(49 days)
The Rhythm View™ Workstation is a computerized system that assists in the diagnosis of complex cardiac arrhythmias. The RhythmView™ 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, Monitor/Display, Computer, Keyboard, Mouse, Software. 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 Rhythm View™ 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 regarding the Rhythm View™ Workstation 4.1, addressing the requested information:
1. Table of Acceptance Criteria and Reported Device Performance
The provided text does not explicitly state specific quantitative acceptance criteria (e.g., accuracy, sensitivity, specificity thresholds) for the Rhythm View™ Workstation 4.1. The performance data section broadly states:
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Conformance to requirements for intended use | "Based upon the software testing that has been performed, which 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 RhythmView™ Workstation is safe and effective for its intended use." |
It appears that the approval was based on the software testing demonstrating conformance to its intended use and a finding of substantial equivalence to predicate devices, rather than meeting specific quantifiable performance metrics. The focus is on the functional equivalence of the new display option ("Rotational Activity Profile") to existing functionalities.
2. Sample Size Used for the Test Set and the Data Provenance
The provided text does not specify the sample size used for any test set or provide details on data provenance (e.g., country of origin, retrospective/prospective). It only mentions "software testing" in a general sense.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
The provided text does not mention any experts being used to establish ground truth for a test set, nor does it describe their qualifications.
4. Adjudication Method for the Test Set
The provided text does not describe an adjudication method for a test set.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size
The provided text does not indicate that a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was performed or discuss any effect size of human readers improving with or without AI assistance. The submission is for a workstation that assists in diagnosis, not explicitly an AI-driven diagnostic tool in the modern sense as described here.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
The provided text does not specify if a standalone performance study was done. The device is described as assisting in diagnosis and displaying information for physician review, implying a human-in-the-loop system.
7. The Type of Ground Truth Used
The provided text does not explicitly state the type of ground truth used for any performance evaluation. Given the nature of the device (analyzing electrical signals to display spatial organization for rhythm disorders), ground truth would likely involve confirmed clinical diagnoses or expert consensus on arrhythmia classification, but this is not detailed.
8. The Sample Size for the Training Set
The provided text does not specify any sample size for a training set. The document primarily focuses on a 510(k) submission for a new version (4.1) of an existing device, which introduces an additional display option. It's less about a new algorithm with a distinct training phase.
9. How the Ground Truth for the Training Set Was Established
The provided text does not provide information on how ground truth was established for any training set.
§ 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).