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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.

vMap is a standalone Software as a Medical Device (SaMD) application. vMap receives electrocardiogram (ECG) data (from other FDA-authorized medical devices) acquired non-invasively from the patient's body surface and processes these signals using proprietary algorithms to transform body surface measurements into cardiac electrical data. vMap utilizes this data to generate 2D cardiac information and 3D color maps that illustrate cardiac electrical features for physician analysis. vMap is intended for use in clinical environments, including electrophysiology (EP) laboratories and hospital settings.

vMap includes a main user application that provides an intuitive user interface to guide clinicians through the mapping workflow. vMap enables users to:

a. Create and manage mapping cases through an organized case management system.
b. Upload ECG data acquired from compatible recording systems.
c. Identify arrhythmias to be mapped, including marking arrhythmic beats on ECG plots.
d. Generate two-dimensional (2D) and three-dimensional (3D) heatmaps representing likely arrhythmia source locations.
e. View and interact with mapping results within the software interface.
f. Export results for integration with external electroanatomic mapping systems (e.g., Carto™, Ensite™)
g. Produce detailed case reports summarizing the mapping session and findings.

vMap SaMD operates on compatible general-purpose computing hardware that includes an off-the-shelf processing unit, monitor, keyboard and mouse. The vMap software is compatible with equivalent hardware components.

Principles of Operation:

vMap receives electrocardiographic signals acquired non-invasively from the body surface. The ECG signals are used in proprietary algorithms to transform the measured body surface signals into cardiac signals. These algorithms leverage simulated focal or rotor activity from simulated source locations across the entire heart. vMap analyzes focal-based mechanisms for focal-type and anatomical reentry-type arrhythmias (Focal Atrial Tachycardia, Premature Atrial Complex, Atrial Pacing, Ventricular Tachycardia, Premature Ventricular Complex, Ventricular Pacing, and Atrioventricular Reentrant Tachycardia, Typical Atrial Flutter and Atypical Atrial Flutter), and rotor-based mechanisms for fibrillation-type arrhythmias (Atrial Fibrillation and Ventricular Fibrillation). vMap software utilizes this data to provide various 2D cardiac information and interactive 3D color maps, including cardiac electrical features, for analysis by a physician.

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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:

1. The vMap™ Software, which drives vMap™ and its core analysis functionalities;
2. The vMap™ Hardware, the computer workstation which facilitates the use of the vMap™ Software; and
3. 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

Note: The document states that the outcomes of this clinical study validated the performance of vMap™ by confirming that the Device... was able to provide information accurately across all nine supported arrhythmia and pacing types and in patients with and without structural heart disease. While it lists specific percentage ranges for the endpoints, it doesn't explicitly define what threshold was considered "acceptable clinical accuracy performance," but rather states the results demonstrated acceptable clinical accuracy performance because the endpoints were achieved. To interpret the acceptance criteria precisely, one would typically need a predefined numerical threshold (e.g., "accuracy > 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.

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