(391 days)
The FemAssist™ is an external female continence device indicated for the management of urinary leakage in women suffering from stress urinary incontinence (SUI).
The FemAssist™ device is a small (3.5cm in diameter) cylindrical device with a short profile (2.0cm in height) designed and constructed (molded) to fit over the female urethra, between the labia, posterior to the clitoris and anterior to the vagina. The FemAssist™ supports and reinforces the natural action of the muscles that control urine output and prevents accidental urine loss. The female urethra is located between the vagina and the clitoris, in the center of the area about 3cm in diameter. The FemAssist™ product is place by it's own mild vacuum action.
Here's a breakdown of the acceptance criteria and study information for the FemAssist™ Urinary Incontinence Device, based on the provided text:
Acceptance Criteria and Device Performance
| Acceptance Criteria (Measured Outcome) | Reported Device Performance |
|---|---|
| Clinical Effectiveness: Achieve at least a 50% reduction in urine loss during a one-hour standard pad weight test. | 76.7% of women achieved at least a 50% or greater reduction in urine loss. |
| Clinical Effectiveness: Maintain dryness for a high percentage of days while using the device (as recorded in a one-week voiding diary). | Women remained dry for approximately 65.9% of the recorded days. |
| Clinical Safety: Low incidence of reported adverse events such as discomfort, urinary tract infection, urethral irritation, bleeding, discharge, and yeast infection over 30 days of use. | Discomfort: 35% |
| Urinary Tract Infection: 10% | |
| Urethral Irritation: 6% | |
| Bleeding: 5% | |
| Discharge: 3% | |
| Yeast Infection: 1% | |
| Biocompatibility Testing: Device materials must pass a range of biocompatibility tests to ensure safety for human contact (e.g., microbial limits, mutagenicity, toxicity, sensitization, cytotoxicity, pyrogen, hemolysis, mucosal irritation, muscle implantation with histopathology). | NAmSA Microbial Limits Preparatory Test (Staphylococcus Aureus, Pseudomonas Aeruginosa, Escherichia Coli, Salmonella Typhimurium), NAmSA Microbial Limits Screening, NAmSA Ames Salmonella/Mammalian Microsome Mutagenicity Assay, NAmSA USP Intracutaneous Toxicity Test, NAmSA Delayed Contact Sensitization Study, NAmSA Cytotoxicity Testing, NAmSA Pyrogen Test, NAmSA Hemolysis Test in Vitro, NAmSA Vaginal Mucosal Irritation Study (Saline and Cottonseed Oil Extracts), USP Muscle Implantation (4, 9, and 13 weeks with Histopathology). |
| Benchtop Safety & Performance Testing: Device must withstand specified mechanical and functional tests (e.g., tensile test, pull test, lift off pressure test, vacuum test, water leakage test) to ensure structural integrity and proper function. | Tensile Test, Pull Test, Lift Off Pressure Test, Vacuum Test, Water Leakage Test. (Specific pass/fail criteria or quantitative results not provided in the summary, only that these tests were performed.) |
Study Details
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Sample size used for the test set and the data provenance:
- Clinical Efficacy Test Set: Data from 73 women from one clinical site.
- Clinical Safety Test Set: 222 women initially enrolled. 138 patients were followed for at least 30 days. Data was collected at three (3) US sites.
- Data Provenance: United States (US sites), prospective clinical study.
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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 or qualifications of experts used to establish ground truth for the clinical study. The effectiveness measure (pad weight test) and adverse event reporting would likely have involved clinical personnel (doctors, nurses) at the study sites, but their specific roles in "ground truth establishment" are not detailed.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- The document does not describe any specific adjudication method for the clinical test set data. Adverse events were "obtained from voiding diaries and physician visits," and pad weight tests are objective measurements.
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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:
- This was not an AI-based device, nor was it a multi-reader, multi-case study. It's a medical device for urinary incontinence.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- This question is not applicable as the device is a physical, external medical device and not an algorithm or AI system. Its performance is tested entirely standalone (device only) as it's designed to be used by the patient without the need for human intervention or interpretation beyond initial fitment and instructions.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Clinical Effectiveness: Objective measurements - urine leakage measured by the change in pad weight (standardized one-hour pad weight test) and patient self-reported dryness days from voiding diaries.
- Clinical Safety: Patient self-reported adverse events (from voiding diaries) and physician observations during visits.
- Biocompatibility/Benchtop: Pass/fail criteria established by recognized standards (NAmSA, USP) for laboratory tests.
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The sample size for the training set:
- The concept of a "training set" is not applicable here as this is a physical medical device, not a machine learning model.
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How the ground truth for the training set was established:
- Not applicable (see point 7).
§ 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.