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510(k) Data Aggregation
(62 days)
FEMASSIST FLEXIBLE
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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