(272 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 System with SPU 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. 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 electrograms and cardiac maps display based on the received intracardiac signals from the catheters. The CARTO® 3 System uses two distinct types of location technology – magnetic sensor technology and Advanced Catheter Location (ACL) technology.
The CARTO® 3 System with SPU consists of the following components:
Patient Interface Unit (PIU) Graphic User Interface (GUI) Wide-Screen monitors, keyboard, and mouse Intracardiac In Port Intracardiac Out Port Power Supply Patches Connection Box and Cables Pedals Location Pad SPU
It appears you've provided an FDA 510(k) Summary for the CARTO® 3 EP Navigation System with Signal Processing Unit (K200484). This document primarily focuses on demonstrating substantial equivalence to a predicate device, rather than providing a detailed clinical study demonstrating the device's performance against specific acceptance criteria for a new and unproven diagnostic or AI-driven medical device.
The provided document describes the device, its intended use, and its technological characteristics compared to a predicate device. It states that the differences are the addition of a Signal Processing Unit (SPU), an upgrade to Windows 10, and blocking certain optional features.
Therefore, the study design and acceptance criteria outlined in your request (particularly related to AI performance, human reader improvement, and extensive ground truth establishment) are not applicable to this specific 510(k) submission. This is because the submission is for a modification of an already cleared device, where the key is to show that the modifications do not negatively impact safety or effectiveness, rather than a de novo submission or a submission for a novel AI diagnostic algorithm.
However, I can extract the information that is present and explain why certain sections of your request cannot be fulfilled from this document.
Here's an analysis based on the provided document:
Acceptance Criteria and Device Performance (Not Applicable in the Requested Format)
- The document primarily focuses on demonstrating that the modifications (addition of SPU, OS upgrade, blocked features) to the CARTO® 3 system do not negatively affect its safety and effectiveness, and that the new accessory (SPU) functions as intended.
- It does not present acceptance criteria in the format of specific sensitivity, specificity, accuracy, or other performance metrics, nor does it typically involve a clinical study demonstrating diagnostic accuracy with human readers or standalone AI performance.
- Instead, the "acceptance criteria" were met through:
- Bench Testing: Verifying visualization of catheters, system behavior, location accuracy of catheters position, ECG channel characteristics and performance, load capacity, and data synchronization.
- Functional Verification: Testing functional requirements, hardware configurations with SPU, regression testing of legacy features, system functionality for supported catheters, and usability.
- Animal Testing: Evaluating functionality under simulated clinical workflow.
- The reported performance is that "All testing passed in accordance with appropriate test criteria and standards, and the modified device did not raise new questions of safety or effectiveness." and "All testing performed met the acceptance criteria." and "All system features were found to perform according to specifications and met the tests acceptance criteria."
1. Table of Acceptance Criteria and Reported Device Performance
As explained, discrete quantitative performance metrics (like sensitivity/specificity for a diagnostic AI) are not presented because this is a 510(k) for a device modification, not a novel diagnostic AI.
| Acceptance Criteria Category | Specific Tests/Verification | Reported Device Performance |
|---|---|---|
| Electrical Safety & EMI | IEC 60601-1, IEC 60601-1-2 | In compliance with standards |
| Proof of Design | Visualization of catheters, system behavior, | |
| location accuracy, ECG channel characteristics/performance, | ||
| load capacity, data synchronization | All testing met acceptance criteria | |
| Functional Verification | Functional requirements & HW configurations with SPU, | |
| regression for legacy features, supported catheter functionality, usability (IEC 60601-1-6) | All system features performed according to specifications and met test acceptance criteria | |
| Simulated Clinical Use | Animal Testing for SPU functionality under simulated clinical workflow | All test protocol steps successfully completed and expected results achieved |
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size: Not applicable in the context of human patient data for an AI performance study. The "test set" consisted of bench models, simulated conditions, and animal subjects. No specific number of "cases" or "patients" for a diagnostic accuracy study is provided.
- Data Provenance: The bench and animal testing were conducted by Biosense Webster, Inc., with manufacturing facilities in Israel and the USA. The data is pre-clinical/bench data, not clinical patient data from specific countries.
- Retrospective/Prospective: The testing described is prospective, in that it was specifically designed and executed to evaluate the device changes for this 510(k) submission.
3. Number of Experts Used to Establish Ground Truth and Qualifications
- Not applicable. This submission does not involve evaluation of an AI or diagnostic algorithm requiring expert-established ground truth on medical images or data. The "ground truth" for the engineering and animal tests would be the known electrical and positioning parameters of the system, established by engineering specifications and direct measurement.
4. Adjudication Method for the Test Set
- Not applicable. No human experts were adjudicating clinical cases for ground truth in this type of submission.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No. This was not a comparative effectiveness study for human readers with or without AI assistance. The submission is about the performance of the CARTO® 3 system itself, including its new SPU accessory, for its intended use in cardiac EP procedures, not about a diagnostic AI.
6. Standalone Performance (Algorithm Only without Human-in-the-Loop)
- Not applicable in the AI sense. While the device performs complex calculations (e.g., location determination, signal processing), it is inherently a system that assists a human clinician during EP procedures. It's not a standalone diagnostic AI algorithm that provides a diagnosis without human interaction. The "performance data" presented relates to the system's ability to accurately process signals and determine catheter location, which is a standalone function of the device's software and hardware.
7. The Type of Ground Truth Used
- For bench testing: Engineering specifications, known physical parameters, and reference measurements.
- For animal testing: Physiological responses within the animal model relative to expected system behavior.
- This is not "expert consensus, pathology, or outcomes data" in the typical sense of a diagnostic AI study.
8. The Sample Size for the Training Set
- Not applicable. This document does not describe the development or validation of a new AI algorithm requiring a training set. The CARTO® 3 system's underlying algorithms would have been developed and refined over many years, potentially using large internal datasets, but this 510(k) is about a modification, not the initial development or a significant new AI feature.
9. How the Ground Truth for the Training Set Was Established
- Not applicable. As above, this document does not refer to a "training set" for a new AI algorithm.
In summary, the provided FDA 510(k) notification focuses on demonstrating the safety and effectiveness of a modified medical device through engineering and pre-clinical verification, rather than the clinical validation of a new diagnostic AI system. Therefore, many of the questions related to AI study design and clinical ground truth establishment are not addressed in this specific document.
§ 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).