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The ACUVUE (senofilcon A) Soft (hydrophilic) Contact Lens with photochromic additive (spherical) is indicated for daily wear for the optical correction of refractive ametropia (myopia and hyperopia) in phakic persons with non-diseased eyes who may have 1.00D or less of astigmatism.

The ACUVUE (senofilcon A) Soft (hydrophilic) Contact Lens with photochromic additive TORIC is indicated for daily wear for the optical correction of refractive ametropia (myopia and hyperopia) in phakic or aphakic persons with nondiseased eyes who may have 10.00D or less of astigmatism.

The ACUVUE (senofilcon A) Soft (hydrophilic) Contact Lens with photochromic additive MULTIFOCAL is indicated for daily wear for the optical correction of refractive ametropia (myopia and hyperopia) and/or presbyopia in phakic or aphakic persons with non-diseased eyes who may have 0.75D or less of astigmatism.

The ACUVUE (senofilcon A) Soft (hydrophilic) Contact Lens with photochromic additive MULTIFOCAL TORIC is indicated for daily wear for the optical correction of refractive ametropia (myopia, and/or astigmatism) and presbyopia in phakic or aphakic persons with non-diseased eyes who may need up to 4.00D of ADD power and may have 10.00D or less of astigmatism.

These lenses are also indicated for the attenuation of bright light as they contain a photochromic additive which dynamically absorbs visible light.

These lenses contain a UV Blocker to help protect against transmission of harmful UV radiation to the cornea and into the eye.

Eye Care Professionals may prescribe the lenses either for daily disposable wear or frequent/planned replacement wear with cleaning, disinfection and scheduled replacement. When prescribed for daily disposable wear, no cleaning or disinfection is required. Lenses should be discarded upon removal. When prescribed for frequent/planned replacement wear, the lenses may be disinfected using a chemical disinfection system only and should be discarded after the recommended wearing period as prescribed by the Eye Care Professional. When the lenses are worn in a frequent/planned replacement modality, they are intended to be worn for up to 2-weeks (14 days).

The subject device is a soft (hydrophilic) contact lens available in a spherical, toric, multifocal and/or multifocal-toric design. The composition of the lens is 62% senofilcon A and 38% water by weight when hydrated and stored in the buffered saline solution with methyl ether cellulose. The lens is supplied sterile (steam) in a foil sealed plastic package. The lenses are hemispherical or hemitoric shells. To date a 2-year shelf-life has been established.

The subject device is made of a silicone hydrogel material containing an internal wetting agent and UV absorbing monomers. A combination of a benzotriazole UV absorbing monomer and a naphthopyran monomer (photochromic additive) is used to block UV radiation and dynamically absorbs visible light. The transmittance characteristics for these lenses are less than 1.0% in the UVB range of 280 nm to 315 nm and less than 10.0% in the UVA range of 316 nm to 380 nm for the entire power range.

Additionally, the photochromic additive absorbs visible light in the range from 380 nm to 780 nm to a minimum 84% transmittance in the inactivated (closed) state. The activated (open) state dynamically absorbs visible light dependent on the lens thickness and the level of UV and high energy visible (HEV) radiation to a minimum of 23% transmittance.

Here's a breakdown of the acceptance criteria and study information for the ACUVUE® (senofilcon A) Soft Contact Lens with Photochromic Additive, based on the provided document:

Acceptance Criteria and Device Performance

The document doesn't explicitly list "acceptance criteria" for clinical performance in a pass/fail format with numerical thresholds. Instead, it describes general safety and effectiveness. However, it does provide specific physicochemical properties with target values and the outcome of the clinical study regarding visual acuity and driving performance.

For physicochemical properties, the "Subject Device" column implicitly represents the reported device performance against the defined properties. For clinical performance, the statement "no evidence of driving performance or visual acuity concerns" indicates the device met the safety and performance expectations.

Table of Acceptance Criteria (or Expected Properties) and Reported Device Performance

Note: The "Acceptance Criteria" for clinical performance are inferred as "no concerns" based on the study's conclusion.

Study Information

1. Sample Size used for the test set and the data provenance:

   • Test Set Sample Size: 24 subjects
   • Data Provenance: Australia (field-based driving studies on a closed-road driving circuit at night and during the day). The study was prospective/real-world.

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

   • The document does not specify the number or qualifications of experts for establishing ground truth related to visual acuity or driving performance. The results are based on quantitative measurements of vision and driving performance, suggesting objective data collection rather than expert adjudication for ground truth.

3. Adjudication method for the test set:

   • The document does not mention an adjudication method for the test set, as the primary and secondary endpoints involved quantitative measurements (e.g., overall driving performance score, visual acuity, contrast threshold, road sign recognition percentage, hazard avoidance percentage, pedestrian recognition distance).

4. 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:

   • No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This study is focused on the performance of a contact lens in human subjects, not an AI system assisting human readers.

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

   • No, a standalone algorithm performance study was not done. This device is a contact lens, not a computational algorithm.

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

   • The ground truth for the clinical study was based on quantitative measurements of human physiological and behavioral responses. This includes:
     • Low luminance high contrast distance visual acuity
     • Distance visual acuity
     • Low luminance contrast threshold
     • Road sign recognition (percentage)
     • Percentage of hazards avoidance
     • Pedestrian recognition distance
     • Overall driving performance score.

7. The sample size for the training set:

   • There is no training set mentioned in the context of this device's evaluation. The studies described are for the validation of the contact lens itself, not for an AI algorithm.

8. How the ground truth for the training set was established:

   • Not applicable, as there was no training set for an AI algorithm mentioned.

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