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The intended use of the CARTO® XP System with CARTOXPRESS™ Module (V10) is catheter-based atrial and ventricular mapping.

The CARTO® XP System with CARTOXPRESS™ Module (V10) 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 system display screen.

CARTO® XP System with CARTOXPRESS™ Module (V10) includes the CARTOMERGE® capability to import, register, and merge CT or MRI structural images with CARTO Maps physiological information and real-time catheter navigation. CARTO XP System with CARTOXPRESS™ Module (V10) also allows the integration of intracardiac echo (ICE) 2D images to provide 3D combined maps.

CARTO® XP System with CARTOXPRESS™ Module (V10) includes Fast Anatomical Mapping (FAM) that is a method for quick creation of cardiac anatomical volumes using catheters with magnetic location sensors, supports the LASSO® NAV Catheter with location sensors, displays Complex Fractionated Atrial Electrograms (CFAE), and adds Pace-Mapping Software (PaSo) ECG signal correlation tool.

The CARTO® XP System with CARTOXPRESS™ Module (V10) (aka CARTO XP V10 System), is designed to acquire cardiac anatomic and physiologic data and display catheter position in real time superimposed on a reconstructed 3D electroanatomical map of the human heart.

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 V10 System continues to include all features from CARTO® XP EP Navigation System, Version 9 (aka CARTO XP V9 System), including:

• 1. CARTOMERGE® capability to import, register, and merge CT or MRI structural images with CARTO Maps physiological information and real-time catheter navigation.
• 2. CARTOSOUND™ functionality that allows for the real time integration of intracardiac echo (ICE) to provide 3D combined maps. The CARTO® XP V 10 System interfaces with several ultrasound machines from various manufacturers.
• 3. Support of the NAVISTAR® family of catheters except for the new LASSO® NAV Catheter that is added in this submission.

CARTO® XP V10 System adds the following features to CARTO® XP V9 System:

• l . Fast Anatomical Mapping (FAM): The method used to create a 3D anatomical surface of a heart chamber and its vessels using locations gathered continuously from the mapping catheter. FAM creates high-resolution anatomic maps as the EP physician moves the mapping catheter through the cardiac chamber. This method provides an accurate way to map the heart chambers faster than the regular gated electroanatomical CARTO method of mapping. FAM technology also permits detailed visual enhancement of a specific area of interest within the heart. FAM maps can be combined with electroanatomical maps, CARTOSOUND contour maps, or previously acquired FAM maps.
• 2. Support of LASSO® NAV Catheter: This new catheter adds new functionalities that enable display of this catheter's circular loop based on the position of magnetic single axial sensors (SAS), selective pacing through the loop electrodes, and perform fast anatomical mapping of the atrial heart chambers. (The LASSO® NAV Catheter is in pending 510(k) K093376.)
• 3. Complex Fractionated Atrial Electrograms (CFAE): The capability to display maps that are colored according to the duration and repetitions of fragmented electrograms.
• 4. Pace Mapping Software (PaSo) Module: Provides for paperless comparison between recorded induced ECG signals and pace mapping signals.
• 5. Support of two additional ultrasound systems: Siemens Acuson X300 and GE Vivid i/q.

The provided submission (K093566) is a 510(k) for the CARTO® XP System with CARTOXPRESS™ Module (V10). It describes a cardiac mapping system. However, the document does not contain detailed acceptance criteria or a specific study that proves the device meets those criteria in a quantitative manner.

Instead, it relies on substantiating equivalence to predicate devices and general statements about testing.

Here's a breakdown of the available information based on your request:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not provide a table of precise acceptance criteria with corresponding performance metrics. It makes a general statement:

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

The document does not specify the sample size for any test sets used. It mentions "Bench and Animal Testing" without providing specifics on the number of samples, animals, or data points involved.

• Data Provenance: The testing involved "Bench and Animal Testing." The country of origin for this testing is not explicitly stated, although the manufacturer is Biosense Webster (Israel) Ltd.

3. Number of Experts Used to Establish Ground Truth and Qualifications

The document does not mention the use of experts to establish ground truth for any test set or specific qualifications of such experts. The system is for "anatomic navigation and mapping of the human heart," which implies direct measurement and system-generated outputs rather than expert interpretation of images for ground truth.

4. Adjudication Method

The document does not mention any adjudication method. This is consistent with the nature of the device, which is a mapping system that generates data rather than one requiring subjective interpretation that would necessitate adjudication.

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

An MRMC comparative effectiveness study was not done. The device's function as a cardiac mapping system does not inherently lend itself to this type of study, as its primary purpose is to assist in real-time navigation and mapping, not to diagnose or interpret in a way that requires multiple human readers. The document does not discuss human reader improvement with or without AI assistance.

6. Standalone Performance Study (Algorithm Only)

The document does not describe a standalone (algorithm only) performance study in terms of specific metrics like sensitivity, specificity, accuracy, etc. The "Bench and Animal Testing" are framed as validation of new algorithms and functionalities as part of the integrated system. The focus is on the integrated system's performance and substantial equivalence.

7. Type of Ground Truth Used

The document does not explicitly state the type of ground truth used. Given the nature of cardiac mapping and navigation, the "ground truth" would likely be derived from direct physical or electrical measurements, anatomical references, or established physiological parameters within the animal studies or bench tests, rather than expert consensus, pathology, or outcomes data in the typical sense of a diagnostic imaging device. For example, in an animal study, the actual catheter tip position might be considered ground truth against which the system's displayed position is compared.

8. Sample Size for the Training Set

The document does not specify any sample size for a training set. As this is a 510(k) for a medical device (cardiac mapping system) from 2010, the concept of "training set" and "AI" as it's typically understood today (e.g., in deep learning) was not as prevalent or explicitly reported in regulatory submissions of this type for such devices. The "new algorithms" mentioned are likely deterministic or model-based, rather than machine learning algorithms requiring large training datasets as described for modern AI.

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

Since no training set is mentioned, the method for establishing its ground truth is also not described.

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