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The ECGenius™ System is an electrophysiology measurement system and analysis tool used to acquire, filter, digitize, amplify, display, record, and analyze data obtained during electrophysiological studies and related procedures. The system is compatible with a 3rd-party stimulator, intended to be used for diagnostic cardiac stimulation during electrophysiological testing of the heart.

The PVI Analyzer™ feature is a secondary measure of pulmonary vein isolation and should not replace traditional methods of confirming isolation.

The ECGenius™ System is an electrophysiology (EP) recording system used in EP procedures as part of the diagnosis and treatment of cardiac arrhythmias. ECGenius™ System (with ECGenius™ Software V3.0) is similar to ECGenius™ System (with ECGenius™ Software V2.0) but has two additional software modules.

The Signal Complexity™ software module analyzes various properties of the signals from a connected 10-pole catheter and visualizes them on a colormap. No clinical claims are made for Signal Complexity™.

The PVI Analyzer™ software module aids the user in evaluating the isolation status of a pulmonary vein. The module performs automated real time analysis of electrograms (EGM) from compatible connected 8- or 10-pole circular mapping catheters during a PVI procedure. The result of the analysis (Isolated vs Non-isolated) is presented in a visual plot to the user. The PVI Analyzer™ feature is a secondary measure of pulmonary vein isolation and should not replace traditional methods of confirming isolation.

The ECGenius™ System consists of an electrophysiology amplifier (Cube Amplifier), recording system software (ECGenius™ Software) running on a PC, and additional components including external cable assemblies, PC monitors, and a printer. Electrophysiological signals are filtered, amplified, and digitized in the Cube Amplifier, and sent to the PC and recording system software for further processing, analysis, visualization, and recording. The ECGenius™ System works in an EP laboratory or operating room in hospitals in conjunction with several other devices from other manufacturers.

The ECGenius™ System includes the following items:

• Cube Amplifier
• Two IECG pin box cables for connection of catheters
• Surface ECG trunk cable and ECG leadwires
• Blood pressure cables
• Data cable to host computer
• Stimulator cable
• Analog-out and analog-in cables
• ECGenius™ Software with the PVI Analyzer™ and Signal Complexity™ software modules
• Host computer (PC), monitors and printer
• Isolation transformers

The provided document is a 510(k) Summary for the CathVision ApS ECGenius™ System. Section 510(k) summaries disclose information to FDA about how a specific device is substantially equivalent to other devices already legally marketed in the U.S. This document outlines the device description, indications for use, comparison to a predicate device, and various performance testing conducted. However, it does not contain details about specific acceptance criteria or a study design that quantitatively evaluates the device's performance against pre-defined metrics.

The document states that the ECGenius™ System with ECGenius™ Software V3.0 introduces two new software modules: PVI Analyzer™ and Signal Complexity™.

• The PVI Analyzer™ is described as a "secondary measure of pulmonary vein isolation" and explicitly states it "should not replace traditional methods of confirming isolation."
• The Signal Complexity™ module "analyzes various properties of the signals" and "No clinical claims are made for Signal Complexity™."

Given this, the document asserts that these new modules "do not present different questions of safety or effectiveness because they are only intended to provide the physician with additional information that supplements common clinical practice and do not alter the Intended Use."

Therefore, based solely on the provided text, a detailed table of acceptance criteria and a study proving the device meets these criteria cannot be constructed as the necessary information is not present in this 510(k) summary. The document focuses on demonstrating substantial equivalence to a predicate device and outlines general performance testing (e.g., software verification, cybersecurity, biocompatibility), but not a specific clinical performance study with acceptance criteria for the new features.

The document does not contain the following information typically found in a clinical performance study write-up:

• A table of acceptance criteria and reported device performance for the new features.
• Sample sizes used for a test set.
• Number of experts used to establish ground truth or their qualifications.
• Adjudication methods.
• Results of a multi-reader multi-case (MRMC) comparative effectiveness study.
• Standalone (algorithm only) performance.
• Type of ground truth used (e.g., pathology, outcomes data).
• Sample size for the training set.
• How ground truth for the training set was established.

The document details the device's technological characteristics and compares them to those of its predicate and reference devices, focusing on demonstrating equivalence rather than proving clinical performance against specific quantitative metrics for the new features.

