(396 days)
The VISCO Soft (Hydrophilic) Contact Lenses is indicated for the correction of refractive ametropia (myopia and hyperopia) in phakic or aphakic persons with non-diseased eyes who exhibit refractive astigmatism of 2.00D or less where the astigmatism does not interfere with visual acuity. Eyecare practitioners may prescribe the lens for either single-use disposable wear, or for frequent/planned replacement wear, with cleaning, disinfection, and scheduled replacement. When prescribed for frequent replacement, the lens may be disinfected using a chemical disinfection system only. The VISCO Soft (Hydrophilic) Contact Lenses help protect against transmission of harmful UV radiation to the cornea and into the eye.
The VISCO Soft Contact Lens is a spherical lens with UV blocker. The VISCO Soft Contact Lens is available in hemispherical shell. The lens material is a silicon combination hydrogel. It is a copolymer of 1-vinyl-2-pyrrolidinone (NVP) and Siloxane macromer. The water content is 47%. The VISCO Soft Contact Lens is light blue tinted with "reactive Blue19" for handling visibility purpose. A benzotriazole UV absorbing monomer is used to block UV radiation. The transmittance characteristics are less than 5% (1.1%) in the UVB range of 280-315nm and less than 50% (9.4%) in the UVA range of 316-380nm. The lens is supplied in a sterile state, packaged in a buffered saline solution.
The provided document describes the Visco Soft Contact Lens and its substantial equivalence to a predicate device. However, it does not contain a detailed study report with acceptance criteria for device performance in the context of an AI/ML algorithm. Instead, it focuses on the physicochemical and mechanical properties of the contact lens.
Therefore, many of the requested details regarding AI/ML study design, such as sample size for test/training sets, data provenance, expert ground truth, adjudication methods, and MRMC studies, are not applicable to this document.
Here's an analysis based on the information available:
1. A table of acceptance criteria and the reported device performance
The document does not specify formal "acceptance criteria" in the context of an AI/ML device performance study with specific metrics like sensitivity, specificity, or AUC. Instead, it presents a comparison of the physical and mechanical properties of the Visco Soft Contact Lens to a predicate device. The performance is assessed by showing that these properties are comparable.
| Characteristic | Visco Soft Contact Lens Performance | Predicate Device (BIOFINITY) Performance | Comment |
|---|---|---|---|
| Physicochemical: | |||
| Water Content | 47% | 48% | Similar |
| Oxygen Permeability (Dk) | 150 (Fatt method) | 128 (Fatt method) | Higher Dk for Visco (indicating potentially better oxygen transmission) |
| Refractive Index | 1.410 | 1.40 | Similar |
| Light Transmittance | 94% | >97% | Slightly lower, but still high. The document states it is for handling visibility and UV blocking, which has stricter criteria as below. The UV transmittance values are 1.1% in UVB and 9.4% in UVA, which are below the 5% and 50% benchmarks. |
| Mechanical Strength: | |||
| Tensile strength (Mpa) | $0.55 \pm 0.06$ | $0.50 \pm 0.07$ | Comparable |
| Modulus (Mpa) | $0.59 \pm 0.05$ | $0.8 \pm 0.1$ | Visco has a lower modulus, implying it is softer than the predicate. This feature is a subjective measure, and not a criteria as such. |
| Elongation at break (%) | $106 \pm 5$ | $130 \pm 2$ | Lower elongation at break than the predicate. This feature is a subjective measure, and not a criteria as such. |
| Toughness (J/m³) | $0.26 \pm 0.02$ | Not reported | Compare to Frequency 55: 0.38. Visco is less tough than Frequency 55. This feature is a subjective measure, and not a criteria as such. |
| UV Blocking: | Not explicitly detailed |
§ 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.