(177 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 – 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.
Here's an analysis of the provided text regarding the acceptance criteria and study for the RhythmView Workstation:
The provided document does not contain explicit stated acceptance criteria in terms of specific performance metrics (e.g., sensitivity, specificity, accuracy, or quantitative thresholds for signal processing or display characteristics). Instead, it states that the system "passed all verification and validation tests in accordance with predetermined specifications and appropriate test criteria." It primarily demonstrates substantial equivalence to predicate devices based on technological characteristics and overall safety and effectiveness.
Therefore, the following table and subsequent sections will reflect the information available in the document, highlighting what is stated and what is not.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (as described/implied) | Reported Device Performance |
|---|---|
| Safety and Effectiveness | - "Passed all verification and validation tests" |
| - "Demonstrate that it was as safe and as effective as the predicate devices." | |
| - "Results demonstrate that the RhythmView is safe and effective when used in accordance with its intended use and labeling." | |
| Technological Characteristics - Signal Processing | Yes (matches predicate devices) |
| Technological Characteristics - Post processing display - propagation map | Yes (matches one predicate, different from another) |
| Technological Characteristics - Grid display of electrode signals | Yes (matches one predicate, different from another) |
| Compliance with Predetermined Specifications and Test Criteria | "Passed all verification and validation tests in accordance with predetermined specifications and appropriate test criteria." |
| No New Questions of Safety and Effectiveness | "There were no new questions of safety and effectiveness raised." |
Note: The document does not provide specific numerical performance metrics (e.g., accuracy, precision) for the device's diagnostic assistance capabilities. The "acceptance criteria" are broadly defined as passing verification and validation tests and demonstrating equivalence to predicate devices in safety and effectiveness.
2. Sample size used for the test set and the data provenance
- Sample Size for Test Set: The document states that the RhythmView System underwent "extensive bench testing, including a data wide variety of cardiac electrogram data." However, no specific numerical sample size (number of cases or electrogram recordings) for the test set is provided.
- Data Provenance: The document mentions "a data wide variety of cardiac electrogram data." The country of origin for this data is not specified. The document does not explicitly state whether the data was retrospective or prospective. Given the context of "bench testing" and "variety of cardiac electrogram data," it implies existing data sources were used.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Number of Experts: Not specified.
- Qualifications of Experts: Not specified. The document does not mention the involvement of experts in establishing ground truth for the test data.
4. Adjudication method for the test set
- Adjudication Method: Not specified. The document does not describe any adjudication process for interpreting the test data or establishing ground truth.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- MRMC Comparative Effectiveness Study: No, an MRMC comparative effectiveness study was not done (or at least not reported in this summary). The document focuses on the device's performance in isolation ("bench testing") and its substantial equivalence to predicate devices based on technological characteristics and overall safety/effectiveness, not on human reader performance with or without the device.
- Effect Size of Improvement: Not applicable, as no such study was reported.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Standalone Performance Study: Yes, in essence, the "extensive bench testing" of the RhythmView System, where it "passed all verification and validation tests," represents a standalone evaluation of the algorithm and system's performance. The device is described as "assists in the diagnosis," implying it's a tool, but the testing described focuses on the system itself, not its impact on a human reader's performance.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Type of Ground Truth: The document refers to "cardiac electrogram data" and the device assisting in the "diagnosis of complex cardiac arrhythmias." This implies that the ground truth for the test data would be the actual presence or absence, and specific type, of cardiac arrhythmias as determined by established clinical or electrophysiological standards, which often involves expert interpretation of electrograms and clinical correlation. However, the specific method (e.g., expert consensus, comparison to gold standard recordings) for establishing this ground truth is not explicitly stated.
8. The sample size for the training set
- Sample Size for Training Set: Not specified. The document does not partition data into training and test sets or mention details about a training set. This suggests that the device's development and validation might have relied on a traditional engineering V&V process rather than a machine learning model requiring a distinct training set in the current common understanding.
9. How the ground truth for the training set was established
- How Ground Truth for Training Set was Established: Not specified. As the document doesn't explicitly mention a training set, details on its ground truth establishment are also absent.
§ 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).