(207 days)
VIVO is intended for acquisition, analysis, display and storage of cardiac electrophysiological data and maps for analysis by a physician.
VIVO is intended to be used as a pre-procedure planning tool for patients with structurally normal hearts undergoing ablation treatment for idiopathic ventricular arrhythmias.
The VIVO system is a noninvasive pre-procedure planning tool that provides a 3D mapping of the heart to aid in the identification of the general location of the origin of focal ventricular arrhythmias prior to electrophysiology procedures. VIVO requires acquisition of MRI or CT images and standard ECG recordings and lead (electrode) placement. Electrocardiographic potentials are measured from the torso using standard 12 lead electrocardiogram (ECG) sensors placed on the surface of the body. A DICOM image (CT or MR scan) of the thorax and heart is acquired and then segmented to provide a detailed, three-dimensional (3D) anatomy of the endocardial and epicardial surface of the heart. A 3D photograph of the patient's chest with the precise ECG lead positions used to acquire the 12 lead ECG is merged with the torso and heart model to determine the spatial relationship between the electrodes and the heart. From these data, the system uses a mathematical algorithm to use the geometrical information to transform the measured body surface potentials into myocardial potentials via solving the cardiac inverse problem. The VIVO system uses an off the shelf laptop computer and a handheld 3D camera. The VIVO software creates, displays, and stores a cardiac model that displays the site of earliest activation of ventricular arrhythmias.
VIVO software is comprised of two software applications, VIVO Anatomy and VIVO Analysis.
VIVO Anatomy merges the imported cardiac MR/CT image data with a model to create a heart and torso model representative of a patient's specific anatomy. The MR/CT image data must be imported via a DVD containing the images in DICOM format (Note: VIVO does not have a web interface). The DICOM image is then overlayed on top of one of a number of preloaded anatomical models to fine tune the preloaded model. The model that best matches the patient's anatomical profile is chosen. Specific cardiac structures and tissues are identified by the User within the images to better match the patient anatomy. An outline of the chambers and tissue walls is automatically created by VIVO which is then finetuned by the User for a precise match to the patient's anatomy.
VIVO Analysis combines the heart and torso model generated from VIVO Anatomy with ECG data, and a 3D photograph of the ECG lead placement to identify the location of the arrhythmia foci. After ECG leads are placed on the patient, a 3D photograph of the patient's chest is captured to accurately record lead locations. Arrhythmic ECG signals are recorded from these electrodes and imported into the VIVO software. This data is combined and a mathematical algorithm is used create a 3D rendering of the patient's heart with superimposed color coding to indicate the area of earliest activation.
Here's a breakdown of the acceptance criteria and the study that proves the device meets them, based on the provided text:
Acceptance Criteria and Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Accuracy to properly identify a PVC or VT foci in the right, left, or septal region of the heart | 100% agreement with CARTO localization (45 out of 45 subjects) |
Study Details
2. Sample size used for the test set and the data provenance:
- Sample Size: 45 patients
- Data Provenance: Prospective, non-randomized study conducted at 6 US centers.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
The document does not explicitly state the number of experts or their qualifications for establishing the ground truth. However, it indicates that the VIVO localization was compared with "CARTO localization", implying that CARTO mapping results were used as the reference standard (ground truth), which would typically be interpreted by electrophysiologists.
4. Adjudication method for the test set:
The document does not explicitly describe an adjudication method. The comparison states "VIVO localization... agreed (was a match) with the CARTO localization," suggesting a direct comparison without a complex adjudication process between multiple readers.
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, a multi-reader, multi-case (MRMC) comparative effectiveness study was not conducted. This study focused on the standalone accuracy of the VIVO system compared to CARTO localization.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
Yes, a standalone assessment of the VIVO system's performance was done. The study "assessed VIVO's ability to accurately determine the anatomical location of a particular ventricular origin," and its localization was directly compared to CARTO results. While physicians analyze the VIVO output, the study evaluates the accuracy of the system itself in producing the localization.
7. The type of ground truth used:
The ground truth used was CARTO localization. CARTO is an established electroanatomical mapping system used to create 3D maps of the heart and identify arrhythmia origins.
8. The sample size for the training set:
The document does not provide information regarding the sample size for the training set. The clinical study described is for validation/performance assessment.
9. How the ground truth for the training set was established:
The document does not provide information on how the ground truth for any training set was established. The clinical study described focuses on the performance of the finished device.
§ 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).