(112 days)
The UroMed Patch is indicated for the prevention or decrease of urine leakage in women with stress urinary incontinence.
The UroMed Patch is indicated for the prevention or decrease of episodes of urine leakage in women with stress urinary incontinence.
The UroMed Patch is a single use, disposable foam pad that is coated on one side with an adhesive gel. The patch is worn over the urethra between times of unination. The product is intended to prevent unine form escaping the environs of the urethra, and is replaced each time the patient urinates.
The UroMed Patch is a single-use, disposable foam pad with an adhesive gel coating used to prevent or decrease urine leakage in women with stress urinary incontinence.
Here's an analysis of its acceptance criteria and the study proving its effectiveness:
1. Table of Acceptance Criteria and Reported Device Performance:
The submission does not explicitly state acceptance criteria in terms of specific thresholds for improvement or statistical significance for each performance parameter. However, the study results, all achieving a p-value of 0.0001, strongly suggest that the observed improvements were considered statistically significant and indicative of efficacy. The improvements themselves can be interpreted as the de-facto acceptance criteria for clinical effectiveness.
| Parameter | Implied Acceptance Criteria (Demonstrated Improvement) | Reported Device Performance (Improvement vs. Control) | p-value |
|---|---|---|---|
| Mean Number of Leakage Episodes per week | Significant decrease (e.g., >60%) | 65.5%* decrease | 0.0001 |
| Perceived Severity of Leakage | Significant decrease (e.g., >70%) | 71.1% decrease | 0.0001 |
| Impact on Quality of Life | Significant decrease (e.g., >70%) | 71.4% decrease | 0.0001 |
| Leakage (grams/hour) | Significant decrease (e.g., >60%) | 61.1% decrease | 0.0001 |
*Note: The submission mentions an average improvement of 60% when reviewing leakage episodes at weeks 9, 13, and 17, compared to the initially reported 65.5% at 12 weeks. Both are substantial improvements.
2. Sample Size Used for the Test Set and Data Provenance:
The document does not explicitly state the sample size (number of participants) for the clinical testing. It only states that the UroMed Patch has been "extensively tested for its safety and efficacy."
The data provenance (country of origin, retrospective/prospective) is not explicitly stated. However, given the context of a 510(k) submission to the FDA, it is highly likely that the data was collected in a prospective clinical study, most likely within the United States, or at least following good clinical practice (GCP) guidelines.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
This information is not provided in the submission. The clinical study focused on patient-reported outcomes (leakage episodes, perceived severity, quality of life) and objective measurements (leakage in grams/hour). These do not typically involve experts establishing a "ground truth" in the same way an imaging device might (e.g., radiologist consensus).
4. Adjudication Method for the Test Set:
This information is not applicable and therefore not provided, as the study does not involve image interpretation or similar tasks requiring expert adjudication. The primary data points were quantitative measurements and patient self-assessment collected during a standard clinical trial.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not conducted for this device. The UroMed Patch is a therapeutic device for incontinence, and its efficacy is measured by objective physiological parameters and patient-reported outcomes, not by human interpretation of diagnostic cases. Therefore, the concept of human readers improving with or without AI assistance is not relevant here.
6. Standalone (Algorithm Only Without Human-in-the-Loop) Performance:
The concept of "standalone performance" (algorithm only) is not applicable to the UroMed Patch. This device is a physical product directly used by patients, not a diagnostic algorithm. Its performance is assessed through its direct physical effect on reducing urine leakage and its impact on the user.
7. Type of Ground Truth Used:
The ground truth for the clinical study was established using a combination of:
- Objective Physiological Measurements: Leakage measured in grams per hour.
- Patient-Reported Outcomes (PROs):
- Mean number of leakage episodes per week (self-reported).
- Perceived severity of leakage (patient-rated scale).
- Impact on Quality of Life (patient-rated scale).
These measures collectively served as the "ground truth" for assessing the device's efficacy.
8. Sample Size for the Training Set:
This information is not applicable as the UroMed Patch is a physical medical device, not an AI/ML algorithm that requires a "training set." Its development would involve engineering, material science, and possibly in-vitro testing, but not an algorithmic training set in the AI sense.
9. How the Ground Truth for the Training Set Was Established:
This information is not applicable as there is no "training set" in the context of this physical device. The "ground truth" for its development would involve established engineering standards, material properties, and biocompatibility testing criteria (e.g., ISO 10993 for biocompatibility), rather than a statistically derived ground truth for an algorithm.
§ 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.