(50 days)
The Saview-Aqua 58 UV (etafilcon A) Visibility Tinted Soft (Hydrophilic) Contact Lens is indicated for daily wear for the correction of refractive ametropia (myopia, hyperopia) in aphakic or not-aphakic persons with non-diseased eyes that may exhibit refractive astigmatism up to 2.00 diopters that does not interfere with visual acuity.
The Saview-Aqua 58 UV Toric (etafilcon A) Visibility Tinted Soft (Hydrophilic) Contact Lens is indicated for daily wear for the correction of refractive ametropia (myopia, hyperopia and astigmatism) in aphakic or not-aphakic persons with non-diseased eyes that may exhibit refractive astigmatism up to 2.50 diopters that does not interfere with visual acuity.
The Saview-Aqua 58 UV Multifocal (etafilcon A) Visibility Tinted Soft (Hydrophilic) Contact Lens is indicated for daily wear for the correction of refractive ametropia (myopia and hyperopia) and presbyopia in aphakic or not-aphakic persons with non-diseased eyes that may exhibit refractive astigmatism up to 2.00 diopters that does not interfere with visual acuity and require add power of up to +3.25 diopters.
The Saview-Aqua 58 UV, Saview-Aqua 58 UV Toric and Saview-Aqua 58 UV Multifocal lenses help protect against transmission of harmful UV radiation to the cornea and into the eye.
The lenses are to be prescribed for single-use daily disposable wear and not intended to be cleaned or disinfected and should be discarded after a single use.
The lens material (etafilcon A) is a hydrophilic polymer of 2-hydroxyethyl methacrylate and methacrylic acid crosslinked with 1, 1, 1-trimethylol propane trimethacrylate. A UV absorbing monomer, 2-[3-(2H-Benzotriazol-2y1)-4hydroxyphenyl]] ethyl methacrylate, is incorporated into the lens polymer and used to block UV radiation. The UV blocker for Saview-Aqua 58 UV (etafilcon A) Visibility tinted Soft (Hydrophilic) Contact Lens averages 85.063 % in the UVA range of 316 nm to 380 nm and 97.984 % in the UVB range of 315 nm to 280 nm. The lens contains 58% water by weight and each lens is supplied sterile in a blister container containing SYS TO.2 % hyaluronic acid polymer in saline solution. The lens is visibility tinted Pigment Blue 15(Copper phthalocyanine) to make the lens more visible for handling.
The Saview-Aqua 58 UV (etafilcon A) Visibility Tinted Soft (Hydrophilic) Contact Lens is available as a single vision lens.
The Saview-Aqua 58 UV Toric (etafilcon A) Visibility Tinted Soft (Hydrophilic) Contact Lens is available in a double slab-off back surface design. The lens design incorporates a cylinder and base curve. From the bi-curve reduced optic front surface, there exists a slab-off of the upper and lower half of the lens. This makes both sides thicker at the horizontal level on the front surface to keep the axis stable.
The Saview-Aqua 58 UV Multifocal (etafilcon A) Visibility Tinted Soft (Hydrophilic) Contact Lens is available as an aspherical multifocal lens.
The provided document is a 510(k) summary for contact lenses and does not describe AI/ML device performance, acceptance criteria, or a study that evaluates such a device. Since the request pertains to AI/ML device performance and related studies, and the document is not about an AI/ML device, I cannot fulfill the request based on the provided text.
The document focuses on the substantial equivalence of new contact lenses to previously approved predicate devices, based on material properties, chemical composition, and non-clinical testing (stability, toxicology, physical/chemical testing). It explicitly states: "Clinical data is not required for this submission."
Therefore, I cannot provide information on:
- A table of acceptance criteria and reported device performance for an AI/ML device.
- Sample sizes for test sets, data provenance, number of experts for ground truth, or adjudication methods for an AI/ML device.
- Multi-reader multi-case (MRMC) comparative effectiveness studies or standalone performance of an AI/ML algorithm.
- Type of ground truth for an AI/ML device.
- Sample size for the training set or how ground truth for the training set was established for an AI/ML device.
§ 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.