(149 days)
The Volta AF-Xplorer assists operators in the real-time manual or automatic annotation of 3D anatomical and electrical maps of human atria for the presence of multipolar intra-cardiac atrial electrograms exhibiting spatiotemporal dispersion during atrial fibrillation or atrial tachycardia.
The Volta AF-Xplorer is a machine and deep learning based-algorithm designed to assist operators in the real-time manual or automatic annotation of 3D anatomical and electrical maps of the human heart for the presence of electrograms (EGMs) exhibiting spatio-temporal dispersion, i.e., dispersed EGMs.
The Volta AF-Xplorer device is a non-sterile reusable medical device, composed of a computing platform and a software application. Volta AF-Xplorer works with all existing 510(k)-cleared catheters that meet specific dimension requirements and with one of the three specific data acquisition systems:
- Two compatible EP recording systems: the LabSystem Pro EP Recording System (Boston Scientific) (K141185) or the MacLab CardioLab EP Recording System (General Electric) (K130626),
- a 3D mapping system: EnSite X 3D mapping system (Abbott) (K221213).
A connection cable is used to connect the corresponding data acquisition system to the Volta AF-Xplorer system, depending on the type of communication used:
- Unidirectional analog communication with the EP recording systems via a custom-made cable (two different variants: DSUB, Octopus) and an Advantech PCI-1713U analog-to-digital converter, which acquires analog data, digitizes it, and transmits the digital signals to the computer that hosts the Volta AF-Xplorer software.
- Bidirectional digital communication with the EnSite 3D mapping system via an ethernet cable (four different lengths: 20, 10, 5 or 2m) which transmits the digital signals directly to the computer.
The computer and its attached display are located outside the sterile operating room area. The Volta AF-Xplorer software analyzes the patient's electrograms to cue operators in real-time to intra-cardiac electrograms of interest for atrial regions harboring dispersed electrograms as well as a cycle length estimation from electrograms recorded with the mapping and the coronary sinus catheters. The results of the analysis are graphically presented on the attached computer display and/or on a secondary medical screen or on an operating room widescreen. The identified regions of interest are either manually (all configurations) or automatically (only available in digital bidirectional communication with the EnSite X 3D mapping system) tagged in the corresponding 3D mapping system.
Based on the provided FDA 510(k) clearance letter for the Volta AF-Xplorer, here's a breakdown of the acceptance criteria and the study used to demonstrate device performance. It's important to note that the document primarily focuses on demonstrating substantial equivalence to a predicate device, and the "acceptance criteria" discussed here are implicitly related to clinical effectiveness and safety, rather than specific performance metrics (like sensitivity/specificity) for the algorithm itself.
The core of the "study that proves the device meets acceptance criteria" is the Tailored-AF study, which the manufacturer uses to support an updated Indications for Use statement for the Volta AF-Xplorer. The acceptance criteria are essentially the favorable clinical outcomes demonstrated by this study, which allowed for the removal of cautionary language in the indications for use.
1. Table of Acceptance Criteria and Reported Device Performance
Given that this is a 510(k) clearance for an update based on clinical evidence, the "acceptance criteria" are interpreted as the clinical outcomes required to justify the change in the Indications for Use. The device performance is represented by the outcomes of the Tailored-AF study.
| Acceptance Criteria (Implied) | Reported Device Performance (Tailored-AF Study - VX1 device) |
|---|---|
| Primary Effectiveness: Demonstrated superiority in freedom from AF | 88% of patients in the "Tailored" group (AI-assisted ablation + PVI) achieved freedom from AF (lasting > 30 seconds after 3-month blanking, through 12 months post-ablation, with or without AADs). |
| 70% of patients in the "Anatomical" group (PVI-only) achieved this outcome. | |
| **18% difference, statistically significant (log-rank p |
§ 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).