(217 days)
The Occlusion Perfusion Catheter 10 is indicated for localized infusion or irrigation of various diagnostic and therapeutic agents into the peripheral vasculature. It is not indicated for use in the neurovasculature.
Not Found
This looks like a 510(k) clearance letter for a medical device (Occlusion Perfusion Catheter), not a study report or a document detailing acceptance criteria and device performance in the context of an AI/algorithm.
Therefore, I cannot extract the requested information (acceptance criteria table, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth details, or training set information) from the provided text. These details are typically found in a clinical study report, a pre-submission document, or a detailed technical report that supports the 510(k) application, not in the FDA clearance letter itself.
The provided document only states that the device is "substantially equivalent" to legally marketed predicate devices and outlines the indications for use. It does not contain any information about performance testing against specific acceptance criteria for an AI or algorithm.
§ 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).