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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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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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The CARTO™ XP EP Navigation System is intended to acquire real time catheter based cardiac electrophysiolgical maps in patients who are eligible for a conventional electrophysiological study. The CARTO™ XP EP Navigation System is restricted for use by licensed medical practitioner who participated in a CARTO™ training course. There are no special contraindications when using the CARTO™ XP EP Navigation System.

The intended use of the CARTO™ XP mapping system is catheter-based atrial and ventricular mapping.

The intended use of the modified device is the same as for Predicate Device A cleared under 510(k) Number K020863. The indications for use have been expanded to include the CARTOMERGE™ capability to import, register and merge CT or MRI structural images with CARTO maps physiological information and real time catheter navigation.

The CARTO™ XP EP Navigation system 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, 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 CARTOMERGE module provides for the import, processing, visualization and analysis of pre-acquired cardiac images, superimposed to the CARTO XP EP maps. The CARTOMERGE supports import of Computed Tomography (CT) and Magnetic Resonance (MRI) images in DICOM format.

The provided text does not contain detailed information about acceptance criteria for device performance or a specific study proving the device meets those criteria. The 510(k) summary focuses on the device description, indications for use, and a statement of substantial equivalence to predicate devices, rather than detailed performance metrics and study results.

However, based on the information provided, here's what can be extracted and what is missing:

1. Table of Acceptance Criteria and Reported Device Performance

Missing Information for this Section:

• Specific quantitative acceptance criteria (e.g., "mapping accuracy must be within X mm," "image registration error must be less than Y mm").
• Detailed reported device performance metrics against these criteria.

2. Sample size used for the test set and the data provenance

• Sample Size: Not specified. The document mentions "non-clinical bench and animal testing" but does not give sample sizes for these tests or for any human clinical test sets.
• Data Provenance: Not specified. It's likely the "non-clinical bench and animal testing" were conducted internally by the manufacturer (Biosense Webster, Inc., with manufacturing in Israel), but no country of origin for specific data is provided. The tests are described as "non-clinical bench and animal testing," which implies prospective studies in controlled environments, but this is not explicitly stated for a "test set" in the context of human data.

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

• This information is not provided in the given text.

4. Adjudication method for the test set

• This information is not provided in the given text.

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

• This information is not provided in the given text. The device is a "EP Navigation System" that aids in mapping, and while it processes information, it's not described as an AI system that improves human readers in a diagnostic sense that would typically involve an MRMC study comparing AI-assisted vs. unassisted performance.

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

• While the system "acquires, analyzes, and displays" information, its intended use is to assist a "licensed medical practitioner." The text does not describe a standalone algorithm-only performance evaluation, but rather emphasizes its role in conjunction with human expertise in electrophysiological studies.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

• This information is not provided in the given text. For electro-anatomical mapping, ground truth would typically be established by highly experienced electrophysiologists based on combined electrical and anatomical data, but the document does not detail this.

8. The sample size for the training set

• This information is not provided in the given text. Given the device's nature as an EP navigation system for mapping rather than a machine learning model trained on large datasets for diagnosis, the concept of a "training set" in the modern AI sense might not be directly applicable or detailed. The functionality is described more as signal processing and display.

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

• This information is not provided in the given text, and for the reasons mentioned above, a "training set" as commonly understood in AI/ML might not be central to the device's development as described.

In summary: The provided 510(k) summary is a high-level regulatory document focused on demonstrating substantial equivalence to predicate devices and outlining the device's intended use and technical specifications. It lacks the detailed performance study information, including specific acceptance criteria, sample sizes, ground truth methodology, and expert involvement, that would be found in a comprehensive clinical or technical validation study report.

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The intended use of the CARTO XP mapping system is catheter-based atrial and ventricular mapping.

The CARTO XP mapping system allows real-time display of cardiac maps in a number of The CARTO AT mapping system and no no roar cardiac electrical activation maps, cardiac difficient formation maps, cardiac electrical potential maps, cardiac chamber geometry maps and cardiac impedance maps. The acquired patient signals, including body surface maps and cardiac impodation may also be displayed in real time on the display screen.

The CARTO™ XP mapping system is designed to acquire, analyze, and display electroanatomical 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. In the CARTO XP mapping system the location information needed to create the cardiac maps is acquired using locatable-tip catheters equipped with a magnetic location sensor.

The provided text is a 510(k) summary for the CARTO™ XP Mapping System. It briefly describes the device, its intended use, and states that non-clinical bench and animal testing demonstrate its safety and effectiveness compared to a predicate device. However, it does not contain specific acceptance criteria, detailed study results, or the other requested information regarding sample sizes, ground truth establishment, or expert involvement.

Therefore, I cannot populate the table or answer the specific questions directly from the provided text.

Based on the provided text, the following information can be extracted, though it does not fully answer the request:

Acceptance Criteria and Device Performance:

• The document states: "The non-clinical bench and animal testing show that the device is as safe and as effective I he noti-cinneal belief and allinal testing the which it is being compared and does not raise any new questions of safety or effectiveness." This is a general statement about meeting safety and effectiveness, but no specific performance metrics or acceptance criteria are listed.

Additional Information Not Available in the Document:

1. Sample size used for the test set and the data provenance: Not mentioned.
2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not mentioned.
3. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not mentioned.
4. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, if so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not mentioned. The device is a "mapping system" and not explicitly stated as an AI-driven diagnostic aid that assists human readers.
5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not mentioned.
6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not mentioned.
7. The sample size for the training set: Not mentioned.
8. How the ground truth for the training set was established: Not mentioned.

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