(174 days)
The Vektor Computational ECG Mapping System (vMap™) is intended for the analysis, display, and storage of cardiac electrophysiological data and maps for analysis by a physician.
The Vektor Computational ECG Mapping System (vMap™) is a non-invasive software-driven tool for beat-by-beat, multi-chamber, two-dimensional ("2D") and three-dimensional ("3D") analysis and mapping of the heart. vMap" analyzes standard, 12-lead electrocardiographic signals acquired non-invasively from the body surface. vMap™ uses this data to provide various 2D cardiac information and interactive 3D color maps, including cardiac electrical features for analysis by a physician. vMap™ can be used in the clinical environment, such as the electrophysiology ("EP") lab, and in a hospital environment.
The vMap™ System consists of three key components:
- The vMap™ Software, which drives vMap™ and its core analysis functionalities;
- The vMap™ Hardware, the computer workstation which facilitates the use of the vMap™ Software; and
- The vMap™ Disposables, which includes a "Mapping Key" that serves as a license mechanism for the software. Commercial off-the-shelf components such as a USB flash drive and a set of FDA-cleared ECG leads are provided for the physician's convenience.
The electrocardiogram (ECG) signals are displayed and used in proprietary algorithms to transform the measured body surface signals into cardiac signals. vMap™ provides information directly to the physician to help assess patients exhibiting abnormal heart rhythmias). vMap" provides this information by analyzing electrocardiographic information with reference to an arrhythmia-specific cardiac voltage library.
Here's a breakdown of the acceptance criteria and the study details for the Vektor Computational ECG Mapping System (vMap™), based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| **Primary Endpoint (Specific Arrhythmia - PVC and VT in Structurally Normal Hearts, 90%"). Based on the phrasing, the achieved values themselves were implicitly considered acceptable. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size (Clinical Study/Test Set):
- Initially: 225 patients associated with 255 arrhythmia/pacing episodes.
- For Primary Endpoint analysis: 75 episodes (PVC and VT arrhythmias in cases with structurally normal hearts and less than 10% scar).
- For Secondary Endpoints analysis: 255 total episodes.
- Data Provenance: Retrospective, multi-center clinical study conducted across four investigational sites within the United States.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
The document does not explicitly state the number or qualifications of experts used to establish the ground truth for the test set. It mentions "clinical arrhythmia ('CAT') location as determined by ground truth," but does not detail how this ground truth was derived (e.g., if it was established by a panel of electrophysiologists).
4. Adjudication Method for the Test Set
The document does not specify an adjudication method (e.g., 2+1, 3+1, none) for establishing the ground truth or evaluating the device's output against the ground truth.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not explicitly mentioned. The study focused on the standalone performance of the vMap™ system in identifying arrhythmia locations against a ground truth. There is no information provided about human readers improving with or without AI assistance.
6. Standalone Performance Study (Algorithm Only Without Human-in-the-Loop Performance)
Yes, a standalone performance study was conducted. The clinical study details focus on the vMap™ system's ability to "correctly identify" the CAT location and segment based on ground truth, indicating an evaluation of the algorithm's performance without explicit mention of human interpretation of the device's output being a variable in the reported accuracy metrics. The system is "intended for the analysis, display, and storage... for analysis by a physician," but the performance metrics are attributed directly to the device's identification capabilities.
7. Type of Ground Truth Used
The ground truth used was the "clinical arrhythmia (CAT) location as determined by ground truth." While the exact methodology for establishing this "ground truth" is not detailed, it would typically be derived from invasive electrophysiology mapping procedures and expert interpretation, which is considered high-fidelity clinical data.
8. Sample Size for the Training Set
- vMap™ (Proposed Device): The document states that the system leverages a "pre-computed cardiac voltage library which uses forward models and mathematical algorithms to derive cardiac signals from body surface signals." This library, called "RhythmMatrix," is described as "a collection of over one million precomputed cardiac voltage library solutions." Each solution includes a simulated cardiac activation source location and its corresponding vectorcardiogram. This over one million pre-computed simulations constitutes the "training" or foundational data for the vMap™'s core analytical parameters.
- Volta Medical VX1 (Primary Predicate): For comparison, its training set is described as a "very large database of 1.5 second snippets of multipolar intra-cardiac atrial electrograms."
9. How the Ground Truth for the Training Set Was Established
For vMap™'s "RhythmMatrix" (the pre-computed cardiac voltage library), the ground truth was established through simulated cardiac activation source locations that correspond to "pre-computed solutions" derived using "forward models and mathematical algorithms." This indicates a computational modeling approach rather than directly observed clinical data for the training of the underlying models; the clinical study then validates the system's performance on real-world patient data.
§ 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).