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Focus® DAILIES® Visitint® (nelfilcon A) ONE-DAY CONTACT LENSES are indicated for daily wear for the optical correction of refractive ametropia (myopia, hyperopia, and astigmatism) in not-aphakic persons with non-diseased eves.

Focus® DAILIES® Visitint® ONE-DAY CONTACT LENSES are to be prescribed for single use daily disposable wear. Focus® DAILIES® Visitint® LENSES are not intended to be cleaned or disinfected and should be discarded after a single use.

Alternate Indications For Use (spherical lens only):

Focus® DAILIES® Visitint® (nelfilcon A) ONE-DAY CONTACT LENSES are indicated for daily wear for the optical correction of refractive ametropia in not-aphakic persons with non-diseased eyes who are myopic or hyperopic and may have minimal astigmatism that does not interfere with visual acuity.

Focus® DAILIES® Visitint® (nelfilcon A) ONE-DAY CONTACT LENSES are to be prescribed for single use daily disposable wear. Focus® DAILIES® Visitint® LENSES are not intended to be cleaned or disinfected and should be discarded after a single use.

The Focus® DAILIES® Visitint® (nelfilcon A) ONE-DAY CONTACT LENS is a daily wear soft contact lens intended for single use daily disposable wear. The lens material is 69% water and 31% nelfilcon A polymer (polyviny) alcohol partially acetalized with N-formylmethy) acrylamide). The lenses are made by incorporating a color additive (Jphthalocyaninato (2-)] copper) into the nelfilcon polymer. The lenses are tinted for visibility purposes to make them easier to see when handling.

Focus® DAILIES® Visitint® (nelfilcon A) ONE-DAY CONTACT LENSES are available in a spherical lens design of the following unnensions.

• Chord Diameter: 13.8
• Center Thickness: 0.09 to 0.17 mm (0.10 at -3.00)
• Base Curve: 8.6 mm
• Powers: +4.00D to -6.00D (0.25D steps)
-6.50D to -8.00D (0.50D steps)

A lens has the following properties:

• · Specific gravity: 1.06
• · Refractive index: 1.38 (hydrated)
• · Light transmittance: 96%
• · Water content : 69% by weight in normal saline
• · Oxygen permeability 26 x 10-11(cm 2/sec)(ml O2 /ml.mmHg)} at 35°C (Fatt corrected).

Lenses are supplied sterile in foil sealed blister packs containing isotonic buffered saline solution.

The provided text is a 510(k) summary for a contact lens, not an AI/ML medical device. As such, it does not contain the information requested in the prompt regarding acceptance criteria, study details, and AI/ML specific performance metrics like sample sizes for test and training sets, expert ground truth establishment, or MRMC studies.

The document describes the physical properties, intended use, and non-clinical testing for the Focus® DAILIES® Visitint® (nelfilcon A) ONE-DAY CONTACT LENSES to establish substantial equivalence to a predicate device.

Therefore, I cannot fulfill the request for information specific to AI/ML device studies based on the provided text.

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