(271 days)
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.
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.
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 Metric | Acceptance Criteria (Implied) | Somryst Performance (UC+SHUTi) - ANU Study (N=574) | Somryst Performance (UC+SHUTi) - UVA Study (N=151) |
|---|---|---|---|
| Insomnia Severity Index (ISI) Score Reduction | Significant 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. |
§ 882.5801 Computerized behavioral therapy device for psychiatric disorders.
(a)
Identification. A computerized behavioral therapy device for psychiatric disorders is a prescription only device intended to provide a computerized version of condition-specific behavioral therapy as an adjunct to clinician supervised outpatient treatment to patients with psychiatric conditions. The digital therapy is intended to provide patients access to therapy tools used during treatment sessions to improve recognized treatment outcomes.(b)
Classification. Class II (special controls). The special controls for this device are:(1) Clinical data must be provided to fulfill the following:
(i) Describe a validated model of behavioral therapy for the psychiatric disorder; and
(ii) Validate the model of behavioral therapy as implemented by the device.
(2) Software must be described in detail in the software requirements specification (SRS) and software design specification (SDS). Software verification, validation, and hazard analysis must be performed. Software documentation must demonstrate that the device effectively implements the behavioral therapy model.
(3) The following labeling must be provided:
(i) Patient and physician labeling must include instructions for use, including images that demonstrate how to interact with the device.
(ii) Patient and physician labeling must list compatible devices.
(iii) Patient and physician labeling must include a warning that the device is not intended for use as a standalone therapy.
(iv) Patient and physician labeling must include a warning that the device does not represent a substitution for the patient's medication.
(v) Physician labeling must include a summary of the clinical testing with the device.