LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K984219
    Device Name
    COLORMAX COLOR VISION ENHANCEMENT LENSES
    Manufacturer
    COLOR VISION TECHNOLOGIES, INC.
    Date Cleared
    1999-11-18

    (358 days)

    Product Code
    NAI
    Regulation Number
    886.5844
    Type
    Traditional
    Panel
    Ophthalmic
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Product Code :

    NAI

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

    ColorMax Lenses are indicated for use as an optical aid for Deutan and Protan color vision deficiencies.

    Device Description

    ColorMax Lenses are colored prescription spectacle lenses that are designed to aid color discrimination performance for those with Deutan and Protan color vision deficiencies. ColorMax Lenses are designed for binocular use. Use of this product may enhance the discrimination of certain colors and may reduce the discrimination of certain colors. This product is not a cure for color vision deficiencies or colorblindness.

    AI/ML Overview

    Here's an analysis of the provided information regarding the acceptance criteria and study for the ColorMax Lens, structured as requested:

    Acceptance Criteria and Study for ColorMax Lens (K984219)

    1. Table of Acceptance Criteria and Reported Device Performance

    Acceptance CriteriaReported Device Performance
    Improvement in color discrimination performance for Deutan and Protan color vision deficiencies.Clinical performance studies with the Farnsworth Panel D-15 color vision test demonstrated effectiveness by showing that ColorMax Lenses enable red-green color deficient subjects to distinguish between their usual confusion colors.
    Potential risks associated with altered color discrimination are comparable to other tinted prescription spectacle lenses (e.g., colored prescription sunglasses).Implicit: The FDA's substantial equivalence determination implies that the risks were deemed acceptable and comparable to predicate devices. No specific quantitative risk assessment is provided in the summary.

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

    • Sample Size: Not explicitly stated. The document mentions "red-green color deficient subjects" in the plural, but provides no specific number.
    • Data Provenance: Not explicitly stated. However, given the context of a US FDA submission, it is highly probable the data was collected in the United States. The study is described as "clinical performance studies," suggesting a prospective nature, although this is not explicitly confirmed.

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

    • Number of Experts: Not specified.
    • Qualifications of Experts: Not specified. The study relied on the Farnsworth Panel D-15 color vision test, which has established methods for interpreting results. It's therefore more about the standardized interpretation of a test result rather than expert consensus on individual cases.

    4. Adjudication Method for the Test Set

    • Adjudication Method: Not applicable or not specified. The Farnsworth Panel D-15 test is a standard color vision test with objective scoring based on the arrangement of color caps by the subject. Ground truth is derived directly from the test's protocol, not from expert adjudication of subjective assessments.

    5. 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

    • MRMC Study: No. This device is a physical optical aid, not an AI-powered diagnostic or assistive tool for human readers/analysts. Therefore, an MRMC study comparing human readers with and without AI assistance is not relevant to this device.

    6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

    • Standalone Performance: Not applicable. The ColorMax Lens is a passive optical device, not an algorithm. Its performance is evaluated through its direct effect on human visual perception when wearing the lenses, hence "human-in-the-loop" is its primary mode of operation.

    7. The Type of Ground Truth Used

    • Type of Ground Truth: The ground truth for effectiveness was established using the Farnsworth Panel D-15 color vision test. This test objectively measures a subject's ability to discriminate between specific colors, providing a quantifiable measure of color vision deficiency and the device's impact on it. The "ground truth" here is the objective performance on a standardized test designed to assess color discrimination.

    8. The Sample Size for the Training Set

    • Sample Size for Training Set: Not applicable. This document describes a medical device submission, not a machine learning model. There is no concept of a "training set" in the context of the ColorMax Lens. The development of the lens itself would have involved optical engineering and material science, likely iterative design and testing, but not a data-driven training set in the AI sense.

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

    • How Ground Truth for Training Set Was Established: Not applicable, as there is no "training set" for this optical device.
    Ask a Question

    Ask a specific question about this device

    Page 1 of 1