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510(k) Data Aggregation
(30 days)
The FemVue™ Cornual Balloon Catheter is intended for the delivery of contrast media during hysterosalpingogram (HSG) and saline infusion hysterosonography (SIS) for the evaluation of the fallopian tube(s) selectively and/or the uterus. The following are some clinical indications: suspected polyps, fibroids, adhesions, or endometrial thickening, and/or the selective evaluation of fallopian tube patency.
The FemVue Cornual Balloon Catheter ("FCBC") is a latex-free Balloon Catheter within a transcervical Delivery Sheath.
Here's a breakdown of the requested information based on the provided text:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Biocompatibility (cytotoxicity, irritation, sensitization, acute systemic toxicity) | Met (tested by ISO 10993 methods) |
| Tensile strength of joint bonds | Met (tensile testing performed) |
| Component functionality | Met (tested) |
| Inflation balloon integrity | Met (tested) |
| Substantially equivalent in functionality, safety, and effectiveness to predicate device (K083690) | Achieved (based on non-clinical methods listed above and FDA's substantial equivalence determination) |
Note: The document explicitly lists the types of tests performed to demonstrate substantial equivalence but does not provide specific numerical acceptance criteria (e.g., "tensile strength of X Newtons") or the exact numerical results for the device performance. The FDA's clearance indicates that the device met the necessary criteria for substantial equivalence.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document describes non-clinical testing only. Therefore, there is no human subject test set in the traditional sense of a clinical study described in this submission. The tests performed are engineering and bench-top tests of the physical device.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not applicable. This submission relies solely on non-clinical, bench-top testing. There were no human experts establishing ground truth for a clinical test set.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. There was no clinical test set requiring adjudication.
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 device is a catheter for delivering contrast media, not an AI-powered diagnostic tool. No MRMC study was performed.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a medical device (catheter), not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable for a clinical ground truth. For the engineering tests, the "ground truth" was established by the specifications and performance characteristics of the predicate device and relevant international standards (e.g., ISO 10993 for biocompatibility).
8. The sample size for the training set
Not applicable. This device is not an AI/machine learning algorithm that requires a training set. The tests performed are for a physical medical device.
9. How the ground truth for the training set was established
Not applicable. As noted above, there is no training set for this type of device.
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