(113 days)
The CardioInsight Cardiac Mapping System is intended for acquisition, analysis, display and storage of cardiac electrophysiological data and maps for analysis by a physician.
The CardioInsight Cardiac Mapping System is a non-invasive mapping system for beat-by-beat, multi-chamber, 3D mapping of the heart. The CardioInsight Cardiac Mapping System displays cardiac maps and virtual electrograms from real-time chest ECG signals (measured by a Sensor Array placed on the torso) and CT scan data. The ECG signals in concert with the CT scan information (geometrical information) are used in mathematical algorithms to transform the measured body surface signals into epicardial signals via solving the cardiac inverse problem. The CardioInsight Cardiac Mapping System software uses this data to provide various cardiac signal analyses and displays interactive 3D color maps including potential, activation, voltage, propagation, and phase maps. The CardioInsight Cardiac Mapping System is mobile and can be used for mapping at the patient's bedside or in the EP lab.
Here's a breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The provided 510(k) summary does not explicitly state quantitative acceptance criteria or a direct comparison of the proposed device's performance against such criteria. Instead, it details that the device underwent various verification and validation tests to ensure it meets design inputs and performs as intended, and that it is "substantially equivalent" to its predicate device. The performance data section describes the types of testing performed rather than specific numerical results or acceptance thresholds.
| Acceptance Criteria (Inferred from testing goals) | Reported Device Performance |
|---|---|
| Compliance with safety and specifications | "Performance testing was completed on the CardioInsight Cardiac Mapping System which verified that the System complies with the safety and specifications and performs as designed; it is suitable for its intended use." (Page 6) |
| Algorithm requirements met and function as intended | "Algorithm Testing and Integration – verified the algorithms met requirements and functioned as intended, and when integrated, performed as expected. Bench testing and simulated use testing evaluated the following: Max -dV/dt vs. Mid-Point Activation Algorithm Detection via new IBCD Algorithm, Remove bad channels from inverse calculation" (Page 6) |
| Product design output meets design input requirements (integration testing) | "Integration testing to conclude that the product design output meets the design input requirements of the integration of algorithm code." (Page 6) |
| Product design output meets design input requirements (verification testing) | "Verification testing to conclude the product design output meets the design input requirements." (Page 6, and repeated on Page 7 for System V&V) |
| Incremental changes made to the system perform as intended from user perspective | "Validation testing to conclude the design validation for the incremental changes made to the system performs as intended from the user perspective" (Page 7) |
| Usability per IEC 62366-1 Edition 1.0 2015-02 | "Usability testing consisted of Human Factors testing for the incremental changes made to the system, including formative evaluation activities, use error analysis, user interface design, mockup reviews, labeling review, and formal/informal simulated use evaluations." (Page 7) |
| Substantial Equivalence to Predicate Device | "The data presented in this submission demonstrate that the CardioInsight Cardiac Mapping System v3.5 is substantially equivalent to the predicate device identified in intended use, device design, fundamental technology and performance." (Page 7) The software version v3.5 (proposed) has identical intended use, indications for use, system components, and principles of operation compared to v3.0 (predicate). Software/firmware/algorithm has "Identical workflows; software enhancements throughout." (Page 5) Off-the-shelf software components were updated while maintaining core functionality. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the sample size used for the test set or the data provenance (e.g., country of origin, retrospective/prospective). The testing described is primarily focused on software and system verification and validation in simulated environments, bench testing, and usability testing. There is no mention of clinical data or patient-specific test sets in this summary.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not provided. Given that the testing described is primarily technical and simulated, the concept of "ground truth established by experts" in a clinical context isn't directly applicable for all tests mentioned. Usability testing would involve users, but their qualifications are not detailed.
4. Adjudication Method for the Test Set
This information is not provided. As mentioned above, the testing appears to be primarily technical validation rather than clinical adjudication of results against a gold standard.
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
No MRMC study is mentioned in the provided text. The device is a cardiac mapping system, and the changes are related to software enhancements, algorithm improvements, and usability, rather than an AI-assisted diagnostic aid for human readers.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done
The document describes "Algorithm Testing and Integration" and "Bench testing" which would fall under standalone performance evaluation of the algorithms. However, explicit metrics or results from such standalone performance are not provided, only that the algorithms "met requirements and functioned as intended." The system itself is explicitly designed for "analysis by a physician," indicating a human-in-the-loop design.
7. The Type of Ground Truth Used
For the algorithm testing, the ground truth would likely be defined by the requirements themselves and the expected output of the algorithms given specific simulated inputs. For usability testing, the 'ground truth' would be user feedback and whether the system functions as expected from a user perspective. There is no mention of pathology, outcomes data, or expert consensus from clinical cases as a ground truth in this summary.
8. The Sample Size for the Training Set
This information is not provided. The document focuses on verification and validation of the updated system against a predicate device and engineering requirements, not on the development or training of new machine learning models.
9. How the Ground Truth for the Training Set Was Established
This information is not provided, as the submission does not detail the training of a new AI/ML model.
§ 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).