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The Vibrant System is an orally administered Capsule that is indicated for the treatment of adults with chronic idiopathic constipation who have not experienced relief of their bowel symptoms by using laxative therapies at the recommended dosage for at least one month.

The Vibrant System is designed to mechanically induce peristaltic activity in the colon, thus aiding in relieving constipated patients. Constipation relief is achieved by the Capsule's stimulation in the colon, consequently inducing peristaltic activity which promotes transit and facilitates defecation. The stimulation protocol is designed to activate at specific times during the day (i.e., afternoon and evening). The Vibrant System is comprised of two components: a reusable pod and a single use capsule. The Capsule is expelled from the body during the patient's bowel movements.

This document outlines the acceptance criteria and study proving the device meets those criteria, based on the provided text.

1. Acceptance Criteria and Reported Device Performance

The acceptance criteria are implicitly defined by the primary efficacy endpoints of the clinical study, which aim to demonstrate superior performance of the active device over placebo.

Conclusion on Acceptance Criteria: The study successfully met the acceptance criteria for the CSBM1 success rate, demonstrating a statistically significant improvement with the active device compared to placebo. The CSBM2 success rate, while numerically higher in the active arm, did not meet the statistical significance criteria. However, the overall study was deemed successful based on the CSBM1 outcome.

2. Sample Size and Data Provenance

• Test Set Sample Size: 100 subjects were enrolled and randomized in the study.
  • Intend-to-Treat (ITT) analysis set: 100 subjects.
  • Modified Intend-to-Treat (mITT) analysis set: 96 subjects (randomized subjects who met the inclusion criteria).
• Data Provenance: The study was conducted in the United States (US). It was a prospective, randomized, multi-center, double-blinded, placebo-controlled study.

3. Number of Experts and Qualifications for Ground Truth Establishment (Test Set)

The document does not explicitly state the number of experts used or their qualifications for establishing the ground truth for the test set. The primary efficacy endpoints (CSBM1 and CSBM2 success rates) are based on patient-reported outcomes (Complete Spontaneous Bowel Movements), not expert interpretation of diagnostic images or data. Therefore, expert consensus in the traditional sense for diagnostic accuracy might not be directly applicable here.

4. Adjudication Method (Test Set)

The document does not describe a formal adjudication method (e.g., 2+1, 3+1) for the test set data. Given that the endpoints are based on patient-reported bowel movements, the data would likely be collected directly from subjects and analyzed statistically without a need for expert adjudication in the same way imaging studies might require.

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

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study typically involves multiple human readers interpreting diagnostic data (e.g., medical images) with and without AI assistance to measure the AI's impact on their performance. The Vibrant System is a therapeutic device that directly treats constipation, and its effectiveness is measured by direct physiological outcomes (bowel movements), not by aiding human interpretation of data.

6. Standalone Performance

Yes, a standalone study (algorithm only without human-in-the-loop performance) was done, as the Vibrant System is a device designed to deliver a therapeutic effect independently. The clinical study directly evaluated the device's efficacy in patients by comparing the active device to placebo, without human intervention in the device's mechanism of action or interpretation beyond general patient care.

7. Type of Ground Truth Used

The ground truth used in this study is based on patient-reported outcomes, specifically:

• Complete Spontaneous Bowel Movements (CSBMs): Number of bowel movements that are spontaneous (not induced by laxatives or suppositories) and complete.
• Changes from baseline in average straining.
• Changes from baseline in average stool consistency.
• Changes from baseline in average bloating.
• Quality of life measurements.

These are direct measures of the therapeutic effect and patient experience, rather than expert consensus on a diagnostic finding or pathology.

8. Sample Size for the Training Set

The document does not provide information regarding a specific "training set" sample size for an algorithm. The clinical study described is an efficacy study to support the device's safety and effectiveness, not a study to train an AI algorithm. While the device utilizes an "adaptive delay mechanism," the details of its development or any associated training data are not described in this regulatory submission summary.

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

As no specific training set for an AI algorithm is directly mentioned or detailed in the provided document, there is no information on how ground truth for a training set was established. The clinical study's ground truth was established through direct patient outcomes measurement as described in point 7.

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The Vibrant System is an orally administered Capsule that is indicated for the treatment of adults with chronic idiopathic constipation who have not experienced relief of their bowel symptoms by using laxative therapies at the recommended dosage for at least one month.

