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EnSite™ Velocity™ Cardiac Mapping System v5.2:
The EnSite Velocity Cardiac Mapping System is a suggested Diagnostic tool in patients for whom electrophysiology studies have been 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™ 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™ 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.

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 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.

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.

Device Description

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 NavLink connects surface electrodes and the system reference surface electrode to the Amplifier. The ArrayLink connects the EnSite Array Multi-electrode 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™ 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 position 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.

Expansion Module Device Description
The EnSite™ Velocity™ Cardiac Mapping System v5.2 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™ AutoMap Module - an optional module that automatically collects mapping points based on criteria set by the user
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.

AI/ML Overview

Based on the provided FDA 510(k) submission summary for the EnSite™ Velocity™ Cardiac Mapping System v5.2 and EnSite Precision™ Cardiac Mapping System v2.2 (K183128), here's an analysis regarding acceptance criteria and the study proving the device meets them:

Crucial Observation: This 510(k) summary is for a Special 510(k) submission. A Special 510(k) is used for modifications to a legally marketed device where the modification does not affect the device's fundamental scientific technology or lead to a new intended use. As stated in the document:

"The proposed labeling modifications to the subject device pertain to warnings only. The labeling modifications include removal of the black box warning from the cover of the Instructions for Use as well as the addition of a warning in the warnings section of the Instructions for Use. There are no new or increased risks that result from the proposed modifications presented within the submission, and the changes do not raise any new questions of safety and effectiveness in regards to the subject device."

"No new non-clinical testing was completed, nor relied upon, in support of this Special 510(k) submission."

This means that the submission does not contain new performance data or a new study proving the device meets specific acceptance criteria for functionality or clinical impact. Instead, it relies on the predicate device's existing performance, as the changes are limited to labeling and deemed not to affect safety or effectiveness.

Therefore, many of the details typically associated with studies proving device performance against acceptance criteria (like sample sizes for test sets, expert adjudication, MRMC studies, standalone performance, and detailed ground truth establishment for new data) are not applicable to this specific Special 510(k) submission.

Addressing your points based on the available information:

1. Table of Acceptance Criteria and Reported Device Performance

Since this is a Special 510(k) for labeling changes only, there are no explicit new "acceptance criteria" for device performance in this document, nor new "reported device performance" data from new studies. The device's performance is implicitly accepted as equivalent to the predicate device.

If we were to infer "acceptance criteria" from the premise of a Special 510(k), it would be that the modified device must perform no worse than the predicate and introduce no new risks.

Acceptance Criteria (Inferred for Special 510(k))	Reported Device Performance (from this submission)
No new or increased risks introduced	"No new or increased risks that result from the proposed modifications"
No new questions of safety and effectiveness	"The changes do not raise any new questions of safety and effectiveness"
Same fundamental scientific technology as predicate	"The technological characteristics for the devices are the same as the predicate devices."
Same intended use and indications for use as predicate	"Both the subject and predicate devices have the same intended use, indications for use..."

2. Sample sizes used for the test set and the data provenance

Sample Size: Not applicable. No new test set data was used or generated for this Special 510(k) submission, as stated: "No new non-clinical testing was completed, nor relied upon, in support of this Special 510(k) submission."
Data Provenance: Not applicable for new performance data. The device relies on the established performance of its predicate, EnSite™ Velocity™ Cardiac Mapping System v5.2 (K182644) and EnSite™ Precision™ Cardiac Mapping System v2.2 (K182644). The provenance of data for the predicate would be detailed in its original 510(k) submission.

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

Not applicable. No new test set requiring expert ground truth was created for this submission.

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

Not applicable. No new test set requiring adjudication was created for this submission.

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 applicable. The device (EnSite Velocity/Precision Cardiac Mapping System) is a "Programmable Diagnostic Computer" primarily for displaying catheter position and cardiac electrical activity. It's not described as an AI-powered diagnostic device in the context of assisting human readers with interpretation (e.g., radiology AI). Therefore, an MRMC study comparing human readers with and without AI assistance is not relevant to the information provided for this device.

