(32 days)
Spherical: DuraSoft® 3 Spherical (phemfilcon A) Clear, Colored, Complements ColorBlends and Handling Tint Soft (Hydrophilic) Contact Lenses are indicated for the correction of visual acuity in persons with non-diseased eyes that are myopic (nearsighted) or hyperopic (farsighted) and may exhibit refractive astigmatism of up to 2.0 diopters that does not interfere with visual acuity. The lens range in power from -20.00 to +20.00 diopters for daily wear.
OptiFit Toric: DuraSoft® 3 OptiFit Toric (phemfilcon A) Clear, Colored, Complements ColorBlends and Handling Tint Soft (Hydrophilic) Contact Lenses are indicated for the correction of visual acuity in persons with non-diseased eyes that are myopic (nearsighted) or hyperopic (farsighted) and may exhibit refractive astigmatism of up to 6.0 diopters. The lens range in power from -20.00 to +20.00 diopters for daily wear.
Prosthetic: DuraSoft® 3 Prosthetic (phemfilcon A) Soft (Hydrophilic) Contact Lenses are indicated for Daily Wear to enhance or alter the apparent eye color, including ocular masking, either in sighted or non-sighted eyes that require a prosthetic contact lens for cosmetic management of conditions such as comeal, ins or lens abnormalities. The lens may also be prescribed for the correction of refractive ametropia (myopia, hyperopia and astigmatism) or for occlusive therapy conditions such as diplopia, amblyopia or extreme photophobia.
The lenses are indicated for Daily Wear in not-aphakic and/or aphakic persons. The eve care practitioner may prescribe the lens for daily use with routine cleaning, ninsing and disinfection. The lens may be disinfected using a chemical (not heat) disinfection system only.
DuraSoft 3 Contact Lenses with UV-absorbing monomer help protect against transmission of harmful UV radiation to the comea and into the eye.
The dimensions of DuraSoft® 3 and DuraSoft® 3 UV (phemfilcon A) Spherical and OptiFit Toric hydrophilic contact lenses in Clear, Colors, Complements, ColorBlends and Handling Tint are the same as approved in PMA 830037/S41 and K982344.
The lens material (phemfilcon A) is a hydrophilic copolymer of 2-hydroxyethyl methacrylate and 2-ethoxyethyl methacrylate. The DuraSoft® 3 UV (phemfilcon A) contact lenses are made by adding the UV absorber to the monomer mixture. The physical properties of the lenses are listed below. The light transmittance table has been added as approved for the Supplement No. 42 PMA P830037 and 510(k) K991550 (FreshLook Bifocal UV-absorbing (phemfilcon A) contact lenses). The data to support this table is available in Section X, Exhibit -3.
Physical properties of the lenses:
Specific Gravity: 1.178
Refractive Index: 1.411
Light Transmittance:
Handling Tint: 95% minimum
Color: 95% minimum
Surface Characteristics: Lathed and polished
Water Content: 55%
Optical Zone:
Handling Tint: 5 mm to 9 mm (varies with power)
Colors: 5 mm
Oxygen Transmissibility (Dk/L): 32.2 x 10 to the power of -9 ml O2 cm at 35° C sec ml mm Hg
Light Transmittance
a) Visible (600 nm)≥95%
b) UV (250-400 nm) †
DuraSoft® 3UV with Handling Tint
UVA (315-380 nm) +2.00 0.6, -4.00 4.0, -3.00* 2.3
UVB (280-315 nm) +2.00 3.1, -4.00 10.7, -3.00* 7.3
DuraSoft® 3UV with Carbazole violet in-monomer tint
UVA (315-380 nm) +2.00 0.7, -4.00 2.7, -3.00* 2.9
UVB (280-315 nm) +2.00 1.7, -4.00 5.2, -3.00* 5.6
† The referenced data was determined from "Methods for Determining Ultraviolet Transmission of UV-blocking Contact Lenses," by Dr. H. Faubl, International Contact Lens Clinic, Vol. 25, no.5, 1998.
Representative of the thinnest lens design.
The provided text is a 510(k) Pre-market Notification for contact lenses. It serves to establish substantial equivalence to a predicate device and does not contain information on device performance studies or acceptance criteria in the manner typically found for AI/ML-based diagnostic devices.
Therefore, I cannot extract the requested information regarding acceptance criteria, device performance, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth establishment. This document is a regulatory submission for a medical device (contact lenses), not a report on a clinical study or performance evaluation with statistical metrics for an AI/ML system.
§ 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.