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The intended use of the CARTO® XP EP Navigation System, Version 9, is catheter-based atrial and ventricular mapping.

The CARTO® XP EP Navigation System, Version 9, allows real-time 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, impedance maps, and cardiac chamber geometry maps. The acquired patient signals, including body surface ECG and intracardiac electrograms may also be displayed in real-time on the display screen.

CARTO® XP EP Navigation System, Version 9, includes the CARTO CAR Capability to import, register and merge CT or MRI structural images with CARTO Maps physiological information and real-time catheter navigation. CARTO® XP EP Navigation System, Version 9 also allows the integration of intracardiac echo (ICE) visualization to provide 3D combined maps.

The CARTO® XP EP Navigation System, Version 9, is designed to acquire, analyze, and display electro-anatomical maps of the human heart. The maps are reconstructed using the combination of information gathered from the integration of intracardiac electrograms with their respective endocardial locations. Maps may be displayed as electrical activation maps, electrical propagation maps, electrical potential maps, impedance maps and chamber geometry maps. The acquired patient signals, including body surface ECG and intracardiac electrograms may also be displayed in real-time on the display screen.

The CARTO® XP EP Navigation System, Version 9, includes the following capabilities:

• The CARTOMERGE Module, released with the CARTO® XP EP . Navigation System, Version 8 under 510(k) K042999. This module enables the integration of pre-acquired Computed Tomography (CT) and Magnetic Resonance (MR) images.
• The now CARTOSOUND" Image Integration Module. This module, when used on the CARTO® XP EP Navigation System, Version 9, with a SOUNDSTAR 3D Ultrasound Catheter (510(k) bundled with the CARTO XP Version 9 FP Navigation System Traditional 510(k) CARTO" XP EP Navigation System Version 9 System submission) enables interfacing with intracardiac ultrasound devices, providing for real-time integration of ultrasound (U/S) images with CARTO electromagnetic acquired maps.

The Biosense Webster SOUNDSTAR 3DTM Ultrasound Catherer is a 90 cm 10F IntraCardiac Echo (ICE) catheter with an acoustic array embedded in the catherer tip that allows the acquisition of real time ultrasound images. The catherer also contains a location sensor that enables the accurate location of the U/S-observed intrucardiac analomics in the CARTO® XP EP Navigation System Version 9 spatial coordinates.

The CARTO® XP EP Navigation System, Version 9, underwent bench and electrical testing and was also tested under simulated use conditions in animals. The System passed all intended criteria in accordance with appropriate test criteria and standards and did not raise any 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:

The document mentions "simulated use conditions in animals" for testing. However, it does not specify the exact sample size (number of animals) used, nor does it provide information on the country of origin of the data or whether it was retrospective or prospective.

3. Number of experts used to establish the ground truth for the test set and their qualifications:

This information is not provided in the document.

4. Adjudication method for the test set:

This information is not provided in the document.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and if so, what was the effect size of how much human readers improve with AI vs without AI assistance:

No MRMC comparative effectiveness study is mentioned. This device is an EP navigation system, not an AI diagnostic tool designed to assist human readers in image interpretation or diagnosis.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:

The device is a system that acquires and displays electro-anatomical maps for catheter-based cardiac procedures. It functions as a tool for clinicians, with a human-in-the-loop by design. The performance described (bench, electrical, simulated use) would inherently assess the system's ability to function as intended in this context, rather than as a standalone algorithm in the absence of human interaction.

7. The type of ground truth used:

For the simulated use in animals, the ground truth would inherently be the physiological data and anatomical structures within the animal's heart that the CARTO system is designed to map and display. This would involve direct observation and measurement of cardiac electrical activity and anatomy.

8. The sample size for the training set:

The document does not mention a separate training set. The descriptions of testing (bench, electrical, simulated use) relate to validation and verification of the system's performance, rather than a machine learning training phase.

9. How the ground truth for the training set was established:

As no separate training set is explicitly mentioned in the context of machine learning, this information is not applicable. The system's functionality appears to be based on established engineering principles and medical understanding of cardiac electrophysiology and anatomy, rather than being "trained" on a dataset in the modern AI sense.

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