(29 days)
The Achieve Advance mapping catheter is indicated for multiple electrophysiological mapping of the cardiac structures of the heart, i.e. recording or stimulation only. The Achieve Advance mapping catheter is designed to obtain electrograms in the atrial regions of the heart.
The Achieve Advance Mapping diagnostic catheter is an intra-cardiac electrophysiology recording catheter and can be used for cardiac stimulation during electrophysiology studies. The distal mapping section of the Achieve Advance Mapping Catheter is a circular loop with evenly spaced electrodes to map electrical conduction within the atrium. The Achieve Advance Mapping Catheter is available in a 15mm, 20mm, or 25mm pre-shaped distal loop diameter.
I am sorry, but the provided text does not contain the information required to answer your request. The document is primarily a 510(k) summary for a medical device (Achieve Advance Mapping Catheter) and focuses on demonstrating substantial equivalence to a predicate device. It lists design features and the types of performance testing conducted (bench testing), but does not detail acceptance criteria or specific study results in the manner requested for an AI/ML device. There is no mention of an algorithm or AI component, human reader studies, ground truth establishment, or training/test set sizes.
§ 870.1220 Electrode recording catheter or electrode recording probe.
(a)
Identification. An electrode recording catheter or an electrode recording probe is a device used to detect an intracardiac electrocardiogram, or to detect cardiac output or left-to-right heart shunts. The device may be unipolar or multipolar for electrocardiogram detection, or may be a platinum-tipped catheter which senses the presence of a special indicator for cardiac output or left-to-right heart shunt determinations.(b)
Classification. Class II (performance standards).