(29 days)
The CARTO® 3 V1.05 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 V1.05 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 communication channel to the Stereotaxis Niobe Catheter Navigation System. The CARTO 3 V1.05 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 volumes 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 V1.05 EP Navigation System is a catheter-based atrial and ventricular 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 V1.05 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. 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 V1.05 System incorporates the following features:
- Visualization of multiple catheters using ACL technology
- Integration with Stereotaxis Niobe Catheter Magnetic Navigation System -. Remote Magnetic Technology (RMT)
- Integration with Ultrasound (ULS) systems CARTOSOUND™ Module .
- Fusion of CT and MRI images CARTOMERGE® PLUS Image Integration . Module with Image Processing Package
- . Fast Anatomocal Mapping
- Complex Fractionated Atrial Electrogram (CFAE) mapping tool
- . Impedance mapping
The provided text does not contain a detailed study with acceptance criteria and reported device performance metrics in tabular format. It focuses on regulatory submission (510(k) summary) and device description rather than a comprehensive performance study report.
However, based on the available information, I can extract and infer some details:
1. A table of acceptance criteria and the reported device performance:
The document states, "The System passed all intended criteria in accordance with appropriate test criteria and standards and no new questions of safety or effectiveness were raised." However, the specific acceptance criteria and corresponding performance results are not detailed in the provided text. The document lists various functionalities of the device but doesn't provide quantitative performance metrics against specific criteria.
2. Sample size used for the test set and the data provenance:
The document mentions "bench testing" and "simulated use conditions in animals" for testing the CARTO® 3 V1.05 EP Navigation System.
- Test Set Sample Size: Not specified.
- Data Provenance: The testing was conducted internally as part of the device development and regulatory submission process. The locations of the manufacturing facilities are given (Israel for System & System Cables, USA for Accessories), but the specific country of origin for the animal study data or bench testing is not explicitly stated. The nature of the studies ("simulated use conditions in animals") indicates prospective data collection.
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 given text. The document does not describe the methodology for establishing ground truth for any performance evaluations, or the involvement or qualifications of experts.
4. Adjudication method (e.g. 2+1, 3+1, none) 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 CARTO® 3 V1.05 EP Navigation System is a cardiac mapping system, and the description does not suggest "human readers" interpreting images in a way that would be typical for an MRMC study related to AI assistance in diagnosis. The system aids EP procedures by displaying electroanatomical maps, not by interpreting diagnostic images with human readers in a comparative AI-assisted vs. non-assisted setup.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
The device described is an "EP Navigation System" that "allows real-time display of 3D anatomical and electroanatomical maps of the human heart." It is inherently a system where "human-in-the-loop" (the clinician) uses the information generated by the algorithm to perform a procedure. The document doesn't describe an "algorithm only" performance evaluation separate from its intended use in EP procedures. Its stated function is to "acquire and analyze data points, and use this information to display 3D anatomical and electroanatomical maps," implying the output is for human interpretation and guidance during a procedure.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
This information is not provided in the given text. For a cardiac mapping system, ground truth might involve highly accurate invasive measurements or correlation with clinical outcomes, but the document does not specify.
8. The sample size for the training set:
The document describes performance testing (bench and animal studies). It does not mention a "training set" in the context of machine learning model development. The CARTO® system's functionality is based on established principles of magnetic and Advanced Catheter Location (ACL) technology to acquire and display electroanatomical information, rather than a machine learning model that would typically require a training set.
9. How the ground truth for the training set was established:
As no training set is mentioned (see point 8), this information is not applicable.
§ 870.1425 Programmable diagnostic computer.
(a)
Identification. A programmable diagnostic computer is a device that can be programmed to compute various physiologic or blood flow parameters based on the output from one or more electrodes, transducers, or measuring devices; this device includes any associated commercially supplied programs.(b)
Classification. Class II (performance standards).