(66 days)
The Rhythm View Workstation is a computerized system that assists in the diagnosis of complex cardiac arrhythmias. The Rhythm View Workstation is used to analyze electrogram and electrocardiogram signals and display them in a visual format.
The RhythmView™ Workstation is comprised of the following components: Cart, Keyboard, Monitor/Display, Mouse, Computer Software, Radio-Frequency Identification (RFID) Reader/Writer (new component), Two Port USB Switch (new component), Solid State Hard Drive (new optional component). RhythmView™ takes electrical signals collected from multi-polar electrophysiology catheters and outputs a graphic display that assists in the diagnosis of cardiac arrhythmias. The RhythmView™ computes and displays electrical rotors or focal beat sources responsible for maintaining human heart rhythm disorders including focal AT, AFL, other SVT, AF, VT and VF in a given patient. The product takes as input electrical signals recorded during the heart rhythm disorder under consideration, typically from multiple specified locations within the heart during an electrophysiological study. The RhythmView™ then uses proprietary patented algorithms and methods to compute spatial organization during the heart rhythm disorder. These computed elements are displayed graphically in interactive form for review to aid diagnosis by the physician during an electrophysiology study.
Here's an analysis of the provided text to extract the requested information about acceptance criteria and the study proving device performance:
1. Table of Acceptance Criteria and Reported Device Performance
The provided document does not explicitly state quantitative acceptance criteria or a specific table detailing device performance against such criteria. The closest information is a general statement about testing:
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Conformance to requirements for intended use, safety, and effectiveness. | "The Software, Hardware (RFID, Two Port USB Switch and SSD Performance data Qualification Testing and EMC Testing) and User testing that have been performed provide reasonable assurance that the proposed device has been tested to verify conformance to requirements for its intended use. Therefore, it has been demonstrated that the Rhythm View™ Workstation is safe and effective for its intended use." |
2. Sample Size for Test Set and Data Provenance
The document does not specify a sample size for any test set or the provenance (country of origin, retrospective/prospective) of the data used in testing. It only mentions "User testing" in a general sense.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
The document does not mention the use of experts to establish ground truth for a test set, nor does it provide qualifications for any such experts. The device is described as assisting physicians in diagnosis, implying that the physician ultimately establishes the diagnosis.
4. Adjudication Method for the Test Set
No information is provided regarding an adjudication method for a test set.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
The document does not indicate that a multi-reader multi-case (MRMC) comparative effectiveness study was performed. It focuses on the device assisting physicians rather than comparing physician performance with and without the device.
6. Standalone (Algorithm Only) Performance Study
The document implies a standalone function as the device "computes and displays electrical rotors or focal beat sources" using algorithms, but there is no explicit separate study reporting standalone algorithm-only performance. The "User testing" mentioned likely involves human interaction with the device.
7. Type of Ground Truth Used
The document does not explicitly define the type of ground truth used for any testing. Given the device's function to "assist in the diagnosis of complex cardiac arrhythmias by analyzing electrogram and electrocardiogram signals," it is implied that the ultimate ground truth would be a clinical diagnosis established by a physician based on all available clinical information, potentially including the device's output.
8. Sample Size for the Training Set
The document does not provide any information regarding a training set sample size.
9. How Ground Truth for the Training Set Was Established
The document does not provide any information regarding how ground truth for a training set was established.
§ 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).