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510(k) Data Aggregation
(410 days)
Avation Medical, Inc.
The Vivally® System is a wearable neuromodulation system to treat patients with the bladder conditions of urge urinary incontinence and urinary urgency.
The Vivally System is a wearable, non-invasive, bladder control therapy with a mobile application to treat patients with the conditions of urge urinary incontinence and urinary urgency, without the need for surgery, implants, drugs, or needle-electrodes. The Vivally System utilizes neuromodulation to deliver electrical signals to the tibial nerve. The tibial nerve is a mixed (motor and sensory) peripheral nerve that feeds into the sacral plexus which contains the nerves that innervate the detrusor muscle surrounding the urinary bladder. The Vivally System also includes an analog input that measures the electromyogram (EMG) signal from the patient's foot via three additional EMG electrodes embedded on the Garment. The system operates in a combination of closed-loop using EMG as the physiological feedback, as well as in open-loop when the feedback signal is unreliable or unreadable. The main components of the Vivally System include a rechargeable-controller (Stimulator) powered by a rechargeable lithium-ion battery, an ankle worn Garment designed to be used on the left or right ankle, Gel Cushions and charging accessories. The Vivally System also includes a mobile application on the patient's personal device and a HIPAAcompliant cloud database. The Vivally Mobile Application allows the patient to start and manage a therapy session and provides access to condition support tools such as an electronic bladder diary to record symptoms, fluid intake and other factors impacting their condition and a record of therapy compliance. The HIPAA-compliant Vivally Cloud Database collects patient therapy statistics, therapy compliance and symptom tracking over time and can be accessed by the patient and physician as a tool to monitor and manage treatment.
Here is a summary of the acceptance criteria and study information for the Vivally System, based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state pre-defined acceptance criteria for the clinical study in the form of numerical thresholds for responder rates or symptom reduction required for clearance. Instead, it describes what was reported from the study. The FDA's conclusion indicates that the study demonstrated clinically meaningful improvement in UUI and urinary urgency symptoms.
| Effectiveness Metric | Acceptance Criteria (Not explicitly stated as numeric thresholds for clearance, but implied by FDA's conclusion of "clinically meaningful improvement") | Reported Device Performance (12 Weeks) | Reported Device Performance (6 Months) | Reported Device Performance (12 Months) |
|---|---|---|---|---|
| UUI (Urinary Incontinence Events, ≥ 50% improvement) Responder Rate | Implied to be a clinically meaningful percentage | 61.8% | 62.8% | 62.9% |
| Urges (Urinary Urgency Events, ≥ 50% improvement) Responder Rate | Implied to be a clinically meaningful percentage | 55.4% | 69.4% | 69.0% |
| Voiding Frequency (Voiding Events, ≥ 30% improvement) Responder Rate | Implied to be a clinically meaningful percentage | 34.8% | 34.1% | 27.8% |
| Quality of Life (QOL) Assessments | Exceed threshold validated for minimal clinically important difference | All QOL domains exceeded threshold | Not explicitly broken down | Not explicitly broken down |
| Safety | Favorable safety profile, low incidence of severe adverse events | 12 device/procedure related AEs (all mild/moderate), no severe | 1 device-related AE (mild), no severe | Not explicitly detailed |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size (Test Set):
- Intent-to-Treat (ITT) population: 96 subjects
- Evaluable population: 94 subjects
- Per Protocol (PP) population: 73 subjects
- 6-month follow-up: 47 subjects
- 12-month follow-up: 39 subjects
- Data Provenance: Prospective, multi-center study conducted at nine centers within the United States.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
The document describes a clinical study where subjects reported their symptoms using a 3-day bladder diary. There is no mention of external experts establishing the ground truth for the test set. The patients themselves provided the data on their symptoms (UUI, urges, voids) which served as the "ground truth" for assessing effectiveness, as measured by symptom reduction and responder rates against their baseline.
4. Adjudication Method for the Test Set
The document does not describe an adjudication method for the test set. The symptom data was derived from patient-recorded 3-day bladder diaries.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This study was a single-arm clinical trial evaluating the device in a cohort of patients, not comparing human readers' performance with and without AI assistance.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
Yes, the effectiveness outcomes presented are for the device (Vivally System) as a standalone treatment used by the patient at home. While personalization of therapeutic range was set by a physician, and a mobile application and cloud database are part of the system for therapy management and patient/physician access, the effectiveness results are based on the device's direct therapeutic action. The study assessed the device's ability to reduce symptoms and improve QOL.
7. The Type of Ground Truth Used
The ground truth for effectiveness outcomes was based on patient-reported symptoms recorded in a 3-day bladder diary at baseline and various follow-up periods. Quality of Life (QOL) assessments were also patient-reported using validated questionnaires (OAB-q, I-QoL, IIQ-7, PGIC, and OHG).
8. The Sample Size for the Training Set
The document describes a clinical study for product evaluation, not an AI/algorithm development study with distinct "training" and "test" sets in the typical machine learning sense. Therefore, there is no specified "training set" sample size for an algorithm in this context. The clinical study enrolled 96 subjects who served as the study population for evaluating the device's effectiveness.
9. How the Ground Truth for the Training Set Was Established
As there is no distinct "training set" in the context of an AI algorithm, this question is not applicable based on the provided text. The clinical study evaluated the device's performance directly using patient-reported outcomes as the "ground truth."
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