(374 days)
reSET-O™ is intended to increase retention of patients with opioid use disorder (OUD) in outpatient treatment by providing cognitive behavioral therapy, as an adjunct to outpatient that includes transmucosal buprenorphine and contingency management, for patients 18 years or older who are currently under the supervision of a clinician. reSET-O is indicated as a prescription-only digital therapeutic.
reSET-O™ is a 12-week interval prescription digital therapeutic for Opioid Use Disorder (OUD). reSET-O™ is modeled on the Community Reinforcement Approach (CRA) and engineered to deliver behavioral therapy for patients with OUD. reSET-O™ delivers CRA therapy as a series of interactive therapy lessons. Each therapy lesson is comprised of a cognitive behavioral therapy component and skill building exercises. Therapy lesson content is delivered primarily via text or audio, and may include videos, animations and graphics.
reSET-O™ is intended as an adjunct to standard of care for patients with OUD. It is limited to persons with a valid prescription from their licensed provider. reSET-O™ supports clinician-patient communication between visits, by providing a means for patients to self-report cravings and triggers, and buprenorphine use/non-use. reSET-O™ reinforces the importance of using buprenorphine for treatment of OUD.
Acceptance Criteria and Study for reSET-O
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Increase patient retention in outpatient treatment | Dropout rate in TES (reSET-O) group was 17.6% compared to 31.6% in the TAU group (p value 0.0224), demonstrating a significant reduction in treatment dropout. |
Note: While the study also evaluated abstinence, it was stated that "The ability of reSET-O to improve abstinence has not been established as clinically significant." Therefore, enhanced abstinence is not listed as an acceptance criterion met by the device.
2. Sample Size and Data Provenance
- Sample Size for Test Set: 170 patients
- Data Provenance: The document does not explicitly state the country of origin. The study was a randomized clinical trial, indicating a prospective study design.
3. Number of Experts and Qualifications for Ground Truth
The document does not provide information on the number of experts used to establish ground truth or their specific qualifications for the test set. The ground truth appears to be based on the clinical trial outcomes (dropout rates, abstinence) rather than expert consensus on individual cases.
4. Adjudication Method for the Test Set
The document does not describe an adjudication method for the test set. The outcomes (dropout and abstinence) were measured directly during the randomized clinical trial.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not explicitly described in the provided text. The study design was a randomized controlled trial comparing the reSET-O device (referred to as TES) plus Treatment As Usual (TAU) against TAU alone. This is a direct comparison of a treatment arm with the device versus a control arm, not an MRMC study comparing human readers with and without AI assistance.
6. Standalone Performance
The study design assessed the effectiveness of reSET-O (TES) as an adjunct to Treatment As Usual (TAU) compared to TAU alone. It does not evaluate the device's standalone performance without human-in-the-loop (i.e., without the adjunctive standard of care). The device is explicitly indicated as an "adjunct to outpatient treatment."
7. Type of Ground Truth Used
The ground truth used was based on clinical outcomes data from a randomized controlled trial:
- Treatment Dropout: Defined as the percentage of patients who discontinued treatment during the 12-week intervention.
- Abstinence: Defined as the "longest documented period of continuous abstinence from opioids and cocaine for each participant," measured through thrice-weekly urine drug screens (UDS).
8. Sample Size for the Training Set
The document does not provide information about a separate training set or its sample size. The clinical study described served as the validation (test) set for the device's effectiveness.
9. How Ground Truth for the Training Set Was Established
As no separate training set is mentioned, the method for establishing its ground truth is not provided. The provided text focuses on the clinical validation study.
§ 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.