(303 days)
The ChromaGen v2.0 Haploscopic System & Color Discrimination Enhancement Soft Contact Lenses are indicated for daily wear to enhance color discrimination in patients with protan or deutan (red-green) color vision deficiencies. The lens may also be prescribed for the correction of refractive ametropia (myopia, hyperopia and astigmatism) in aphakic and not aphakic persons with non-diseased eyes. The lenses are disinfected using a hydrogen peroxide lens care system only and are available in a frequent replacement program.
The ChromaGen v2.0 Color Discrimination Enhancement filters are designed specifically to improve discrimination between colors that are normally confused by people with protan or deutan (red-green) color vision deficiencies. The ChromaGen v20 Color Discrimination Enhancement Soft Contact Lenses are a range of soft contact lenses with precision tinted pupils of varying hue and saturation which, when used monocular and binocularly, have been shown to be of use in patients with defective color vision. Use of this product may enhance the discrimination of certain colors and may reduce the discrimination of certain colors. This device in not a cure for color vision deficiencies or colorblindness. The ChromaGen v2.0 Color Discrimination Enhancement Soft Contact Lenses are tinted with FDA "listed" color additives. The color additives are used in amounts not to exceed the minimum reasonably required to accomplish the intended coloring effect. As part of the manufacturing process, the lens containing the color additives are thoroughly washed to remove unbound reactive color additives. The manufacturing process alters and/or changes the specifications to the clear version of a contact lens by affixing a listed reactive on that portion of the anterior (front) surface of the lens that corresponds to the iris. The ChromaGen v2.0 Color Discrimination Enhancement Soft Contact Lenses are tinted to the eyecare professional instructions. The ChromaGen color additive effect is formed by reacting one or more of the reactive color additives listed in this paragraph with (poly hydroxyethy) methacrylate). The reactive color additives that may be used either alone or in combination are: reactive black 5, reactive blue 21, reactive blue 19, reactive blue 4, reactive blue 163, reactive red 11, reactive red 180, reactive yellow 15, reactive yellow 86, or reactive orange 78. The color additives used are not removed by lens handling or approved cleaning/disinfecting procedures. The ChromaGen v2.0 Haploscopic System & Color Discrimination Enhancement Soft Contact Lenses tinting process does not alter the optical and/or performance characteristics of the finished tinted soft contact lens.
The provided text is a 510(k) summary for the "ChromaGen v2.0 Haploscopic System & Color Discrimination Enhancement Soft Contact Lens". It focuses on establishing substantial equivalence to previously marketed devices rather than presenting a performance study with acceptance criteria and a detailed study report for the device itself.
Therefore, much of the requested information (acceptance criteria, reported device performance, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, training set details, and ground truth establishment for a performance study) is not available in the provided document.
The document primarily describes the device's characteristics and compares them to predicate devices, focusing on materials, manufacturing, intended use, and general safety aspects (like color additives). It does not contain a study designed to quantify the "enhancement of color discrimination" with specific metrics against defined acceptance criteria.
However, I can extract the available information:
- Device Name: ChromaGen v2.0 Haploscopic System & Color Discrimination Enhancement Soft Contact Lens
- Intended Use: To enhance color discrimination in patients with protan or deutan (red-green) color vision deficiencies. The lens may also be prescribed for the correction of refractive ametropia (myopia, hyperopia, and astigmatism) in aphakic and non-aphakic persons with non-diseased eyes.
Not Applicable/Not Provided due to the nature of the 510(k) summary:
- A table of acceptance criteria and the reported device performance: This information is not present. The 510(k) summary is for substantial equivalence, not a performance study against acceptance criteria.
- Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): No specific test set or study data is presented to evaluate clinical performance.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, as no clinical performance study is detailed with a test set and ground truth establishment.
- Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This device is not an AI-powered diagnostic tool; it's a contact lens.
- If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable, as no clinical performance study for color discrimination enhancement is described with a ground truth methodology. The document mentions improvement in discrimination based on the design of the filters and previous device history.
- The sample size for the training set: Not applicable, as this is not an AI/algorithm-based device requiring a training set.
- How the ground truth for the training set was established: Not applicable.
§ 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.