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The Restore Continence Device is an external female continence device indicated for the management of urinary leakage in women suffering from stress urinary incontinence. Although it can help control urinary incontinence, it will not correct the underlying cause of the condition.

The Restore Female Continence device is a simple, non invasive suction cup device which fits over the urinary meatus. Similar to a suction cup, air is squeezed out of the device's cap while it is positioned over the urinary meatus. When the cap is released, the device self-adheres to the anterior vaginal wall over the meatus via self-suction. If inadequate suction occurs, Aquaphor or an equivalent ointment can be applied to the outside rim of the device to enhance adhesion. The suction or negative pressure created by the device causes coaptation and occlusion of the meatus and therefore, increased urethral resistance. The amount of negative pressure generated by the device is optimized to counteract increases in intra-abdominal and intravesical pressure during valsalva thereby decreasing or preventing leakage.

The NEBL Restore Female Continence Cap is a device designed to manage urinary leakage in women suffering from stress urinary incontinence.

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

1. Table of Acceptance Criteria and Reported Device Performance:

Note: The document does not explicitly state pre-defined acceptance criteria values in the way a modern regulatory submission might. Instead, it presents baseline (Control) measurements and then demonstrates statistically significant improvement in the device utilization period. The "acceptance criteria" here are interpreted as the baseline performance levels that the device aims to significantly improve upon.

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

• Sample Size: 100 women.
• Data Provenance: The study was conducted at "Investigational Sites in the U.S." This indicates the data is from the United States and is prospective, as it involves the use of the device over a 12-week period.

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

The document does not specify the number of experts or their qualifications for establishing ground truth for the clinical tests (PdWt, PST, IEPD, I-QOL), as these are objective and subjective measurements rather than interpretations by experts.

4. Adjudication Method for the Test Set:

Not applicable, as the tests involve objective measurements (Pad Weight, Provocative Stress Test, Incontinence Episodes Per Day) or patient self-reporting (I-QOL, satisfaction surveys) rather than expert adjudication of qualitative data.

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

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not performed. The study focuses on the device's effectiveness compared to a baseline (control) measurement in individual patients, not on comparing performance between human readers with and without AI assistance. The device itself is not an AI system.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:

Yes, in a sense. The described efficacy tests (PdWt, PST, IEPD, I-QOL) measure the direct physical and perceived impact of the device on the patient's incontinence. There isn't an "algorithm" in the modern AI sense, but the device's physical mechanism of occlusion is being tested standalone without human intervention affecting its core function once applied. The study assesses the device's inherent ability to reduce or prevent incontinence.

7. Type of Ground Truth Used:

The ground truth for the clinical study was established using a combination of:

• Objective Measures:
  • Pad Weight Test (PdWt): A quantitative measure of urine leakage.
  • Provocative Stress Test (PST): A measure of leakage under stress conditions.
• Subjective Measures (Patient-Reported Outcomes):
  • Voiding Diary: Documenting the number of incontinence episodes per day (IEPD).
  • Incontinence Impact Questionnaire (I-QOL): Measuring the impact of incontinence on quality of life.
  • Satisfaction Survey: Evaluating aspects like function, comfort, and ease of use.
• Safety Data: Urine cultures (for bacteriuria), irritation questionnaires, and periodic physical examinations.

8. Sample Size for the Training Set:

Not applicable. The NEBL Restore Female Continence Cap is not an AI device that requires a training set. It is a physical medical device. The "training" in the context of this device refers to patients becoming more proficient with device placement, not an algorithmic training process.

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

Not applicable, as there is no training set for an AI algorithm.

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