The Vibrant System is designed to mechanically induce peristaltic activity in the colon, thus aiding in relieving constipated patients. Constipation relief is achieved by the Capsule's stimulation in the colon, consequently inducing peristaltic activity which promotes transit and facilitates defecation. The stimulation protocol is designed to activate at specific times during the day (i.e., afternoon and evening). The Vibrant System is comprised of two components: a reusable Pod and a single use capsule. The Capsule is expelled from the body during the patient's bowel movements.

The provided text does not contain specific acceptance criteria or a detailed study of the device's performance against such criteria. Instead, it describes general compliance with standards and the substantial equivalence to a predicate device.

However, based on the Performance Data section, we can infer the types of criteria that were considered and the studies conducted to demonstrate compliance, even if specific metrics are not given.

Here's a breakdown of what can be extracted and what information is missing:

1. A table of acceptance criteria and the reported device performance

2. Sample size used for the test set and the data provenance

• Sample Size for Test Set: Not specified for any of the listed performance data. For example, it's not mentioned how many packages were tested for transportation validation or how many Pods were used for bench testing.
• Data Provenance: Not specified. It does not mention country of origin or whether studies were retrospective or prospective.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

• This information is not provided because the document focuses on engineering and regulatory compliance tests rather than clinical performance based on expert review. There is no mention of ground truth establishment in this context.

4. Adjudication method for the test set

• Not applicable as this document describes technical and regulatory compliance testing, not a clinical study involving human readers and ground truth adjudication.

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 was not conducted or described. The device is not an AI-assisted diagnostic tool for human readers; it's an orally administered capsule system for constipation.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

• The device itself is a standalone system (the capsule and pod). The performance data listed are for the device's technical and safety aspects. There isn't an "algorithm only" performance reported in the sense of a diagnostic AI system, but the software validation (IEC 62304) is a standalone evaluation of the device's software.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

• For the technical and safety performance data listed, the "ground truth" would be defined by the standards themselves (e.g., a package either passed ASTM D4332-14 or it didn't; the device either met IEC 60601-1 safety requirements or it didn't). These are objective engineering and regulatory standards rather than clinical ground truth established by medical experts or pathology.

8. The sample size for the training set

• Not applicable. The document describes a medical device, not an AI/machine learning model that requires a "training set" in the conventional sense.

9. How the ground truth for the training set was established

• Not applicable, as there is no "training set" for this device's performance evaluation as described.

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The Vibrant System is an orally administered Capsule that is indicated for the treatment of adults with chronic idiopathic constipation who have not experienced relief of their bowel symptoms by using laxative therapies at the recommended dosage for at least one month.

The Vibrant System is comprised of two components; a Pod and a single use Capsule. The Pod activates the Capsule using radio frequency (RF) communication. After activation, the Capsules are taken orally. After a pre-programmed activation delay, the Capsules begin to vibrate. The marketed device will have an activation delay of 14 hours. (The 14 hours activation delay corresponds to Active Mode 1 of the pivotal study described below: the pivotal study also included an Active Mode 2 with a 9 hour activation delay.) As they pass through the gastrointestinal tract, the Capsules vibrate for four pre-programmed periods of 100 min, 120 min, 100 min. 180 min. It takes about three days for the Capsules to pass through the gastrointestinal tract, at which point thev are excreted in a bowel movement.

The Capsule is comprised of a motor that vibrates (2.5 Vdc. 70 ma), electronic card, batteries (2x 1.5V 60 mAh, alkaline/0% Hg coin battery) and connector. The capsule is a two-piece shell made from Polycarbonate Makrolon 2458. The Capsule dimensions are as follows: length: 24.5 ± 0.1 mm; diameter: 11.20 ± 0.05 mm; weight 4.0 ± 0.1 g. The Capsules have a vibration force between 200 and 550 gf, with vibration cycles of 3 seconds on and16 seconds off (190 cycles per hour).

Here's a breakdown of the acceptance criteria and the study proving the device meets them, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The provided text details acceptance criteria for bench testing and clinical effectiveness.

Bench Testing Acceptance Criteria & Results (from Table 1)

Clinical Effectiveness Acceptance Criteria & Results (from "Effectiveness results" section for mITT analysis set)

Study Proving Device Meets Acceptance Criteria

The primary study proving the device meets the acceptance criteria is the V270 pivotal study.

