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Pegavision (Etafilcon A) Color SPHERE and ASPHERE Daily Disposable Soft (Hydrophilic) Contact Lenses are indicated for daily wear for the correction of ametropia (myopia and hyperopia) in aphakic and/or non-aphakic persons with non-diseased eves in powers from +6.00 to -12.00 diopters. The lenses may be worn by persons who exhibit astigmatism of 2.00 dioters or less that does not interfere with visual acuity. The lens is available tinted and may be used to enhance or alter the apparent color of the eye.

Pegavision (Etafilcon A) Color Toric Daily Disposable Soft (Hydrophilic) Contact Lenses are indicated for daily wear for the correction of ametropia (myopia with astigmatism) in aphakic and/or non-aphakic persons with non-diseased eves in powers from +6.00 to -12.00 diopters and astigmatic corrections from -0.25 to -3.50 diopters. The lens is available tinted and may be used to enhance or alter the apparent color of the eye.

Pegavision (Etafilcon A) Color Multifocal Daily Disposable Soft (Hydrophilic) Contact Lenses are indicated for daily wear for the correction of refractive ametropia (myopia and presbyopia in aphakic and/or non-aphakic persons with non-diseased eyes in powers from +6.50 to -12.25 diopters and with non-diseased eyes who may require a reading addition from +0.25 to +3.00 diopters. The lenses may be worn by persons who exhibit astigmatism of 2.00 diopters or less that does not interfere with visual acuity. The lens is available tinted and may be used to enhance or alter the apparent color of the eye.

Pegavision (Etafilcon A) Color Daily Disposable Soft (Hydrophilic) Contact Lenses are intended for single-use disposable wear.

Pegavision (Etafilcon A) Color SPHERE Soft (Hydrophilic) Contact Lenses are indicated for daily wear for the correction of ametropia (myopia and hyperopia) in aphakic persons with non-diseased eyes in powers from +6.00 to -12.00 diopters. The lenses may be worn by persons who exhibit astigmatism of 2.00 diopters or less that does not interfere with visual acuity. The lens is available tinted and may be used to enhance or alter the apparent color of the eye.

Pegavision (Etafilcon A) Color Toric Soft (Hydrophilic) Contact Lenses are indicated for daily wear for the correction of ametropia (myopia or hyperopia with astigmatism) in aphakic persons with non-diseased eyes in powers from +6.00 to -12.00 diopters and astigmatic corrections from -0.25 to -3.50 diopters. The lens is available tinted and may be used to enhance or alter the apparent color of the eye.

Pegavision (Etafilcon A) Color Multifocal Soft (Hydrophilic) Contact Lenses are indicated for daily wear for the correction of refractive ametropia) and hyperopia) and presbyopia in aphakic and/or non-aphakic persons with non-diseased eyes in powers from +6.50 to -12.25 diopters and with non-diseased eyes who may require a reading. addition from +0.25 to +3.00 diopters. The lenses may be worn by persons who exhibit astigmatism of 2.00 diopters or less that does not interfere with visual acuity. The lens is available tinted and may be used to enhance or alter the apparent color of the eye.

Pegavision (Etafilcon A) Color Soft (Hydrophilic) Contact Lenses are intended for frequent/planned replacement wear with cleaning, rinsing, disinfection and scheduled replacement as prescribed by the eye care professional. When prescribed for frequent/planned replacement wear, the lens may be disinfected using a chemical (not heat) lens care system only.

Pegavision (Etafilcon A) Color Soft (Hydrophilic) Contact Lenses and Pegavision (Etafilcon A) Color Daily Disposable Soft (Hydrophilic) Contact Lenses are available as spherical, aspherical, toric and multifocal designs lenses. The model illuminated with high water (58 %). These hydrogel lens materials are random copolymer of 2-hydroxyethyl methacrylate (HEMA) and methacrylic acid (MAA), which were crosslinked with and 1,1,1-trimethylolpropane trimethacrylate (TMPTMA) via photo-polymerization. These lenses are tinted blue using C.I. reactive blue 19 to make them more visible for handling. The contact lens color additives use FDA approved colorants and combination pigmented area that will mask or enhance the apparent color of the eyes.

These lenses contain UV blocker, a benzotriazole UV absorbing monomer to block UV radiation. The average transmittance characteristics of theses lenses are less than 5% in the UVB range of 280-315 nm and less than 50% in the UVA range of 315-380nm. Lenses are supplied sterile in sealed blister package containing sterile isotonic borate buffered saline solution with Tween 80. Sodium Hyaluronate and Polyethylene Glycol.

The provided text contains information about the regulatory clearance of contact lenses, specifically Pegavision (Etafilcon A) Color Daily Disposable Soft (Hydrophilic) Contact Lenses and Pegavision (Etafilcon A) Color Soft (Hydrophilic) Contact Lenses.

*However, the document does not describe an AI/ML-based device and therefore does not contain information about acceptance criteria, test sets, ground truth establishment, or clinical studies involving human readers and AI assistance for such a device.

Instead, it focuses on demonstrating substantial equivalence to predicate contact lenses through:

• Physicochemical Properties Tests: Measuring properties like water content, refractive index, oxygen permeability, and light transmittance.
• Biocompatibility Tests: Including cytotoxicity, maximization sensitization, and ocular irritation tests.
• Shelf Life Test and Sterility Test.
• Extractable Test.
• Compatibility Test of Care Solution.

The document explicitly states: "Clinical studies for Pegavision (Etafilcon A) Color Soft (Hydrophilic) Contact Lenses of the present device are not required for the premarket notification as the USAN name and process or color additive are the same as the above mentioned predicate devices." This indicates that the safety and effectiveness were established through non-clinical testing and comparison to already cleared devices, not through a clinical trial with human subjects/readers.

Therefore, I cannot provide the requested information about acceptance criteria for an AI/ML device, test set details, ground truth, expert adjudication, or MRMC studies, as these concepts are not applicable to the content of the provided regulatory filing for contact lenses.

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