(83 days)
The CARTO® 3 V2.2 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 V2.2 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 V2.2 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 V2.2 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 catheters and reference devices. The system allows real-time display of electrograms and cardiac maps based on the received intra cardiac signals in a number of different formats. The acquired patient signals, including body surface ECG and intracardiac electrograms may also be displayed on the display screen. The CARTO® 3 V2.2 System uses two distinct types of location technology - magnetic sensor technology and Advanced Catheter Location (ACL) technology.
Here's an analysis of the provided text regarding the CARTO® 3 V2.2 EP Navigation System, structured to address your specific points:
Acceptance Criteria and Device Performance Study
The provided text describes a special 510(k) for software additions and hardware modifications to an existing device, the CARTO® 3 V2.0 EP Navigation System. As such, the study primarily focuses on demonstrating that the new features do not negatively impact existing features and that the modified device remains safe and effective. It does not present a typical "acceptance criteria vs. reported performance" table for a novel device, nor a comparative effectiveness study in the usual sense (e.g., human readers with vs. without AI).
Summary of Study Information:
| Section/Element | Details from Text | Inference/Explanation |
|---|---|---|
| 1. Acceptance Criteria and Reported Device Performance | "The CARTO® 3 V2.2 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." | The text states that the device passed all tests according to appropriate test criteria and standards. However, the specific quantitative acceptance criteria (e.g., accuracy thresholds, latency limits) and the detailed results showing how well it performed against these criteria are not explicitly provided in the summary. The core acceptance criterion for this 510(k) appears to be demonstrating non-inferiority or equivalence to the predicate device regarding safety and effectiveness, and that the new features function as intended without adverse effects. |
| 2. Sample size and Data Provenance (test set) | "The CARTO® 3 V2.2 EP Navigation System underwent extensive bench and animal testing..." | The specific sample sizes for the bench and animal tests are not provided. The data provenance is described as "bench and animal testing," implying controlled laboratory and in-vivo environments, rather than human clinical data. No country of origin is specified for these tests, but the manufacturer is Biosense Webster (Israel) Ltd. |
| 3. Number of experts and qualifications (ground truth for test set) | This information is not provided. | Given the nature of a 510(k) for modifications to an established device, and the use of "bench and animal testing," the ground truth would likely be established through engineering specifications, known physiological parameters, direct measurement, or potentially expert veterinary assessment for animal studies. |
| 4. Adjudication method (test set) | This information is not provided. | Adjudication methods like '2+1' are typically relevant for human-read evaluations (e.g., radiologists reviewing images). Since the evaluation involves "bench and animal testing," such adjudication methods are unlikely to apply in the same way. Performance would be assessed against defined metrics and expected behavior. |
| 5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study | "The CARTO® 3 V2.2 EP Navigation System underwent extensive bench and animal testing to verify the new and enhanced features and to demonstrate with regression testing that the new features did not negatively affect existing features." | No MRMC comparative effectiveness study involving human readers with and without AI assistance was described. This type of study (human readers improve with AI) is not relevant for this device, which is an EP Navigation System providing real-time 3D anatomical and electroanatomical maps, not an AI diagnostic aid that assists human readers in interpreting images. The "AI" here refers to algorithms within the system (e.g., for mapping, signal analysis, Fluoro Effect Reduction), integrating into the EP procedure, not directly enhancing human interpretation of data in a comparative fashion. The study focused on functional verification and safety/effectiveness equivalence to the predicate. |
| 6. Standalone (algorithm only without human-in-the-loop) performance | "The CARTO® 3 V2.2 EP Navigation System underwent extensive bench and animal testing to verify the new and enhanced features..." The system is designed for real-time display and analysis. | The functionality of the core algorithms (e.g., for 3D mapping, electrical activation, impedance, FAM, Fluoro Effect Reduction) would inherently be tested in a standalone manner during bench testing to verify their performance against specifications, even though the system is intended for use with a human operator. The "no human in the loop" aspect is a bit ambiguous for an interactive navigation system, but the algorithms themselves are evaluated for their independent accuracy and function. |
| 7. Type of ground truth used (test set) | "bench and animal testing" | For bench testing, ground truth would likely be established through engineering specifications, simulations, or phantom models with known properties. For animal testing, it would involve direct physiological measurements, established anatomical landmarks, and possibly expert veterinary assessment during the procedures. It would not be expert consensus on image interpretation or pathology in the typical sense. |
| 8. Sample size for the training set | This information is not provided. | The text describes a system that acquires and analyzes data, implying algorithms are involved. However, the specific training data for any machine learning components (if present and central to the new features in this version) is not detailed. Given the focus on demonstrating equivalence for updates to an existing system, it's possible much of the core algorithm training was conducted for prior versions. |
| 9. How ground truth for the training set was established | This information is not provided. | Similar to the test set, if training was involved for new or refined algorithms, it would likely rely on similar methods – well-characterized physiological data from research, controlled simulations, or animal studies where ground truth could be directly observed or measured. |
Key Takeaways from the Provided Text:
- Focus on Equivalence: This 510(k) is a "Special 510(k)" which typically means minor changes to an already cleared device. The primary goal is to demonstrate "substantial equivalence" to the predicate device (CARTO® 3 V2.0) and that the new features (Fluoro Effect Reduction, support for specific catheters, hardware modification) do not negatively affect safety or effectiveness.
- Study Types: The study involved "extensive bench and animal testing."
- Lack of Quantitative Details: The summary intentionally lacks detailed quantitative acceptance criteria and specific performance metrics. This is often the case in 510(k) summaries where the full study report (not publicly provided) would contain such details. The summary indicates that the tests were passed according to "appropriate test criteria and standards."
- No Human Reader Study: There is no mention of a human reader study or a comparative effectiveness study involving human readers with/without AI assistance. The device is a navigation system, not a diagnostic imaging AI designed to assist human interpretation.
§ 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).