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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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