The V270 study was described as:

• Design: Prospective, randomized, multi-center, double-blinded, placebo-controlled pivotal study.
• Arms: Initially two active treatment arms (Active Mode 1 and Active Mode 2) and a control arm. Active Mode 2 was dropped after interim analysis, continuing with Active Mode 1 and control.
• Treatment Duration: 8 weeks.
• Population: Adults with chronic idiopathic constipation (CIC) refractory to existing OTC or Rx treatments or intolerant of side effects.

Additional Information:

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

• Sample Size for Test Set (Clinical Study - V270):
  • Consented and Screened: 904 subjects
  • Randomized (ITT analysis set): 349 subjects (Active Mode 1: 163, Active Mode 2: 37, Control: 149)
  • Modified Intent-to-Treat (mITT) analysis set: 336 subjects (Active Mode 1: 158, Active Mode 2: 34, Control: 144) - This was the primary effectiveness analysis population.
  • Per Protocol (PP) analysis set: 333 subjects (Active Mode 1: 155, Active Mode 2: 34, Control: 144)
  • Primary Safety Analysis Set (ITT): 349 subjects (Active Mode 1 & 2 combined: 200, Control: 149)
• Data Provenance: The document does not explicitly state the country of origin for the clinical study data but mentions the sponsor information is Vibrant Ltd. Hakochav P.O. Box 516 Yokneam, Israel. Given it's a pivotal FDA study, it often involves sites in the US and potentially other regions, but this is not specified. The study was prospective.

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

• For this type of device (orally ingested capsule for constipation), the "ground truth" for effectiveness endpoints (CSBMs, straining, stool consistency, bloating) is patient-reported outcomes (PROs) based on diary entries. These outcomes are not typically established by "experts" in the sense of image readers or diagnosticians.
• For safety, adverse events were reported by subjects and assessed by study investigators, who are implicitly qualified medical professionals overseeing the clinical trial. The document doesn't specify the number or specific qualifications (e.g., years of experience) of these investigators beyond them being the "study investigators."

4. Adjudication Method for the Test Set

• The text does not mention an "adjudication method" in the context of expert review for establishing ground truth, as the primary effectiveness endpoints are patient-reported.
• For adverse events, "study investigators" classified AEs as "possibly, probably, or definitely related to the study treatment or procedure" (Table 8), implying an internal review process, but no specific multi-reviewer adjudication method (like 2+1 or 3+1) is described.

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

• No, an MRMC comparative effectiveness study was not done. This device is a therapeutic capsule, not an AI-assisted diagnostic tool that would involve human readers interpreting cases. Therefore, the concept of improving human readers with AI assistance does not apply.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

• This device is a physical, orally ingested capsule with pre-programmed vibration patterns. It does not involve an "algorithm" in the sense of AI performing a diagnostic task. The "algorithm" here refers to the embedded software controlling the capsule's operation (vibration start time, duration, sequence, rest time). The performance of this software in controlling the physical device was assessed via bench testing ("Mode of Operation" test).

7. The Type of Ground Truth Used

• The primary ground truth for effectiveness was patient-reported outcomes (PROs) from daily diaries (e.g., number of CSBMs, straining levels, Bristol Stool Scale scores, bloating).
• The ground truth for safety was adverse events reported by subjects and assessed by investigators.

8. The Sample Size for the Training Set

• This is not an AI/machine learning device that typically has a separate "training set" for model development. The "training" for this device would be its design, engineering, and iterative testing, not data-driven model training.
• The various non-clinical (bench) and animal studies served as early development and validation steps prior to the pivotal human clinical trials. Five smaller clinical trials involving a total of 499 subjects were conducted prior to V270, but these did not fully support effectiveness and are mentioned as providing cumulative safety data, not as a "training set" for an algorithm.

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

• As this is not an AI/machine learning device with a typical "training set," this question is not directly applicable. The "ground truth" for the development and bench testing of the capsule's physical and functional properties would be established through engineering specifications, physical measurements, and adherence to biological/physiological parameters (e.g., pH conditions, vibration specifications).
• For the earlier clinical trials (499 subjects), the ground truth for safety and preliminary effectiveness would have been established similarly to the pivotal study – patient-reported outcomes and investigator assessment of adverse events.

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