Search Results

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 EP Navigation System Version 4.35 and Accessories with COHERENT MAPPING module is a catheterbased atrial and ventricular mapping system designed to acquire and analyze data points, and use this information to display 3D anatomical and electro-anatomical maps of the human heart. The location information needed to create the cardiac maps and the local electrograms are acquired using a set of specialized mapping catheters and reference devices. The system allows electrograms and cardiac maps display based on the received intracardiac signals from the catheters. The CARTO® 3 System V4.35 uses two distinct types of location technology - magnetic sensor technology and Advanced Catheter Location (ACL) technology.

CARTO® 3 EP Navigation System Version 4.35 and Accessories with COHERENT MAPPING module consists of the following components:

• Patient Interface Unit (PIU)
• . 3D graphical Workstation that serves as the Graphic User Interface (GUI), Wide-Screen monitors, keyboard, and mouse
• Intracardiac In Port
• . Intracardiac Out Port
• Power Supply
• . Patches Connection Box and Cables
• Pedals
• Location Pad

All hardware components of the CARTO® 3 System V4.35 are identical to those described for the predicate CARTO® 3 System V4.2.

This File covers the functionality, introduced by the changes made in the CARTO®3 Navigation System 4.35 and Accessories with COHERENT MAPPING module

Because CARTO® 3 System V4.35 with COHERENT MAPPING module is only available on this version, the CARTO® 3 System V4.35 will be marketed in parallel with the CARTO® 3 System V6.0 software. Future software releases, may incorporate this functionality pending company business decisions.

Here's an analysis of the provided text regarding the acceptance criteria and study for the CARTO® 3 EP Navigation System, Version 4.35:

1. Table of Acceptance Criteria and Reported Device Performance

The provided text does not explicitly define quantitative acceptance criteria for the new COHERENT MAPPING feature, nor does it provide specific numerical performance metrics for this feature. The document generally states that the device "passed all tests in accordance with appropriate test criteria and standards."

The main claim of the new version 4.35 is to "improve the representation of the electric wave propagation over the atria by adding new coloring and electric wave direction vector." The performance is described qualitatively as "This improved representation of conduction velocity vectors may help the physician to focus his/her attention on the displayed path of cyclic arrhythmia propagation."

Therefore, a table cannot be constructed with specific numerical acceptance criteria and reported performance figures.

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

The document mentions "extensive bench, pre-clinical testing under simulated clinical conditions and retrospective validation." While it refers to a "test set," the specific sample size used for the test set is not provided.

The data provenance for this validation is also not explicitly detailed. The mention of "pre-clinical testing under simulated clinical conditions" suggests controlled experiments, but it doesn't specify if these were conducted in humans or animals, or the geographic origin of any data if human data was used. "Retrospective validation" implies the use of existing data, but again, the specifics are missing.

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

The document does not provide any information about the number of experts used to establish the ground truth for the test set or their qualifications. The nature of the "improved representation" suggests that expert review would be crucial, but there's no mention of it.

4. Adjudication Method for the Test Set

The document does not mention any adjudication method used for the test set.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size

The document does not indicate that a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was performed. The focus is on the "improved representation" and how it may help physicians, rather than a quantifiable improvement in physician performance with and without the AI. Therefore, no effect size of how human readers improve with AI vs. without AI assistance is provided.

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

The text describes the COHERENT MAPPING module as providing "new coloring and electric wave direction vector" and improving the "representation of the electric wave propagation." This is an enhancement of human visualization and interpretation, not a standalone diagnostic algorithm. The system provides information for "catheter-based cardiac electrophysiological (EP) procedures" and helps in understanding "electrical activity of the heart and about catheter location." Therefore, a standalone (algorithm only) performance study as typically understood for AI diagnostics would not be applicable or was not reported for this device's new feature. Its primary function is to assist human operators.

7. The Type of Ground Truth Used

Given the nature of the "improved representation of conduction velocity vectors," the ground truth would likely be expert consensus or accepted electrophysiological principles regarding the accurate depiction of cardiac electrical activity. However, the document does not explicitly state the type of ground truth used for the validation of the COHERENT MAPPING feature.

8. The Sample Size for the Training Set

The document does not provide any information about a training set or its sample size. This suggests the COHERENT MAPPING module might be based on refining existing algorithms for data visualization rather than a new machine learning model trained on a specific dataset.

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

Since no training set is mentioned (or implied heavily for a new ML-based algorithm), there is no information on how ground truth for a training set was established.

Ask a specific question about this device