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

Not applicable for this Special 510(k) for reasons similar to point 5. The device's function is to display mapping information, not to provide an automated diagnosis that would be evaluated in a standalone manner without human oversight.

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

Not applicable for new data in this submission. The "ground truth" for catheter mapping systems typically relates to the accuracy of position sensing and electrical signal display, which would have been established during the development and clearance of the predicate devices. This might involve phantom studies, in-vitro testing, and potentially clinical correlation, but this specific document does not detail new ground truth establishment.

8. The sample size for the training set

Not applicable. The document does not describe any machine learning or AI components that would require a "training set" in the conventional sense for image or signal interpretation. The system is a diagnostic computer that processes and displays data, not an AI model that learns from large datasets.

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

Not applicable, as there is no mention of a training set for an AI/ML model.

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K Number

K182644

Device Name

EnSite Velocity Cardiac Mapping System v5.2, EnSite Precision Cardiac Mapping System v2.2

Manufacturer

Abbott

Date Cleared

2018-10-19

(25 days)

Product Code

Regulation Number

Type

Panel

Reference & Predicate Devices

K172396

Intended Use

EnSite™ Velocity™ Cardiac Mapping System v5.2:
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™ 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 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.

Device Description

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.

Expansion Module Device Description:

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™ AutoMap Module - an optional module that automatically collects mapping points based on criteria set by the user
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.

AI/ML Overview

The provided document does not contain information about a study that proves a device meets acceptance criteria for an AI/ML-based medical device. Instead, it is a 510(k) clearance letter for the EnSite™ Velocity™ Cardiac Mapping System v5.2 and EnSite Precision™ Cardiac Mapping System v2.2, which are described as programmable diagnostic computer systems. These systems are used for catheter navigation and mapping in electrophysiology studies.

The document discusses validation activities for functional testing related to hardware and software modifications, as well as verification testing against industry standards. However, it does not detail a clinical study with acceptance criteria and performance metrics typically associated with proving the effectiveness of an AI/ML diagnostic tool, such as sensitivity, specificity, accuracy, or human-AI comparative performance.

Therefore, I cannot extract the requested information to fill in the table and describe the study as it pertains to AI/ML device performance. The testing described largely relates to electrical safety, electromagnetic compatibility, basic system function, system-level accuracy, and software/hardware verification after proposed modifications.

To answer your request, if this were an AI/ML device, the study would typically involve:

A table of acceptance criteria and the reported device performance: This would list specific thresholds for metrics like sensitivity, specificity, AUC, or agreement rates, and the actual performance achieved by the AI device.
Sample size used for the test set and data provenance: Details on the number of medical images/cases in the test set, their origin (e.g., specific hospitals, geographical regions), and whether the data was collected retrospectively or prospectively.
Number of experts used to establish the ground truth and qualifications: How many, and what level of experience (e.g., board-certified radiologists with X years of experience in the specific domain), defined the true labels for the test data.
Adjudication method for the test set: How disagreements among experts were resolved (e.g., majority vote, senior expert review).
MRMC comparative effectiveness study: If human readers were involved, how their performance changed with and without AI assistance (e.g., increase in true positives, decrease in false negatives).
Standalone performance: The performance of the algorithm without any human intervention.
Type of ground truth: Whether ground truth was established by expert consensus, biopsy/pathology results, clinical follow-up data, or other definitive methods.
Sample size for the training set: The number of cases used to train the AI model.
How the ground truth for the training set was established: Similar to the test set, how the true labels for the training data were determined.

The provided document, while comprehensive for a 510(k) submission for a non-AI/ML device, does not contain these specific details.

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K Number

K172396

Device Name

EnSite Velocity Cardiac Mapping System v5.2

Manufacturer

St. Jude Medical

Date Cleared

2018-04-23

(258 days)

Product Code

Regulation Number

Type

Panel

Reference & Predicate Devices

K172393,K160187,K160210,K160218

Intended Use

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.

Device Description

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:

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™ AutoMap Module - an optional module that automatically collects mapping points based on criteria set by the user
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.

AI/ML Overview

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.

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.
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.
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.
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.
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.
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.
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.
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.
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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