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The EnSite Precision™ Cardiac Mapping System is a suggested diagnostic tool in patients for whom electrophysiology studies have been indicated.

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.

The EnSite Precision™ Cardiac Mapping 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 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 Precision™ Cardiac Mapping System with version 2.0 software is a new module that is designed to allow the system to interface to the EnSite Precision™ Module, Sensor Enabled, which is an alternative magnetic field-based medical positioning hardware kit for magnetic field scaling functionality.

This document does not contain the detailed acceptance criteria and study results in the format requested. While it outlines the device, its intended use, and that verification/validation activities were performed, it does not provide specific metrics or performance tables.

Here's what can be extracted and what is missing:

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

• Missing. The document states "Design verification/validation activities were performed with their respective acceptance criteria to ensure that the modifications do not affect the safety or effectiveness of the device. All testing performed met the established performance specifications." However, it does not specify what those acceptance criteria were or what the measured performance results were against those criteria.

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

• Partially Missing. The document mentions "Dynamic Wetlab Bench Comparative and Preclinical Animal testing."
  • Sample Size: Not specified.
  • Data Provenance: "Wetlab Bench" and "Preclinical Animal testing" suggest laboratory/animal studies, which are prospective. Country of origin not specified.

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 Applicable / Missing. This device is a cardiac mapping system for electrophysiology studies. The "ground truth" in this context would likely be precise catheter location measurements, which are typically established through highly accurate measurement systems, not expert consensus in the same way an image diagnosis would be. The document describes "magnetic field-based catheter localization" and "impedance locations" as mechanisms for determining position, suggesting instrumental ground truth rather than expert interpretation.

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

• Not Applicable / Missing. As the ground truth is instrumental (catheter position) rather than interpretive (e.g., diagnosing an image), adjudication methods by human readers are not relevant here.

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. This document describes a K160210 submission for a cardiac mapping system, focusing on its technical performance and equivalence to predicate devices, not on AI assistance for human readers in diagnostic interpretation. The testing involved comparisons of model rendering and catheter electrode localization between the subject and predicate devices, and workflow performance.

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

• Yes, implicitly. The testing described ("Electrical, Mechanical, Accuracy and Repeatability, Packaging, shelf life, Biocompatibility, Preclinical Animal Studies") focuses on the device's technical performance. The "accuracy testing for use with the magnetic field scaling feature" and comparisons of "model rendering and location of catheter electrodes" are examples of standalone performance evaluation of the system's ability to accurately map and localize.

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

• The ground truth would be based on highly accurate physical measurements for catheter positions in the wetlab/animal studies. The document states "magnetic field-based catheter localization used for field scaling during model creation involves sensing of the magnetic fields generated through small coil sensors embedded inside the enabled device." This implies a physical, instrumental ground truth for position validation.

8. The sample size for the training set:

• Not Applicable / Missing. This document describes a device approval, not a machine learning algorithm that requires a "training set" in the conventional sense. The "training" here refers to the device's development and validation, which uses various engineering and animal studies.

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

• Not Applicable / Missing. See point 8. The ground truth for validation testing (such as catheter position) would be established through precise physical measurement techniques in the wetlab or animal models.

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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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