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510(k) Data Aggregation
(82 days)
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(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.
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(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.
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(62 days)
The INSIGHT Medical FemAssist™ Flexible is an external female continence device indicated for the management of urinary leakage in women suffering from stress urinary incontinence (SUI).
The INSIGHT Medical FemAssist™ device consists of a small, flexible, cylindrical, non-sterile device with a short profile which is manufactured from soft silicone material. The FemAssist™ fits over the external female urethral opening, between the labia, posterior to the clitoris and anterior to the vagina. The FemAssist™ is placed directly over the urettral opening where it is held in place by its own mild vacuum action, supporting and reinforcing the natural action of the muscles that control wine output and preventing accidental urine loss. Aquaphor oinment is applied to the device flange area prior to placing it over the urethral opening to help achieve a good seal. The flange area of the FemAssist™ Flexible device is thimer than that of the standard FemAssist™ cleared in K963858 for increased patient comfort.
Here's an analysis of the provided text regarding the acceptance criteria and study for the FemAssist™ Flexible device:
Acceptance Criteria and Device Performance Study
The provided 510(k) summary for the INSIGHT Medical Corp. FemAssist™ Flexible describes a device intended to manage stress urinary incontinence (SUI) in women. The acceptance criteria and supporting studies focus on physical characteristics, safety, and a limited clinical evaluation.
1. Table of Acceptance Criteria and Reported Device Performance
The document doesn't explicitly define quantitative acceptance criteria for the clinical performance, but rather focuses on equivalence to a predicate device and positive patient feedback. For physical characteristics, the acceptance criterion is equivalence to the predicate device.
| Acceptance Criteria Category | Specific Criteria (Implicit/Explicit) | Reported Device Performance |
|---|---|---|
| Physical Characteristics | Tensile strength equivalent to predicate FemAssist™ | Demonstrated equivalence |
| Pull-off force equivalent to predicate FemAssist™ | Demonstrated equivalence | |
| Lift-off pressure equivalent to predicate FemAssist™ | Demonstrated equivalence | |
| Clinical Efficacy | Reduction in urine leakage (quantitative) | 5 out of 14 patients achieved quantitative improvement |
| Patient satisfaction/comfort (subjective) | 2 additional women liked the device, another found it more comfortable (even without full leakage control during strenuous activity) | |
| Overall effectiveness in controlling urine loss (subjective) | 2 remaining patients reported effectiveness | |
| Biocompatibility | Materials identical to predicate device (implied acceptable biocompatibility) | Materials identical to predicate device; no new testing performed |
| Safety | No adverse events reported (implied) | Not explicitly stated, but "safe and effective" conclusion implies no significant safety issues found within the study. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size (Clinical Test Set): 14 women.
- Data Provenance: Retrospective (early 1997) market evaluation conducted at the Peakhurst Community Health Centre, Peakhurst, New South Wales, Australia.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
The document does not specify the number or qualifications of experts used to establish ground truth for the clinical test set. The clinical evaluation primarily relies on quantitative 1-hour pad weight testing and patient self-reporting for subjective feedback.
4. Adjudication Method for the Test Set
The document does not describe any formal adjudication method beyond the quantitative pad weight testing and subjective patient reports. There's no mention of expert consensus or arbitration for ambiguous cases.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No. A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not conducted for this device. The evaluation was a clinical market evaluation with patients.
6. Standalone (Algorithm Only) Performance Study
No. This device is a physical medical device, not an algorithm or AI. Therefore, a standalone (algorithm only) performance study was not applicable and not performed.
7. Type of Ground Truth Used (Clinical Test Set)
The ground truth for the clinical test set was a combination of:
- Quantitative Outcome Data: Reduction in urine leakage measured by 1-hour pad weight testing.
- Patient-Reported Outcomes (PROs): Subjective feedback on comfort, liking the device, and perceived effectiveness in controlling urine loss.
8. Sample Size for the Training Set
The document does not mention a separate "training set" in the context of device development or clinical evaluation. The initial "standard" FemAssist™ device (K963858) would have undergone its own development and testing, which might be considered an ancestral "training" for the modified Flexible version, but no specific data is provided. This device is a physical product, not an AI/ML algorithm that typically uses training datasets.
9. How the Ground Truth for the Training Set Was Established
As there is no mention of a training set in the context of AI/ML, this question is not applicable to the information provided for this medical device. The "ground truth" for the predicate standard FemAssist™ would have been established via its own development and clinical evaluation processes, which are not detailed in this submission for the modified Flexible device.
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(217 days)
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:
| Test | Acceptance Criteria (Control) | Reported Device Performance (Week 12) | % Improvement | P-value |
|---|---|---|---|---|
| Pad Weight Test (PdWt) | 6.67gm | 0.19gm | 97% | <.0001 |
| Provocative Stress Test (PST) | 2 | 0 | 100% | <.0001 |
| Incontinence Episodes Per Day (IEPD) | 3.4 | 0.3 | 91% | <.0001 |
| Incontinence-Specific Quality of Life (I-QOL) | 62.3 | 90.4 | 45% | <.0001 |
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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(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
-
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.
-
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.
-
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.
-
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.
-
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.
-
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.
-
How the ground truth for the training set was established:
- Not applicable (see point 7).
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(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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