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510(k) Data Aggregation
(59 days)
ELITONE Urge is a non-implanted muscle stimulator designed to treat urge urinary incontinence in women. It applies stimulation to the pelvic floor muscles and surrounding tissues.
The ELITONE Urge Urinary Incontinence Device (hereafter ELITONE URGE or ELITONE UUI) provides electrical muscle stimulation (commonly called EMS or E-stim) to treat urge urinary incontinence. Stimulation is delivered to the pelvic floor muscles and surrounding structures through a disposable cutaneous electrode applied to the perineal region. One end of the thin, flexible electrode is positioned proximate the pubis and the other end is positioned proximate the ischial tuberosity. Mildly adhesive and electrically conductive hydrogel portions of each electrode to the perineal tissues and allow comfortable transfer of electrical stimulation through the pelvic floor. The stimulation is controlled by a battery powered, wearable control unit. The housing of the control unit is approximately 55mm x 45mm x 10mm. It includes two pushbuttons that allow the user to increment the voltage (i.e., intensity), and to start, pause and stop device operation. The stimulation utilizes a symmetric, amplitude-modulated, sinusoidal waveform. The output intensity operates over a range of levels (0-35) that approximately correspond to a 0-15mA RMS current. The stimulation frequency is 10 Hz, a frequency typically used to calm detrusor muscle activity, decreasing symptoms of urgency type incontinence. Each treatment session lasts 20 minutes, after which the device turns off automatically. Women are recommended to use the device 4-5 times per week.
The Elidah ELITONE Urge Urinary Incontinence Device (ELITONE UUI) is a non-implanted muscle stimulator designed to treat urge urinary incontinence in women. The device applies stimulation to the pelvic floor muscles and surrounding tissues.
Here's an analysis of its acceptance criteria and the study that proves it meets them:
1. Acceptance Criteria and Reported Device Performance
The acceptance criteria for the ELITONE UUI device are primarily based on achieving significant reductions in key symptoms of urge urinary incontinence and maintaining a good safety profile. These criteria and the reported performance are summarized below:
| Acceptance Criteria (Primary Efficacy Endpoint) | ELITONE UUI Reported Performance |
|---|---|
| ≥50% reduction in urge leaks per day | 76% of participants responded |
| Acceptance Criteria (Secondary Efficacy Endpoints) | ELITONE UUI Reported Performance |
|---|---|
| ≥50% reduction in urgency episodes | 76% of participants responded |
| ≥50% reduction in pad use | 32% of participants responded |
| ≥2.5 points change in I-QoL score | 91% of participants responded |
| Acceptance Criteria (Safety Endpoint) | ELITONE UUI Reported Performance |
|---|---|
| Proportion of adverse events that result in an injury or require medical treatment | None reported |
2. Sample Size and Data Provenance for the Test Set
- Sample Size for Test Set: 34 subjects
- Data Provenance: The clinical testing was conducted on women with urge urinary incontinence in the U.S. The study was prospective in nature, with subjects self-administering treatment for 6-weeks.
3. Number of Experts and Qualifications for Ground Truth
The document does not explicitly state the number of experts used to establish the ground truth or their qualifications. The study design was a single-arm study where the patient served as their own control (comparison to baseline). This suggests that the ground truth for individual symptom reduction was self-reported by the participants based on their baseline data and data collected during treatment.
4. Adjudication Method for the Test Set
The document does not describe an adjudication method involving multiple experts for the test set. Given the self-reported nature of the primary and secondary endpoints (urge leaks per day, urgency episodes, pad use, and I-QoL score), it appears that participant self-reporting against a pre-treatment baseline served as the primary measure.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No Multi-Reader Multi-Case (MRMC) comparative effectiveness study was mentioned. The study focused on the effectiveness of the device itself rather than comparing human reader performance with and without AI assistance.
6. Standalone Performance Study
Yes, a standalone clinical performance study was conducted. The study evaluated the ELITONE UUI device by itself without a human-in-the-loop component. The device is intended for self-administration.
7. Type of Ground Truth Used
The primary ground truth used for efficacy was patient self-reported data against a baseline.
- Primary Efficacy Endpoint: Percent change in urge leaks per day was determined by comparing 7-day baseline data with data from the 6th week of treatment.
- Secondary Efficacy Endpoints: Changes in urgency episodes, pad use, and I-QoL score were similarly assessed by comparing pre-treatment baseline data to and data from the 6th week of treatment.
- Safety Endpoint: Self-reported adverse events that resulted in an injury or required medical treatment.
8. Sample Size for the Training Set
The document does not mention a separate "training set" in the context of an algorithm or AI model development. The clinical study described served as the primary evidence for the device's efficacy and safety for regulatory submission.
9. How the Ground Truth for the Training Set was Established
Since no separate training set for an AI algorithm is explicitly mentioned, this question is not directly applicable in the context of the provided information. The "training" of the device's effectiveness was evaluated through the described clinical study.
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