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EnSite™ X EP System: The EnSite™ X EP System is a suggested diagnostic tool in patients for whom electrophysiology studies have been indicated. The EnSite™ X EP System provides information about the electrical activity of the heart and displays catheter location during conventional electrophysiological (EP) procedures.

EnSite™ X EP System Contact Force Software License: When used with the TactiSys™ Quartz Equipment, the EnSite™ X EP System Contact Force Module is intended to provide visualization of force information from compatible catheters.

EnSite™ X EP System Surface Electrode Kit: The EnSite™ X EP Surface Electrode Kit is indicated for use with the EnSite™ in accordance with the EnSite™ X EP System indications for use.

Advisor™ VL Circular Mapping Catheter, Sensor Enabled™: Advisor™ VL Circular Mapping Catheter, Sensor Enabled™ is a steerable electrophysiology catheter with integrated sensors. The catheter is used for recording intracardiac stimulation during diagnostic electrophysiology studies. The cather can be used to map the atrial regions of the heart.

Advisor™ FL Circular Mapping Catheter, Sensor Enabled™: The Advisor™ FL Circular Mapping Catheter, Sensor Enabled™ is steerable electrophysiology catheter with integrated sensors. The catheter is used for recording intracardiac stimulation during diagnostic electrophysiology studies. The catheter can be used to map the atrial regions of the heart.

Advisor™ HD High Density Mapping Catheter, Sensor Enabled™: The Advisor™ HD Grid Mapping Catheter, Sensor Enabled™, is indicated for multiple electrophysiological mapping of cardiac structures in the heart, i.e., recording or stimulation only. This catheter is intended to obtain electricular regions of the heart.

The EnSite™ X EP System is a catheter navigation and mapping system. A catheter navigation and mapping system is capable of displaying the 3-dimensional (3-D) position of conventional and Sensor Enabled™ (SE) electrophysiology catheters, as well as displaying cardiac electrical activity as waveform traces and as three-dimensional (3D) isopotential and isochronal maps of the cardiac chamber.

The contoured surfaces of the 3D maps are based on the anatomy of the patient's own cardiac chamber. The system creates a model by collecting and labeling the anatomic locations within the chamber. A surface is created by moving a selected catheter to locations within a cardiac structure. As the catheter moves, points are collected at and between all electrodes on the catheter. A surface is wrapped around the outermost points.

Advisor™ VL Circular Mapping Catheter, Sensor Enabled™ (Advisor VL) is a variable radius, circular mapping catheter. It has an adjustable 4 French (F) distal loop size with a diameter ranging from 15mm - 25mm with models containing both ten (10) equidistant or twenty (20) paired platinum-iridium electrodes. The catheter has integrated sensors with two impedance-based navigational electrodes and two magnetic sensors located at the distal end of the shaft. The catheter is intended to be used with the EnSite Precision™ Cardiac Mapping System, or the EnSite™ X EP System.

Advisor™ FL Circular Mapping Catheter, Sensor Enabled™ (Advisor FL, SE) is a circular mapping catheter for performing electrophysiology mapping procedures and providing pacing signals to the heart during electrophysiology procedures. The catheter handle and shaft design allows for improved maneuverability. A magnetic sensor in the distal shaft pocket provides compatibility with visualization and navigation systems. The catheter is compatible with Abbott's EnSite Precision™ Cardiac Mapping System, MediGuide™ System, or EnSite™ X EP System.

The Advisor™ HD Grid Mapping Catheter, Sensor Enabled™, is a sterile, single use, irrigated, high-density mapping catheter with a 7.5F shaft and an 8F distal shaft deflectable section. It is available in a D-F bi-directional curve model that is deflected using the actuator located on the catheter handle. The catheter working length is 110 cm. The device consists of a paddle-shaped distal tip with 16 electrodes, two distal shaft ring electrodes, two magnetic sensors, polymer braided shaft, handle, fluid lumen extension with a luer, and an electrical connector. The catheter also has an introducer tool intended to compress and guide the distal paddle into, and withdraw from, the hemostasis valve of an introducer sheath. The catheter is compatible with the EnSite™ Velocity, EnSite Precision™, and EnSite™ X EP Cardiac Mapping Systems and other accessories, including the connecting cable and commercially available irrigation pumps.

