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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 EnSite Velocity Cardiac Mapping System is a suggested Diagnostic tool in patients for whom electrophysiology studies are indicated.
When used with EnSite Array Catheter, the EnSite Velocity Cardiac Mapping System is intended to be used in the right atrium of patients with complex arthythmias that may be difficult to identify using conventional mapping system alone.
Or
When used with the EnSite Velocity Surface Electrode Kit, the EnSite Velocity Cardiac Mapping System is intended to display the position of conventional electrophysiology (EP) catheters in the heart

EnSite Precision Cardiac Mapping System v2.2:
The EnSite Precision™ System interfaces to either the MediGuide™ Technology System or the EnSite Precision™ Module to combine and display magnetic processed patient positioning and navigation mapping information. When used with the EnSite™ Array™ Catheter, the EnSite Precision™ Cardiac Mapping System is intended to be used in the right atrium of patients with complex arrhythmias that may be difficult to identify using conventional mapping systems alone.
or
When used with an EnSite Precision™ Surface Electrode Kit, the EnSite Precision™ Cardiac Mapping System is intended to display the position of conventional electrophysiology (EP) catheters in the heart.

EnSite™ Verismo™ Segmentation Tool: The EnSite Verismo™ Segmentation Tool is indicated for use in generating 3D models from CT, MR or rotational angiography DICOM image data. Generated models are intended to be displayed on the EnSite Velocity System.

EnSite™ Derexi™ Module: When used with EnSite Derexi ™ Module, the EnSite System interfaces to the EP-WorkMate™ System / WorkMate Claris™ System for synchronizing and display of patient information.

EnSite™ Courier™ Module: When used with EnSite Courier Module allows the patient data to be archived to, and retrieved from, a DICOM conformant PACs server.

EnSite™ Fusion™ Registration Module: EnSite Fusion is indicated for registering the EnSite NavX navigation system to anatomic models, derived from CT scans, of the four individual cardiac chambers.

EnSite™ Contact Force Module: When used with the SJM Contact Force Unit, the EnSite™ Contact Force Module is intended to provide visualization of force information from compatible catheters.

EnSite™ AutoMap Module: When used with the EnSite AutoMap Module, the EnSite System is intended to automatically collect mapping points based on criteria set by the user.

EnSite™ AutoMark Module: When used with compatible hardware, the AutoMark Module is intended to automatically catalog and display various parameters associated with RF information on the 3D model in real-time.

The EnSite™ Velocity™ Cardiac Mapping System with software version 5.2 / EnSite Precision™ Cardiac Mapping System with software version 2.2 is a catheter navigation and mapping system capable of displaying the three-dimensional (3D) position of conventional electrophysiology catheters, as well as displaying cardiac electrical activity as waveform traces and as dynamic 3-D isopotential maps of the cardiac chamber. The contoured surfaces of these three-dimensional maps are based on the anatomy of the patient's own cardiac chamber.

The EnSite™ Velocity™ Cardiac Mapping System is used as a diagnostic tool in electrophysiology (EP) Studies. An EP study involves the introduction of one or more electrode catheters into the heart to record its electrical activity. These catheters connect to the EnSite™ Velocity™ Cardiac Mapping System through specialized catheter input modules (CIMs). The EnSite™ Velocity™ Cardiac Mapping System v5.2 is designed for use in the EP laboratory in conjunction with other equipment.

