(127 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, Monitor/Display, Computer, Radio-Frequency Identification (RFID) Reader/Writer, Solid State Hard Drive (optional component), Keyboard, Mouse, Two Port USB Switch, Video Splitter (new component - streaming option only), *Panel box required, 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 Rhythm View 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.
The provided text describes the RhythmView Workstation SW V5.0, a computerized system that assists in the diagnosis of complex cardiac arrhythmias by analyzing electrogram and electrocardiogram signals.
Here's an analysis of the acceptance criteria and study information, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The FDA clearance document for the RhythmView Workstation SW V5.0 (K151245) indicates that the device's performance was evaluated through verification and validation testing, including Electrical Safety and EMC testing, and usability testing. The document states that these tests provide "reasonable assurance that the proposed device conformances to the appropriate requirements for its intended use" and that "it has been demonstrated that the RhythmView Workstation is safe and effective for its intended use."
However, specific numerical acceptance criteria (e.g., sensitivity, specificity, accuracy thresholds) and their corresponding reported performance values are not explicitly detailed in the provided text. The document focuses on demonstrating substantial equivalence to predicate devices and adherence to general safety and performance standards rather than quantitative clinical performance metrics.
The "Device Characteristic" table in Appendix 1: 510(k) Summary compares the proposed and predicate RhythmView Workstations in terms of features and functionality. This table can be interpreted as a set of functional requirements or acceptance criteria for the new version, demonstrating that it either maintains existing functionality ("Yes" in both columns) or introduces new features ("Yes" in Proposed, "No" in Predicate).
| Device Characteristic | Expected Performance (Acceptance Criteria, implicit from Predicate) | Reported Device Performance (Proposed RhythmView™ Workstation) |
|---|---|---|
| Signal processing | Yes | Yes |
| Post-processing display | Yes | Yes |
| Grid display of electrode signals | Yes | Yes |
| Programming Language | C++ | C++ |
| Export of processed file into video format | Yes | Yes |
| Manual tagging by user of electrograms | No | No |
| OTS Software requirements | Same as Predicate | Same as Predicate |
| Display options for review of processed signals | • Electrical Activity | |
| • Contours Only | ||
| • DContours | ||
| • Rotational Activity Profile | • Electrical Activity | |
| • Contours Only | ||
| • DContours | ||
| • Rotational Activity Profile | ||
| RAP display (optional) | Monochromatic only | Multi-color with monochromatic option available |
| RFID Reader/Writer Function | Yes | Yes |
| Data transfer via Two Port Switch | Yes | Yes |
| Direct data transfer via USB cable to RV Workstation from EP system | Option available | Option available |
| Atrial Function | Yes | Yes |
| Ventricular Function | Option available | Option available |
| Signal Quality Indicator | No (new feature) | Yes |
| Spotlight Feature | No (new feature) | Yes |
| Streaming real-time electrograms | No (new feature) | Option available |
2. Sample Size Used for the Test Set and Data Provenance
The provided text does not specify the sample size used for any test set or the data provenance (e.g., country of origin, retrospective or prospective) for the studies mentioned. The testing described is primarily focused on software and hardware verification/validation, and usability, rather than a clinical performance study with patient data.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not provided in the text. Given that the testing mentioned is primarily verification, validation, and usability, it's unlikely that a traditional "ground truth" for clinical performance, as established by multiple clinical experts, was a primary component of this regulatory submission.
4. Adjudication Method for the Test Set
This information is not provided in the text.
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
A Multi-Reader Multi-Case (MRMC) comparative effectiveness study is not mentioned in the provided text. The device is described as "assisting" in diagnosis and displaying information for a physician's review, but there is no data presented on human reader performance improvement with or without the AI.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
A standalone performance study of the algorithm is not explicitly mentioned in the provided text in terms of quantitative clinical metrics (e.g., sensitivity, specificity). The focus is on the workstation as a whole and its functionality in assisting a physician. The statement "The RhythmView then uses proprietary patented algorithms and methods to compute spatial organization during the heart rhythm disorder" confirms the presence of an algorithm, but its standalone performance is not quantified.
7. The Type of Ground Truth Used
The text does not explicitly state the type of ground truth used for any clinical performance evaluation. The "ground truth" for the verification and validation (V&V) testing would likely refer to engineering specifications and expected software behavior, and for usability testing, it would relate to user task completion and satisfaction. For the underlying algorithms that "compute spatial organization," the ground truth, if evaluated, would typically be established based on accepted electrophysiological principles or expert consensus in the field.
8. The Sample Size for the Training Set
The text does not provide any information regarding a training set sample size. This type of detail is typically associated with the development of the "proprietary patented algorithms and methods" but is not part of this 510(k) summary.
9. How the Ground Truth for the Training Set Was Established
The text does not provide any information regarding how the 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).