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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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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 clinical significance of utilizing the Volta AF-Xplorer software to help identify areas with intra-cardiac atrial electrograms exhibiting spatiotemporal dispersion for catheter ablation of atrial arrhythmias, such as atrial fibrillation, has not been established by clinical investigations.

The Volta AF-Xplorer is a machine and deep learning based-algorithm designed to assist operators in the real-time manual or automation of 3D anatomical and electrical maps of the human heart for the presence of electrograms exhibiting spatio-temporal dispersion, i.e., dispersed electrograms.

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 (identical to VX1 and VX1+ (Volta Medical (K201298, । K223516)): the LabSystem Pro EP Recording System (Boston Scientific) (K141185) or the MacLab CardioLab EP Recording System (General Electric) (K130626),
• a 3D mapping system (new compared to VX1 and identical to VX1+): 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 diferent 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.

The provided text describes the 510(k) summary for the Volta AF-Xplorer and its substantial equivalence to previous predicate devices (VX1+ and VX1). However, the document does not contain specific details about the acceptance criteria or the study that proves the device meets those criteria in a structured format. Instead, it generally states that "The testing and acceptance criteria are the same as those in the predicate VX1+ and VX1 devices" and that "The processing was evaluated and demonstrated equivalent performance with the acceptance criteria from the VX1+ and VX1 studies."

Therefore, I cannot directly extract the specific information requested in your prompt regarding acceptance criteria, reported performance, sample sizes, expert details, or ground truth establishment based solely on the provided text. The document indicates that such studies were performed for the predicate devices and that the Volta AF-Xplorer maintained equivalent performance, but the specifics of those studies are not detailed here.

To answer your request, I would need access to the performance data and study reports for the VX1+ and VX1 devices, which are referenced but not included in this 510(k) summary.

Based on the available text, I can only provide the following information from the document:

• Device Performance (General Statement): The Volta AF-Xplorer demonstrated "equivalent performance with the acceptance criteria from the VX1+ and VX1 studies."
• Study Type (Inferred): The document refers to "software design verification" and "bench testing" that was previously conducted for the VX1+ (K201298) to demonstrate "rigorous software verification testing including unitary testing of the main algorithm modules."
• Training Set (Not specified in this document): Information about the training set size or how its ground truth was established is not present in this document.
• Test Set (Not specified in this document): Information about the test set size, data provenance, number/qualifications of experts, or adjudication methods is not present.
• MRMC Study / Standalone Performance: The document does not describe a multi-reader multi-case (MRMC) comparative effectiveness study or provide details on standalone (algorithm-only) performance.
• Ground Truth Type (Not specified in this document): The specific type of ground truth used (e.g., expert consensus, pathology, outcomes data) is not detailed.

In summary, the provided FDA 510(k) letter and summary state that the performance data for Volta AF-Xplorer were deemed sufficient through equivalence to its predicate devices, but it does not detail the underlying studies, acceptance criteria, or performance metrics themselves.

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The VX1+ 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 clinical significance of utilizing the VX1+ software to help identify areas with intra-cardiac atrial electrograms exhibiting spatiotemporal dispersion for catheter ablation of atrial arrhythmias, such as atrial fibrillation, has not been established by clinical investigations.

The VX1+ 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 exhibiting spatio-temporal dispersion, i.e., dispersed electrograms (DEs).

The VX1+ device is a non-sterile reusable medical device, composed of a computing platform and a software application. VX1+ 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 (identical to VX1 (Volta Medical (K201298)): the LabSystem Pro EP Recording System (Boston Scientific) (K141185) or the MacLab CardioLab EP Recording System (General Electric) (K130626),
• a 3D mapping system (novelty compared to VX1): EnSite X 3D mapping system (Abbott) (K221213).

A connection cable is used to connect the corresponding data acquisition system to the VX1+ 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-todigital converter, which acquires analog data, digitizes it, and transmits the digital signals to the computer that hosts the VX1+ 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 VX1+ software analyzes the patient's electrograms to cue operators in real-time to intracardiac electrograms of interest for atrial regions harboring DEs 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.

The provided text describes the acceptance criteria and a study for the Volta Medical VX1+ device. However, it does not contain a detailed table of acceptance criteria with specific performance metrics (e.g., sensitivity, specificity, accuracy, F1-score) and corresponding reported device performance, nor does it detail a multi-reader multi-case (MRMC) comparative effectiveness study.

