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AIR OPTIX® COLORS (lotrafilcon B) spherical soft contact lenses with refractive power are indicated for daily wear for the optical correction of refractive ametropia (myopia) in phakic or aphakic persons with non-diseased eyes and up to approximately 1.50 diopters of astigmatism that does not interfere with visual acuity.

AIR OPTIX® COLORS (lotrafilcon B) toric soft contact lenses are indicated for daily wear for the optical correction of refractive ametropia (myopia and hyperopia) in phakic persons with non-diseased eyes with 6.00 diopters (D) or less of astigmatism.

AIR OPTIX® COLORS (lotrafilcon B) multifocal soft contact lenses are indicated for daily wear for the optical correction of presbyopia with or without refractive ametropia) in phakic or aphakic or aphakic persons with non-diseased eyes who may require a reading addition of +3.00 diopters (D) or less and who may have up to approximately 1.50 diopters of astigmatism.

AIR OPTIX® COLORS (lotrafilcon B) lenses with or without refractive power act to enhance or alter the apparent color of the eye.

The lenses may be prescribed for frequent/planned replacement wear with daily removal for cleaning and disinfection (chemical, not heat) prior to reinsertion, as recommended by the eye care professional.

The lens material of AIR OPTIX® COLORS is 33% water and 67% lotrafilcon B, a fluorosilicone containing hydrogel which is surface treated. Lotrafilcon B is classified as a Group 5 (silicone hydrogel) hydrogel contact lens material according to ISO 18369-1:2017. A cosmetic pattern is embedded into the back surface of the lens, containing a combination of the following color additives: carbazole violet, iron oxides, [phthalocyaninato (2-)] copper, phthalocyanine green and titanium dioxide.

Cleared lens designs for AIR OPTIX® COLORS (lotrafilcon B) include spherical, toric, and multifocal lenses in the following parameter range:
• Diameter Range: 13.0 to 15.0 mm
• Base Curve Range: 8.0 to 9.2 mm
• Power Range: -20.00 D to +20.00 D
• Center Thickness: varies with design and power (0.08 mm for -3.00 D spherical)

Lenses have the following properties:
• Refractive index: 1.42 (hydrated)
• Luminous transmittance: 95 ± 5%
• Water content: 33% by weight in normal saline
• Oxygen permeability: 110 x 10-11 (cm²/sec)(ml O₂ /ml x mm Hg), measured at 35 °C (intrinsic Dk – Coulometric method)

Lenses are supplied sterile in sealed blister packs containing phosphate buffered saline solution (PBS) with 1% Copolymer 845 (labeled as buffered saline containing 0.2% VP/DMAEMA Copolymer). The compatibility and package integrity of the blister pack packaging system has been demonstrated and successfully used for other marketed lens products, and packaged lenses are effectively steam sterilized in a validated autoclave. Blister pack containers are labeled with the lens parameters, lens color, lot number and product expiration date. The expiration date has been established through stability studies that have assessed the chemical stability of the lens and package integrity (ability to maintain sterility). Shelf-life studies are ongoing to further extend the labeled expiration date.

The provided text describes a 510(k) premarket notification for a medical device, specifically AIR OPTIX® COLORS (lotrafilcon B) Soft Contact Lenses, and a modification to its primary packaging. It details the device, its intended use, and a comparison to a predicate device. However, it does not include detailed acceptance criteria or a study proving the device meets performance criteria in the way typically expected for an AI/ML medical device.

The context of the document is a regulatory submission for a contact lens and a packaging change, not a software or AI device. Therefore, the specific information requested in the prompt related to AI/ML device evaluation (e.g., test set sample size, ground truth establishment, MRMC study, effect size, training set) is not applicable or present in this document.

Instead, the document focuses on demonstrating substantial equivalence to a predicate device for a physical medical product and a packaging modification. The "Performance Data" section primarily addresses non-clinical testing to verify equivalence for the packaging change, rather than performance of the contact lens itself (which was previously established for the predicate).

Here's a breakdown of the relevant information provided, adapted to the context of the document:

1. A table of acceptance criteria and the reported device performance

The document doesn't present a formal table of acceptance criteria and performance for the device itself (the contact lens) because the 510(k) is primarily for a packaging modification. Instead, it states that "Testing resulted in all acceptance criteria being met" for the packaging modification.

Acceptance Criteria and Reported Device Performance (Related to Packaging Modification)

Study Proving Device (Packaging Modification) Meets Acceptance Criteria

The study described is a non-clinical evaluation to demonstrate that the modified packaging (alternate foil lidding material from "Constantia-Pirk") does not negatively impact the safety and performance of the AIR OPTIX® COLORS contact lenses.

2. Sample sized used for the test set and the data provenance

• Sample Size: Not explicitly stated. The document mentions "representative lotrafilcon B soft contact lenses" were used for stability, biocompatibility, and process validation testing, but does not provide specific numbers.
• Data Provenance: Not explicitly stated, but it would be from internal Alcon Laboratories, Inc. testing facilities or contracted laboratories for the specific non-clinical tests conducted. The testing is reported as "successful," implying it was conducted as part of the regulatory submission process.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This is not applicable as the submission is for a physical medical device (contact lens) and a packaging change, not an AI/ML device requiring expert ground truth for image interpretation or diagnosis. The evaluation relied on scientific and engineering testing for stability, biocompatibility, and process validation.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This is not applicable for a contact lens packaging modification. Adjudication methods are typically used in clinical studies involving interpretation of data by multiple experts, which is not the nature of this submission. The "adjudication" here would be the scientific review and approval of the test results by qualified personnel within Alcon and subsequently by the FDA.

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

This is not applicable as the device is a contact lens, not an AI-assisted diagnostic tool. No human readers or AI assistance are involved in the performance evaluation described.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

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

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

The concept of "ground truth" as typically applied to AI/ML devices is not applicable here. For this submission, the "truth" is established by adherence to validated scientific and engineering testing methods for characteristics like material stability, sterility, and biocompatibility, as outlined in relevant standards and guidelines (e.g., FDA guidance for contact lenses, ISO standards).

8. The sample size for the training set

This is not applicable as the device is a contact lens and not an AI/ML model that requires a training set.

9. How the ground truth for the training set was established

This is not applicable as the device is a contact lens and not an AI/ML model.

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