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MamaLift Plus is a prescription-only digital therapeutic intended to provide neurobehavioral interventions to patients 22 years of age and older, as an adjunct to clinician-managed outpatient care. MamaLift Plus treats mild to moderate postpartum depression by improving a patient's symptoms of depression.

MamaLift Plus is a digital therapy designed to treat symptoms of postpartum depression by delivering evidence-based therapeutic components of Cognitive Behavioral Therapy (CBT) via software on a mobile application (smartphone or tablet). MamaLift Plus is indicated as a behavioral health intervention for patients 22 years of age and older with mild to moderate symptoms of depression by improving their symptoms of depression. As with face- to-face CBT, MamaLift Plus uses personalized cognitive restructuring as the main therapeutic component to improve the symptoms of postpartum depression. This element is mapped onto standard, evidence-based CBT interventions that are developed for and provided by a therapist in a face-toface care setting with a patient. The content is conveyed via a sequence of eight self-guided and interactive treatment modules daily over a period of eight to nine weeks sequentially.

Patients are encouraged to complete all eight modules of the MamaLift Plus application at the rate of one module per week. However, the entire program can last up to 9 weeks, inclusive of the baseline and posttreatment assessment periods. Full engagement by prescribing clinicians and their support staff facilitates effective use by patients of the prescribed treatment and their continued use in conjunction with ongoing monitoring by the clinician.

The content of MamaLift Plus is delivered through a variety of features which include text, personalized goal setting, graphical feedback based on inputted symptoms, and illustrations to enrich comprehension, quizzes to test and enhance user knowledge, video vignettes to promote user identification with material, and video-based expert explanations. Periodic notifications or "nudges" are also sent to increase user engagement and encourage program adherence. Additional features of MamaLift Plus include a daily tracker in which patients can self- monitor and record standardized sleep parameters (e.g., sleep and naps), self-reports of perceived Sleep Quality, and self-reports of perceived Energy Level. In addition, MamaLift Plus offers a daily mood tracker and activity tracker. The application provides personalized cognitive restructuring guidance based on the individual's beliefs, context, and attitudes.

To facilitate its use as an adjunct to outpatient standard of care conducted under the supervision of a qualified health care provider, MamaLift Plus includes a clinician facing dashboard summarizes patient use of the mobile application during the treatment period thereby enabling the clinician to assess and monitor their patient's progress throughout the therapeutic period. Clinical data collected via the patient interface, including self-reports of depressive symptoms/moods, and sleep data, are also displayed via the clinician dashboard. (All data are encrypted and compliant with data privacy and patient confidentiality requirements of the Health Insurance Portability Act.) These features are intended to support the clinician and enable patient follow up, engagement and communication of healthcare decisions. This facilitates treatment adherence and achievement of optimal patient outcomes. These are critical components that demonstrate the effectiveness of MamaLift Plus.

The provided text describes the MamaLift Plus device, its intended use, and the studies conducted to demonstrate its safety and effectiveness.

Here's an analysis based on your requested information:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for MamaLift Plus are based on improvements in the Edinburgh Postpartum Depression Scale (EPDS) scores.

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Rejoyn is a prescription digital therapeutic for the treatment of Major Depressive Disorder (MDD) symptoms as an adjunct to clinician-managed outpatient care for adult patients with MDD aged 22 years and older who are on antidepressant medication. It is intended to reduce MDD symptoms.

Rejoyn (also known as CT-152) is a digital therapeutic smartphone application (app) for the treatment of Major Depressive Disorder (MDD) symptoms. Rejoyn is a prescription smartphone app-based digital therapeutic administered to a user via the user's smartphone device (running Apple iPhone operating system [iOS®] or Android™ operating system [OS]), which delivers a proprietary interactive cognitiveemotional and behavioral therapeutic intervention. The core components of Rejoyn are the Emotional Faces Memory Task (EFMT) exercises, brief cognitive behavioral therapy (CBT)-based lessons to learn and apply key therapeutic skills, and short message service (SMS) text messaging to reinforce CBT-based lesson content and to encourage engagement with the app. It is intended for the treatment of MDD symptoms as an adjunct to clinician-managed outpatient care for adult patients with MDD aged 22 years and older. It is intended to reduce MDD symptoms.

Rejoyn is designed for use as an adjunct to clinician-managed outpatient care over a period of 6 weeks for the treatment of MDD symptoms, followed by a 4-week extension period where CBT-based lesson content will be accessible but no new therapeutic content or EFMT exercises will be available. Rejoyn is not intended to be used as a stand-alone therapy or as a substitution for the patient's clinician prescribed medications.

