(119 days)
The RHYTHMIA HDx™ Mapping System and accessories are indicated for catheter-based atrial and ventricular mapping. The mapping system allows real-time visualization of intracardiac catheters as well as display of cardiac maps in a number of different formats. The acquired patient signals, including body surface ECG and intracardiac electrograms, may also be recorded and displayed on the system's display screen.
The RHYTHMIA HDx™ Mapping System is a diagnostic medical device designed for 3D cardiac mapping, catheter navigation and display of cardiac electrophysiological data collected during an Electrophysiology (EP) study. Based on user-defined criteria, the Mapping System can acquire data over multiple cardiac beats.
The maps are constructed using magnetic and impedance-based localization technology and data from intracardiac and surface electrograms. Maps may be displayed as anatomical maps and electroanatomical maps in different formats. When used in conjunction with a magnetically tracked mapping catheter, the Mapping System can acquire data leading to high resolution map creation. The Mapping System allows real-time and recorded visualization of intracardiac catheter location(s). The acquired patient signals, including body surface ECG and intracardiac electrograms, may also be recorded and displayed on the system's display screen.
The Mapping System consists of reusable capital equipment, intended to be used in an electrophysiology laboratory by licensed medical practitioners fully trained in cardiac electrophysiology and Boston Scientific Mapping Specialists.
The Mapping System includes a dedicated Signal Station (SiS) and related accessories which provide data connection pathways for external input/output devices (e.g., catheters and recording systems) and serve as the data conduit to the System's Workstation computer and software.
The provided text describes the RHYTHMIA HDx™ Mapping System and its updates, but it does not contain the detailed acceptance criteria and a specific study proving the device meets those criteria, as requested. The "Performance Data" section lists general types of testing performed (Software/Firmware and Cybersecurity Verification and Validation, Design Verification, EMC and Electrical Safety, Usability Validation, and Design Validation) and states that successful results were achieved, but it lacks the quantitative details, methodology, and specific results required to answer your questions.
Therefore, I cannot provide the requested table or answer the specific questions about sample size, data provenance, number of experts, adjudication method, MRMC studies, standalone performance, ground truth type, and training set details.
The text does provide information regarding:
- Device Name: RHYTHMIA HDx™ Mapping System
- Intended Use: Catheter-based atrial and ventricular mapping. Allows real-time visualization of intracardiac catheters, display of cardiac maps, and recording/display of patient signals (body surface ECG and intracardiac electrograms).
- Technological Characteristics (Enhancements in v6.0):
- Compatibility with Magnetically Tracked FARAWAVE NAV PFA Catheter.
- Improved compatibility with Magnetically Tracked FARAPOINT PFA Catheter.
- Sheath detection visualization.
- Import of CT or MRI cardiac images from PACS Server (for visual reference only).
- Field Tag™ (tagging visualization when using FARAWAVE NAV PFA catheter).
- Catheter shadows (visualize last ablation location).
- Ablation statistics.
§ 870.1425 Programmable diagnostic computer.
(a)
Identification. A programmable diagnostic computer is a device that can be programmed to compute various physiologic or blood flow parameters based on the output from one or more electrodes, transducers, or measuring devices; this device includes any associated commercially supplied programs.(b)
Classification. Class II (performance standards).