(47 days)
The EkoSonic Endovascular System is intended for the infusion of solutions into the pulmonary arteries.
The EkoSonic Endovascular System is an infusion Device designed to deliver fluids via a multi sidehole catheter. The fluid is dispersed via multiple ultrasound transducers distributed linearly along the length of an MicroSonic Device which is placed into the center lumen of the catheter. This device is intended to deliver physician-specified agents or fluids into the peripheral vasculature.
The provided documents are FDA 510(k) letters related to the EKOS EkoSonic Endovascular System. These documents confirm the regulatory classification and substantial equivalence of the device but do not contain information about specific acceptance criteria or the study data proving the device meets those criteria, especially not in the context of an AI/ML-driven device or study.
The description you've requested (acceptance criteria, test set details, expert qualifications, adjudication, MRMC study, standalone performance, ground truth, training set details) is typically found in detailed clinical study reports or 510(k) summaries for AI/ML devices, which this document is not. This document is a regulatory approval letter for a medical device (a catheter system), not an AI algorithm.
Therefore, I cannot fulfill your request using only the provided text. The information is not present in these FDA 510(k) general correspondence letters.
§ 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).