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The CardioNXT iMap™ 3D Mapping & Navigation System is intended for the display of compatible electrophysiology catheter position and cardiac electrical activity when used with the MultiLink CS Catheter during conventional electrophysiological procedures.

The MultiLink CS Catheter is used for electrogram recording and as a navigation reference during conventional electrophysiological procedures.

The CardioNXT iMap™ 3D Mapping and Navigation System (iMap™ System) 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 electroanatomical maps of the cardiac chamber. The contoured surfaces of these threedimensional maps are based on the anatomy of the patient's cardiac chamber. The iMap™ System utilizes electromagnetic tracking and impedance tracking to track conventional catheters and paint the surfaces of cardiac chambers in 3D to generate a patient-specific image of the heart, also called a geometry. The iMap System measures cardiac electrogram (EGM) information from navigated catheter electrodes throughout the heart and displays this information on the patient-specific geometry. The iMap System utilizes a Coronary Sinus(CS)catheter with both electromagnetic sensors and electrodes as a reference for its navigation coordinate system.

The provided text describes the CardioNXT iMap™ 3D Mapping & Navigation System, but it does not contain acceptance criteria and specific study results in the format requested. Instead, it lists various types of testing performed and concludes that the device meets performance specifications and is substantially equivalent to predicate devices.

Here's a breakdown of what is and isn't present, based on your request:

1. Table of Acceptance Criteria and Reported Device Performance:

• Not provided. The document states that bench testing demonstrates the system meets performance specifications, but it does not list those specifications or the quantitative results against them.

2. Sample Size Used for the Test Set and Data Provenance:

• Sample size for test set: Not explicitly stated. The document mentions a "GLP animal study" and "bench testing," but doesn't give specific numbers of animals or test items.
• Data provenance: "GLP animal study" implies prospective animal data. "Bench testing" would be laboratory-based. No mention of human data, retrospective or prospective, for performance evaluation against acceptance criteria.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:

• Not provided. The document mentions "usability testing demonstrating usability by licensed cardiac electrophysiologist physicians," but this is for usability, not for establishing ground truth for device performance metrics.

4. Adjudication Method:

• Not provided.

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

• Not performed/reported. The document does not mention an MRMC study or any effect sizes of human reader improvement with AI assistance.

6. Standalone Performance:

• A standalone performance study was likely done as part of the "bench testing demonstrating substantially equivalent safety, performance, and accuracy to predicate" and the "GLP animal study." However, the specific metrics and results of this standalone performance are not detailed in the provided text. The overall conclusion is that it meets specifications, but the specifics are absent.

7. Type of Ground Truth Used:

• For the "GLP animal study" and "bench testing," the ground truth would typically be established through direct measurements, established physiological parameters, or physical phantom models with known properties. However, the document does not explicitly specify the type of ground truth (e.g., direct measurement, histological analysis, etc.) for each performance metric evaluated.

8. Sample Size for the Training Set:

• Not provided. The document does not mention any "training set." The iMap™ System is described as a "programmable diagnostic computer" and a "mapping and navigation system," implying it might use algorithms, but no details on machine learning model training or associated datasets are given.

9. How the Ground Truth for the Training Set Was Established:

• Not applicable/Not provided. Since no training set is mentioned, the method for establishing its ground truth is also not mentioned.

In summary, the provided document focuses on regulatory clearance and substantial equivalence by listing various types of testing performed (bench, animal, electrical safety, biocompatibility, etc.) and concluding that the device meets requirements. However, it lacks the detailed quantitative acceptance criteria and specific study results that you requested to demonstrate how those criteria were met.

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The MediGuide™ Technology system is intended for the evaluation of vascular and cardiac anatomy. It is intended to enable real time tip positioning and navigation of a MediGuide Enabled™ (equipped with a magnetic sensor) invasive device used in vascular or cardiac interventions in the Cath Lab environment, on both live fluoroscopy or recorded background. The System is indicated for use as an adjunct to fluoroscopy.

MediGuide Technology enables navigation of devices on pre-recorded X-ray images allowing the physician to reduce the duration of live X-ray during a procedure. MediGuide Technology applies 3D visualization and precise navigation to pre-recorded 2D X-ray images and can be used by the physician to perform complex electrophysiology procedures and CRT implants. MediGuide Technology is analogous to a global positioning system (GPS) in that it uses a low powered electromagnetic field to locate device-based sensors in three-dimensional space. The system uses this location information to overlay MediGuide™ Enabled/Sensor Enabled™ devices on the corresponding pre-recorded X-ray image, which allows the physician to reduce the duration of live X-ray during a procedure. MediGuide creates a real-time clinical environment by compensating for patient motion, respiration and heart rate variability

I am sorry, but the provided text does not contain the detailed information necessary to fully answer your request. The document describes the "MediGuide Technology System (Version 17.0)" and its regulatory clearance (K162643) by the FDA. It outlines the device's intended use and briefly mentions non-clinical testing.

However, it does not include:

• A specific table of acceptance criteria and reported device performance.
• Details about sample sizes for a test set, data provenance, ground truth establishment, or sample size for a training set.
• Information on the number and qualifications of experts or the adjudication method used.
• Any mention of a multi-reader multi-case (MRMC) comparative effectiveness study or a standalone (algorithm only) performance study.

