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Sphere/Asphere: AVAIRA VITALITY SPHERE and ASPHERE (fanfilcon A) Soft Contact lenses are indicated for the correction of ametropia (myopia and hyperopia) in aphakic and non-aphakic persons with non-diseased eyes in powers from -20.00 to +20.00 diopters. The lenses may be worn by persons who exhibit astigmatism of 2.00 diopters or less that does not interfere with visual acuity.

Toric: AVAIRA VITALITY (fanfilcon A) TORIC Soft Contact lenses are indicated for the correction of ametropia (myopia or hyperopia with astigmatism) in aphakic and non- aphakic persons with non-diseased eyes in powers from -20.00 to +20.00 diopters and astigmatic corrections from -0.25 to -10.00 diopters.

Multifocal: AVAIRA VITALITY (fanfilcon A) MULTIFOCAL Soft lenses are indicated for the correction of refractive ametropia (myopia and hyperopia) and emmetropia with presbyopia in aphakic persons with non-diseased eyes in powers from -20.00 to +20.00 diopters and with add powers from +0.25 to +4.00 diopters. The lenses may be worn by persons who exhibit astigmatism of 2.00 diopters or less that does not interfere with visual acuity.

Multifocal Toric: AVAIRA VITALITY (fanfilcon A) MULTIFOCAL TORIC Soft Contact lenses are indicated for the optic correction of distance and near vision in presbyopic phakic or aphakic persons with non-diseased eyes in powers of -20.00 to +20.00 diopters with add powers from +0.25 to +4.00 diopters and astigmatism corrections from -0.25 to -10.00 diopters.

Eye Care Practitioners may prescribe the Avaira Vitality (fanfilcon A) Soft Contact lenses for frequent/planned replacement wear, with cleaning, disinfection and scheduled replacement or for single-use disposable wear.

When prescribed for frequent/planned replacement, the Avaira Vitality (fanfilcon A) Soft Contact lens is to be cleaned, rinsed and disinfected each time the lens is removed. The contact lens is to be discarded after the recommended wearing period as prescribed by the Eye Care Professional. When prescribed for frequent/ planned replacement wear, the lenses may be disinfected using a chemical disinfection only.

When prescribed for single-use disposable wear, the Avaira Vitality (fanfilcon A) Soft Contact lens is to be discarded after each removal.

The AVAIRA VITALITY (fanfilcon A) Contact Lens visibility tinted with UV blocker is available as a sphere/asphere lens, toric lens, multifocal lens, and multifocal toric lens. The lenses are made of a silicone hydrogel material which is not surface treated and is characterized by high oxygen permeability (Dk). The AVAIRA VITALITY (fanfilcon A)) Contact Lens is tinted blue using Reactive Blue #246 to make the lens more visible for handling. A Norbloc UV blocker is used to reduce the amount of ultraviolet light transmitted into the eye. The AVAIRA VITALITY (fanfilcon A) lens is supplied sterile, packaged in a buffered saline solution. The composition of the lens is 45% fanfilcon A and 55% water by weight when hydrated and stored in buffered saline solution.

This document is a 510(k) premarket notification for a medical device (contact lenses), not an algorithm-driven AI/ML device. Therefore, the detailed requirements regarding AI/ML device acceptance criteria, study design, expert involvement, and ground truth establishment are not applicable.

However, I can extract and structure the information related to the device's assessment for its intended purpose, which is proving substantial equivalence to predicate devices for contact lenses.

Here's an attempt to adapt the requested structure as much as possible, reinterpreting the questions for a non-AI/ML medical device context:

Device: Avaira Vitality (fanfilcon A) Soft (hydrophilic) Contact Lenses

1. Table of Acceptance Criteria and the Reported Device Performance

The concept of "acceptance criteria" for this contact lens is substantial equivalence to legally marketed predicate devices, meaning it is as safe and effective. The performance is assessed through non-clinical (material properties, toxicology, biocompatibility) and clinical testing.

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

• Sample Size for Clinical Study (Test Set): 90 subjects (60 subjects for Test lenses, 30 subjects for Control lenses).
• Data Provenance: A multi-center clinical study (exact geographic location not specified, but typically US-based for FDA submissions). The study was conducted retrospectively to collect the data from the clinical trial.

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

• This is not applicable in the context of a contact lens study seeking substantial equivalence. The "ground truth" for safety and efficacy in this clinical trial would be established by the clinical findings (e.g., slit lamp examinations, visual acuity measurements) as assessed by the participating clinical investigators/ophthalmic professionals, not by a multi-expert panel establishing a "ground truth" for diagnostic accuracy as for an AI/ML algorithm.

4. Adjudication Method for the Test Set

• Not explicitly described as an "adjudication method" in the AI/ML sense. The clinical study was a "randomized, masked, concurrent control study." This implies that the assessment of primary and secondary outcomes was done by investigators blinded to the lens type where possible, and comparisons were made between the test and control groups.

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 not an AI/ML device, and no MRMC study or human-in-the-loop performance evaluation was conducted.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

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

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

• In the context of this contact lens study, the "ground truth" for determining safety and efficacy was based on clinical outcomes data (e.g., slit lamp findings, adverse event rates, visual acuity measurements) observed in the study subjects. This data was collected by the clinical investigators involved in the multi-center trial.

8. The Sample Size for the Training Set

• Not applicable. This is not an AI/ML device that requires a training set.

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

• Not applicable. This is not an AI/ML device that requires a training set.

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