(63 days)
The Gelflex Delta (methafilcon A) Soft Contact Lenses in clear or blue visitint are indicated for daily wear in aphakic and non-aphakic persons with nondiseased eyes. The Gelflex Delta (methafilcon A) Spherical Soft Contact Lens is indicated for the correction of refractive ametropia (myopia and hyperopia) with astigmatism of 0.5 diopters or less which does not interfere with visual acuity. The Gelflex Delta (methafilcon A) Toric Soft Contact Lens is indicated for the correction of refractive ametropia (myopia and hyperopia) with astigmatism of up to 6.00 diopters. The Gelflex Delta (methafilcon A) Translating Bifocal Lens is indicated for the correction of distance and near vision in presbyopic persons with astigmatism of 0.5 diopters or less which does not interfere with visual acuity. The Gelflex Delta (methafilcon A) Translating Toric Bifocal Lens is indicated for the correction of distance and near vision in presbyopic persons with astigmatism of up to 6.00 diopters.
The Gelflex Alpha (polymacon) Soft Contact Lenses in clear or blue visitint are indicated for daily wear in aphakic and non-aphakic persons with nondiseased eyes. The Gelflex Alpha (polymacon) Spherical Soft Contact Lens is indicated for the correction of refractive ametropia (myopia and hyperopia) with astigmatism of 0.5 diopters or less which does not interfere with visual acuity. The Gelflex Alpha (polymacon)Toric Soft Contact Lens is indicated for the correction of refractive ametropia (myopia and hyperopia) with astigmatism of up to 6.00 diopters. The Gelflex Alpha (polymacon) Translating Bifocal Lens is indicated for the correction of distance and near vision in presbyopic persons with astigmatism of 0.5 diopters or less which does not interfere with visual acuity. The Gelflex Alpha (polymacon) Translating Toric Bifocal Lens is indicated for the correction of distance and near vision in presbyopic persons with astigmatism of up to 6.00 diopters.
The lenses may only be prescribed for daily wear and must be cleaned and disinfected as recommended by the eye care practitioner. The Gelflex Delta (methafilcon A) Soft Contact Lenses may be disinfected using chemical (not heat) or hydrogen peroxide disinfection systems as recommended by your eye care practitioner. The Gelflex Alpha (polymacon) Soft Contact Lenses may be disinfected using heat, chemical (not heat) or hydrogen peroxide disinfection systems as recommended by your eye care practitioner.
Gelflex Delta Soft Contact Lens Material Methafilcon A 55% water content clear or blue visitint. Gelflex Alpha Soft Contact Lens Material Polymacon 38% water content clear or blue visitint.
This document is a 510(k) clearance letter from the FDA for Gelflex Alpha and Gelflex Delta soft contact lenses. It does not contain information about acceptance criteria or a study proving the device meets acceptance criteria in the context of an AI/ML medical device. This letter is a notification of substantial equivalence to legally marketed predicate devices, not a performance study for a new technology like AI.
Therefore, I cannot extract the requested information regarding acceptance criteria and a study from this document.
§ 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.