(28 days)
The Thrombuster II Aspiration Catheter is indicated for the removal and thrombi from vessels in the coronary and peripheral system. The Thrombuster II is not in the cerebral vasculature.
Thrombuster II Aspiration Catheter [Thrombuster II] is a rapid exchange type of dual lumen catheter for embolectomy. The main body consists of a distal shaft, proximal shaft, ring marker, hub, and strain relief. The catheter working length is 1400 mm. This product includes a core wire to resist kink during delivery in clinical usage, syringe kit (extension tube, stopcock, and lock syringe) for connecting the catheter main body and aspiration of fresh, soft emboli and thrombi, and accessories (flushing needle and filter). After insertion of the catheter into a patient body, this product aspirates and removes emboli or thrombi from a target lesion by transmitting negative pressure generated by connected lock syringe to the distal end of the catheter.
Apologies, but the provided text from the FDA 510(k) Premarket Notification for the Thrombuster II Aspiration Catheter does not contain any information regarding acceptance criteria or the study that proves the device meets those criteria from the perspective of an AI/ML medical device.
The document describes the physical medical device (a catheter for removing thrombi) and its substantial equivalence to a predicate device based on engineering performance testing (trackability, dimensional verification, aspiration performance).
Therefore, I cannot fulfill your request to populate the table or answer the questions related to AI/ML device acceptance criteria, study details, sample sizes, expert involvement, or MRMC studies. The content simply does not address these topics as it is about a non-AI medical device.
§ 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).