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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,

1. RhythmView hardware – Computer, monitor, keyboard, and mouse
2. 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

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.

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The intended use of the NOGA™ XP Cardiac Navigation System with QwikMap™ Software is catheter-based cardiac mapping.

The NOGA™ XP Cardiac Navigation System with QwikMap™ Software allows realtime display of cardiac maps in a number of different formats. Maps may be displayed as cardiac electrical activation maps, cardiac electrical propagation maps, cardiac electrical potential maps, cardiac chamber geometry maps, cardiac dynamic maps, cardiac hemodynamic maps, and cardiac electromechanical maps. The acquired patient signals, including body surface ECG and intracardiac electrograms may also be displayed in real time on the display screen.

The NOGA™ XP Cardiac Navigation System with QwikMap™ Software is a modification of the NOGA™ Cardiac Navigation System cleared for marketing under K000332. Like the predicate device, the NOGA™ XP System is a computerized electromechanical mapping system designed to acquire, analyze, and display electromechanical maps of the heart in a clear and intuitive manner. Maps are constructed by combining and integrating information from intracardiac electrograms with the respective endocardial locations. Like the CARTO™ Cardiac Navigation systems (K992968, K993729, K000248, K000190, K013083, and K020863), all commercially available Biosense Webster catheters equipped with the proprietary location sensor(s) that provide(s) real-time information on the location of the catheter can be used with the NOGA™ XP Cardiac Navigation System.

The current NOGA™ Cardiac Navigation System software was upgraded to allow for:

• . on-screen visualization of the catheter shaft.
• reduction of the steps required to create electromechanical maps .
  • · NOGA™ XP software creates the equivalent of a 50-point map with only 8-10 contact points, and
  • · easier mapping of transient events.

Here's an analysis of the provided text regarding the acceptance criteria and study for the NOGA™ XP Cardiac Navigation System with QwikMap™ Software:

Acceptance Criteria and Device Performance Study

The provided document describes the NOGA™ XP Cardiac Navigation System with QwikMap™ Software as a modification to an existing device, the NOGA™ Cardiac Navigation System. The primary method for demonstrating safety and effectiveness relied on showing substantial equivalence to predicate devices. This means that instead of establishing new performance metrics, the device's performance was compared to that of already cleared devices to ensure it performed in an equivalent manner and did not raise new questions of safety or effectiveness.

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size Used for the Test Set and Data Provenance

• Test Set Sample Size: The document does not specify a distinct "test set" in terms of number of cases, patients, or data points for a traditional clinical study. Instead, it mentions "non-clinical bench and animal testing."
  • For the animal testing, it explicitly states "testing in the porcine model." The number of animals used is not provided.
• Data Provenance:
  • Bench Testing: Implied to be laboratory-based.
  • Animal Testing: Porcine (pig) model.
  • The document does not mention human data for either retrospective or prospective studies. The focus is on demonstrating equivalence through non-clinical means.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

The document does not mention the use of experts to establish ground truth for the "test set" in the context of a clinical study or even for the bench and animal testing. The evaluation appears to be based on engineering and physiological testing rather than expert-derived ground truth.

4. Adjudication Method for the Test Set

Not applicable. There is no mention of a ground truth adjudication process involving multiple reviewers for a test set.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance

No, a Multi Reader Multi Case (MRMC) comparative effectiveness study was not conducted or reported in this document. The device is a "cardiac navigation system," which is a tool for clinicians, but the submission focuses on its technical equivalence and functionality rather than changes in human reader performance or diagnostic accuracy.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

The device is a "cardiac navigation system" and "programmable diagnostic computer." It is inherently a device that provides information and displays data for human clinicians. Therefore, a purely standalone algorithm performance without human-in-the-loop context would not be directly applicable to its intended use. The "performance data" section focuses on the system's ability to acquire, analyze, and display information equivalently to predicate devices.

7. The Type of Ground Truth Used

• For the bench testing, the ground truth would likely be based on engineering specifications, known physical properties, electrical signal characteristics, and defined system outputs.
• For the animal (porcine) model testing, the ground truth would be based on physiological measurements and observations within the animal model, ensuring the system accurately represented cardiac activity and geometry as expected.

8. The Sample Size for the Training Set

The document does not mention a "training set" or machine learning aspects in a way that implies a distinct dataset for training an AI algorithm. The device is described as a "computerized electromechanical mapping system," suggesting a model-based or rule-based system rather than a machine learning one that requires a dedicated training set. Software validation typically involves testing against requirements and known scenarios, not "training" in the AI sense.

9. How the Ground Truth for the Training Set Was Established

Not applicable, as a discrete "training set" for an AI algorithm is not identified in the provided text.

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