The provided FDA 510(k) summary (K202066) focuses on the substantial equivalence of the EnSite X EP System and associated catheters to previously cleared predicate devices. It largely relies on the similar intended use, indications for use, fundamental scientific technology, and performance of the subject devices compared to the predicate devices. The primary change described is compatibility with the EnSite™ X EP System and updated labeling.

However, the document does not contain specific acceptance criteria, reported device performance metrics, or details of a study structured to prove the device meets pre-defined acceptance criteria in the manner that would be expected for a novel AI/ML diagnostic device with a specific performance claim (e.g., sensitivity, specificity for a disease).

Instead, the non-clinical testing summary focuses on design verification activities, compliance with industry standards, and in vivo preclinical studies to evaluate substantial equivalence, and human factors evaluations. This suggests that the "acceptance criteria" here are more about demonstrating that the new system and its components function as intended and do not raise new questions of safety or effectiveness compared to the predicate(s).

Given this context, I will extract the information available and note where specific details regarding AI/ML performance studies or traditional clinical performance metrics are not present, as they do not appear to be the primary focus of this 510(k).

Acceptance Criteria and Study for K202066

1. Table of Acceptance Criteria and Reported Device Performance

As mentioned, this 510(k) does not present performance in terms of specific diagnostic metrics (e.g., sensitivity, specificity, accuracy) with numerical acceptance criteria. Instead, the "acceptance criteria" are implied by successful completion of design verification activities, adherence to standards, and performance in preclinical studies demonstrating substantial equivalence to predicate devices. The reported device performance generally refers to its ability to function as intended and similar to predicate devices.

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

The document mentions "In vivo Preclinical Studies" for the EnSite™ X EP System and Sensor Enabled™ Catheters. However, it does not specify the sample size (e.g., number of patients, cases, or animal subjects) used for these studies, nor does it explicitly state the country of origin or whether the data was retrospective or prospective. The term "preclinical" typically refers to animal studies rather than human clinical data.

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

The document does not specify the use of experts to establish ground truth for a test set in the context of diagnostic interpretation. The studies described are more focused on the functional performance and substantial equivalence of the hardware and software components rather than a diagnostic accuracy study requiring expert human interpretation as ground truth.

4. Adjudication Method for the Test Set

Since the document does not describe a diagnostic study requiring expert interpretation or ground truth establishment in a clinical sense, there is no mention of an adjudication method (e.g., 2+1, 3+1).

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

The document does not indicate that an MRMC comparative effectiveness study was done. The focus is on demonstrating that the device itself performs comparably to predicate devices, which may include functional performance in in-vivo settings, but not a study of human readers' performance with and without AI assistance for improving diagnostic outcomes.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

While the EnSite™ X EP System performs functions involving data processing ("programmable diagnostic computer"), the K202066 submission does not present it as a standalone AI/ML diagnostic algorithm with specific performance metrics (e.g., sensitivity, specificity) proven in a standalone study. The system provides "information about the electrical activity of the heart and displays catheter location" and "visualization of force information." The testing described confirms the system's functional integrity and similarity to predicate devices, rather than a standalone diagnostic performance claim often associated with AI/ML algorithms.

7. Type of Ground Truth Used

For the "in vivo Preclinical Studies" and bench testing, the ground truth would likely be based on:

• Physical measurements and established physiological parameters: For evaluating catheter position, orientation, and electrical activity recording accuracy.
• Comparison to predicate device performance: Demonstrating similar outputs and behavior.
• Engineering specifications and design requirements: For functional tests of hardware and software components.

There is no mention of "pathology" or "outcomes data" being used as ground truth for the evaluations described.

8. Sample Size for the Training Set

The document does not provide any information regarding a training set size. This indicates that the regulatory submission is likely not for a device that relies on continuously learning or adaptive AI/ML algorithms that require specific training data sets in the typical sense. The "software verification" and "system level" testing suggest traditional software development and testing, rather than a machine learning model's training and validation.

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

Since there is no mention of a training set or a machine learning component requiring one, there is no information provided on how ground truth for a training set was established.

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