(43 days)
The Bashir™ Plus Endovascular Catheters are intended for the controlled and selective infusion of physician-specified fluids, including thrombolytics, into the peripheral vasculature.
The Bashir™ Plus Endovascular Catheter is a continuous flush catheter designed to enable delivery of physician-specified fluids, including thrombolytics, into the peripheral circulation. There are four models of the Bashir™ Plus Endovascular Catheter, (Ref. No. 7210, 7220, 7230, 7240). The design of the Bashir™ Plus Endovascular Catheter allows for delivery and positioning of the catheter at the target peripheral location via a sheath, over a guidewire using fluoroscopic guidance. Depending on the target location, the infusion can be initiated into a distal infusion basket via the Basket Port either in the non-expanded position (for vessels with smaller diameters), or by controlled expansion of the infusion basket to a desired dimension inside the vessel by the interventional specialist under fluoroscopic guidance. The physician-specified solution is delivered via multiple laserdrilled holes through the infusion limbs of the Bashir™ Plus Endovascular Catheter after placement.
The Bashir™ Plus Endovascular Catheter has a second Shaft Port, for delivery of infusion solutions into the shaft lumen where multiple laser-drilled holes cover 10 cm of length (Ref. No. 7210), 20 cm (Ref. No. 7220), 30 cm (Ref. No. 7230) or 40 cm (Ref. No. 7240).
After the completion of solution delivery, the infusion limbs are collapsed to a straight position and then the Bashir™ Plus Endovascular Catheter is retracted into the sheath and removed.
The Bashir™ Plus Endovascular Catheter is comprised of common materials used in vascular catheters. The catheter is mechanical and contains no electrical components.
I apologize, but the provided text does not contain information about the acceptance criteria and the study that proves a device meets these criteria in the context of an AI/human reader performance study. The document is an FDA 510(k) clearance letter for a medical device called the "Bashir Plus Endovascular Catheter," which is a physical device used for infusing fluids into the peripheral vasculature.
The text describes:
- The device's intended use and mechanism of action.
- Regulatory information (product codes, classification).
- Comparison to a predicate device.
- General information about the submitter and correspondent.
It does not include any details related to:
- Performance metrics for an AI system.
- Acceptance criteria for an AI system's performance.
- Description of a study involving human readers or AI assistance.
- Sample sizes for test or training sets for an AI.
- Ground truth establishment methods for AI datasets.
- MRMC studies or effect sizes of AI assistance.
- Standalone AI performance.
Therefore, I cannot fulfill your request for the specific information regarding AI performance studies based on the provided text.
§ 870.5150 Embolectomy catheter.
(a)
Identification. An embolectomy catheter is a balloon-tipped catheter that is used to remove thromboemboli, i.e., blood clots which have migrated in blood vessels from one site in the vascular tree to another.(b)
Classification. Class II (performance standards).