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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

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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.

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