Based on the available information, here's a breakdown of what can be extracted and what is missing:

Acceptance Criteria and Device Performance

The document describes non-clinical and clinical tests performed, implying certain underlying acceptance criteria were met for substantial equivalence to the predicate device (VX1). However, explicit quantitative acceptance criteria (e.g., "sensitivity > 90%") are not provided in the text. The reported device performance is described generally as "acceptably correlate" and "reliably assists."

Table of Acceptance Criteria and Reported Device Performance (as inferred and with missing specifics):

Study Details

1. Sample sizes used for the test set and the data provenance:

   • Clinical Study (OUS):
     • Sample Size: 22 patients.
     • Data Provenance: OUS (Outside US) clinical study. The text does not specify the country beyond "OUS." It is a prospective clinical study as it "involved 1 center, 4 operators, and 22 patients" and was "aimed at evaluating the reliability of VX1+ detection of dispersed electrograms and automatic tagging function."
   • Non-Clinical (Algorithm Performance):
     • The text alludes to a "Reader Study described in VX1's 510(k) (K201298) and intended to show that the algorithm's adjudications acceptably correlate with unlimited-time expert visual analysis, was replayed with VX1+ dispersion algorithm." The specific sample size for this "replayed" test set is not provided in the current document, nor is its provenance explicitly stated, other than being "replayed" data.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

   • For the non-clinical algorithm performance, it refers to "unlimited-time expert visual analysis" for ground truth. The number and qualifications of these experts are not detailed in this document; they would presumably be in the predicate VX1's 510(k) (K201298).
   • For the clinical study, the text states "4 operators" were involved. It's unclear if these operators are considered the "experts" for ground truth or if an independent "expert" review was performed. Their qualifications are not stated.

3. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

   • The document does not specify the adjudication method used for either the non-clinical re-analysis or the clinical study.

4. 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:

   • A formal MRMC comparative effectiveness study demonstrating human reader improvement with AI assistance vs. without AI assistance is not explicitly described in this document. The clinical study aimed at evaluating the reliability of VX1+ detection and auto-tagging, and its assistance to operators, rather than directly measuring an improvement in human reader performance (e.g., diagnostic accuracy or speed).

5. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:

   • Yes, the "Reader Study described in VX1's 510(k) (K201298) and intended to show that the algorithm's adjudications acceptably correlate with unlimited-time expert visual analysis, was replayed with VX1+ dispersion algorithm." This suggests a standalone evaluation of the algorithm's output against an expert-derived ground truth.

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

   • The ground truth for the non-clinical algorithm evaluation was based on "unlimited-time expert visual analysis." This implies expert review/consensus.
   • For the clinical study, the ground truth is implicitly tied to the "reliable assistance" to operators in identifying dispersed electrograms, suggesting it was established through the clinical workflow and potentially by the operating physicians themselves. The method of establishing definitive ground truth (e.g., independent adjudication, follow-up outcomes) is not explicitly stated.

7. The sample size for the training set:

   • The document does not provide the sample size for the training set used for the VX1+ machine and deep learning-based algorithm.

8. How the ground truth for the training set was established:

   • The document does not provide details on how the ground truth for the training set was established.

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The VX1 assists operators in the real-time manual 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 clinical significance of utilizing the VX1 software to help identify areas with intra-cardiac atrial electrograms exhibiting spatiotemporal dispersion for catheter ablation of atrial arrhythmias, such as atrial fibrillation, has not been established by clinical investigations.

The VX1 "" is a machine and deep learning based-algorithm designed to assist operators in the real-time manual annotation of 3D anatomical and electrical maps of the human atria for the presence of electrograms exhibiting spatiotemporal dispersion during atrial fibrillation or atrial tachycardia", i.e., dispersed intra-cardiac atrial electrograms (DEs). The device works with all existing 510(k) cleared catheters that meet specific dimension requirements and with two data acquisition systems: the LabSystem Pro Acquisition System (Boston Scientific) (K141185) and the MacLab CardioLab Acquisition System (General Electric) (K130626). A connection cable is used to connect the data acquisition system with an Advantech PCI-1713U analog-to-digital converter, which transmits the acquired information to a nearby computer that hosts the VX1 software. The computer and its attached display are located outside the sterile operating room area. The VX1 software analyzes the patient's electrograms to cue operators in real-time to intra-cardiac electrograms of interest for atrial regions harboring DEs 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.

1. Table of Acceptance Criteria and Reported Device Performance:

   The document does not explicitly present a table of acceptance criteria with corresponding performance values in the way typically seen in a formal statistical analysis plan. However, the outcomes of the "Reader Study" and the "Limited Time Annotation Testing" serve as a form of acceptance criteria, where the device's agreement with expert consensus is evaluated.

