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The CARTO® 3 V1.0 System is intended for catheter-based atrial and ventricular mapping. The mapping system allows real-time display of cardiac maps in a number of different formats. Maps may be displayed as anatomical maps, cardiac electrical activation maps, cardiac electrical propagation maps, cardiac electrical potential maps, impedance maps, cardiac chamber geometry maps and ECG fragmentation maps. The acquired patient signals, including body surface ECG and intracardiac electrograms may also be displayed in real time on the System's display screen. The CARTO® 3 V1.0 System is also intended to support EP procedures, maintaining CARTO® System capabilities, in the presence of a high metallic environment and magnetic field strengths upto 0.1 T and provide a data mgn munication channel to the Stereotaxis Niobe® Catheter Navigation System. The CARTO® 3 V1.0 System includes CARTOMERGE® PLUS functionality to import, register and merge CT or MRI structural images with CARTO® map's physiological information and real time catheter navigation. The system includes the Fast Anatomical Mapping (FAM) functionality that allows for the quick creation of cardiac anatomical yolumes using catheters with magnetic location sensors. The system's CARTOSOUND™ image integration functionality enables integration of intracardiac echo (ICE) to enable visualization of 3D combined maps. In addition to the use of specialized navigation catheters with magnetic location sensors, the system is also intended for use with conventional, non-navigational, electrophysiology catheters without magnetic location sensors.

The CARTO® 3 V1.0 EP Navigation System is a catheter-based atrial and ventrioular 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 catheter and reference device. The system allows real-time display of electrograms and cardiac maps based on the received intra cardiac signals from the catheters in a number of different formats. For example, maps may be displayed as anatomical maps, cardiac electrical activation maps, cardiac electrical propagation maps, cardiac electrical potential maps, impedance maps, cardiac chamber geometry and ECG fragmentation maps. The acquired patient signals, including body surface ECG and intracardiac electrograms (IECG) may also be displayed on the display screen.

The CARTO® 3 V1.0 System uses two distinct types of location technology - magnetic sensor technology and Advanced Catheter Location (ACL) technology. The system utilizes magnetic sensor technology to locate the magnetic location sensor housed within a navigational catheter. The system uses "ACL technology" in conjunction with the magnetic sensor technology to locate the catheter electrodes. ACL was previously referred to as "Active Current Localization" in the CARTO" III 510(k) submission (K072202). Following clearance of K072202, the acronym "ACL" was changed to Advanced Catheter Location for marketing purposes. External reference patches are needed for magnetic sensor-based as well as for ACL-based localization. The external reference patches are accessories to the system. Three patches are placed on the patient's chest and three are placed on the patient's back. Each patch connects to a location sensor mounted on the patch unit cables that extend from the CARTO® 3 System.

Magnetic sensor location is calculated in reference to an axis origin based on external references. In order to locate the magnetic location sensor of mapping (navigational) catheters (such as the NAVISTAR catheter), the system compares the location of the mapping catheter sensor to the mean calculation obtained from the three sensors located on the patch cables attached to the patient's back.

In order to locate and visualize the electrodes on a catheter using ACL technology, three patch cables must be attached to the patches placed on the patient's chest and three patch cables must be attached to the patches placed on the patient's back.

The CARTO® 3 V1.0 System was implemented on the same hardware and software platform as the predicate CARTO® III System, cleared on November 17, 2007 via the CARTO® III 510(k) K072202.. The purpose of this 510(k) is to expand functionalities on the base CARTO® III System. The information presented below details the system's enhanced or additional functionality.

There are three basic categories of added functionality for the CARTO® 3 V1.0 system:

• a) Enhanced base model features: These are features that were included in the previously cleared CARTO® III System. However, the features have been enhanced for the CARTO® 3 V 1.0 System.
  The enhanced base model features discussed in this submission include:

• Improved Magnetic Location Algorithm. ...

• ii. Improved ECG signal quality.

• iii. Catheter visualization using an enhanced ACL algorithm.

• iv. Gated and Non-gated catheter visualization.

• b) Features acquired from predicate devices: These are CARTO® 3 features that have been adopted from previously cleared CARTO® Systems.

The features acquired from predicate CARTO® Systems discussed in this submission include:

• Integration with Stereotaxis Niobe® Catheter Magnetic Navigation System - Remote Magnetic Technology (RMT)
• ii. Integration with Ultrasound (ULS) Systems CARTOSOUND™ Module.
• iii. Fusion of CT and MRI images CARTOMERGE® PLUS Image Integration Module with Image Processing Package.
• iv. Impedance mapping.
• c) Features new to the CARTO® platform: These are new features not yet reviewed and cleared by the FDA.

The new features discussed in this submission include:

• i. Fast Anatomical Mapping (FAM).
• ii. Complex Fractionated Atrial Electrogram (CFAE) mapping tool.
• iii. Window of interest templates.

Here's a breakdown of the acceptance criteria and study information for the CARTO® 3 V1.0 EP Navigation System, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The provided 510(k) summary does not specify quantitative acceptance criteria. Instead, it makes a general statement about the device passing tests.

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

• Test Set Sample Size: Not specified. The document states "bench and electrical testing" and "simulated use conditions in animals" but does not provide numbers for these tests.
• Data Provenance: Not explicitly stated regarding country of origin or whether it was retrospective or prospective. The testing involved "simulated use conditions in animals."

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

• Not applicable. The ground truth for this device's performance evaluation appears to be based on engineering and preclinical testing standards, not expert clinical assessment of images or data.

4. Adjudication Method

• Not applicable. The evaluation methods described (bench testing, electrical testing, simulated animal use) do not typically involve human adjudication in the context of diagnostic accuracy.

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

• No, an MRMC comparative effectiveness study involving human readers comparing performance with and without AI assistance was not mentioned or described. This type of study is more common for diagnostic imaging AI.

6. Standalone (Algorithm Only) Performance Study

• Yes, this appears to be the primary mode of performance evaluation described. The "bench and electrical testing" and "simulated use conditions in animals" are evaluations of the device's inherent functionality, independent of human interpretation or use in a clinical reader study. The purpose of the 510(k) is to "expand functionalities on the base CARTO® III System," and the testing aims to confirm these expanded functionalities meet appropriate standards.

7. Type of Ground Truth Used

• The ground truth appears to be based on engineering standards, specifications, and preclinical physiological measurements in simulated animal models. For example, "Improved Magnetic Location Algorithm" and "Improved ECG signal quality" would be evaluated against established electrical and positional accuracy benchmarks.

8. Sample Size for the Training Set

• Not applicable. This device is a navigation system that provides real-time mapping data. There is no mention of a training set as would be found in a machine learning or AI algorithm development, where data is used to train a model. The "algorithms" mentioned (e.g., "Improved Magnetic Location Algorithm," "enhanced ACL algorithm") are likely deterministic or model-based, rather than learned from a large dataset.

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

• Not applicable, as there is no mention of a training set for machine learning.

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