(26 days)
The intended use of the CARTO mapping system is catheter-based cardiac mapping.
The CARTO mapping system allows real-time display of cardiac maps in a number of different formats. Maps may be displayed as cardiac electrical activation maps, cardiac electrical propagation maps, cardiac electrical potential maps, cardiac chamber geometry maps and cardiac impedance maps. The acquired patient signals, including body surface ECG and intracardiac electrograms may also be displayed in real time on the display screen.
The CARTO mapping system is designed to acquire, analyze, and display electroanatomical maps of the human heart. The maps are reconstructed using the combination of information gathered from the integration of intracardiac electrograms with their respective endocardial locations. In the CARTO mapping system the location information needed to create the cardiac maps is acquired simultaneously with the local electrogram using locatable-tip catheters equipped with a magnetic location sensor.
Here's an analysis of the provided text regarding the CARTO Mapping System's acceptance criteria and studies, organized by your requested information:
1. A table of acceptance criteria and the reported device performance
The provided 510(k) summary (K992968) for the CARTO Mapping System does not explicitly state specific numerical acceptance criteria for performance metrics (e.g., accuracy, sensitivity, specificity) nor does it provide detailed quantitative results from studies that would match such criteria directly.
Instead, the summary relies on a demonstration of substantial equivalence to a previously marketed device (CARTO mapping system, 510(k) No. K954395). The primary claim regarding performance is qualitative:
| Acceptance Criterion (Implicit) | Reported Device Performance |
|---|---|
| Safety and Effectiveness Equivalence | "The non-clinical bench and animal testing show that the device is as safe and as effective as the previously marketed device to which it is being compared and does not raise any new questions of safety or effectiveness." |
| Compliance with Safety Standards | Complies with EN 60601-111990, EN 60601-1 A1/1993, EN 60601-1 A2/1995, EN 60601-2-27/1994. |
| Intended Use | Catheter-based cardiac mapping, real-time display of various cardiac maps (electrical activation, propagation, potential, chamber geometry, impedance), and display of patient signals (body surface ECG, intracardiac electrograms). |
| Radiation Exposure Reduction | "may reduce exposure to dangerous ionizing radiation." |
2. Sample sizes used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document mentions "non-clinical bench and animal testing" but does not provide details about the sample sizes for these tests, nor the data provenance (e.g., country of origin, retrospective/prospective nature). The specificity required to determine if these were "test sets" in the context of clinical performance evaluation for acceptance criteria is not present.
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)
The document does not provide any information regarding the number of experts, their qualifications, or their involvement in establishing ground truth for any test set. This type of detail is typically associated with clinical studies involving human subject data, which are not detailed in this 510(k) summary beyond the general statement of "non-clinical bench and animal testing."
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Since no details are provided about expert involvement or ground truth establishment (as per point 3), there is no information available regarding any adjudication method.
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
The document does not mention any MRMC comparative effectiveness study, nor does it discuss human reader improvement with or without AI assistance. The CARTO Mapping System is described as a cardiac mapping system utilizing magnetic location technology, and while it processes information, it predates the widespread use and regulatory discussion of "AI" in medical devices as commonly understood today.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
The 510(k) summary focuses on demonstrating substantial equivalence through "non-clinical bench and animal testing" and compliance with safety standards. While the device acquires and displays data, the document does not explicitly describe a standalone algorithm-only performance study in the way one might discuss an AI algorithm's performance without human input. The system is inherently designed to assist clinicians in cardiac mapping, implying a human-in-the-loop interaction.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Given the reliance on "non-clinical bench and animal testing" and the absence of detailed clinical study descriptions, the specific type of ground truth used is not specified. For animal studies, "ground truth" might refer to direct physiological measurements or post-mortem analysis. For bench testing, it would likely involve known physical parameters or simulated conditions.
8. The sample size for the training set
The document does not mention a training set or any details about machine learning model development. This 510(k) submission, dated 1999, predates the era where "training set" would be a common term in medical device submissions for AI/ML-driven devices.
9. How the ground truth for the training set was established
As no training set is mentioned (see point 8), there's no information on how its ground truth might have been established.
§ 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).