(238 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 Version 5.2 and Accessories 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 V5.2 uses two distinct types of location technology - magnetic sensor technology and Advanced Catheter Location (ACL) technology. The CARTO® 3 EP Navigation System Version 5.2 is a modification to the CARTO® 3 EP Navigation System Version 4.2 to add the CARTOFINDER™ Module and workstation as an accessory to the CARTO® 3 System. The CARTOFINDER™ Module sends recorded electrical signals collected from multi-connector electrode catheters to the CARTOFINDER™ workstation, which generates new visual format maps to be displayed in the CARTO® 3 EP Navigation System.
The provided text describes a 510(k) summary for the CARTO® 3 EP Navigation System, Version 5.2 and Accessories with the CARTOFINDER Module. This document focuses on demonstrating substantial equivalence to a predicate device rather than presenting a detailed clinical study for novel claims with specific acceptance criteria. Therefore, the information requested regarding acceptance criteria, study design, and quantitative performance metrics is largely not available in this type of regulatory document.
However, based on the information provided, here's what can be inferred and stated:
1. A table of acceptance criteria and the reported device performance
The document does not specify quantitative acceptance criteria or provide a table of reported device performance values in relation to such criteria. The performance data section broadly states: "The CARTO® 3 EP Navigation System, Version 5.2 passed all tests in accordance with appropriate test criteria and standards, and the modified device did not raise new questions of safety or effectiveness." This indicates that predefined criteria were met for functional safety and effectiveness, but the specific metrics are not detailed.
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: The document mentions "Biosense Webster sponsored studies, published literature, and manuscripts" were used for clinical data to support the performance of the new maps. However, it does not specify the sample size for these studies or for any dedicated test set.
- Data Provenance: The provenance (country of origin, retrospective/prospective) of the clinical data is not specified.
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)
This information is not provided in the document. For diagnostic devices, expert review is often part of establishing ground truth, but the details are absent here.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
The document does not specify any adjudication method for establishing ground truth in a test set.
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 a multi-reader multi-case (MRMC) comparative effectiveness study, nor does it provide any effect size for human reader improvement with AI assistance. The CARTOFINDER™ Module is an enhancement to a mapping system, generating "new visual format maps," but the document doesn't frame its evaluation as an AI-assisted interpretation study for human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
The document states that the new maps produced by the CARTOFINDER™ Module are for "diagnostic purposes only" and that "Therapeutic treatment should rely on all available information in the EP lab." This implies that the output of the CARTOFINDER™ Module is intended to be used by a clinician as part of a larger diagnostic and treatment workflow, rather than as a standalone diagnostic device. The "performance data" section focuses on verification of functionality and integration rather than standalone diagnostic accuracy metrics. Therefore, a standalone (algorithm-only) diagnostic performance study is not explicitly described or quantified.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The document does not explicitly state the type of ground truth used for the clinical data from the "Biosense Webster sponsored studies, published literature, and manuscripts." For cardiac electrophysiology, ground truth often involves a combination of clinical assessment, catheter ablation outcomes, and consensus among experienced electrophysiologists, but this is not detailed here.
8. The sample size for the training set
The document does not mention a training set or its sample size. This type of regulatory submission typically focuses on validation and verification rather than detailing the development (training) phase of the algorithms.
9. How the ground truth for the training set was established
Since a training set is not mentioned, the method for establishing its ground truth is also 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).