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The Revi System is indicated for the treatment of patients with symptoms of urgency incontinence alone or in combination with urinary urgency.

The Revi System is a tibial neuromodulation system that consists of the following four different components:

1. Implant: An implantable wireless neurostimulation component that is implanted in the vicinity of the tibial neurovascular bundle. The implant is battery-less and does not have an internal power source.
2. Rechargeable Wearable Unit: This unit is comprised of a wearable device and leg band. The wearable device contains an electrical circuit board, flexible antenna, and rechargeable battery with dedicated charger. The Rechargeable Wearable Unit, when used by the patient, is designed to be paired to a specific implant. Once paired, the Rechargeable Wearable Device transmits power and can only communicate (through magnetic coupling) with the specific implant to which it is paired.
3. Clinician Programmer (CP): This application is the system's interface used by the healthcare providers for treatment control, status evaluation, parameter programming and data acquisition. Access to the CP is password protected to allow access only to authorized users. The CP transfers data to and from the Rechargeable Wearable Unit via a wireless Bluetooth connection.
4. HealthGo Micro (Hub): The Hub communicates with the Rechargeable Wearable Unit using a Bluetooth connection and acquires and transmits data to the Cloud only during the charging sessions of the Rechargeable Unit. The Hub allows health care providers access to device data logs between visits without the need for in-person visits. The Hub is a Class I 510(k) exempt device (Product code OUG, 21 CFR 880.6310).

Acceptance Criteria and Device Performance for the Revi System

This document outlines the acceptance criteria for the Revi System and details the studies that demonstrate the device meets these criteria.

1. Table of Acceptance Criteria and Reported Device Performance

The Revi System's clinical performance was evaluated against primary and secondary effectiveness endpoints with pre-defined performance goals (PG). The device's safety was assessed by the incidence of adverse events.

2. Sample Size and Data Provenance

• Test Set (Pivotal Clinical Study):

  • Sample Size: 151 implanted subjects (Intent to Treat (ITT) analysis set).
  • Data Provenance: Prospective, multi-center study conducted at 27 sites. 17 sites were in the United States, and the remaining 10 sites were in England (2), Belgium (2), Netherlands (5), and Germany (1). The study enrolled female subjects only.

• Pilot Study:

  • Sample Size: 34 implanted subjects.
  • Data Provenance: Not explicitly stated whether it was prospective or retrospective, but it preceded the pivotal trial and was used to gather preliminary safety and effectiveness data. It included both male (5 subjects) and female subjects.

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

The ground truth for the clinical study was established through patient-reported outcomes (voiding diaries, questionnaires) and objective medical assessments by clinical staff.

• Number of Experts: The study was conducted at 27 sites, implying a significant number of medical professionals (investigators, nurses, study coordinators) involved in data collection and subject assessment. The document mentions that the investigators could deem subjects unsuitable for enrollment based on history or physical examination.
• Qualifications of Experts: The clinical study was overseen by healthcare providers, including physicians who determined treatment parameters and assessed patient tolerability and response. While specific qualifications (e.g., "radiologist with 10 years of experience") are not provided, it is implicitly understood that qualified medical professionals were involved in the diagnosis, implantation, follow-up, and assessment of patients for overactive bladder symptoms. An independent Data and Safety Monitoring Board (DSMB) monitored the study's safety, conduct, scientific validity, and data integrity.

4. Adjudication Method for the Test Set

• Adverse Events Adjudication: An independent Clinical Events Committee (CEC) adjudicated adverse events. For instance, one AE was initially reported but adjudicated by the CEC as part of normal wound healing rather than an actual AE. This indicates a formal process for reviewing and classifying reported events.

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

• No Multi-Reader Multi-Case (MRMC) comparative effectiveness study was reported. The study was a single-arm, open-label pivotal study evaluating the Revi System's effectiveness and safety in patients with OAB symptoms. It did not involve comparing human readers with and without AI assistance, as the device is a therapeutic implant rather than an AI-driven diagnostic tool.

6. Standalone Performance (Algorithm Only)

• The Revi System is a physical neuromodulation device and does not have a standalone (algorithm-only) performance component in the typical sense of AI/ML algorithms. Its performance is directly tied to the interaction of its hardware components with the human body to deliver electrical stimulation. The software component manages device function but its "performance" is evaluated as part of the overall system's functionality, not as an independent diagnostic or predictive algorithm.

7. Type of Ground Truth Used

The ground truth for effectiveness in the pivotal clinical study was primarily based on:

• Patient Voiding Diaries: 7-consecutive day voiding diaries were used to measure the average number of UUI episodes, urgency episodes, and voids per day at baseline and follow-up. This is objective patient-reported data.
• Patient Reported Outcomes (PROs): Health Related Quality of Life (HRQL) was assessed using the Overactive Bladder Questionnaire (OAB-q).
• Medical Assessments: Sensory and motor assessments were performed by clinicians during device activation and follow-up visits to tailor stimulation parameters based on individual patient responses.
• Adverse Event Reporting: Adverse events were reported by patients and documented by clinical staff, then adjudicated by an independent CEC.

8. Sample Size for the Training Set

The document describes a pivotal clinical study and a pilot study which serve as the primary sources of clinical data. It does not mention a separate "training set" in the context of an AI/ML algorithm being developed or refined. All clinical data presented are related to the evaluation of the device as a medical treatment.

• Pivotal Clinical Study (Evaluation): 151 implanted subjects.
• Pilot Study (Preliminary Evaluation): 34 implanted subjects.

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

As noted above, the Revi System is a therapeutic device, not an AI/ML system that would typically have a distinct "training set" for an algorithm. Therefore, the concept of establishing ground truth for a training set in this context is not applicable. The clinical studies (Pivotal and Pilot) directly assessed the device's safety and effectiveness in treating OAB symptoms, with efficacy endpoints based on patient voiding diaries and validated questionnaires, and safety endpoints based on AE reporting and adjudication.

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