The document primarily focuses on regulatory aspects, comparison to a predicate device, and compliance with standards, rather than the specifics of a clinical or technical performance study in the way implied by your request. The "Summary on Non-Clinical Testing" section notes that "design verification activities for functional testing were performed with their respective acceptance criteria to ensure that software modifications and hardware addition do not affect the safety or effectiveness of the device. All testing performed met the established performance specifications." However, it does not detail these acceptance criteria or the specific results.

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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 arrhythmias 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

Device Name: AutoMark Module v1.0.1
Indications for Use:
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 5.0.1 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, Model EE3000 consists of a display workstation subsystem (DWS) and an Amplifier subsystem. The EnSite Amplifier collects the data from the patient connections and sends them to the DWS Workstation. The Amplifier connects to the DWS through a fiber optic cable and a media converter to convert the optical signals to digital signals. The EnSite™ Velocity™ DWS software displays the cardiac signal data received from the Amplifier on the workstation monitors and stores it for later retrieval.

Display Work Station (DWS) Subsystem

• DWS The DWS houses the system software and connects all the components . together.
• . Monitors - Two monitors display patient information. One monitor is positioned near the workstation and keyboard for system operation, and the physician places the second monitor near the patient table for use.
• . Isolation transformer - All system components on the DWS connect to line power through a medical-grade isolation transformer.
• . Printer - Allows for printing study data

Amplifier Subsystem

• Amplifier contains electronic circuitry and firmware responsible for collecting . and transmitting the electrical signal data of the patient to the DWS software application via fiber Ethernet. The Amplifier converts these signals to a digital format and sends them to the workstation for processing.
• NavLink Connects surface electrodes and the system reference surface . electrode to the Amplifier.
• ArrayLink Connects the EnSite Array Multi-electrode Diagnostic Catheter to . the Amplifier. It also has a connection for an auxiliary unipolar reference electrode.
• . CathLink - Connects the diagnostic catheters to the Amplifier
• . GenConnect - Connects the ablation catheter and dispersive surface electrodes to the Amplifier.
• . RecordConnect - The RecordConnect allows simultaneous connection for catheters and surface ECG to a recording system and to the Amplifier.
• . ECG cable - The ECG cable connects standard ECG electrodes to the Amplifier.

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 v5.0.1 is designed for use in the EP laboratory in conjunction with other equipment as described in the labeling.

Expansion Module Device Description:
The AutoMark Module is an optional add-on module to the EnSite™ Velocity™ System v5.0.1. The software module allows the user to set criteria for ablation-related parameters and the software automatically displays the lesion marks on the EnSite Velocity model during RF ablation when the user set criteria are met. The color, size, and ranges of the AutoMark are defined by the user.

Secondary Predicate Device Descriptions
The following secondary predicate devices are provided to ensure that all features of the proposed AutoMark Module are demonstrated to be substantially equivalent to features of currently cleared medical devices

WorkMate Claris System
The WorkMate Claris™ System is a fully computerized system for capturing and measuring physiological data in the clinical electrophysiology (EP) laboratory. It provides digital signal acquisition and display of those electrical signals on high resolution monitors.

The WorkMate Claris System is connected to electrophysiology catheters that are guided into various locations within the heart, and to surface electrocardiogram (ECG) cables. Intracardiac and ECG signals are then acquired from electrodes on the indwelling catheters and ECG leads connected to the amplifier, which amplifies and conditions the signals before they are received by the WorkMate Claris System computer for display, measurement and storage.

During the procedure, cardiac signals are acquired and an automated software waveform detector (trigger) performs online recognition of cardiac activation on preselected leads. Temporal interval measurements are computed on a beat-by-beat basis on multiple channels and dynamically posted on the Real Time display. Intervals are calculated between waveforms from the same source on a specific channel (intra-channel measurements) and from multi-source signals across two or more channels (inter-channel measurements).

Signals are also presented on a review monitor for measurement and analysis. Continuous capture of the digitized signals can be invoked, and the user can also retrieve and display earlier passages of the current study without interruption of the real-time display. The system can also acquire, display and record data from other interfaced devices in use during the procedure, such as imaging devices and ablation generators.

The provided text describes a 510(k) premarket notification for the "EnSite Velocity Cardiac Mapping System v5.0.1 with AutoMark Module v1.0.1". However, it does not include detailed information regarding specific acceptance criteria, a study proving the device meets those criteria, or quantitative performance metrics typically found in clinical validation studies for AI/CADe devices.

The document focuses on demonstrating substantial equivalence to predicate devices, software verification and validation, and risk management. It does not contain the kind of clinical study details requested in the prompt.

Therefore, many of the requested fields cannot be filled from the provided text.

Here's what can be extracted and what cannot:

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

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

• Sample size for test set: Not specified.
• Data provenance: Not specified (since no specific test set or study is detailed).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)

• Not specified.

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

• Not specified.

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

• Not mentioned. The document states "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." This indicates functional testing, not a comparative effectiveness study with human readers.

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

• The document describes "Design verification activities for functional testing" and "software verification and validation." This implies standalone testing of the software's functionality, but no specific performance metrics like sensitivity/specificity are provided.

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

• Not specified. The "AutoMark module automatically displays the lesion marks on the EnSite Velocity model during RF ablation when the user set criteria are met." The ground truth would likely relate to the accuracy of these displayed marks based on the user-defined criteria, but the method for establishing this is not detailed.

8. The sample size for the training set

• Not specified.

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

• Not specified.

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