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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.

2. Sample Size and Data Provenance

• Test Set (Trial Population): The Tailored-AF study included a total of 370 patients randomized (1:1 ratio) to two arms:
  • "Tailored" group: 187 patients
  • "Anatomical" group: 183 patients
  • Modified Intention-To-Treat (mITT) Population: 180 patients in the Tailored arm and 177 patients in the Anatomical arm were included in the primary analysis after excluding early dropouts.
• Data Provenance: The Tailored-AF study was an international, multicenter, randomized, controlled, single-blind, superiority trial. It was conducted at 26 centers across 5 countries in Europe and the United States. This indicates prospective data collection.

3. Number of Experts and Qualifications for Ground Truth

The document does not explicitly state the number of experts used to establish "ground truth" in the context of the study's endpoints. However, the study involved:

• 51 operators performing the catheter ablation procedures. These would be electrophysiologists with experience in performing AF ablations.
• The primary and secondary endpoints (freedom from AF/atrial arrhythmia, complications, etc.) were assessed based on clinical data, including 12-lead ECGs, 24-hour Holter monitoring, and recordings from Kardia portable monitors. The analysis and interpretation of these clinical endpoints would typically involve trained medical personnel (e.g., cardiologists, electrophysiologists) following specific protocols, but the exact number or individual qualifications of those adjudicating the final outcomes are not detailed.

4. Adjudication Method for the Test Set

The document does not specify a separate adjudication method (e.g., 2+1, 3+1 consensus) for the clinical endpoints. The study design (randomized, single-blind trial) implies that patient outcomes were assessed according to predefined criteria and standard clinical practice, with data collection through scheduled visits, ECGs, and Holter monitoring. An independent Clinical Events Committee or similar body often adjudicates endpoints in such trials, but this is not explicitly stated in the provided text.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No, a traditional MRMC comparative effectiveness study was not conducted in the context of human readers improving with AI vs. without AI assistance for the specific task of annotating electrograms.

Instead, the Tailored-AF study was a clinical trial evaluating the effectiveness of an AI-assisted ablation strategy (using VX1, the predecessor to Volta AF-Xplorer) compared to a standard PVI-only ablation strategy. It compared patient outcomes between a group where physicians used the AI device to guide ablation (along with PVI) and a group where physicians performed PVI without the AI guidance.

Therefore, it's not about "how much human readers improve with AI vs. without AI assistance" in terms of measurement accuracy, but rather how much patient outcomes improve when physicians use the AI-guided strategy.

• Effect Size of AI-assisted strategy on patient outcomes:
  • Primary Effectiveness Endpoint: The AI-assisted "Tailored" group demonstrated an 18% absolute difference in freedom from AF compared to the "Anatomical" (PVI-only) group (88% vs. 70%), which was statistically significant (log-rank p<0.0001). This indicates a substantial positive effect on the primary clinical outcome when the AI-guided strategy was employed.

6. Standalone (Algorithm Only) Performance Study

The document does not describe a standalone performance study for the Volta AF-Xplorer algorithm (or its predecessor VX1) in terms of its diagnostic accuracy (e.g., sensitivity, specificity, or AUC) for identifying dispersed electrograms compared to an expert ground truth.

The Tailored-AF study focused on the clinical efficacy and safety of an AI-guided intervention, not on the standalone accuracy of the algorithm's identification of dispersed electrograms itself. The algorithm's output (identification of dispersed EGMs) was then used by human operators for intervention, integrating the AI into a human-in-the-loop workflow.

7. Type of Ground Truth Used

The ground truth for the Tailored-AF study (clinical outcomes) was based on clinical follow-up data, including:

• Documented atrial fibrillation lasting more than 30 seconds (from 12-lead ECGs, 24-hour Holter monitoring, and Kardia portable monitor recordings).
• Freedom from any atrial arrhythmia (including atrial fibrillation and atrial tachycardia).
• Death, cerebrovascular events, or serious treatment-related adverse events.
• Procedure-related complications.
• Quality of life questionnaires (AFEQT and SF-36).

This is best categorized as outcomes data and expert-interpreted clinical findings.

8. Sample Size for the Training Set

The document does not provide any information regarding the sample size used for training the Volta AF-Xplorer (or VX1) algorithm. The focus of this 510(k) submission is on demonstrating substantial equivalence based on the clinical study, not on detailing the algorithm's development or internal validation.

9. How Ground Truth for the Training Set Was Established

The document does not provide any information on how the ground truth for the training set (if any was used for algorithm development) was established.

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