(267 days)
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.
| Acceptance Criterion (Implicit) | Reported Device Performance (from GATE Trial) |
|---|---|
| Primary Efficacy Endpoints: | |
| 1. Remission based on CGI-I scores of 1 or 2 (co-primary) | Week 10: |
| Daylight: 71% remission (n=103) | |
| Psychoeducation Control: 35% remission (n=54) | |
| **Odds Ratio (OR): 4.63; p **Adjusted Difference: 3.42 (2.50, 4.34), Cohen's d: 1.04, p **Adjusted Difference: 3.58 (2.66, 4.50), Cohen's d: 1.09, p **Adjusted Difference: 3.15 (2.21, 4.09), Cohen's d: 0.96, 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.