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510(k) Data Aggregation

    K Number
    K012132
    Device Name
    CHROMAGEN V3.0 READING AID SOFT CONTACT LENS
    Manufacturer
    CANTOR & NISSEL LTD.
    Date Cleared
    2002-05-09

    (304 days)

    Product Code
    NIC
    Regulation Number
    886.5925
    Type
    Traditional
    Panel
    Ophthalmic
    Reference & Predicate Devices
    K990757,K994320
    Predicate For
    K022373
    Why did this record match?
    Reference Devices :

    K990757, K994320

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    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.

    Device Description

    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.

    AI/ML Overview

    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

    Acceptance CriteriaReported Device PerformanceMetric
    Subjective preference for ChromaGen lenses over placebo lenses72.5% of subjects preferred ChromaGen lenses to placebo lenses (29 out of 40 subjects who expressed an opinion)Percentage
    Improved "ease of reading" with ChromaGen lenses compared to placebo lensesMedian "ease of reading" grading was 7.0 for ChromaGen lenses vs. 4.5 for placebo lenses (on a scale from -10 to +10)Median Score
    Statistical significance of improved "ease of reading"p-value < 0.001 (Wilcoxon analysis)p-value

    2. Sample Size and Data Provenance

    • Sample Size for Test Set: 47 subjects completed the study. (53 subjects initially entered, but 6 were excluded from the analysis for not providing an opinion on lens preference)
    • Data Provenance: The document does not explicitly state the country of origin. The study was conducted by Cantor & Nissel Limited, an English company, implying the data likely originated from the UK. The study was prospective, as it involved recruiting subjects and conducting new tests.

    3. Number and Qualifications of Experts for Ground Truth

    • The study did not use experts to establish ground truth in the traditional sense of diagnostic accuracy.
    • The ground truth was based on the subjective experience of the participants, who were asked to grade their own "ease of reading" and express their preference between lenses.

    4. Adjudication Method

    • None. There was no adjudication method described. The outcome was based on individual subjective reports from the participants.

    5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

    • No, a multi-reader multi-case (MRMC) comparative effectiveness study was not conducted. This study focused on the subjective experience of individual users with and without the device.

    6. Standalone (Algorithm Only) Performance Study

    • Not applicable. The ChromaGen v3.0 Reading Aid Soft Contact Lens is a physical device (tinted contact lens), not an algorithm or AI system. Therefore, a standalone algorithm performance study was not performed.

    7. Type of Ground Truth Used

    • Subjective Patient Self-Report / Patient Reported Outcomes (PROs): The ground truth was based on the participants' subjective grading of "ease of reading" and their expressed preference between the ChromaGen lenses and placebo lenses.

    8. Sample Size for Training Set

    • Not applicable. This device is a physical product (tinted contact lens) and does not involve a "training set" in the context of machine learning or algorithms. The clinical study evaluated the device's performance in a test set of patients.

    9. How Ground Truth for Training Set Was Established

    • Not applicable, as there was no training set for this device.
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