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Lotrafilcon B spherical soft contact lenses are indicated for the optical correction of refractive ametropia (myopia and hyperopia) 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.

Lotrafilcon B toric soft contact lenses are indicated for the optical correction of refractive ametropia (myopia and hyperopia) in phakic or aphakic persons with non-diseased eyes and up to 6.00 diopters (D) or less of astigmatism.

Lotrafilcon B multifocal soft contact lenses are indicated for the optical correction of presbyopia with or without refractive ametropia (myopia and hyperopia) in phakic 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.

Lotrafilcon B multifocal toric soft contact lenses are indicated for the optical correction of refractive ametropia (myopia and hyperopia) and presbyopia in phakic persons with non-diseased eves and up to 6.00 diopters (D) or less of refractive and/or corneal astigmatism.

Eye care professionals may prescribe the lenses for daily disposable wear (lenses are discarded upon removal from the eye) or daily wear with removal for cleaning and disinfection (chemical, not heat) prior to reinsertion and frequent replacement, as recommended by the eye care professional.

The lens material is 33% water and 67% lotrafilcon B, a fluoro-silicone containing hydrogel which is surface treated. Contact lenses contain the color additive phthalocyanine blue, a light blue handling tint, which helps make them easier to see when handling.

Lotrafilcon B lens designs include spherical. toric, multifocal toric lenses in the following parameter ranges:
• Diameter Range: 13.0 to 15.0 mm
• Base Curve Range: 8.0 to 9.2 mm
• Power Range: -20.00D to +20.00D
• Center Thickness: varies with design and power (Example: 0.08 mm for -3.00D spherical)

Lenses have the following properties:

• . Refractive index: 1.42 (hydrated)
• Light transmittance: > 94 % ●
• Water content : 33% by weight in normal saline
• Oxygen permeability 110 x 10-11 ●
  [(cm2 /sec)(ml O2 /ml mmHg)] measured at 35°C (intrinsic Dk-Coulometric method)

Lotrafilcon B contact lenses are supplied sterile in sealed blister packs containing isotonic phosphate buffered saline solution (PBS) with or without additives [1% Copolymer 845, or 1% Copolymer 845 and 0.04% (400 ppm) polyoxyethylene-polyoxybutylene copolymer (EO45BO10)]. The compatibility and package integrity of the blister pack packaging system have 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, 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).

This document from the FDA is a 510(k) premarket notification for a medical device -- a soft contact lens. It serves to demonstrate substantial equivalence to a predicate device, not necessarily to provide detailed acceptance criteria and a study report designed to prove the device meets these criteria in a typical clinical trial format for AI/ML devices. Therefore, a direct response to all your questions in the requested format for acceptance criteria and a study proving it meets them may not be fully extractable as this is not the primary purpose of this type of regulatory document.

However, I can extract information related to the device and its claimed equivalence.

Here's an attempt to answer your questions based on the provided document, recognizing the limitations of the document's nature:

Acceptance Criteria and Study for AIR OPTIX plus HydraGlyde (lotrafilcon B) Soft Contact Lenses

Given that this is a 510(k) premarket notification for a contact lens, the "acceptance criteria" are not presented as numerical thresholds for an AI/ML device's performance metrics (e.g., sensitivity, specificity, AUC). Instead, the acceptance criteria are implicitly that the new device, when packaged in modified saline, performs equivalently to or better than the predicate device across critical safety and performance characteristics for contact lenses. The "study" here refers to a series of nonclinical tests demonstrating this equivalence.

1. Table of Acceptance Criteria and the Reported Device Performance

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

The document describes "nonclinical tests" performed to demonstrate equivalence. It does not provide specific sample sizes or details on "test sets" in the context of an AI/ML clinical study (e.g., patient data). The testing would have involved laboratory analyses of the lens material, extracts, and packaged solution. The provenance would be laboratory testing data, not patient data from a specific country, and it refers to physical/chemical properties rather than retrospective or prospective patient outcomes.

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

This question is not applicable to this 510(k) submission. "Ground truth" in the context of an AI/ML device (e.g., expert consensus on image interpretation, pathology reports) is not relevant for demonstrating substantial equivalence for a physical medical device like a contact lens. The "truth" here is established by validated laboratory testing methods and comparison to established predicate device properties and clinical performance.

4. Adjudication method for the test set

Not applicable. There's no "adjudication method" in the sense of reconciling disagreements among human readers or experts for device performance, as it's not an AI/ML diagnostic or prognostic device.

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 device is a contact lens, not an AI-assisted diagnostic tool. Therefore, an MRMC study and effects on human reader improvement with AI are not relevant.

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

Not applicable. This device is not an algorithm or AI system.

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

The "ground truth" for the nonclinical tests is based on standardized laboratory testing methods and accepted scientific principles for evaluating the properties of contact lens materials, their biocompatibility, and sterilization effectiveness. The predicate device's established performance serves as the benchmark for equivalence. If patient data were involved in the predicate's original approval, that would likely have included clinical outcomes, but this document focuses on the new device's equivalence via nonclinical tests.

8. The sample size for the training set

Not applicable. There is no AI/ML model, and therefore no "training set."

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

Not applicable, as there is no training set.

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