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The ACUVUE® 2 COLOURS Contact Lenses are indicated for daily wear to enhance or alter the apparent color of the eye and/or for the correction of refractive ametropia (myopia and hyperopia) in aphakic or not aphakic persons with non-diseased eyes who may have 1.00D or less of astigmatism. ACUVUE® 2 COLOURS contact lenses are available in 0.00D for those patients who do not need vision correction but desire the cosmetic benefits of opaque or enhancer cosmetic contact lenses.

The ACUVUE® 2 COLOURS (etafilcon A) Soft (hydrophilic) BIFOCAL Contact Lens is indicated for daily wear for the correction of distance and near vision in presbyopic, aphakic or not aphakic persons with non-diseased eyes who may have 0.75 D of astigmatism or less.

The ACUVUE® 2 COLOURS (etafilcon A) Soft (hydrophilic) TORIC Contact Lens is indicated for daily wear for the correction of visual acuity in aphakic or not aphakic persons with non-diseased eyes that are hyperopic or myopic and may have 10.00 D of astigmatism or less.

The ACUVUE® 2 COLOURS (etafilcon A) Soft (hydrophilic) TORIC-BIFOCAL Contact Lens is indicated for daily wear for the correction of distance and near vision in presbyopic aphakic or not aphakic persons with non-diseased who may have 10.00 D of astigmatism or less.

ACUVUE® 2 COLOURS UV Blocking Contact Lenses help protect against transmission of harmful UV radiation to the cornea and into the eye.

The ACUVUE 2 COLOURS Contact Lenses may be prescribed for daily wear. Eye Care Practitioners may prescribe the lenses either for single-use disposable wear or frequent/planned replacement wear with cleaning, disinfection and scheduled replacement (see "Wearing Schedule"). When prescribed for frequent/planned replacement wear, the lenses may be disinfected using a chemical disinfection system only.

The device description is identical to that cleared under K010114 and K024177.

The provided 510(k) summary for the ACUVUE® 2 COLOURS™ Brand (etafilcon A) Soft Hydrophilic Contact Lens with UV Blocker does not describe any acceptance criteria or the results of a study to prove the device meets such criteria related to AI or algorithm performance.

Instead, this submission is for a medical device (contact lens) where the manufacturer states that no clinical studies were required to demonstrate the safety and effectiveness of the device. This is because the device is deemed "substantially equivalent" to a predicate device already cleared by the FDA (K024177 and K010114).

Therefore, the requested information regarding acceptance criteria, device performance, sample sizes for test/training sets, expert qualifications, ground truth, and comparative effectiveness studies for an AI/algorithm is not applicable based on the provided document.

The document focuses on non-clinical studies typically required for contact lenses, such as:

• Toxicology: USP Ocular Irritation, USP Systemic Toxicity, In-Vitro Cytotoxicity
• Chemistry/Leachables: Formulation and Process, Physical and Mechanical Properties, Leachable Monomer and Additives

The conclusion is that the modified contact lens is substantially equivalent to the previously cleared predicate device, meaning it has the same intended use and technological characteristics, and thus does not require new clinical data to prove safety and effectiveness.

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