(265 days)
The CardioInsight ECVUE Mapping System is intended for acquisition, and storage of cardiac electrophysiological data and maps for analysis by a physician.
ECVUE is a non-invasive mapping system for beat-by-beat, multi-chamber, 3D mapping of the heart. The 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 ECVUE software provides various cardiac signal analyses and displays interactive 3D color maps including potential, activation, voltage, propagation, and phase maps. The system is mobile and can be used for mapping at the patient's bedside or in the EP lab.
The CardioInsight ECVUE Mapping System's acceptance criteria and studies are described below:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Ability to acquire ECG signals | Established in GLP animal study and clinical experience |
| Ability to perform signal analyses | Established in GLP animal study and clinical experience |
| Ability to display 3D maps | Established in GLP animal study and clinical experience |
| Ability to localize various rhythms | Established in GLP animal study |
| Ability to characterize cycle length and activation times | Established in GLP animal study |
| Absence of adverse events | Demonstrated in GLP animal study and clinical experience |
| Meets applicable standards and specifications (software, hardware, electrical safety, EMC) | Demonstrated through in-vitro testing |
| Performance as intended in routine EP clinical practice | Demonstrated through clinical experience from two European centers |
| Substantial equivalence to legally marketed predicate devices | Concluded based on in-vitro, animal, and clinical studies |
2. Sample Size and Data Provenance for Test Set
- Sample Size (Clinical Experience): 60 patients.
- Data Provenance: From two European centers (retrospective, given the phrase "Clinical experience with commercially available device").
- Sample Size (Animal Study): Not explicitly stated, but described as a "controlled porcine model" in a GLP study.
- Data Provenance (Animal Study): Not explicitly stated but assumed to be prospective due to the nature of a GLP "study."
3. Number of Experts and Qualifications for Ground Truth (Test Set)
The document does not explicitly state the number of experts used to establish ground truth for the test set or their specific qualifications (e.g., "radiologist with 10 years of experience").
- For the animal study, the comparison was made "as compared to a standard electrophysiology (EP) study," implying that the ground truth was established by standard EP procedures and potentially interpreted by associated EP specialists.
- For the clinical experience, the data represents "routine EP clinical practice," suggesting that the interpretation and ground truth were established by the treating physicians in those EP centers.
4. Adjudication Method for the Test Set
The document does not explicitly mention an adjudication method (e.g., 2+1, 3+1, none) for establishing ground truth in either the animal study or the clinical experience. The ground truth seems to be derived from the "standard electrophysiology (EP) study" in the animal model and from "routine EP clinical practice" in the clinical experience.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No multi-reader multi-case (MRMC) comparative effectiveness study is described where the effect size of human readers improving with AI vs. without AI assistance is quantified. The focus is on the device's performance compared to standard EP studies or its performance in clinical practice, not on the improvement of human readers specifically with AI assistance.
6. Standalone Performance Study
Yes, a standalone (algorithm only without human-in-the-loop performance) study was effectively done. The GLP animal study aimed to "demonstrate the performance of the ECVUE system in identifying origin and pattern of various rhythms as compared to a standard electrophysiology (EP) study." This suggests an assessment of the device's capability to localize rhythms and characterize timings on its own, without explicit interaction with a human reader for real-time decision-making in the performance evaluation. The clinical experience section also states that the device "performs as intended," implying its standalone functionality.
7. Type of Ground Truth Used
- Animal Study: The ground truth was established by "a standard electrophysiology (EP) study." This typically involves invasive mapping techniques that are considered the gold standard for cardiac electrophysiology.
- Clinical Experience: The ground truth was derived from "routine EP clinical practice," which would involve standard diagnostic and treatment procedures by physicians, using a range of available tools and expert interpretation.
8. Sample Size for the Training Set
The document does not explicitly state the sample size used for the training set.
9. How Ground Truth for the Training Set was Established
The document does not explicitly describe how the ground truth for any potential training set was established. The studies mentioned focus on verification and validation (for performance testing and clinical experience) rather than the development or training of the system.
§ 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).