(29 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 7.2 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 V7.2 uses two distinct types of location technology - magnetic sensor technology and Advanced Catheter Location (ACL) technology.
The CARTO® 3 System V7.2 consists of the following components:
- Patient Interface Unit (PIU)
- Workstation with Graphic User Interface (GUI)
- Wide-Screen monitors, keyboard, and mouse
- Intracardiac In Port
- Intracardiac Out Port
- Power Supply
- Patches Connection Box and Cables (PU)
- Pedals
- Location Pad (LP)
- Signal Processing Unit (SPU) ((510(k)#: K200484)
The provided text describes the CARTO® 3 EP Navigation System Version 7.2 and its regulatory submission. It is a 510(k) summary, which means it primarily focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than providing a detailed clinical study report for new functionalities or a de novo device.
Therefore, the document does not contain the level of detail typically found in a study proving a device meets specific acceptance criteria in terms of a true "performance study" with a test set, ground truth experts, and MRMC studies as might be expected for an AI/ML diagnostic algorithm. The performance data presented is focused on non-clinical verification and validation to demonstrate that the new version maintains the safety and effectiveness of its predicate.
Based on the provided text, here's what can be extracted and what information is missing:
1. A table of acceptance criteria and the reported device performance
The document provides general statements about acceptance criteria being met, but it does not present a formal table with quantitative acceptance criteria and corresponding performance metrics from a clinical study on a patient test set.
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Acceptance Criteria (General):
- Electrical Safety and Electromagnetic Compatibility per IEC 60601-1 and IEC 60601-1-2.
- Proof of Design: verified visualization of catheters, system behavior, location accuracy of catheters position, ECG channel characteristics and performance, load capacity, data synchronization, and verification of legacy re-enabled modules.
- Functional verification: functional requirements and hardware configurations, regression testing of CARTO® 3 System legacy features, system functionality for supported catheters, and interoperability with 3rd party compatible medical devices.
- Usability per IEC 60601-1-6.
- Animal testing: functionality under simulated clinical workflow and conditions, with successful completion of all protocol steps and achievement of expected results.
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Reported Device Performance (General):
- "Test results were in compliance to the standards." (for electrical safety/EMC)
- "All testing performed met the acceptance criteria." (for Proof of Design)
- "All system features were found to perform according to specifications and met acceptance criteria." (for Functional verification and Usability)
- "All test protocol steps were successfully completed and expected results were achieved." (for Animal Testing)
- "All testing passed in accordance with appropriate test criteria and standards, and the modified device did not raise new questions of safety or effectiveness."
2. Sample size used for the test set and the data provenance
The document describes bench testing and animal testing. It does not describe a clinical "test set" of patient data in the sense of a diagnostic AI performance study.
- Sample Size for Bench Testing: Not specified as a number of "samples" in the traditional sense of a test set. It refers to various engineering and functional tests.
- Sample Size for Animal Testing: Not specified, but it implies a pre-clinical study involving animals. No indication of retrospective or prospective for non-human data.
- Data Provenance: Not applicable for a clinical test set from human patients, as such a study is not described.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not present because the document does not describe a clinical study with a human-derived test set requiring expert ground truth.
4. Adjudication method for the test set
This information is not present for the same reason as above.
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
There is no mention of an MRMC study. This device is an EP navigation system, not a diagnostic AI intended to assist human readers in interpreting medical images in the manner that an MRMC study would evaluate. Its purpose is to guide catheter-based procedures and provide real-time information rather than perform diagnostic interpretation that humans would then re-read.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
The device's core functionality is a navigation and mapping system that processes real-time electrical signals and catheter location. Its "performance" is inherently tied to its function in a procedure, not as a standalone diagnostic algorithm providing a final output without human intervention. The testing described is focused on the accuracy of its measurements and display capabilities.
7. The type of ground truth used
For the bench testing, the "ground truth" would be the known inputs, reference standards, and specifications against which the device's output (e.g., location accuracy, ECG channel characteristics) is compared.
For the animal testing, "expected results" were achieved, implying a predefined understanding of the physiological responses or system behavior under simulated clinical conditions.
There is no mention of expert consensus, pathology, or outcomes data as ground truth for a diagnostic performance study.
8. The sample size for the training set
This document describes a 510(k) submission for a software update (Windows 10 compatibility, re-enabling legacy modules, SPU inclusion). It is not a de novo submission for a new AI/ML algorithm that would typically involve a "training set." Therefore, information on a training set sample size is not applicable/not provided.
9. How the ground truth for the training set was established
Not applicable, as it's not an AI/ML algorithm development as typically understood for training.
In summary: The provided document is a 510(k) summary for a software update to an existing EP navigation system. The "study that proves the device meets the acceptance criteria" in this context refers to non-clinical bench and animal testing designed to show that an updated version of a device maintains its safety and effectiveness and is substantially equivalent to predicate devices, rather than a clinical performance study of a diagnostic AI. The typical elements requested (e.g., test set sample size, expert ground truth, MRMC studies) are not part of this type of regulatory submission because they are not relevant to the nature of the device and the changes made.
§ 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).