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Prescribed for the correction of refractive ametropia (myopia, hyperopia and astigmatism) in aphakic and not-aphakic persons.

Prescribed as a colored filter to aid individuals who experience reading discomfort not related to binocular vision problems or uncorrected refractive error.

Prescribed to enhance color discrimination in patients with protan or deutan (red-green) color vision deficiencies.

The ChromaGen v3.0 Reading Aid & Color Discrimination Enhancement, Spectacle Lenses are prescription spectacles that have been precision coated with varying hue and saturation filters similar to antireflection coatings and colored prescription sunglass coatings that are already included in the prescription spectacle lens classification. ChromaGen v30 Reading Aid & Color Discrimination Enhancement are available in varying hues and saturation levels duplicate of that available in the ChromaGen v30 Reading Aid & Color Discrimination Enhancement, Soft Contact Lenses. The ChromaGen v30 Reading Aid & Color Discrimination Enhancement, Spectacle Lens has been designed for binocular use, and when used in combination, have been shown to be of use for patients experiencing visual discomfort when reading.

The ChromaGen v3.0 Reading Aid & Color Discrimination Enhancement, Spectacle Lens coating/tinting process does not alter the optical and/or performance characteristics of the finished spectacle lens.

Here's an analysis of the provided text regarding the ChromaGen v3.0 Reading Aid & Color Discrimination Enhancement Spectacle Lenses, focusing on acceptance criteria and supporting studies:

1. Table of Acceptance Criteria and Reported Device Performance

The provided 510(k) summary does not explicitly state numerical acceptance criteria for the ChromaGen v3.0 Spectacle Lenses. Instead, the basis for clearance is substantial equivalence to previously cleared predicate devices (ChromaGen v3.0 Reading Aid Soft Contact Lenses (K012132) and ChromaGen v2.0 Color Discrimination Enhancement Soft Contact Lenses (K994320)).

The reported device performance, in this context, is that the ChromaGen v3.0 Spectacle Lenses achieve "Substantially Equivalent" efficacy to the predicate soft contact lenses.

2. Sample Size Used for the Test Set and Data Provenance

• Test Set Sample Size: No new clinical studies were conducted for the ChromaGen v3.0 Spectacle Lenses directly. The submission relies on the efficacy established in the predicate contact lens studies (K994320 & K012132). Therefore, the sample size for a new test set for these spectacle lenses is 0.
• Data Provenance: Not specified within this document for the original predicate studies. However, the applicant is based in England. The 510(k) is submitted to the US FDA. We can infer the predicate studies (K994320 & K012132) were likely either performed in the UK or internationally, and were considered acceptable by the FDA for the previous contact lens clearances. This is a retrospective reliance on previously established data.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications

• Since no new studies were conducted, there were no new experts specifically used to establish ground truth for a new test set for these spectacle lenses. The ground truth for the predicate contact lens studies is not detailed in this 510(k) summary.

4. Adjudication Method for the Test Set

• Not applicable, as no new test set was created or adjudicated for these spectacle lenses.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

• No, an MRMC comparative effectiveness study was not done for the ChromaGen v3.0 Spectacle Lenses. The document explicitly states: "Clinical performance studies are not required for the spectacle version of the ChromaGen v3.0 Reading Aid & Color Discrimination Enhancement product line, as efficacy has been established in K994320 & K012132."
• Effect size of human readers improvement with AI vs. without AI assistance: Not applicable as this is not an AI device, and no MRMC study was performed.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Study was done

• Not applicable. This device is a physical spectacle lens with colored filters and is not an algorithm or AI.

7. The Type of Ground Truth Used

• The ground truth for the efficacy of the predicate contact lenses (which this device relies upon) was established via "Clinical study" as stated repeatedly in the table. The specific type of clinical outcome or assessment used to establish efficacy (e.g., improved reading speed, improved scores on color vision tests, patient-reported outcomes) is not detailed in this 510(k) summary but would have been part of the K994320 and K012132 submissions.

8. The Sample Size for the Training Set

• Not applicable. This device does not involve a "training set" in the context of machine learning or AI algorithms. It is a physical medical device.

9. How the Ground Truth for the Training Set was Established

• Not applicable. As stated above, this device does not utilize a training set.

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The ChromaGen v3.0 Reading Aid Soft Contact Lenses are indicated for daily wear for the correction of refractive ametropia (myopia, hyperopia and astigmatism) in aphakic and not-aphakic persons with non-diseased eyes.

Theses lenses may also be prescribed as a colored filter to aid individuals who experience reading discomfort not related to binocular vision problems or uncorrected refractive error. The lenses are disinfected using a hydrogen peroxide lens care system only and are available in a frequent replacement program.

The ChromaGen v3.0 Reading Aid, Soft Contact Lenses are a range of soft lenses with precision tinted I ho on onlying hue and saturation which, when used in combination, have been shown to be of use for patients experiencing visual discomfort when reading. The ChromaGen v3.0 Reading Aid, 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 encoufacturing 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 color additive on that portion of the anterior (front) surface of the lens that corresponds to the iris.

The ChromaGen color additive effect is formed by reacting one or more of the reactive color additives listed in this paragraph with (poly hydroxyethyl methacrylate). The reactive color additives that may be used in and paragraph with (pation 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 v3.0 Reading Aid, Soft Contact Lenses tinting process does not alter the optical and/or performance characteristics of the finished tinted soft contact lens.

Acceptance Criteria and Study for ChromaGen v3.0 Reading Aid Soft Contact Lens

This response details the acceptance criteria and the study conducted to demonstrate the effectiveness of the ChromaGen v3.0 Reading Aid Soft Contact Lens, based on the provided 510(k) summary.

1. Acceptance Criteria and Reported Device Performance

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