The EnSite Velocity™ Cardiac Mapping System consists of hardware and software elements. The EnSite Velocity / EnSite Precision System consists of software, a display workstation (DWS) subsystem (DWS, Monitors, DWS Accessory Kit, and DWS Power Kit), and an amplifier subsystem (Amplifier and Amplifier Accessory Kit). The DWS houses the system software and connects all the components together. The amplifier contains electronic circuitry and firmware responsible for collecting and transmitting the electrical signal data of the patient to the DWS software. Its primary function is to collect and transmit via Ethernet the electrical data detected from the patient. The amplifier accepts signals from NavLink, ArrayLink, CathLink, ECG Cable, RecordConnect, and GenConnect, converts these signals to a digital format, and sends them to the workstation for processing. The NavLink connects surface electrodes and the system reference surface electrode to the Amplifier. The ArrayLink connects the EnSite Array Multielectrode Diagnostic Catheter to the Amplifier. It also has a connection for an auxiliary unipolar reference electrode. The CathLink connects the diagnostic catheters to the Amplifier. The GenConnect connects the ablation catheter and dispersive surface electrodes to the Amplifier. The RecordConnect allows simultaneous connection for catheters and surface ECG to a recording system and to the Amplifier. The ECG cable connects standard ECG electrodes to the Amplifier. The system operates using impedance only or impedance plus magnetics based upon its configuration. The EnSite™ Velocity™ Cardiac Mapping System base software only collects impedance data. Adding EnSite Precision™ software to the base software allows the system to receive both magnetic data from the MediGuide™ Technology System or the EnSite Precision™ Module hardware and impedance data when using magnetic sensor enabled tools. The EnSite Precision™ Module and EnSite Precision™ software (added to the base software) together make up the EnSite Precision™ Cardiac Mapping System. The EnSite Precision™ software interfaces to the MediGuide Technology System or the EnSite Precision™ M Module to collect magnetic position and orientation information. The EnSite Precision™ software uses the magnetic data for magnetic field scaling (NavX SE), shift detection (EnGuide Stability Monitor), and respiration gating. NavX SE field scaling adjusts the dimensions of the navigation field based on both the positon and orientation of magnetic sensors and the electrodes on Sensor Enabled™ (SE) tools, optimizing the appearance of the model. The system uses EnGuide Stability Monitor to notify the user of a potential shift based on a correlation of magnetic and impedance locations when using any Sensor Enabled catheter. The system uses respiration gating to compensate to the end-point of the respiration cycle using magnetic data to determine respiration phase. The EnSite Precision™ Module consists of hardware to support magnetic navigation. The hardware components consist of the EnSite Precision™ Link, EnSite Precision™ Field Frame, and EnSite Precision™ Patient Reference Sensors.

The EnSite™ Velocity™ Cardiac Mapping System v5.2 includes the following optional expansion software modules:

1. EnSite™ Verismo™ Segmentation Tool - an optional expansion module used in generating 3D models from CT, MR or rotational angiography DICOM image data and displaying images on the EnSite™ Velocity™ Cardiac Mapping System. The EnSite™ Verismo™ Segmentation Tool accepts DICOM images from CT and MRI scanners and converts the images into a 3D model of cardiac structures.
2. EnSite™ Derexi™ Module - an optional expansion module that that allows the EnSite Velocity System to interface with the WorkMate™ Recording System to support the exchange of mapping point data and patient setup information between the two systems.
3. EnSite™ Courier™ Module - The EnSite™ Courier™ Module is an optional expansion module that allows the EnSite™ Velocity™ Cardiac Mapping System to communicate with the hospital PACS (Picture Archiving and Communication System) server for the purposes of storing and retrieving patient data in DICOM format.
4. EnSite™ Fusion™ Registration Module - an optional expansion module that provides non-fluoroscopic navigation, mapping, and labeling on a Digital Image Fusion (DIF) model. The module is used with the EnSite™ NavX™ Navigation and Visualization Technology Surface Electrode Kit and CT or MR scans segmented into a compatible file format. 3D models created from digital images from CT and MRI data can be imported onto the EnSite™ Velocity™ System.
5. EnSite™ Contact Force Module - an optional expansion module that provides the display of information from the TactiSys Quartz System. The EnSite Velocity System's EnSite Contact Force Module is intended to provide visualization of force information from compatible catheters.
6. EnSite™ AutoMap Module - an optional module that automatically collects mapping points based on criteria set by the user
7. AutoMark Module - module allows the user to set parameters and the software automatically displays the lesion marks on the EnSite Velocity model during RF ablation. The user set parameters is based on data from Ensite™ Contact Force Module, the Ampere Generator, and the WorkMate Claris™ System which is displayed on the AutoMark Module as lesion marks on the during RF ablation. The color, size, and ranges of the AutoMark are defined by the user.

This document describes the regulatory submission (K172396) for the EnSite™ Velocity™ Cardiac Mapping System v5.2 and EnSite Precision™ Cardiac Mapping System v2.2. The submission is a Traditional 510(k) and focuses on minor software updates and support for a new catheter. The key takeaway regarding acceptance criteria and study data is that this submission primarily relies on non-clinical software verification and validation, performance testing, and preclinical animal studies, rather than large-scale clinical trials involving human experts for ground truth establishment.

