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    K Number
    K191716
    Device Name
    Somryst
    Manufacturer
    Pear Therapeutics, Inc.
    Date Cleared
    2020-03-23

    (271 days)

    Product Code
    QVO,PWE
    Regulation Number
    882.5801
    Type
    Traditional
    Panel
    Neurology
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    Somryst

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

    Somryst is a prescription-only digital therapeutic intended to provide a neurobehavioral intervention (Cognitive Behavioral Therapy for Insomnia - CBT-I) in patients 22 years of age and older with chromic insomnia. Somryst treats chronic insomnia by improving a patient's insomnia symptoms.

    Device Description

    Somryst is a 9-week prescription digital therapeutic (computerized behavioral therapy) used in the treatment of chronic insomnia. Somryst is based on principles of Cognitive Behavioral Therapy (CBT) for Insomnia, Sleep Restriction, and other proven psychosocial treatment elements, which are delivered in a sequence of "cores" of patient education, training and skill building. The therapy is delivered via a mobile application intended to be used on a patient's mobile device and consists of text, video, animation and graphics. Clinicians, as part of a patient's general treatment program, have access to a clinician dashboard that shows patient utilization and engagement with the application.

    AI/ML Overview

    Here's an analysis of the acceptance criteria and the studies that prove Somryst meets these criteria, based on the provided document:

    1. Table of Acceptance Criteria and Reported Device Performance

    The FDA clearance document for Somryst does not explicitly list "acceptance criteria" in a typical quantitative pass/fail format with predefined thresholds for performance metrics. Instead, it demonstrates the device's efficacy by comparing its performance to a control group in several clinical studies. The implicit acceptance criterion is that Somryst should significantly improve insomnia symptoms compared to usual care or a control.

    Below is a summary of the reported device performance from the two principal clinical studies, showing the statistically significant improvements.

    Performance MetricAcceptance Criteria (Implied)Somryst Performance (UC+SHUTi) - ANU Study (N=574)Somryst Performance (UC+SHUTi) - UVA Study (N=151)
    Insomnia Severity Index (ISI) Score ReductionSignificant reduction in ISI compared to control group.Week 9: LS Mean change of -8.63 vs. -2.85 for control (LS Mean Difference: -5.78; p=7-point reduction)Significantly higher proportion of responders than control.
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