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510(k) Data Aggregation
(243 days)
The Miniguard is an external female continence device that is applied to the urinary opening to prevent or decrease episodes of stress incontinence occurs when intraabdominal pressure exceeds urethral resistance as a result of physical stress such as coughing, laughing, or lifting heavy objects. The Miniguard is designed for women who experience urine leakage under conditions of physical stress.
The Miniguard female continence device consists of a small pad that is coated on one side with a biocompatible polymer adhesive. The Miniguard is an external management device that is applied to the urinary opening to prevent or decrease episodes of stress incontinence. The Miniguard's function is to provide occlusion of the urinary opening by creating a seal over the urinary opening. The foam pad backing is intended to facilitate application and removal and for user comfort.
The Advanced Surgical Intervention (ASI) Miniguard Female Continence Device was evaluated for its safety and efficacy in decreasing urinary leakage episodes and improving quality of life in women with stress incontinence.
1. Table of Acceptance Criteria & Reported Device Performance:
The document doesn't explicitly state "acceptance criteria" in a pass/fail format per se, but rather presents the statistically significant improvements as the measure of effectiveness. I've re-framed the reported performance as meeting implied criteria for significant improvement.
| Hypothesis / Study Endpoint | Implied Acceptance Criterion (Significant Improvement) | Reported Device Performance (Average % Improvement) | Statistical Significance (Prob> T) |
|---|---|---|---|
| Overall Efficacy (All participants) | |||
| 1. Decrease in No. of Leakage Episodes (per week) | Statistically and clinically significant decrease | 65.5% decrease | ≤0.0001 |
| 2. Reduction in Perceived Severity of Leakage | Statistically and clinically significant reduction | 71.1% reduction | <0.0001 |
| 3. Reduction in Impact on Quality of Life | Statistically and clinically significant reduction | 71.4% reduction | <0.0001 |
| 4. Reduction in Quantity of Leakage (grams/hr) | Statistically and clinically significant reduction | 61.1% reduction | <0.0001 |
| Safety | |||
| No adverse effect on bladder function | No clinically significant changes | No clinically significant changes noted | Not explicitly stated (qualitative) |
| No increased incidence of vaginal infection | No increased incidence | No increased incidence | Not explicitly stated (qualitative) |
| No increased incidence of urinary tract infection | No increased incidence | No increased incidence | Not explicitly stated (qualitative) |
| Well-tolerated by intralabial mucosa | No significant dermatologic effects | Well-tolerated, no significant dermatologic effects | Not explicitly stated (qualitative) |
| Minimal increase in irritation symptoms | Minor and manageable irritation | Minor increase, majority continued use without intervention | Not explicitly stated (qualitative) |
2. Sample size used for the test set and the data provenance:
- Test Set Sample Size: Over 350 women.
- Broken down by incontinence severity: 124 women (mild), 163 women (moderate), and 69 women (severe).
- Data Provenance: The study was conducted from 12 investigative centers in the United States. It was a prospective study, as women used the device during a 12-week device usage period, with data collected before (Control) and after (Trial 17) this period.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
The document does not specify the number of experts used to establish the ground truth for the test set efficacy outcomes. The efficacy data (number of leakage episodes, perceived severity, quality of life impact, quantity of leakage) were derived from participant-completed voiding diaries, symptom questionnaires, incontinence impact questionnaires, and 12-hour home pad-weight tests. These are subjective and objective measures directly from participants, not externally interpreted "ground truth" established by experts in the same way, for example, a diagnosis from an image would be.
However, for safety data analysis, independent expert teams were utilized:
- Bladder function data: Assessed by leading urologists and urogynecologists.
- Microbiology data: Assessed by a core laboratory at the University of Washington specializing in urogenital microflora.
- Dermatology data: Assessed by an expert in dermatology and gynecology at Emory University.
The specific number of experts within these teams is not provided, nor are their years of experience explicitly stated beyond "leading" and "expert."
4. Adjudication method for the test set:
Not applicable in the context of this device. The "test set" involves patient-reported outcomes and objective measurements (pad-weight test) over time, rather than discrete classifications requiring adjudicators. Clinical outcome parameters were statistically analyzed (paired-t analyses, repeated-measures MANOVA), not adjudicated.
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:
Not applicable. This is not an AI-based diagnostic device. The study evaluates the effectiveness of a physical continence device for patients, not the performance of human readers of medical images or data.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
Not applicable. This is a physical medical device for managing incontinence, not an algorithm.
7. The type of ground truth used:
The "ground truth" for efficacy was established through a combination of:
- Patient-reported outcomes: Voiding diaries, symptom questionnaires, and incontinence impact questionnaires. These reflect the patient's subjective experience and perception of their condition.
- Objective measurement: 12-hour home pad-weight tests to quantify urine leakage.
For safety, the ground truth was based on medical assessments (post-void residual measurements, cystometry, vaginal smears, vaginal and urine cultures, urinalysis, physical examinations, vestibular cytology), confirmed by independent expert review.
8. The sample size for the training set:
Not applicable. This is a physical medical device, not a machine learning algorithm that requires a training set. The clinical study of 350+ women served as the primary evidence for the device's performance.
9. How the ground truth for the training set was established:
Not applicable, as there is no training set for a machine learning algorithm.
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