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STAR Apollo™ Mapping System assists users in the interpretation and manual annotation of 3D anatomical and electrical maps of human atria using data from multipolar, intracardiac, atrial, electrograms during atrial fibrillation. The clinical significance of utilizing the STAR Apollo Mapping System, to help identify areas with intracardiac atrial electrograms, of atrial arrhythmias, such as atrial fibrillation, has not been established by clinical investigations.

The STAR Apollo Mapping System (v1.8) is a software driven system designed to assist operators in identifying Early Sites of Activation (ESA) and Repetitive Patterns of Activation (RPA) in patients undergoing a cardiac mapping procedure for Atrial Fibrillation (AF). The software is designed for use with FDA cleared electroanatomic mapping systems specifically:

• CARTO™ 3 EP Navigation System (V8.1) (K252302) (Biosense Webster) and
  • OPTRELL™ Mapping Catheter with TRUEref™ Technology (K230253) (Biosense Webster)

for exporting geometry data, electrograms and electrode locations over ethernet connection during the electrophysiology procedure with CARTO 3 API (K231207) to provide input data for the STAR Apollo Mapping System.

• Ensite Precision Model EE 3000 Cardiac Mapping System (V2.6) (K201148) and
  • Advisor™ HD Grid Mapping Catheter, Sensor Enabled™ (K172393) (Abbott Medical) or
• EnSite X EP System (V 1.1.1, V 2.0, V 3.0) (K213364) (K221213) (K231415) (Abbott Medical) and
  • Advisor™ HD Grid Mapping Catheter, Sensor Enabled™ (K172393) (Abbott Medical) or
• Ensite X EP System (V 3.1) (K242016) (Abbott Medical) and either:
  • Advisor™ HD Grid Mapping Catheter, Sensor Enabled™ (K172393) (Abbott Medical) or
  • Advisor™ HD Grid X Mapping Catheter, Sensor Enabled™ (K242016) (Abbott Medical)

for exporting geometry data, electrograms and electrode locations via a portable external storage device or over ethernet data connection (Ensite X EP System (V 3.0, V 3.1) with LiveSync module) (K231415) (K242016) during the electrophysiology procedure to provide input data for the STAR Apollo Mapping System.

The principle of STAR Apollo Mapping System analysis is to use data on multiple individual wavefront trajectories to identify Repetitive Patterns of Activation (RPA) or regions of the atrium that represent Early Sites of Activation (ESA) which most often precede activation of neighboring areas, with the aim of helping clinicians to identify regions of the atria that may be the origins for AF activation. The system consists of proprietary STAR Apollo Mapping System software and a hardware component. STAR Apollo Mapping System software consists of 3 main components: Electroanatomic data import, the STAR Apollo Mapping System engine (C++ code) and Graphics User Interface (GUI). The STAR Apollo Mapping System is designed to run on a laptop computer running Windows 11 Operating System. STAR Apollo Mapping System software is pre-installed onto the laptop.

The STAR Apollo Mapping System uses export data from the compatible Mapping System that has been collected with the compatible Mapping Catheter during the electrophysiology procedure. The Mapping Catheter is used to collect anatomy and electrogram data in the atria. Recordings are made for at least 30 seconds with the Mapping Catheter in a stable position and in contact with the atrial wall. These ≥30 second acquisitions are made in multiple, non-overlapping locations, to generate recordings over the entire atrial chamber. The data is exported via an external portable storage device or by streaming via an ethernet data cable connected to the data ethernet port of the EnSite X or CARTO 3 workstation. It is transferred to the laptop computer running the STAR Apollo Mapping System. The export data accepted from the Mapping Systems consists of electrograms, electrode coordinates, ECG recordings and the geometry model. The data is imported utilizing the portable external data storage device or via ethernet into the STAR Apollo Mapping System and then processed by the STAR Apollo Engine to generate a STAR Apollo Map visualized by the GUI. The STAR Apollo Map will highlight sites deemed to be Early Sites of Activation (ESA), as a red sphere at the endocardial locations corresponding to the recording electrode position. These sites are areas where the myocardium has initiated activation earlier than its neighboring sites on multiple occasions and therefore may be a potential site of AF initiation or maintenance. The more repetitive these sites are, the larger the red sphere appears on the STAR Apollo Map. The system will rank the ESA according to their repetition frequency and cycle length and identify the most relevant 3 sites. The system is designed to show the physician Repetitive Patterns of Activation (RPA). These are shown as colored arrows, which start from the leading electrode position, following the summarized activation sequence. The more repetitive or consistent that activation pattern is, the wider the white arrow. Based on this information the physicians may then use this as an additional guide for further mapping of the AF, using FDA cleared mapping system catheters.

The STAR Apollo Mapping System operates outside the sterile field and is only connected to the EnSite Precision, EnSite X EP or CARTO 3 workstation and not to the amplifier, patient, or any other devices used in the procedure. No data is transferred from the STAR Apollo Mapping System back to the EnSite Precision, EnSite X EP mapping system, or CARTO 3 i.e., data transfer is only in one direction. No modifications to the EnSite Precision, EnSite X EP mapping systems or CARTO 3 are made to accommodate the STAR Apollo Mapping System. The STAR Apollo Maps may be used to give physicians additional information about the AF activations. The physician may use them as an additional aid to identify areas within the atria that may warrant further and close examination using the mapping system, and the compatible Mapping Catheter. The STAR Apollo System is never directly connected to a patient, nor does it deliver therapy. It is used as a software tool that provides supplementary information to the physician in an electrophysiology procedure.

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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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