Here's a breakdown of the requested information based on the provided document:

Acceptance Criteria and Device Performance

The document states that "Design verification activities for functional testing were performed with their respective acceptance criteria to ensure that the software modifications do not affect the safety or effectiveness of the device. All testing performed met the established performance specifications." However, specific numerical acceptance criteria and reported device performance values are not explicitly detailed in the provided text. The general statement indicates that all criteria were met.

The device is a "Programmable Diagnostic Computer" for cardiac mapping. The performance is assessed based on:

• Catheter compatibility
• Catheter impact
• Functional testing
• EnGuide stability
• System accuracy
• Effective installation and continued intended use of the software version
• Overall clinically acceptable performance (from preclinical animal studies)

Since the document does not provide a table with specific numerical acceptance criteria and performance metrics, it's not possible to create one. The general acceptance criterion is that the software updates and new catheter support do not adversely affect the safety or effectiveness and meet established performance specifications.

Study Details

Given the nature of this submission (minor software update to an existing device, supporting a new catheter), the studies are primarily non-clinical.

1. A table of acceptance criteria and the reported device performance:

   • As mentioned above, specific numerical acceptance criteria and performance data are not provided in this document. The submission states that all testing performed met the established performance specifications.

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

   • Test Set (Non-Clinical): The document refers to "software verification and validation," "performance testing on the bench," and "preclinical animal studies."
     • Software Verification/Validation & Performance Testing: The exact sample sizes (e.g., number of test cases, number of bench tests) are not specified.
     • Preclinical Animal Studies: The sample size (number of animals) is not specified.
   • Data Provenance: The studies were conducted as part of the regulatory submission process for St. Jude Medical (now Abbott). The location of the testing is not specified, but it would typically be conducted at the manufacturer's facilities or a contract research organization. The studies are prospective as they were conducted to support this specific regulatory submission for the updated device.

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

   • For non-clinical software and performance testing, "ground truth" is typically established by comparing the device's output against known, pre-defined correct behaviors or physical measurements using validated reference standards. This does not involve "experts" in the sense of clinicians interpreting patient data.
   • For the preclinical animal studies, the "ground truth" would be established by the animal study protocols, surgical procedures, and direct physiological measurements, assessed by veterinary and scientific personnel involved in the study. The number and qualifications of such experts are not specified in the document. This is not a human-in-the-loop clinical study requiring expert readers for ground truth.

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

   • Given that this is primarily non-clinical testing (software verification, bench testing, animal studies), traditional clinical adjudication methods (like 2+1 reader consensus for image interpretation) are not applicable and not mentioned. Results would be evaluated against engineering specifications and veterinary assessments.

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, an MRMC comparative effectiveness study was not done. The document describes updates to a cardiac mapping system, which is a diagnostic tool, but not an AI-assisted diagnostic imaging system in the sense that would typically require an MRMC study to show human reader improvement. The updates are to the system's core mapping and navigation capabilities, and its interoperability, not directly to an AI component for image interpretation requiring human reader evaluation.

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

   • The software updates and new catheter support were evaluated for their standalone performance (e.g., software verification, bench testing to ensure system accuracy and stability, and animal studies to confirm proper function). The "algorithm only" performance would be part of the "functional testing" and "system accuracy" mentioned. Specific standalone performance metrics or studies are not detailed beyond the general statements that testing met specifications.

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

   • For software verification and bench testing: The ground truth is based on engineering specifications, expected software behavior, physical measurements from laboratory equipment, and established hardware/software interface standards.
   • For preclinical animal studies: Ground truth is established through direct physiological data collection, procedural observations, and possibly post-mortem analysis in the animal models, as per the study protocol.
   • There is no mention of "expert consensus," "pathology," or "outcomes data" from human subjects for establishing ground truth in this particular submission.

8. The sample size for the training set:

   • The document does not mention a training set in the context of machine learning or AI models. This submission is for updates to a pre-existing cardiac mapping system, not the initial development or a significant AI component that would require a distinct "training set." The testing described is verification and validation of software changes and new hardware compatibility.

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

   • Since no training set for a machine learning/AI model is mentioned, this question is not applicable to the information provided.

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