon A, hexafocon B) Rigid Gas Permeable (RGP) Contact Lens is indicated for daily wear for the correction of visual acuity in aphakic persons with nondiseased eyes with myopia or hyperopia. The lens may be disinfected with a chemical disinfection system only.

The QUASAR TORIC® (hybufocon A, hexafocon A, paflufocon B) Rigid Gas Permeable (RGP) Contact Lens is indicated for daily wear for the correction of visual acuity in aphakic and not aphakic persons with non-diseased eyes with myopia or hyperopia and/or possesses refractive astigmatism not exceeding 10.00 diopters. The lens may be disinfected with a chemical disinfection system only.

The QUASAR PLUS® (hybufocon A, hexafocon A, paflufocon B) Rigid Gas Permeable (RGP) Contact Lens is indicated for daily wear for the correction of visual acuity in aphakic and not aphakic persons with non-diseased eyes with myopia or hyperopia and/or possesses refractive astigmatism not exceeding 4 diopters and are presbyopic requiring add power of up to +4.00 diopters. The lens may be disinfected with a chemical disinfection system only.

The QUASAR® - QUASAR PLUS® - QUASAR TORIC® Contact Lenses are fabricated from the hydrophobic contact lens materials (hybufocon A, paflufocon B). When placed on the human cornea, the QUASAR® - QUASAR PLUS® - QUASAR TORIC® rigid gas permeable contact lenses act as a refracting medium to focus light rays upon the retina.

The QUASAR® and QUASAR TORIC® series of contact lenses are aspheric from center to edge. The QUASAR® and QUASAR TORIC® are designed with the central area consisting of a modified conic profile, which is designed to flatten at a much slower rate than a fixed elliptical curve. This improves centration characteristics and eliminates any significant positive/astigmatic aberration over the central 7mm. This aspheric geometry results in slight apical clearance and close alignment over the mid-peripheral cornea. Edge clearance is achieved by the addition of a second aspheric edge band resulting in the optimal final tear lens profile as shown in the figure below. Constant apical and edge clearance are maintained independent of base curve and the total diameter of the lens.

The QUASAR PLUS® multifocal design cleverly utilizes the eyes' own tears to provide precise vision at distance, intermediate and near. The QUASAR PLUS® is a distance center multifocal with a graduated annulus of near vision where the progressive power is incorporated into the optics back surface of the The aspheric design of the optical zone is based upon the patient's degree of ametropia and the lens. reading addition required. By incorporating the asphericity into the back surface, the profile of the tear film will be altered resulting in a fluorescein pattern different than that of a single vision lens.

The provided text does not describe a study involving acceptance criteria for a device's performance, nor does it detail a study that proves the device meets such criteria in the context of an AI/human comparative effectiveness or standalone algorithm performance.

Instead, the document is a 510(k) Premarket Notification for contact lenses, which focuses on demonstrating substantial equivalence to predicate devices rather than proving performance against specific acceptance criteria through a clinical study. The tables provided present characteristics of the new device (QUASAR® - QUASAR PLUS® - QUASAR TORIC® contact lenses) and compare them to predicate devices, but these are material and manufacturing specifications, not performance metrics based on a clinical trial.

Therefore, I cannot provide the requested information from the given input. The categories below are not applicable to the provided document.

1. Table of acceptance criteria and the reported device performance:
N/A - The document describes substantial equivalence based on material properties and intended use, not performance metrics from a clinical study with acceptance criteria.

2. Sample size used for the test set and the data provenance:
N/A - No test set or clinical data is described.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
N/A - No ground truth establishment is described.

4. Adjudication method for the test set:
N/A - No adjudication method is described.

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:
N/A - This document is for contact lenses and does not involve AI or human reader performance.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
N/A - This document is for contact lenses and does not involve an algorithm.

7. The type of ground truth used:
N/A - No ground truth is described.

8. The sample size for the training set:
N/A - No training set is described.

9. How the ground truth for the training set was established:
N/A - No ground truth for a training set is described.

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