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510(k) Data Aggregation
(93 days)
RhythmView Workstation
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.
RhythmView uses electrical signals collected from the electrodes of one or more multi-polar electrophysiology (EP) catheters. It provides a dynamic, simplified representation of wave propagation. The RhythmView computes and displays electrical rotors or focal beat sources that may sustain 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 a breakdown of the acceptance criteria and study information for the RhythmView Workstation 6.1, derived from the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
The document primarily focuses on verifying the software updates for the RhythmView Workstation 6.1 and demonstrating that it performs at least as well as the prior versions, particularly concerning Rotational Activity Profile (RAP) detection. While specific numerical acceptance criteria (e.g., sensitivity, specificity thresholds) are not explicitly stated in the provided text, the performance is described in terms of validation and verification against its intended functionality.
| Acceptance Criteria (Inferred from testing objectives) | Reported Device Performance |
|---|---|
| Stability Map and default Stability Filter setting validation (using clinical data sets) | The Stability Map and default Stability Filter setting were validated using clinical data sets. |
| Summation Maps correct compilation of RAP profiles from individual segments | Verification confirmed that the Summation Maps generated are correct compilations of the RAP profiles from individual segments. |
| RAP detection of known rotational targets (at least as well as prior versions) | Validation confirmed that RAP detects known rotational targets at least as well as prior versions of RAP. |
| RAP functionality validation (through Physician reads) | The RAP functionality in RhythmView was validated through Physician reads. |
| New UI features evaluation (through Simulated User testing) | Simulated User testing was conducted to evaluate new features of the UI. |
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size: The document mentions "clinical data sets" for validating the Stability Map and default Stability Filter setting, but does not specify the exact number of cases or patients in these data sets.
- Data Provenance: The data used for validation are described as "clinical data sets." The document does not specify the country of origin of this data or if it was retrospective or prospective. It uses "clinical data sets," implying real patient data.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
- Number of Experts: The document states that "Physician reads" were used to validate RAP functionality. It does not specify the number of physicians involved.
- Qualifications of Experts: The qualifications of the "Physicians" are not explicitly stated (e.g., years of experience, subspecialty).
4. Adjudication Method for the Test Set
The document does not describe a specific adjudication method (e.g., 2+1, 3+1). It only mentions "Physician reads" for validation.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Its Effect Size
The document does not indicate that a multi-reader multi-case (MRMC) comparative effectiveness study was performed to assess the improvement of human readers with AI vs. without AI assistance. The testing described focuses on validating the device's functionality and its comparison to prior versions.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
The document describes testing that evaluates the algorithm's performance (e.g., RAP detection, Stability Map validation) using "clinical data sets." While these tests indirectly assess the algorithm's capabilities, the validation of RAP functionality involved "Physician reads," suggesting a human-in-the-loop component for some aspects. Therefore, it's not strictly a standalone performance study without any human involvement for interpretation.
7. The Type of Ground Truth Used
The ground truth for the test sets (or validation sets) appears to be based on:
- Known rotational targets: For validating RAP detection, the system was validated against "known rotational targets," implying a pre-established understanding of these targets. This could be based on prior clinical assessment, expert consensus, or established electrophysiology principles.
- Physician reads: For RAP functionality validation, physician interpretations served as part of the ground truth or a reference point.
- Clinical data sets: The term "clinical data sets" implies data derived from patient studies, where the outcomes or characteristics might be considered true based on clinical assessment, although explicit details are lacking.
8. The Sample Size for the Training Set
The document does not provide any information regarding the sample size used for the training set.
9. How the Ground Truth for the Training Set Was Established
The document does not provide any information on how the ground truth for the training set was established. In fact, training data details are entirely absent from the provided text, which focuses on validation and verification of software updates.
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(66 days)
RhythmView Workstation
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.
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