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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 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™ 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

Intended Use for the EnSite™ Velocity™ Cardiac Mapping System optional expansion software modules:

EnSite™ Verismo™ Segmentation Tool (K101697) - 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 (K110549) - 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 (K101419) - 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 (K082467) - 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 (K141050) - When used with the SJM Contact Force Unit, the EnSite™ Contact Force Module is intended to provide visualization of force information from compatible catheters.

VeriSense System Software Module (K130727) - When used with the VeriSense System Software Module, the EnSite System is intended for monitoring catheter tip-to-tissue electrical coupling, which may be indicative of catheter tip-to-tissue contact during cardiac electrophysiology procedures via a proprietary Electrical Coupling Index (ECI)

• 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

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.

Expansion Module Device Description:
The EnSite™ Velocity™ Cardiac Mapping System v5.0 includes the following optional expansion software modules:
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.
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.
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.
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.
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.
EnSite™ Velocity™ System VeriSense System Software Module - an optional expansion module that allows the EnSite Velocity System to interface with St. Jude Medical's VeriSense Kit to display the graphical representation of Electrical Coupling Index (ECI).
EnSite™ AutoMap Module - a new optional module that automatically collects mapping points based on criteria set by the user

Based on the provided text, the document is a 510(k) summary for the EnSite™ Velocity™ Cardiac Mapping System v5.0.1 with EnSite™ AutoMap Module v1.0.1.

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

1. Table of Acceptance Criteria and Reported Device Performance

The document does not provide a specific table of acceptance criteria and reported device performance for the EnSite™ Velocity™ Cardiac Mapping System v5.0.1 or its EnSite™ AutoMap Module v1.0.1.

Instead, it broadly states:

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

The document does not specify a sample size for the test set or the data provenance (e.g., country of origin, retrospective/prospective) for any specific performance tests. The testing described is primarily software verification and validation, and risk management, rather than performance evaluation against a clinical or representative dataset of patients.

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

The document does not mention the use of experts to establish ground truth for a test set. The validation described is focused on internal software testing and risk management, not a clinical study requiring expert ground truth.

4. Adjudication Method

No adjudication method is mentioned, as there is no indication of a study requiring expert review or consensus for ground truth.

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

The document does not describe an MRMC comparative effectiveness study, nor does it mention any assessment of how much human readers improve with or without AI assistance. The EnSite™ AutoMap Module is an "optional module that automatically collects mapping points based on criteria set by the user," suggesting an automated function rather than an AI-assisted human reading task.

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

The document implies standalone software testing (software verification and validation), but it does not present quantifiable "standalone performance" metrics in the context of, for example, diagnostic accuracy. The "AutoMap Module" suggests an automated function, which could be considered a standalone algorithm for collecting mapping points, but no specific performance data for this module is provided. The testing mentioned is at a functional level ("met established performance specifications").

7. The Type of Ground Truth Used

The document does not specify the "type of ground truth" (expert consensus, pathology, outcomes data, etc.). The testing described is primarily functional and software-level verification and validation against pre-defined specifications and requirements, rather than against external, medically derived ground truth.

8. The Sample Size for the Training Set

The document does not mention a training set or its sample size. The EnSite™ AutoMap Module is described as automatically collecting mapping points "based on criteria set by the user," which does not necessarily imply a machine learning model that requires a training set in the conventional sense.

9. How the Ground Truth for the Training Set was Established

As no training set is mentioned, there is no information on how its ground truth would have been established.

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