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The intended use of the CARTO® 3 System is catheter-based cardiac electrophysiological (EP) procedures. The CARTO® 3 System provides information about the electrical activity of the heart and about catheter location during the procedure. The system can be used on patients who are eligible for a conventional electrophysiological procedure. The system has no special contraindications.

The CARTO 3 System V4.2 is a catheter-based atrial and ventricular mapping system designed to acquire and analyze data points, and use this information to display 3D anatomical and electroanatomical maps of the human heart in real-time. The location information needed to create the cardiac maps and the local electrograms are acquired using a specialized mapping catheters and reference devices. The system allows realtime display of electrograms and cardiac maps based on the received intracardiac signals from the catheters in a number of different formats. The acquired patient, signals, including body surface ECG and intracardiac electrograms (IECG) may also be displayed on the display screen. The CARTO 3 System V4.2 uses two distinct types of location technology-magnetic sensor technology and Advanced Catheter Location (ACL) technology.

The CARTO® 3 EP Navigation System, Version 4.2, is a catheter-based atrial and ventricular mapping system designed to acquire and analyze data points and use this information to display 3D anatomical and electroanatomical maps of the human heart in real-time. It provides information about the electrical activity of the heart and catheter location during electrophysiological procedures.

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not detail specific quantitative acceptance criteria or objective performance metrics for the CARTO® 3 EP Navigation System, Version 4.2. Instead, it focuses on the device's substantial equivalence to a predicate device and its ability to perform as well as or better than the predicate for its intended use.

The reported performance is described qualitatively:

• "The CARTO 3 EP Navigation System, Version 4.2 passed all tests in accordance with appropriate test criteria and standards, and the modified device did not raise new questions of safety or effectiveness."
• "The Bench and Animal Non-Clinical Testing demonstrated that the CARTO® 3 EP Navigation System, Version 4.2 is as safe, as effective, and performs as well as or better than the predicate device and two reference devices."

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

The document mentions "Bench and Animal Non-Clinical Testing" for verification of new and modified features, but does not specify the sample size for these tests.
The data provenance is implied to be from internal company testing (Biosense Webster, Inc.) and is non-clinical (bench and animal), not human patient data.

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

The document does not provide information regarding the number of experts or their qualifications for establishing ground truth for the non-clinical test set.

4. Adjudication Method for the Test Set:

The document does not specify an adjudication method for the non-clinical test set.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

A multi-reader multi-case (MRMC) comparative effectiveness study comparing human readers with and without AI assistance was not performed or reported in this document. This submission primarily focuses on the device's technical updates and non-clinical performance for substantial equivalence.

6. Standalone (Algorithm Only) Performance:

The document describes "Bench and Animal Testing" which would likely evaluate the device's algorithms and hardware in a standalone manner. The conclusion states that the system "passed all tests" and "performs as well as or better than the predicate device." However, specific standalone performance metrics (e.g., sensitivity, specificity, accuracy) were not provided.

7. Type of Ground Truth Used:

For the non-clinical testing, the ground truth would have been established through controlled experimental setups and measurements in bench and animal models, rather than expert consensus on patient data, pathology, or outcomes data.

8. Sample Size for the Training Set:

The document does not specify a sample size for any training set. Given the nature of the device (an EP navigation system with primarily software enhancements and hardware changes for existing functionalities), it's unlikely a machine learning-based training set in the conventional sense was used for this 510(k) submission. The "algorithms" mentioned are likely deterministic or rule-based, or if they involve machine learning, the details are not provided.

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

As no training set is described, this information is not available in the document.

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