(127 days)
The OPTIMUM GP (roflufocon A, roflufocon B, roflufocon D, and roflufocon D, and rother competition I he OPT I MUM GF (fonulocon A, ronaloon D, ronis is indicated for daily wear for the correction of Spherical Rigid Cas Femicable (NOF) Connect roll it in in-diseased eyes with myopia of hyperopia. The lens may be disinfected with a chemical disinfection system only.
The OPTIMUM GP (roflufocon A, roflufocon B, roflufocon C, roflufocon D, and roflufocon E) Toric Rigid Gas Permeable (RGP) Contact Lens is indicated for daily wear for the correction of visual 1 orie Rigid Gas Penneable (KOT) Condict Dons is insectives with myopia or hyperopia and/or possesses refractive astigmatism not exceeding 10.00 diopters. The lens may be disinfected with a chemical disinfection system only.
The OPTIMUM GP (roflufocon A, roflufocon B, roflufocon C, roflufocon D, and rother man the the The OF I Invitified Rigid Gas Permeable (RGP) Contact Lens is indicated for daily wear for the Munitional Mitocal Night Oas I cimically (1627) okic persons with non-diseased eyes with myopia or correction of visual actiry in apliatio and now tipm not exceeding 4 diopters and are presbyopic requiring liyferopia antivor possesses retraorre antegramar be disinfected with a chemical disinfection system only.
The OPTIMUM GP (roflufocon A, roflufocon B, roflufocon D, and roflufocon D, and roflufocon E) The OF TIMOM Of (Romatooon 14, romalovon act Lens is indicated for daily wear for promoted by atten Keratoconus management with otherwise non-diseased eyes. The lens may also be prescribed for the Correction of refractive ametropia (myopia, hyperopia and astigmatism) in aphakic and not aphakic persons. The lens may be disinfected with a chemical disinfection system only.
Eyecare practitioners may prescribe the lenses for frequent/planned replacement wear, with cleaning, disinfection and scheduled replacement. When prescribed for frequent/planned replacement wear, the lens may be cleaned and disinfected using a chemical (not heat) lens care system.
The OPTIMUM GP series of contact lenses are fabricated from the hydrophobic contact lens materials (roflufocon A), (roflufocon B), (roflufocon C), (roflufocon D), & (roflufocon E). When place on the eye, the lens acts as a refracting medium to focus light rays upon the retina.
The OPTIMUM GP Contact Lens for Daily Wear are available as lathe cut contact lenses with spherical, aspheric, bifocal, multifocal or toric anterior and/or posterior designs in clear and tinted versions.
The OPTIMUM GP Contact Lens for Daily Wear is a rigid gas permeable methacrylate copolymer of Methacrylaxypropyl Methyl methacrylate, 1,1,1,3,3,3 - Hexandovosoprops inc. L. 3,3-tectakis(trimethyl siloxy)disiloxane, 2Tris(trimethylsiloxy) silane, 1,3-bis(methacryloxypropy))-1,1,3,3-tec Tris(trimethylslloxy) shalle, 1,3-bls(includer).com/propy.com/props/inked with Ethylene Glycol Dimethacrylate.
The OPTIMUM GP Contact Lens for Daily Wear incorporates a visibility tint to make the lens more visible for handling. The tinted lenses contain one of the following color additives: D&C Green No.6, C.I. Solvent yellow No. 18, and FD&C Red No. 17.
In the OPTIMUM GP Contact Least Collections of All Justhershappenhenene . The JV to block UV radiation. The UV Blocker is 2,2 - Dihydroxy-4,4 "dimethoxybenzophenone. The UV to block UV radiation. The UV Blocker is 2,2 - Dibydroxy-4,4 "dimethoxy" (21 for to block UV radiation. The UV Blocker is 2,2 -Darydoxy ", Fennances - 1, 1 - 1 blocking for OPTIMUM GP averages > 98% in the UVB range of 280mm - 315mm and 95% in the UVA range of 316 - 380nm.
The provided text describes the 510(k) summary for the OPTIMUM GP Rigid Gas Permeable Contact Lens, but it does not contain information about an AI/ML device or a study proving its acceptance criteria in the context of an AI-powered medical device.
The document pertains to a physical medical device (contact lenses) and its safety and efficacy are demonstrated through preclinical testing (toxicology, packaging, shelf life, solution compatibility) and clinical testing on human subjects, rather than through an AI/ML model's performance metrics.
Therefore, I cannot fulfill the request to provide information based on your numbered criteria (1-9) as they are tailored for AI/ML device evaluations and are not applicable to the content provided. The document does not discuss acceptance criteria or studies related to AI performance, sample sizes for AI test/training sets, expert ground truth, adjudication methods, MRMC studies, or standalone algorithm performance.
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§ 886.5916 Rigid gas permeable contact lens.
(a)
Identification. A rigid gas permeable contact lens is a device intended to be worn directly against the cornea of the eye to correct vision conditions. The device is made of various materials, such as cellulose acetate butyrate, polyacrylate-silicone, or silicone elastomers, whose main polymer molecules generally do not absorb or attract 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.