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510(k) Data Aggregation
(62 days)
INSIGHT MEDICAL CORP.
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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(391 days)
INSIGHT MEDICAL CORP.
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).
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