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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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All four sets of constriction rings, the Rejoyn Constriction Ring Kit, B-100, B-25, and B-10, are used to maintain penile rigidity in men with erectile dysfunction by restricting penile venous outflow after the patient has obtained an erection (either with the aid of a vacuum pump, or naturally). The constriction band is placed around the base of the erect penis to restrict the flow of venous blood leaving the penis.

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The provided documents are a 510(k) clearance letter and an "Indications for Use" statement for the Rejoyn, B-100, B-25, and B-10 Constriction Ring Kits. These documents confirm that the devices have received market clearance based on substantial equivalence to predicate devices, but they do not contain any information about acceptance criteria, device performance studies, sample sizes, expert qualifications, or ground truth establishment.

Therefore, I cannot provide the requested information. The documents are purely regulatory approval notices and do not detail any performance evaluation studies.

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The intended use of the Rejoyn Vacuum Erection Device is to assist users in achieving a full erection, i.e., to create an erection in men with erectile dysfunction by means of an applied vacuum to the penis, which draws blood to the penile corpora cavernosa, causing the penis to become erect and rigid. The constriction bands are then placed around the base of the erect penis to restrict the flow of venous blood leaving the penis.

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I am sorry, but the provided text does not contain any information about acceptance criteria or a study proving that a device meets such criteria. The document is a letter from the FDA regarding a 510(k) submission for the "Rejoyn Vacuum Erection Device." It addresses the substantial equivalence of the device and its indications for use but does not include performance data, study results, or ground truth establishment.

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The Rejoyn Penile Support System is intended for use by men who have an inability to engage in sexual intercourse due to a flaccid or partially erect penis resulting from impotence.

The Rejoyn penile support system consists of a semi-rigid split support sleeve molded from medical grade rubber with an attachment strap. The sleeve is placed over the penis with the split side down and the strap is fastened behind the scrotum. The sleeve is approximately 2 1/4" long. The system may also include a lubricated latex cover which may be worn over the sleeve to enhance comfort.

Another version of the Rejoyn system includes a single-use, disposable support sleeve in lieu of the reusable support sleeve. The single-use sleeve is made of the same materials as the reusable sleeve but is removed after use by breaking off one end of the attachment strap at a specified location.

The Rejoyn system will be available in five different package variations: (1) one support sleeve, three covers and one tube of lubricating jelly; (2) one support sleeve and one tube of lubricating jelly; (3) one support sleeve and three covers; (4) three single-use support sleeves, three covers and one tube of lubricating jelly; and (5) three single-use support sleeves and three covers. Replacement covers and lubricating jelly also will be available separately.

This document (K971576) is a 510(k) premarket notification for a medical device called the "Rejoyn Penile Support System." It primarily focuses on demonstrating substantial equivalence to predicate devices and getting FDA clearance to market.

Crucially, this document does not contain information about acceptance criteria or a study proving the device meets acceptance criteria.

The 510(k) submission process for this type of device (an external penile support system) in 1997 likely relied on the device's technological characteristics being substantially equivalent to legally marketed predicate devices, rather than requiring extensive clinical performance studies with specific acceptance criteria that would typically involve statistical analysis of efficacy or safety endpoints.

Therefore, I cannot populate the requested table or describe a study that proves the device meets acceptance criteria based on this document. The document describes the device, its intended use, and argues for its substantial equivalence to existing devices.

To answer your request, if this were a document that contained such information, it would typically be found in a "Clinical Study," "Performance Testing," or "Validation Report" section, which is absent here.

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