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The intended use of the CARTO™ RMT EP Navigation System v8 is catheter-based atrial and ventricular mapping.

The CARTO RMT System v8 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.

The CARTO RMT System v8 is intended to support EP procedures in the presence of the high metallic environment presented by the NIOBE 1 (PM3.0) and NIOBE 2 (PM3.1 and PM3.2) Stereotaxis Magnetic Navigation Systems (MNS) in magnetic environments of up to 0.1 Tesla.

Although the CARTO™ RMT system requires the use of a magnetic steerable catheter, i.e. the NAVISTAR RMT, when used in conjunction with the Stereotaxis Niobe MNS, it also enables the use of the standard NAVISTAR and QWIKSTAR catheters when the Stereotaxis magnets are stowed away or when used in a conventional EP lab, maintaining full CARTOTM XP capabilities.

CARTO RMT System v8 includes 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™ RMT EP Navigation System v8 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™ RMT System v8 enables cardiac mapping using CARTO™ RMT compatible catheters utilizing the magnetic navigation capabilities of the Stereotaxis Niobe Systems. In this way the system seamlessly combines the benefits of cardiac 3D mapping with remote catheter navigation and may further reduce the hospital staff exposure to dangerous ionizing radiation.

The CARTO" RMT EP Navigation System v8 includes the CARTOMERGE™ module. The CARTOMERGE module provides for the import, visualization and processing of pre-acquired cardiac images. These images are then registered and superimposed to the CARTO RMT EP maps. CARTOMERGE supports import of Computed Tomography (CT) and Magnetic Resonance (MRI) images in DICOM format.

The provided text does not contain detailed acceptance criteria, device performance data beyond a general statement of "bench testing confirms that the Carto™ RMT EP Navigation System v8 can be used according to its intended use," or specific information about a study proving device adherence to acceptance criteria.

Therefore, many of the requested sections cannot be filled from the provided text.

Here's an attempt to answer based on the available information:

1. A table of acceptance criteria and the reported device performance

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This information is not provided in the document. The document only mentions "Bench testing."

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not provided in the document.

4. Adjudication method (e.g. 2+1, 3+1, none) 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, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

There is no mention of a multi-reader multi-case (MRMC) study or any AI component in this device description, which is a "Cardiac mapping system" and "Programmable diagnostic computer." The system facilitates 3D mapping and remote catheter navigation.

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

The document describes the CARTO™ RMT EP Navigation System v8 as a "cardiac mapping system" that "acquires, analyzes, and displays electro-anatomical maps" for "licensed medical practitioners." This strongly suggests it's a human-in-the-loop system, not a standalone algorithm. Performance metrics for a standalone algorithm are not presented.

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

This information is not provided in the document. Given it's a cardiac mapping system, ground truth would likely relate to the accuracy of mapping, but the specific method used for "bench testing" is not detailed.

8. The sample size for the training set

This information is not provided in the document, and there's no mention of a "training set" in the context of an AI/ML device.

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

This information is not provided, as there is no mention of a training set.

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The intended use of the CARTO™ RMT EP Navigation System v8 is catheter-based atrial and ventricular mapping.

The CARTO RMT System v8 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.

The CARTO R.MT System v8 is intended to support EP procedures in the presence of the high metallic environment presented by the NIOBE 1 (PM3.0) and Niobe 2 (PM3.1 and PM3.2) Stereotaxis Magnetic Navigation Systems (MNS) in magnetic environments of up to 0.08 Tesla.

Although the CARTO™ RMT system requires the use of a magnetic steerable catheter, i.e. the NAVISTAR RMT, when used in conjunction with the Stereotaxis Niobe MNS, it also enables the use of the standard NAVISTAR and QWIKSTAR catheters when the Stereotaxis magnets are stowed away or when used in a conventional EP lab, maintaining full CARTOTM XP capabilities.

CARTO RMT System v8 includes 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™ RMT EP Navigation System v8 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 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.

In the conventional procedure both the patient and the physician are exposed to X-Ray radiation during the course of the procedure. The CARTO™ RMT System v8 enables cardiac mapping using CARTO™ RMT compatible catheters utilizing the magnetic navigation capabilities of the Stereotaxis Niobe Systems. In this way the system seamlessly combines the benefits of cardiac 3D mapping with remote catheter navigation and may further reduce the hospital staff exposure to dangerous ionizing radiation.

The CARTO" RMT EP Navigation System v8 includes the CARTOMERGE module. The CARTOMERGE module provides for the import, visualization and processing of preacquired cardiac images. These images are then registered and superimposed to the CARTO RMT EP maps. CARTOMERGE supports import of Computed Tomography (CT) and Magnetic Resonance (MRI) images in DICOM format.

The provided text describes the CARTO™ RMT EP Navigation System v8, an electrophysiological mapping system. It details the device's intended use and general description, but it does not contain any information about specific acceptance criteria or a study proving the device meets those criteria.

Therefore, I cannot fulfill your request for:

1. A table of acceptance criteria and reported device performance.
2. Sample size and data provenance for the test set.
3. Number and qualifications of experts for ground truth.
4. Adjudication method for the test set.
5. MRMC comparative effectiveness study results.
6. Standalone algorithm performance.
7. Type of ground truth used.
8. Sample size for the training set.
9. How ground truth for the training set was established.

The document mainly focuses on:

• 510(k) Summary: Manufacturer, contact, proprietary device name, classification, and predicate devices.
• Intended Use: Acquiring real-time catheter-based cardiac electrophysiological maps for patients eligible for conventional studies. It also notes its use in conjunction with Stereotaxis Niobe Systems to potentially reduce X-ray exposure, and the CARTOMERGE module for importing and processing imaging data (CT/MRI).
• General Device Description: How it acquires, analyzes, and displays electro-anatomical maps (activation, propagation, electrical, impedance, geometry maps) using intracardiac electrograms and endocardial locations.
• FDA Correspondence: Official notification of clearance and substantial equivalence to predicate devices, along with regulatory obligations.

The statement "The non-clinical bench tests and the location accuracy tests performed under the Niobe environment show that the device is as safe and as effective as the previously marketed devices to which it is being compared and does not raise any new questions of safety or effectiveness" is the closest it comes to mentioning testing, but it does not provide any specifics on methodologies, results, or acceptance criteria. It explicitly states "non-clinical bench tests" and "location accuracy tests" but provides no further details on these studies.

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