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Regulora™ is a prescription-only digital therapeutic device intended to provide behavioral therapy through gut-directed hypnotherapy for adults 22 years of age and older who have been diagnosed with Irritable Bowel Syndrome (IBS). Regulora is indicated as a 3-month treatment for patients with abdominal pain due to IBS and is intended to be used together with other IBS treatments.

Regulora™ is prescription-only digital therapeutic software indicated for use in the treatment of abdominal pain due to Irritable Bowel Syndrome (IBS). The Regulora program is Software as a Medical Device (SaMD) that resides on and is accessed through the user's mobile device and can be executed at home. Regulora digitizes scripted therapist-administered GDH behavior therapy and provides 7 unique treatment sessions, each lasting ~30 minutes, every other week over 12 weeks. The treatment sessions are designed to first induce deep physical and autonomic relaxation which is followed by metaphorical storytelling and a combination of direct and indirect suggestions targeted at somatic control mechanisms. Regulora also provides for IBS symptom tracking, which patients can share with their doctor in the management of their IBS.

The provided text describes the Regulora™ device, a prescription-only digital therapeutic for Irritable Bowel Syndrome (IBS), and outlines its performance and supporting studies for FDA clearance.

Here's an analysis of the acceptance criteria and study information:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are not explicitly listed in a separate table within the document. However, based on the narrative, the primary clinical acceptance criteria for Regulora are related to improvements in abdominal pain intensity scores, as specified in the "Performance Testing - Clinical" section. The document also mentions Special Controls for product code QMY, which involve:

• Clinical data describing a model of therapy (validated in a clinical trial).
• Software development documentation (SRS, SDS, V&V, hazard analysis).
• Usability assessment.
• Labeling.

The reported device performance is primarily based on the EASITx clinical trial.

• Final 4 weeks of treatment: 30.9% of Regulora group vs. 21.5% of control group experienced ≥ 30% reduction.
• Throughout weeks 1-12: 29.3% of Regulora group vs. 18.8% of control group experienced ≥ 30% reduction. Regulora demonstrates clinically meaningful results within the intended use population. |
  | Demonstrate within-group improvement from baseline in IBS symptoms. | Within-Group Improvement (Regulora group, 4-week post-treatment):
• 44.9% experienced ≥ 30% improvement in proportion of stools with normal consistency.
• 50.3% were either a pain or stool responder (compared to 47% in predicate device).
• IBS-D subgroup (N=56): 48.2% experienced ≥ 50% reduction in days with loose or watery stools.
• IBS-C subgroup: 39.7% experienced ≥ 1 increased bowel movement per week.
• 64.0% reported Adequate Relief.
• 67.7% reported overall satisfaction.
  Note: These measures did not show statistically significant separation from control and therefore associated endpoints were not met. |
  | Absence of serious adverse events related to treatment. | No treatment-related serious adverse events reported. |
  | Minimal non-serious adverse events related to treatment. | Non-serious adverse events with reasonable possible relation to treatment: headache (0.5%, n=1), fatigue (0.5%, n=1), abdominal pain (0.5%, n=1), constipation (0.5%, n=1). |
  | Ability of subjects to use the program in the intended use environment (mobile device at home). | Clinical data showed study subjects could use the program by downloading, installing, and using Regulora on their mobile device at home. |
  | Compliance with Special Controls (pertaining to clinical data, software development, usability, labeling). | MetaMe complies with the special controls for product code QMY. Clinical data provided, software documented (SRS, SDS, V&V, hazard analysis), usability assessment performed, and labeling includes required instructions, warnings, and clinical summary. |

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

• Sample Size for Test Set: The "Performance Testing - Clinical" section states that 362 evaluable adult subjects with IBS were randomized 1:1 to either the Regulora group (n=181) or the control group (n=181). This entire cohort serves as the test set for evaluating the device's clinical performance.
• Data Provenance: The document does not explicitly state the country of origin. However, the study is referred to as the "EASITx clinical trial (Efficacy and Safety of IBS Digital GDH Treatment, EASITx -NCT04133519)", and NCT numbers are typically assigned to clinical trials registered on ClinicalTrials.gov, which often include studies conducted within the U.S. and internationally. The study design (randomized, controlled trial) indicates it is a prospective study.

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

The concept of "ground truth" concerning patient outcomes (like IBS symptom improvement) is typically established through patient-reported outcomes (PROs) using validated questionnaires and scales, rather than expert consensus on individual cases. The document mentions "clinically validated independent instruments" for measuring outcomes but does not refer to a panel of experts establishing the ground truth for each patient's reported symptoms or improvement. The "ground truth" for efficacy in this context is the patient's change in symptoms as measured by these validated scales.

4. Adjudication Method for the Test Set

As the "ground truth" is predominantly based on patient-reported outcomes from validated instruments, there is no mention of an adjudication method (like 2+1 or 3+1) for the test set. Adjudication methods are typically employed when expert interpretation of data (e.g., medical images) is required to establish ground truth.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, If So, What Was the Effect Size of How Much Human Readers Improve with AI vs Without AI Assistance

No, an MRMC comparative effectiveness study involving human readers or AI assistance in interpretation was not done. Regulora is a digital therapeutic device that delivers behavioral therapy directly to the patient; it is not an AI-powered diagnostic or interpretive tool that assists human "readers" (e.g., radiologists). Therefore, this question is not applicable.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Yes, in a sense, a "standalone" performance evaluation was done. Regulora is designed as a direct-to-patient digital therapeutic. Its clinical performance, as assessed in the EASITx trial, is the outcome of the algorithm/program itself delivering the gut-directed hypnotherapy. There isn't a human-in-the-loop scenario where a clinician is interpreting output from Regulora; rather, Regulora is the intervention. The study directly measures the effect of the Regulora program on patient outcomes.

7. The Type of Ground Truth Used

The ground truth used for clinical efficacy evaluation is based on patient-reported outcomes (PROs) derived from validated instruments and definitions. Specifically, the primary endpoint was a "clinically meaningful 30% reduction in abdominal pain intensity scores," following FDA guidance for Irritable Bowel Syndrome. Other measures included improvements in stool consistency, responder rates (pain or stool), and Adequate Relief, all of which are patient-reported metrics.

8. The Sample Size for the Training Set

The document does not specify a separate "training set" in the context of machine learning model development. Regulora delivers pre-scripted, therapist-administered GDH behavioral therapy; it is described as digitizing existing therapy. While software development involves training for various components, there's no indication of a machine learning model being trained on a specific patient data set to generate the therapy content or personalize it in a way that requires a separate "training set" in the common AI/ML sense. The clinical trial data (n=362) served as the validation set for the device's efficacy.

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

Since a "training set" for an AI/ML model to generate therapy is not explicitly mentioned as being part of Regulora's development, the establishment of ground truth for such a set is not detailed. The therapy itself (Gut-Directed Hypnotherapy) is established behavioral therapy, and the "ground truth" for its effectiveness comes from existing medical literature and clinical practice, which informed the content digitized by Regulora.

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