(55 days)
The HD (polymacon) Aspheric Soft Contact Lenses for daily wear are indicated for the correction of visual acuity in aphakic and not aphakic persons with non-diseased eyes with myopia or hyperopia. The lens may be worn by persons who exhibit refractive astigmatism of 1.50 diopters or less where the astigmatism does not interfere with visual acuity. The lens is available clear or tinted and may be used to enhance or alter the apparent color of the eye.
The HDT (polymacon) Aspheric Toric Soft Contact Lenses for daily wear are indicated for the correction of visual acuity in not aphakic persons with non-diseased eyes with myopia or hyperopia and/or possesses refractive astigmatism not exceeding 5.00 diopters. The lens is available clear or tinted and may be used to enhance or alter the apparent color of the eye.
The PV (polymacon) Multifocal Soft Contact Lenses for daily wear are indicated for the correction of visual acuity in not aphakic persons with non-diseased eyes with myopia or hyperopia and are presbyonic. The lens may be worn by persons who exhibit refractive astigmatism of 1.50 diopters or less where the astigmatism does not interfere with visual acuity. The lens is available clear or tinted and may be used to enhance or alter the apparent color of the eye.
The PVT (polymacon) Multi-Aspheric Toric Multifocal Soft Contact Lenses for daily wear are indicated for the correction of visual acuity in not aphakic persons with non-diseased eyes with myopia or hyperopia, possesses refractive astigmatism not exceeding 5.00 diopters and are presbyopic. The lens is available clear or tinted and may be used to enhance or alter the apparent color of the eye.
Eyecare practitioners may prescribe any of the above lenses for frequent/planned replacement wear, with cleaning disinfection and scheduled replacement. When prescribed for frequent/planned replacement wear, the lens may be disinfected using a chemical disinfecting system.
The HD/HDT, PV/PVT (polymacon) Soft Contact Lenses are hemispherical shells with molded spherical base curves and molded front surfaces.
The nonionic lens material, (polymacon) is a hydrophilic polymer of 2- Hydroxyethyl methacrylate (2-HEMA) and cross-linked with ethylene glycol dimethacrylate (EGDMA), plus an initiator. The co-I his consists of 62% polymacon and 38% water by weight when immersed in normal buffered saline solution. The lenses are available clear or tinted. Lenses that contain a unique timing pattern are subsequently processed to incorporate the 'listed' color additives and contain only the amount of color subsequently processed to morporate and noloring effect. Lenses are tinted with one or a combination of one or more of the following pigments, 'listed' color additives.
Phthalocyanine blue (21 CFR § 74.3045), Phthalocyanine green (21 CFR § 73.3124) and Titanium dioxide (21 CFR § 73.3126)
In the hydrated state, the lens conforms to the curvature of the eye covering the cornea and extending slightly beyond the limbus forming a transparent optical surface. The (polymacon) soft hydrophilic sugary ocyone the minous coming a ace. The hydrophilic properties of the lens require that it be maintained in a fully hydrated state in a solution compatible with the eye. If the lens dries out, it will mannualios in a rany arguited warped however, it will return to its proper configuration when completely rehydrated in the proper storage solution.
The provided document is a 510(k) Premarket Notification for soft contact lenses. It does not describe an AI medical device or a study involving acceptance criteria for such a device. Instead, it focuses on demonstrating substantial equivalence to predicate devices for regulatory approval. Therefore, it does not contain the information requested in the prompt related to AI device performance and studies.
Specifically, the document includes:
- A table of substantial equivalence attributes for the subject device and predicate devices (manufacturing, indication, intended use, manufacturing method, material name, water content, toxicity). This is not an acceptance criteria and reported device performance table for an AI device.
- No sample sizes for test or training sets are mentioned, as this is not a study assessing AI performance.
- No information on experts for ground truth establishment or adjudication methods.
- No multi-reader multi-case (MRMC) comparative effectiveness study is discussed.
- No standalone (algorithm only) performance is provided.
- No ground truth type is discussed in the context of an AI device.
The document is a regulatory submission for contact lenses, not an evaluation of an AI-powered diagnostic or assistive tool.
§ 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.