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510(k) Data Aggregation

    K Number
    K233872
    Device Name
    Daylight
    Manufacturer
    Big Health, Inc.
    Date Cleared
    2024-08-30

    (267 days)

    Product Code
    SCP,DAY
    Regulation Number
    882.5801
    Type
    Traditional
    Panel
    Neurology
    Reference & Predicate Devices
    K191716
    Why did this record match?
    Product Code :

    SCP

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

    Daylight is a prescription device delivering Cognitive Behavioral Therapy and can be made available on the order of a licensed healthcare provider. Daylight is a digital therapeutic intended to treat generalized anxiety disorder (GAD) by improving a patient's GAD symptoms as an adjunct to usual care in patients aged 22 years and older.

    Device Description

    Daylight is a digital therapeutic designed to address the symptoms of adults with generalized anxiety disorder (GAD) through the use of Cognitive Behavioral Therapy (CBT) techniques. The Daylight program is has been demonstrated to help improve symptoms of GAD, if followed correctly, and is supported by evidence from peer-reviewed studies and clinical trials. The program is delivered digitally through the Daylight iOS/Android apps, giving users easy access to effective techniques.

    AI/ML Overview

    The document provided focuses on asserting the substantial equivalence of the Daylight device to a predicate device (Somryst) for regulatory clearance, primarily based on the similarity of their intended use, technological characteristics, and a clinical study demonstrating the efficacy of Daylight for its specific indication (Generalized Anxiety Disorder).

    This type of submission document (510(k) Summary) does not typically contain detailed information about specific acceptance criteria for device performance in the same way one might describe the performance of a diagnostic AI algorithm against a set of quantitative metrics. Instead, "acceptance criteria" here refer to the overall regulatory requirements for establishing substantial equivalence and demonstrating safety and effectiveness for a digital therapeutic. The primary "proof" of the device meeting these criteria is via the clinical trial results.

    Below is an interpretation of "acceptance criteria" in the context of this 510(k) and the information provided to substantiate that the device meets these criteria.

    Acceptance Criteria and Device Performance for Daylight

    Based on the 510(k) summary, the "acceptance criteria" are implicitly tied to demonstrating safety and effectiveness for the device's intended use and establishing substantial equivalence to a predicate device. For a digital therapeutic, effectiveness is primarily demonstrated through clinical outcomes.

    1. Table of Acceptance Criteria and Reported Device Performance

    Given the nature of the device (a digital therapeutic delivering CBT for GAD), the acceptance criteria are not in the form of typical quantitative performance metrics like sensitivity/specificity for a diagnostic device. Instead, they relate to:

    • Clinical Efficacy: Improvement in GAD symptoms.
    • Safety: Acceptable adverse event profile.
    • Substantial Equivalence: Alignment with predicate device in terms of intended use, technology, and risk profile.
    Acceptance Criterion (Implicit)Reported Device Performance (from GATE Trial)
    Primary Efficacy Endpoints:
    1. Remission based on CGI-I scores of 1 or 2 (co-primary)Week 10:
    Daylight: 71% remission (n=103)
    Psychoeducation Control: 35% remission (n=54)
    **Odds Ratio (OR): 4.63; p **Adjusted Difference: 3.42 (2.50, 4.34), Cohen's d: 1.04, p **Adjusted Difference: 3.58 (2.66, 4.50), Cohen's d: 1.09, p **Adjusted Difference: 3.15 (2.21, 4.09), Cohen's d: 0.96, p
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