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510(k) Data Aggregation

    K Number
    K220090
    Device Name
    Visibly Digital Acuity Product
    Manufacturer
    Visibly, Inc.
    Date Cleared
    2022-08-12

    (213 days)

    Product Code
    QTO,OTO
    Regulation Number
    886.1150
    Type
    Traditional
    Panel
    Ophthalmic
    Reference & Predicate Devices
    K113402,K143211,K100095
    Why did this record match?
    Reference Devices :

    K113402, K143211

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

    The Visibly Digital Acuity Product (VDAP) is a web-based, self-quided software application intended for use by adults, ages 22 to 40, who have the capability to perform a self-test at home, to aid in the evaluation of visual acuity with or without correction. The software allows users to view and respond to displayed optotypes and uses the responses to categorize a patient's visual acuity into one of two categories, with an individual output for each eye:

    • . TRUE - visual acuity that is consistent with normal vision
    • FALSE visual acuity that is not consistent with normal vision .
      The Visibly Digital Acuity Product recommendations are intended to be supportive recommendations that will be used by an eye care provider, along with the patient's medical history and profile, prior corrective evewear prescriptions, and subjective vision data. The Visibly Digital Acuity Product does not provide screening or diagnosis of eye health or other disease, nor is it intended to replace an in-person eye exam.
    Device Description

    The Visibly Digital Acuity Product is a web-based, software application intended for use by adults, at home, to aid in the evaluation of visual acuity with or without correction. The standalone software application allows the user to interface with the software via a web browser on two internet-enabled devices:

    • A computer screen (the Display) which displays optotypes. O
    • A touchscreen mobile device (the Remote) which operates as a remote control and o interface for the user to respond to prompts related to the optotypes appearing on the Display while standing 10 feet away.
      The software allows users to view and respond to displayed optotypes and uses the responses to categorize a user's vision acuity into one of two buckets: (1) TRUE - visual acuity that is consistent with normal vision (2) FALSE - visual acuity that is not consistent with normal vision.
    AI/ML Overview

    Here's a breakdown of the acceptance criteria and the study proving the Visibly Digital Acuity Product (VDAP) meets them, based on the provided FDA 510(k) summary:

    1. Table of Acceptance Criteria and Reported Device Performance

    The acceptance criteria are implied by the primary and secondary endpoints described in the "Performance Data" section. There aren't explicit numeric acceptance criteria stated for all metrics (e.g., sensitivity, specificity), but a performance goal is given for reproducibility.

    Metric (Endpoint)Acceptance Criteria/Performance GoalReported Device Performance (Pooled Study Eye and Non-Study Eye)
    Primary Agreement Endpoints
    Positive Predictive Value (PPV)Not explicitly stated, implied to be high for substantial equivalence95.8% (95% CI: 93.6% - 97.6%)
    Negative Predictive Value (NPV)Not explicitly stated, implied to be high for substantial equivalence49.1% (95% CI: 40.0% - 58.1%)
    SensitivityNot explicitly stated, implied to be high for substantial equivalence85.5% (95% CI: 81.9% - 88.9%)
    SpecificityNot explicitly stated, implied to be high for substantial equivalence78.8% (95% CI: 69.1% - 87.6%)
    Primary Reproducibility Endpoint
    Reproducibility (Proportion of study eyes with matching VDAP VA classifications for two VDAP tests)Performance goal of 75%89.3% (95% CI: 85.9% - 92.6%) (p-value
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