(309 days)
The Advisor™ FL Circular Mapping Catheter, Sensor Enabled™ is a sensor-enabled steerable electrophysiology catheter used for recording intracardiac signals and cardiac stimulation during diagnostic electrophysiology studies. The catheter can be used to map the atrial regions of the heart.
The catheter is used with the EnSite Precision™ System to combine and display magnetic processed patient positioning and navigation mapping information.
The catheter is used with the MediGuide™ Technology system to enable real-time positioning and navigation. The MediGuide™ Technology system is indicated for use as an adjunct to fluoroscopy.
Advisor FL Circular Mapping Catheter, Sensor Enabled (Advisor FL, SE) is a circular mapping catheter for performing electrophysiology mapping procedures and providing pacing signals to the heart during electrophysiology procedures. The catheter handle and shaft design allows for improved maneuverability. A magnetic sensor in the distal shaft pocket provides compatibility with visualization and navigation systems. The catheter is compatible with SJM's EnSite™ Precision™ Cardiac Mapping system or MediGuide™ System (MG).
The provided document is a 510(k) Premarket Notification for the St. Jude Medical Advisor™ FL Circular Mapping Catheter, Sensor Enabled™. This document describes a medical device, specifically an electrophysiology catheter, and its substantial equivalence to previously marketed devices. It outlines the device's intended use, technological characteristics, and results from non-clinical testing.
However, the document does not contain the information requested in the prompt regarding acceptance criteria and a study proving a device meets those criteria in the context of an AI/ML medical device. The provided text details:
- Device Type: An electrophysiology catheter, which is a physical medical device, not an AI/ML algorithm.
- Study Type: Bench and animal testing, focusing on physical and electrical properties, biocompatibility, and functional aspects of the catheter. There is no mention of an AI/ML model, its performance metrics (accuracy, sensitivity, specificity), or how it assists human readers.
- Comparison Method: Substantial equivalence to predicate devices based on shared intended use and technological characteristics, as demonstrated through non-clinical testing. This is different from proving an AI/ML algorithm meets specific performance acceptance criteria against a ground truth.
Therefore, I cannot extract the requested information (table of acceptance criteria with reported performance, sample sizes for test/training sets, expert details for ground truth, adjudication methods, MRMC studies, standalone performance, type of ground truth used for AI) from the provided text, as it describes the regulatory review for a physical medical device.
§ 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).