(77 days)
The Reprocessed Webster Duo-Decapolar EP Catheter is indicated for electrophysiological mapping of cardiac structures, i.e. stimulation and recording only. In addition, the Webster Duo-Decapolar catheter is designed to facilitate electrogram mapping in the atrial region of the heart and the coronary sinus.
The Reprocessed Webster Duo-Decapolar Diagnostic Electrophysiology (EP) Catheter has been designed for electrophysiological mapping of heart. The catheters have a hightorque shaft with a deflectable tip section containing an array of platinum electrodes that can be used for stimulation and recording.
The tip deflection is controlled at the proximal end by a tubular handpiece in which a piston slides. When the piston is pushed forward with the thumbknob, the tip is deflected (curved). When the piston is pulled back, the tip straightens. The high-torque shaft allows the plan of the curved tip to be rotated to facilitate accurate positioning of the catheter tip at the desired site.
I am sorry, but the provided text from the FDA 510(k) filing for the Reprocessed Webster Duo-Decapolar Diagnostic Electrophysiology (EP) Catheter does not contain the information required to describe acceptance criteria and a study proving a device meets those criteria, as typically seen for AI-enabled medical devices.
This 510(k) pertains to a reprocessed medical device (a catheter), which means it's a device that has been cleaned, disinfected, sterilized, and functionally tested after prior use to be used again. The documentation focuses on demonstrating that the reprocessed device is substantially equivalent to a new, legally marketed predicate device in terms of design, materials, function, intended use, and safety/effectiveness through bench and laboratory testing.
Here's why the requested information about AI model performance, expert ground truth, multi-reader multi-case studies, and training/test set details is not present in this document:
- This is not an AI-enabled device. The device is a physical catheter used for electrophysiological mapping of the heart. Its function is based on physical properties, electrical contacts, and mechanical manipulation, not on artificial intelligence algorithms analyzing data.
- The "study" refers to bench and laboratory testing. The document lists "Functional and Safety Testing" which includes biocompatibility, cleaning validation, sterilization validation, visual inspection, dimensional verification, electrical continuity and resistance, simulated use, mechanical characteristics, electrical safety testing, and packaging validation. These are standard tests for physical medical devices and do not involve AI performance metrics.
- "Acceptance Criteria" here would relate to physical and electrical specifications. For example, "dimensional verification" might have an acceptance criterion for the catheter's length or diameter, or "electrical continuity" might have a resistance range. These are not framed as AI model performance metrics like sensitivity, specificity, or AUC.
- Ground truth, experts, and adjudication are irrelevant. They are used to establish the correctness of an AI model's output in interpreting medical data (e.g., images, signals). For a reprocessed catheter, the "ground truth" is its physical and electrical integrity compared to a new device.
Therefore, I cannot populate the requested table or answer the specific questions about AI model validation because the provided text describes a reprocessed physical medical device, not an AI-enabled one.
§ 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).