(272 days)
Sleepio is a digital therapeutic intended for the treatment of chronic insomnia disorder as an adjunct to usual care in patients aged 18 and older. Sleepio is a prescription device delivering Cognitive Behavioral Therapy for Insomnia (CBT-I) and can be made available on the order of a licensed healthcare provider.
Sleepio is a digital therapeutic for the treatment of chronic insomnia / insomnia disorder. Sleepio treats chronic insomnia disorder by delivering evidence-based techniques targeting the cognitive and behavioral factors that maintain insomnia and chronic sleep problems. Patient experience is tailored based on symptoms and daily sleep tracking. In addition to core therapeutic components, there is in-the-moment therapeutic content for help falling asleep. Content is delivered via smartphone and tablet applications (iOS and Android), as well as via web. Sleepio is intended as an adjunct to usual care treatment for chronic insomnia / insomnia disorder by a healthcare provider. Healthcare providers have access to a dashboard to track patient engagement with Sleepio.
Based on the provided text, the device in question is Sleepio, a digital therapeutic for the treatment of chronic insomnia disorder. Here's a breakdown of the acceptance criteria and the study proving the device meets them:
Disclaimer: The provided document is an FDA 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device rather than setting explicit acceptance criteria for this specific device's performance in a new, de novo fashion. The clinical data presented serves to support the substantial equivalence claim by showing similar or superior performance to standard care (Sleep Hygiene Education, SHE) and implicitly, to the predicate. Therefore, the "acceptance criteria" table below is inferred from the goals of the clinical study and the claims made about the device's efficacy in the context of demonstrating substantial equivalence for an FDA 510(k) submission.
1. Table of inferred acceptance criteria and the reported device performance
| Acceptance Criteria Category (Inferred) | Specific Criterion (Inferred from study outcomes) | Reported Device Performance and Comparison (Sleepio vs. SHE) |
|---|---|---|
| Primary Endpoints (Co-Primary) | ||
| Insomnia Severity Index (ISI) Improvement | Significant reduction in ISI score compared to control (SHE). | Week 10: Sleepio ISI was 12.11 (SD 6.10) vs SHE ISI 14.74 (SD 5.00). Adjusted difference: -2.37 (SE 0.56) (99% CI: -3.81, -0.92), p |
§ 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.