(184 days)
The RhythmView™ Workstation is a computerized system that assists in the diagnosis of complex cardiac arrhythmias. The RhythmView™M Workstation is used to analyze electrogram and electrocardiogram signals and display them in a visual format.
The RhythmView is comprised of these major components,
- RhythmView hardware - Cart, Computer, monitor, keyboard, and mouse
- RhythmView software - Software pre-installed
The RhythmView Workstation takes electrical signals collected from multi-polar electrophysiology catheters and outputs a graphic display that assists in the diagnosis of cardiac arrhythmias.
The provided text does not contain specific acceptance criteria or details of a study demonstrating the device meets such criteria. It states that "Based upon the RhythmView 4.0 Software V&V Testing and the documentation required to support a Moderate Level of Concern Software Device (per FDA's Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices), it has been demonstrated that the RhythmView is safe and effective for its intended use." However, it does not provide the specifics of this V&V testing, acceptance criteria, or the reported performance.
Therefore, I cannot provide the requested table and study details. The document is a 510(k) summary and the FDA's clearance letter, which describe the device, its intended use, and the regulatory decision, but do not elaborate on the specific performance study results.
§ 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).