(176 days)
The Restore device is indicated for the prevention or decrease of episodes of urine leakage in women with stress incontinence.
Restore Female Continence device is a simple, noninvasive suction cup which fits over the urinary meatus. 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 suction. If inadequate suction occurs. Aquaphor or a petroleum based ointment can be applied to the outside rim of the device to enhance suction. 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 intraabdominal and intravesical pressure during valsalva, thereby decreasing or preventing leakage.
Here's an analysis of the NEBL Restore Female Incontinence Device's acceptance criteria and the study used to prove it, based on the provided 510(k) summary:
Acceptance Criteria and Device Performance for NEBL Restore Female Incontinence Device
1. Table of Acceptance Criteria and Reported Device Performance
The 510(k) summary doesn't explicitly state pre-defined acceptance criteria with numerical targets in the same way a device specification document might. Instead, the "acceptance criteria" are implied by the clinical study's objectives: to demonstrate a statistically significant improvement in objective and subjective efficacy measures, and to show the device is safe and well-tolerated.
Here's a table summarizing the reported device performance against these implied criteria:
| Acceptance Criterion (Implied) | Reported Device Performance |
|---|---|
| Efficacy: | |
| Decrease or prevent incontinence episodes (objective) | Pad Weight Test (PdWt): 97% improvement (from 6.67gm to 0.19gm), p = .0001 |
| Provocative Stress Test (PST): 100% improvement (from 2 to 0), p = .0001 | |
| Decrease or prevent incontinence episodes (subjective) | Incontinence Episodes Per Day (IEPD): 91% improvement (from 3.4 to 0.3), p = .0001 |
| Reduce impact of incontinence on quality of life | Incontinence Quality of Life (I-QOL): 45% improvement (from 62.3 to 90.4), p = .0001 |
| Ease of device placement | Satisfaction Survey (placement): 90% found easy to place at first visit, 95% at 3 months (Rate of Positive Response) |
| Ease of device removal | Satisfaction Survey (removal): 100% found easy to remove (Rate of Positive Response) |
| Overall patient satisfaction with performance | Satisfaction Survey (overall): 93% satisfied at first visit, 98% at 3 months (Rate of Positive Response) |
| Safety: | |
| Low incidence of positive urine cultures | Urine cultures: 1.5% prevalence, 3% incidence of positive cultures during device usage (significantly below historic figures of 10-38% for incontinent females) |
| Minimal vaginal irritation | Irritation Questionnaire/Satisfaction Survey (Q8): Mean Response and Rate of Positive Response were "relatively high" (implying low irritation) throughout the study, indicating device was well-tolerated. |
| Few, minimal, and self-limited adverse events (physical exam) | Physical examinations: Adverse events were few, minimal, and self-limited. No therapeutic intervention required, no complications or sequelae. Only 5% withdrew due to vaginal irritation, and even this subgroup showed significant improvement in incontinence while using the device. |
| Biocompatibility, non-toxicity, well tolerated by tissues (non-clinical) | Nonclinical Tests: Materials and product are biocompatible, non-toxic, and well-tolerated by tissues (based on tests like Delayed Contact Sensitization, Cytotoxicity, Irritation Study, Muscle Implantation, etc.). |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: 100 women
- Data Provenance: The study was conducted in the U.S. across 8 Investigational Sites. It is a prospective clinical study as women used the device during a 12-week device usage period, with baseline (Control) measurements taken before device use and follow-up measurements at Week 12.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
The document does not specify the number of experts used to establish the ground truth or their specific qualifications (e.g., "radiologist with 10 years of experience"). For objective tests like Pad Weight Test and Provocative Stress Test, the "ground truth" is inherently quantitative measurement. For subjective measures like the Incontinence Impact Questionnaire and Satisfaction Survey, the patients' own responses constitute the "ground truth." Clinical assessments (physical exams, urine cultures) would have been performed by medical professionals at the investigational sites, but their specific roles or the number involved in establishing a "ground truth" consensus are not detailed.
4. Adjudication Method for the Test Set
The document does not mention a specific adjudication method (e.g., 2+1, 3+1, none) for the test set. Given that the efficacy parameters were statistically analyzed using paired t-test, repeated-measures analysis, and Wilcoxon signed-rank testing, it implies direct measurement and patient reporting rather than a consensus-based adjudication process for the primary endpoints. Clinical safety assessments would have been part of standard clinical practice at each site.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The study described is a single-arm, pre-post comparison of device performance in a cohort of patients. It does not involve multiple human readers evaluating cases or comparing human performance with and without AI assistance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
This question is not applicable as the NEBL Restore device is a physical medical device (a suction cup) worn by patients, not an AI algorithm. Therefore, there is no "algorithm-only" performance to describe.
7. The Type of Ground Truth Used
The ground truth used for the test set was a combination of:
- Objective Measurements:
- Pad Weight Test (PdWt): Direct measurement of urine leakage in grams.
- Provocative Stress Test (PST): A score representing the severity of leakage during specific maneuvers.
- Urine Cultures: Laboratory results for the presence of bacteriuria.
- Subjective Patient-Reported Outcomes:
- Voiding Diary: Patient-reported number of incontinence episodes per day (IEPD).
- Incontinence Impact Questionnaire (I-QOL): Patient-reported quality of life scores.
- Satisfaction Survey: Patient-reported satisfaction with ease of placement/removal, performance, comfort, and tolerability (e.g., vaginal irritation).
- Clinical Observations:
- Physical Examinations: Observations by medical professionals regarding adverse events.
8. The Sample Size for the Training Set
The document does not mention a "training set" in the context of device development. This term is primarily relevant for machine learning algorithms. For a physical medical device like the Restore, the "training" typically refers to engineering design iterations and perhaps pilot or feasibility studies. The clinical study of 100 women serves as the primary evaluation of the final device design.
9. How the Ground Truth for the Training Set Was Established
As there is no "training set" described for an AI algorithm, this question is not applicable. For the physical device, the "ground truth" during its development phases would have been established through a combination of engineering testing, user feedback on prototypes, and nonclinical studies (e.g., biocompatibility) to refine the design before formal clinical efficacy trials.
§ 876.5160 Urological clamp.
(a)
Identification. A urological clamp for males is a device used to close the urethra of a male to control urinary incontinence or to hold anesthetic or radiography contrast media in the urethra temporarily. It is an external clamp.(b)
Classification. Class I (general controls). Except when intended for internal use, the device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.