(163 days)
The Diagnostic Fixed Electrophysiology Catheter and Diagnostic Electrophysiology Cable are intended for electrogram recording and pacing during diagnostic electrophysiology studies.
The Diagnostic Fixed Electrophysiology Catheter is a sterile, single-use 2F diagnostic catheter with multiple electrodes and a fixed distal curve. The catheter is intended to be placed in the heart percutaneously for the purpose of temporary cardiac pacing and electrophysiology studies of the heart, such as the coronary sinus and atrioventricular annulus. The catheter is connected to separately cleared diagnostic electrophysiology equipment via an accessory, the Diagnostic Electrophysiology Cable. The cable is supplied sterile and is reusable.
The provided document is a 510(k) summary for a medical device (Diagnostic Fixed Electrophysiology Catheter and Diagnostic Electrophysiology Cable) and primarily focuses on proving substantial equivalence to a predicate device. It does not contain the kind of detailed information about acceptance criteria, specific performance metrics, sample sizes for test/training sets, expert qualifications, or adjudication methods that would be relevant for an AI-powered diagnostic device's performance study.
The performance testing section (page 5) lists various non-clinical verifications and validations (Biocompatibility, Mechanical, Electrical, Bench, Cleaning/Re-Sterilization, Reuse, Animal Studies, Packaging). These are standard tests for the safety and functionality of an electrophysiology catheter and cable, not for evaluating the diagnostic accuracy of an AI algorithm.
Therefore, I cannot extract the requested information regarding acceptance criteria and performance study details for an AI device from this document. The document confirms that "The Diagnostic Fixed Electrophysiology Catheter and accessory cable met all requirements as specified by the test protocols," but these protocols are about device safety and fundamental physical/electrical performance, not diagnostic accuracy of an AI.
§ 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).