(22 days)
The FoxCross PTA Catheter is intended for dilatation of lesions in the femoral, renal, iliac, popliteal, peroneal, and profunda arteries and native or synthetic arteriovenous dialysis fistulae. This catheter is not intended for the expansion or delivery of stents.
The FoxCross PTA Catheter is a standard over-the-wire PTA catheter. The double lumen catheter has a balloon located near the distal tip. One lumen is used for inflation of the balloon, while the second lumen allows access to the distal tip of the catheter for guide wire insertion (max 0.035''). The balloon has two radiopaque markers for positioning the balloon relative to the stenosis. The balloon material expands to a known diameter at specific pressures.
The provided text is a 510(k) summary for the FoxCross PTA Catheter and describes its substantial equivalence to predicate devices, but it does not contain information about acceptance criteria or a study proving that the device meets specific performance criteria through a clinical trial or algorithm evaluation.
Instead, the document states: "The results of the in vitro bench tests and analyses demonstrate the safety and effectiveness of the FoxCross PTA Catheter Line Extension." This indicates that the device's safety and effectiveness were demonstrated through bench testing and analyses, not through a clinical study with human subjects, an MRMC study, or a standalone algorithm performance study.
Therefore, I cannot provide the requested information in the table format because the details are not present in the provided text.
Here's an explanation of why the requested information cannot be extracted:
- Acceptance Criteria and Reported Device Performance: This information is typically found in a clinical study report or a detailed summary of verification and validation testing, which is not included here. The document only mentions "in vitro bench tests and analyses" in general terms.
- Sample size for test set and data provenance: No test set is described, as the evaluation was based on bench tests.
- Number of experts and qualifications: Not applicable, as there was no study involving human readers or expert ground truth establishment for a test set in the context of an algorithm.
- Adjudication method: Not applicable.
- Multi Reader Multi Case (MRMC) comparative effectiveness study: No such study is mentioned or implied.
- Standalone (algorithm only) performance: This device is a physical medical device (a catheter), not an algorithm or AI. Therefore, standalone algorithm performance is not relevant.
- Type of ground truth used: Not applicable for this type of device and evaluation.
- Sample size for training set: Not applicable for this type of device.
- How ground truth for training set was established: Not applicable.
§ 870.1250 Percutaneous catheter.
(a)
Identification. A percutaneous catheter is a device that is introduced into a vein or artery through the skin using a dilator and a sheath (introducer) or guide wire.(b)
Classification. Class II (performance standards).