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SPHERICAL AND ASPHERICAL:

AVAIRA (enfilcon A) Sphere and Asphere Soft Contact lenses are indicated for the correction of ametropia (myopia and hyperopia) in aphakic and non-aphakic persons with non-diseased eyes. 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 (enfilcon 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 (enfilcon A) Multifocal lenses are indicated for the correction of refractive ametropia (myopia and hyperopia) and emmetropia with presbyopia in aphakic and non-aphakic persons with non-diseased eyes. The lenses may be worn by persons who exhibit astigmatism of 2.00 diopters or less that does not interfere with visual acuity.

The AVAIRA (enfilcon A) Soft (Hydrophilic) Contact Lenses are indicated for daily wear. When prescribed for planned replacement the lens may be disinfected using a chemical or hydrogen peroxide disinfecting systems. The lens may also be prescribed for singleuse disposable daily wear.

The AVAIRA (enfilcon A) soft contact lens is a daily wear silicone hydrogel contact lens that is not surface treated and is characterized by high oxygen permeability (Dk). The lens material, enfilcon A, is composed of silicone macromers cross linked with other monomers, incorporating phthalocyanine blue as an integrated, handling tint. A UV blocker is added to reduce the amount of ultraviolet light transmitted into the eye. The lens will be manufactured in spherical, aspherical, toric and multifocal configurations.

The CooperVision AVAIRA (enfilcon A) Soft Contact Lens is seeking substantial equivalence to the COOPERVISION AQUAIR (enfilcon A) Soft Contact Lens (K071736). The submission K113759 does not detail a study proving the device meets specific acceptance criteria in the traditional sense of a new feature demonstrating performance against a defined threshold. Instead, it relies on demonstrating substantial equivalence to a predicate device.

Here's an breakdown of the supporting information:

1. Table of Acceptance Criteria and Reported Device Performance

Since this is a substantial equivalence claim for a contact lens, the "acceptance criteria" are implied by the characteristics of the predicate device that the new device aims to match. The "device performance" refers to the new device's characteristics as measured and compared to the predicate.

† polarographic method (corrected)

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

The document states: "Clinical studies were conducted on the predicate device to demonstrate substantial equivalence of the enfilcon A lens as compared with historical data of the COOPERVISION BIOFINITY lens based on performance and safety. No additional clinical study was required for the modified enfilcon A lens."

This means there wasn't a specific "test set" for this device. The substantial equivalence is based on the new device having the same material, manufacturing method, and physical/optical properties as the predicate device (AQUAIR), which itself was cleared based on clinical studies demonstrating equivalence to BIOFINITY.

• Sample Size for Test Set: Not applicable for the AVAIRA lens itself, as no new clinical study was required. The clinical data referred to relates to the predicate device and historical data.
• Data Provenance: The document does not specify the country of origin for the predicate device's clinical data or whether it was retrospective or prospective.

3. Number of Experts Used to Establish Ground Truth and Qualifications

Not applicable. The primary evidence for this submission relies on bench testing (physical and optical studies) and biocompatibility studies demonstrating that the new AVAIRA lens is identical or nearly identical in its key characteristics to the predicate AQUAIR lens. Clinical ground truth, if required for the predicate or its predecessor, would have been established through standard optometric/ophthalmological assessments, but details are not provided in this submission for AVAIRA.

4. Adjudication Method

Not applicable, as no new clinical trial was conducted for the AVAIRA lens that required adjudication of outcomes.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done

No. This type of study is not relevant for the substantial equivalence of a contact lens based on physical and optical properties.

6. If a Standalone Study was Done

"Standalone" performance in the context of an AI algorithm is not applicable here. However, the submission does rely on standalone physical and optical studies and biocompatibility studies of the AVAIRA lens itself (without human-in-the-loop performance, as it's a passive medical device). These studies verified that the AVAIRA lens performed equivalently to the predicate device in terms of measurable characteristics.

7. The Type of Ground Truth Used

The "ground truth" for this substantial equivalence submission is based on:

• Bench Testing Measurements: Physical and optical properties (e.g., water content, Dk, refractive index, dimensions) were measured for the AVAIRA lens and compared against the known values of the AQUAIR predicate device.
• Biocompatibility Testing: According to ISO 10993 standards, for ocular irritation, cytotoxicity, and systemic toxicity.
• Clinical Data from Predicate Device: The clinical performance and safety of the predicate device (AQUAIR) served as the "ground truth" for its own clearance, and AVAIRA leverages this by demonstrating substantial equivalence in material and design.

8. The Sample Size for the Training Set

Not applicable. This device is a contact lens and does not involve AI/machine learning, so there is no concept of a "training set."

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

Not applicable, as there is no training set for this device.

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