(140 days)
The intended use of the CARTO® 3 System is catheter-based cardiac electrophysiological (EP) procedures. The CARTO® 3 System provides information about the electrical activity of the heart and about catheter location during the procedure. The system can be used on patients who are eligible for a conventional electrophysiological procedure. The system has no special contraindications.
The CARTO®3 EP Navigation 3 System, Version 3.2 and Accessories is a catheterbased 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 intracardiac 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 System V3.2 uses two distinct types of location technology magnetic sensor technology and Advanced Catheter Location (ACL) technology.
The provided text describes a 510(k) submission for the CARTO® 3 EP Navigation System, Version 3.2. This submission focuses on software changes and the activation of a previously blocked module. It demonstrates substantial equivalence to a predicate device, rather than proving performance against specific acceptance criteria for a novel device. Therefore, much of the requested information regarding acceptance criteria and a detailed study proving device performance in the typical sense of a new AI/ML device is not directly applicable or available in this document.
However, I can extract information related to the type of testing performed to support the substantial equivalence claim.
Here's a breakdown of the available information in relation to your request:
1. Table of Acceptance Criteria and Reported Device Performance
This document does not specify quantitative acceptance criteria in the format you requested (e.g., sensitivity, specificity, accuracy thresholds) because it is a 510(k) for a software update to an existing device, focusing on substantial equivalence. The "acceptance criteria" here implicitly refer to passing all tests designed to verify modified features and demonstrate regression testing, ensuring no negative impact on existing features.
| Feature Tested/Modified | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Modified Features (Software) | Meets design specifications; functions as intended. | Passed all tests. |
| Existing Features (Regression) | No negative impact on previously cleared functionalities. | Passed all tests; new features did not negatively affect existing ones. |
| Overall System Safety/Effectiveness | As safe and effective as predicate and reference devices. | Demonstrated to be as safe, as effective, and performs as well as or better than predicate and reference devices. |
| SMARTTOUCH™ Module Activation | Functions correctly and safely when activated. | Included in the demonstration of safety and effectiveness. |
| Advanced FAM improvements | Visual improvements are effective and do not degrade mapping. | Part of the overall system that passed testing. |
| RMT Improvements | Enhanced functionality without degradation of existing features. | Part of the overall system that passed testing. |
| Video Export to Recording System | Functions correctly. | Part of the overall system that passed testing. |
| PaSo™ Module Update | Improved functionality without degradation. | Part of the overall system that passed testing. |
2. Sample Size Used for the Test Set and Data Provenance
The document mentions Bench and Animal Testing, and an IDE Clinical Investigation. However, it does not provide specific sample sizes for these tests or the data provenance (e.g., country of origin, retrospective/prospective).
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This information is not provided in the summary. For this type of electromechanical and software system, "ground truth" would likely be established through precise engineering measurements and physiological recordings in animal models, rather than expert consensus on images.
4. Adjudication Method for the Test Set
This information is not provided. Given the nature of the device (cardiac mapping system) and the testing type (bench, animal, clinical investigation), a formal adjudication method as typically applied to image-based AI diagnoses is not explicitly mentioned or clearly implied.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size
This information is not provided. The document focuses on demonstrating substantial equivalence of the modified device to a previous version and a reference device, not on comparing human reader performance with and without AI assistance. The CARTO® 3 system is a tool for EP procedures, not a diagnostic AI interpretation system in the typical sense that would involve human readers interpreting AI output.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study Was Done
The testing performed (Bench, Animal, IDE Clinical Investigation) would inherently evaluate the "standalone" performance of the system's functions. The system itself is designed to provide real-time information to a clinician (human-in-the-loop), but its underlying algorithms and functionality were tested independently to ensure they work as intended. The document doesn't explicitly frame it as a "standalone study" in the context of an AI diagnostic, but rather as verification and validation of the system's software and hardware.
7. The Type of Ground Truth Used
Based on the description of the device (catheter-based atrial and ventricular mapping system), the ground truth for performance testing would likely involve:
- Engineering/Physical Measurements: During bench testing, this would involve highly accurate physical measurements to verify mapping accuracy, location accuracy, and signal integrity.
- Physiological Data: In animal testing and clinical investigations, the "ground truth" would be the actual electrophysiological activity of the heart, as measured by reference devices or established physiological principles, and corresponding catheter locations.
The document does not detail specific methods for establishing ground truth, but these are the likely approaches given the device's function.
8. The Sample Size for the Training Set
This document describes a software update and activation of a module for an existing device. It is not a de novo AI/ML submission where a separate, distinct "training set" would typically be described. The "training" for such a system would involve software development and integration, followed by extensive testing, but not in the sense of training a machine learning model on a labeled dataset. Therefore, this information is not applicable/provided.
9. How the Ground Truth for the Training Set Was Established
As explained above, this concept of a "training set" is not directly applicable to this submission in the way it would be for a typical AI/ML diagnostic algorithm. Therefore, how ground truth for a training set was established is not provided.
§ 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).