   Performance Metric	Acceptance Criteria (Implied)	Reported Device Performance
   Inter-operator agreement	Strong agreement among expert readers	Confirmed. Experts strongly agreed with one another.
   VX1 correlation with expert annotation (Reader Study)	Acceptable correlation with physician annotation	VX1 adjudication acceptably correlates with physician annotation.
   Period estimation performance	Outperform or be comparable to alternative algorithms	VX1 period estimation algorithm outperformed both FFT-based and AC-based algorithms for noisy/non-periodic electrograms.
   VX1 algorithm accuracy (k-fold cross-validation)	High accuracy	Over 89% accuracy.
   VX1 performance vs. unassisted electrophysiologists	Superior agreement to annotating experts than unassisted humans	VX1 algorithm demonstrated superior performance (agreement to annotating experts) to cardiac electrophysiologists.
   Clinical risk and procedure time	No additional risk or procedure time	Not associated with additional risk or procedure time.
   Comparable performance to predicate's CFAE module	Comparable performance	VX1 device demonstrated comparable performance in locating electrical signal transmission pattern disruptions as the predicate's CFAE module.

2. Sample sizes used for the test set and data provenance:

   • Reader Study: 14,370 electrograms.
   • Period Estimation Algorithm Testing: 2,550 electrograms.
   • Limited Time Annotation Testing: 1,020 electrograms.
   • Clinical Study: 300 patients across 8 centers.
   • Data Provenance: The document states "An OUS clinical study was performed..." indicating that at least some clinical data is from outside the US. The "training database of 275,020 1.5 second annotated electrograms" drew on "anonymized information from a very large database". The nature (retrospective/prospective) is not explicitly stated for all datasets, but the clinical study was likely prospective to evaluate usability and efficacy.

3. Number of experts used to establish the ground truth for the test set and qualifications of those experts:

   • Reader Study and Limited Time Annotation Testing: 3 independent experts were used to adjudicate the 14,370 electrograms for the Reader Study. For the Limited Time Annotation Testing, 2 annotating experts were used (who reached a consensus). Their specific qualifications beyond "independent experts" and "annotating experts" are not detailed (e.g., years of experience or board certification).
   • "Unassisted" Human Readers in Limited Time Annotation Testing: 28 cardiac electrophysiologists who underwent a "full-day seminar on spatiotemporal dispersion."

4. Adjudication method for the test set:

   • Reader Study: "adjudicated by three independent experts". It doesn't specify if this was a 2+1, 3+1, or simple majority.
   • Limited Time Annotation Testing: "two annotating experts who were allowed unlimited time to make a classification determination and reach a consensus". This suggests a consensus-based adjudication between two experts.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and the effect size:

   • A comparative study was done during the "Limited Time Annotation Testing" comparing the VX1 algorithm's performance to that of 28 cardiac electrophysiologists. This fits the description of a multi-reader (28 electrophysiologists) multi-case (1,020 electrograms) study.
   • Effect Size: The document states the "VX1 algorithm demonstrated superior performance (agreement to the annotating experts) to the cardiac electrophysiologists in identifying dispersed and non-dispersed intra-cardiac atrial electrograms." However, a specific effect size (e.g., AUC difference, sensitivity/specificity improvement, or statistical significance value) is not provided.

6. If a standalone performance (algorithm only without human-in-the-loop performance) was done:

   • Yes, the "Reader Study" directly compared the VX1's classification to expert annotation, implying a standalone performance evaluation.
   • The "Period estimation algorithm testing" also evaluated the algorithm's performance independently.
   • The k-fold cross-validation is a standalone algorithm performance test.

7. The type of ground truth used:

   • Expert Consensus: The primary ground truth for the Reader Study and Limited Time Annotation Testing was established by "independent experts" or "annotating experts" reaching a consensus on the presence or absence of dispersed intra-cardiac atrial electrograms.

8. The sample size for the training set:

   • The k-fold cross-validation was performed on a "training database of 275,020 1.5 second annotated electrograms."

9. How the ground truth for the training set was established:

   • The training database drew on "anonymized information from a very large database... of 1.5 second snippets of multipolar intra-cardiac atrial electrograms located on a dedicated data server". The document does not explicitly state how these 275,020 electrograms were annotated (e.g., by experts, or through a different automated process). However, the context of comparing the algorithm to expert annotations in the validation suggests that expert annotation would be the most robust method for establishing ground truth for training as well. Without explicit mention, it's inferred to be expert-annotated.

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