Search Results

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.

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.

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.

Ask a specific question about this device

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

Ask a specific question about this device