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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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The ComfortKone™ Keratoconus Aspheric (hybufocon A, filofocon A, pemufocon A) Rigid Gas Permeable (RGP) Daily Wear Contact Lens (Clear and Tinted, Lathe-cut from Lens Blank) is indicated for daily wear for persons requiring Keratoconus management with otherwise non-diseased eyes. The lens may be prescribed for the correction of refractive ametropia (myopia, hyperopia and astigmatism) in aphakic and not-aphakic persons. The lens may be disinfected with a chemical disinfection system.

The ComfortKone" Keratoconus Aspheric Contact Lens is fabricated from the hydrophobic contact lens materials (hybufocon A, filotocon A, pemufocon A). When placed on the human cornea, the Comfort Keratoconus Aspheric rigid gas permeable contact lenses act as a refracting medium to focus light rays upon the retina.

The Comfort Kone" is a aspheric contact lens. It is designed to provide optimum comfort and visual acuity to the keratoconus patient. The ComfortKone™ lens design begins with a spherical 4.0 mm ontic zone that fits the peak of the cone and provides for good visual acuity. The lens then thattens into the aspheric curve, which is considered the fitting curve of the lens. The aspheric curve will vary in rate of change depending on how far the keratoconus has advanced and creates optimal corneal alignment. design finishes with two junctioniess peripheral aspheric curves to maintain alignment.

The provided document is a 510(k) summary for a contact lens, specifically for the addition of three new RGP materials to a previously cleared design and indication for use. The document does not contain information about acceptance criteria or a study that proves the device meets specific performance criteria in the way typically seen for AI-enabled diagnostic devices.

Instead, this submission focuses on demonstrating substantial equivalence to a predicate device based on material properties, manufacturing methods, and intended use. The "acceptance criteria" here are effectively the demonstration of comparable physical characteristics and safety profile to the predicate device.

Therefore, many of the requested sections (sample sizes, expert ground truth, adjudication, MRMC, standalone performance, training set details) are not applicable to this type of regulatory submission as it's not a de novo device or a performance study for a new diagnostic algorithm.

Here's an attempt to answer the questions based on the available information, noting where information is not present:

Description of Acceptance Criteria and Study to Prove Device Meets Acceptance Criteria

This 510(k) submission for the ComfortKone™ Keratoconus Aspheric Contact Lens (with new materials hybufocon A, filofocon A, and pemufocon A) focuses on demonstrating substantial equivalence to a previously cleared predicate device (ComfortKone™ Keratoconus Aspheric (paflufocon C), K990264). The "acceptance criteria" are implied by the comparative evaluation of various characteristics between the new device and the predicate device. The study to "prove" meeting these criteria is a direct comparison of physical and chemical properties and intended use.

1. Table of Acceptance Criteria and Reported Device Performance:

Note: The acceptance criteria are essentially the properties of the predicate device that the new device's properties are compared against for substantial equivalence.

2. Sample Size Used for the Test Set and Data Provenance:

This document describes a comparison of material properties, not a clinical "test set" in the sense of patient data. The properties are inherent to the materials themselves. The "study" involves characterizing these materials and comparing them to the predicate. The document doesn't specify sample sizes for material testing, but it's implied that standard material characterization methods were used. There is no information about country of origin for data or whether it's retrospective/prospective in a clinical trial sense. The referenced 510(k) numbers for the raw materials (K021977, K000485, K944223) indicate that the physical properties of these materials were previously characterized and accepted independently.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:

Not applicable. Ground truth for a clinical "test set" is not relevant here as this is a material and design modification submission. The "ground truth" for the material properties would be established through laboratory testing and characterization.

4. Adjudication Method for the Test Set:

Not applicable, as there is no clinical "test set" or diagnostic reading being adjudicated.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:

No, an MRMC comparative effectiveness study was not done. This submission is for contact lens material additions, not a diagnostic imaging device with human-in-the-loop performance evaluation.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done:

Not applicable. This device is a contact lens, not an algorithm.

7. The Type of Ground Truth Used:

The "ground truth" used for this submission is the established physical and chemical properties of the new materials, as well as the design parameters of the ComfortKone™ lens, all compared to the previously cleared predicate device. This is based on laboratory characterization of materials and established manufacturing processes, not expert consensus, pathology, or outcomes data in a clinical sense for this specific submission. The established safety profile (pre-clinical toxicology and manufacturing/chemistry data) of the device is stated to be equivalent to the predicate device.

8. The Sample Size for the Training Set:

Not applicable. This is not a machine learning or AI device.

9. How the Ground Truth for the Training Set Was Established:

Not applicable. This is not a machine learning or AI device.

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