(56 days)
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.
§ 886.5925 Soft (hydrophilic) contact lens.
(a)
Identification. A soft (hydrophilic) contact lens is a device intended to be worn directly against the cornea and adjacent limbal and scleral areas of the eye to correct vision conditions or act as a therapeutic bandage. The device is made of various polymer materials the main polymer molecules of which absorb or attract a certain volume (percentage) of water.(b)
Classification. (1) Class II if the device is intended for daily wear only.(2) Class III if the device is intended for extended wear.
(c)
Date PMA or notice of completion of a PDP is required. As of May 28, 1976, an approval under section 515 of the act is required before a device described in paragraph (b)(2) of this section may be commercially distributed. See § 886.3.