(29 days)
The CARTO® 3 V2.0 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 V2.0 System is also intended to support EP procedures, maintaining CARTO® System capabilities, in the presence of a high metallic environment and magnetic field strengths up to 0.1 T and provide a data communication channel to the Stereotaxis Niobe® Catheter Navigation System. The CARTO® 3 V2.0 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 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 V2.0 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 realitime. The location information needed to create the cardiac maps and the local elector mans 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. The acquired patient signals, including body surface ECG and intracardiac electrograms (IECG) may also be displayed on the display screen. The CARTO® 3 V2.0 System uses two distinct your of location technology - magnetic sensor technology and Advanced Catheter Location (ACL) technology.
The provided text describes a 510(k) submission for the CARTO® 3 V2.0 EP Navigation System. It details the device's purpose, its substantial equivalence to predicate devices, and the non-clinical performance testing conducted. However, the document does not contain explicit acceptance criteria in a quantitative format, nor does it present detailed studies with specific performance metrics against those criteria.
Instead, the document states: "The CARTO® 3 V2.0 EP Navigation System passed all tests in accordance with appropriate test criteria and standards, and the modified device did not raise new questions of safety or effectiveness." and "The Bench and Animal Non-clinical Testing demonstrated that the CARTO® 3 V2.0 EP Navigation System is as safe, as effective, and performs as well as or better than the predicate devices."
Therefore, based on the provided text, I cannot complete the requested tables and information regarding specific acceptance criteria and detailed study results. The submission focuses on demonstrating substantial equivalence through general non-clinical testing rather than reporting on a specific study designed to meet predetermined acceptance metrics.
Here's an analysis of the questions where information can be extracted or where the document is silent:
1. A table of acceptance criteria and the reported device performance
- Cannot be provided based on the input document. The document states that the device "passed all tests in accordance with appropriate test criteria and standards," but it does not specify what those criteria were (e.g., minimum accuracy, maximum error) or provide numerical performance data for the CARTO® 3 V2.0 EP Navigation System.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size: Not specified. The document mentions "extensive Bench and Animal Testing," but no details on the number of individual tests, animals, or test conditions are provided.
- Data Provenance: Not specified. The document does not indicate the country of origin of the data or whether the studies were retrospective or prospective.
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)
- Not applicable/Not specified. The document describes "Bench and Animal Testing," which typically involves engineers, technicians, and potentially veterinary specialists, rather than human expert interpretation of data for ground truth in the way a medical imaging AI would. There is no mention of "experts" in this context.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable/Not specified. Adjudication methods are typically used in studies involving human interpretation or subjective assessments. For bench and animal testing of a navigation system, validation usually involves direct measurement against known standards or physical benchmarks, rather than expert consensus on interpretive tasks.
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
- No, an MRMC comparative effectiveness study was not done. The document describes non-clinical "Bench and Animal Testing" to verify and regression test the new features. It's not a study involving human readers or AI assistance in the way an MRMC study would typically evaluate. The CARTO® system itself is a navigation and mapping system, not an AI for image interpretation that would assist human readers in diagnosis.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Partially applicable, but in a different context. The "Bench and Animal Testing" can be considered a form of standalone performance evaluation for the system's functionalities (e.g., accuracy of location, mapping capabilities). However, the document does not present specific "algorithm-only" performance metrics as one might expect from an AI diagnostic device. It focuses on the overall system's safety and effectiveness compared to predicate devices.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Reference standards/known physical parameters. For "Bench Testing," ground truth would typically be established by highly accurate measurement devices or known physical properties of test phantoms. For "Animal Testing," ground truth would likely involve direct measurements, invasive procedures, or established physiological benchmarks within the animal model, rather than expert consensus or pathology in the context of clinical decision-making. The document does not specify these details.
8. The sample size for the training set
- Not applicable. The CARTO® 3 V2.0 EP Navigation System is not described as an AI/ML device that requires a "training set" in the conventional sense. It's a real-time navigation and mapping system. The document does not mention any machine learning components that would have been trained on a dataset.
9. How the ground truth for the training set was established
- Not applicable. As the device is not described as a machine learning system, the concept of a "training set" and its associated ground truth establishment does not apply here.
§ 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).