Here's a summary of the acceptance criteria and the study that proves the device meets them, based on the provided text:

Device Name: Rejoyn™
Regulation Number: 21 CFR 882.5801
Regulation Name: Computerized Behavioral Therapy Device For Psychiatric Disorders
Regulatory Class: Class II

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for Rejoyn are defined by the "Special Controls" for computerized behavioral therapy devices for psychiatric disorders. These special controls mandate clinical data and detailed software documentation. The device's performance is demonstrated through the Mirai trial.

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size (Test Set):

  • Intent-To-Treat (ITT) population: 386 participants (194 Rejoyn, 192 Sham)
  • Modified Intent-To-Treat (mITT) population: 354 participants (177 Rejoyn, 177 Sham) (This was the primary population for the primary efficacy endpoint analysis).
  • Safety Sample: 373 participants (187 Rejoyn, 186 Sham)

• Data Provenance: The Mirai trial (NCT04770285) was a pivotal, multicenter, remote, double-blinded (patients also blinded to hypothesis), randomized, controlled trial. The study was conducted virtually, with participants across multiple centers, implying a prospective and multi-site data collection. No specific country of origin is mentioned, but "multicenter" typically implies multiple sites within a region (e.g., US).

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications

The ground truth for the clinical effectiveness was established through commonly used and validated psychiatric assessment scales:

• Montgomery-Asberg Depression Rating Scale (MADRS): This is a clinician-rated scale. The study states the benefit was "consistently rated by independent assessors via the MADRS," indicating multiple clinicians likely contributed to these assessments. Specific number and qualifications are not detailed, but it is implied they are qualified clinicians for psychiatric assessment.
• Clinical Global Impression-Severity Scale (CGI-S): This is also a clinician-rated scale, where benefit was "rated by study investigators via the CGI-S." Again, specific numbers and qualifications of these "study investigators" are not explicitly stated, but they would be medical professionals involved in the clinical trial.

4. Adjudication Method for the Test Set

The text indicates that the trial was "double-blinded (patients also blinded to hypothesis)" and assessments were made by "independent assessors" (for MADRS) and "study investigators" (for CGI-S). There is no explicit mention of an adjudication method like 2+1 or 3+1 for resolving discrepancies in assessments. However, the use of "independent assessors" for the primary outcome measure (MADRS) suggests a measure to reduce bias.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No, an MRMC comparative effectiveness study was not done in the context of radiologists or similar image interpretation professions. This device is a digital therapeutic for psychiatric disorders, not an imaging diagnostic tool requiring multiple readers to interpret cases. The effectiveness study compared the device (Rejoyn) to a Sham control group, not human readers with and without AI assistance.

6. Standalone Performance

Yes, a standalone (algorithm only without human-in-the-loop performance) study was effectively done. Rejoyn is a "prescription digital therapeutic" that provides "proprietary interactive cognitive-emotional and behavioral therapeutic intervention" directly to the user via a smartphone app. The trial design assessed the effectiveness of this app-based intervention (Rejoyn) against a Sham app, with both groups continuing "clinician-managed outpatient care" and "antidepressant medication." The primary efficacy endpoint measured the change in MADRS total score directly attributable to the Rejoyn app's use as an adjunct, demonstrating its standalone contribution to reducing MDD symptoms beyond standard care.

7. Type of Ground Truth Used

The ground truth was based on expert clinical assessments and patient-reported outcomes using validated scales:

• Clinician-rated scales: Montgomery-Asberg Depression Rating Scale (MADRS) and Clinical Global Impression-Severity Scale (CGI-S).
• Patient-reported outcomes (PROs): Patient Health Questionnaire-9 (PHQ-9) and Generalized Anxiety Disorder-7 (GAD-7).

These are standard, widely accepted measures for assessing depressive and anxiety symptoms in clinical trials.

8. Sample Size for the Training Set

The provided document describes a pivotal clinical trial (Mirai Trial) used for validation. It does not provide details about a training set for the development of the Rejoyn algorithm itself. Digital therapeutics often undergo iterative development and testing, but the specifics of a "training set" in the machine learning sense are not included in this regulatory summary, which focuses on the clinical validation of the final product.

9. How the Ground Truth for the Training Set Was Established

As mentioned above, the document does not include information about a "training set" for the algorithm itself. The focus is on the clinical validation of the device's effectiveness using the Mirai trial. If Rejoyn's "proprietary interactive cognitive-emotional and behavioral therapeutic intervention" involves machine learning components that were "trained," the methods and ground truth for that training are not detailed in this 510(k) summary. The summary highlights that the software documentation demonstrates Rejoyn "effectively implements the behavioral therapy model," suggesting the model itself is based on established therapeutic principles (EFMT and CBT).

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