AccurECG Analysis System (v2.0)

The AccurECG Analysis System v2.0 is a software-based ECG analysis tool intended for use by qualified healthcare professionals to assess recorded ambulatory ECG data from adults aged 22 and older. It provides single-lead beat-by-beat analysis, detects ventricular and supraventricular ectopic beats, measures heart rate, and performs rhythm analysis, generating a standard report to support physician decision-making. The system is not for use in life-supporting systems, ECG monitors, or cardiac telemetry devices.

The subject device differs from the predicate in two main areas: execution environment changed from Windows Virtual Machines to Ubuntu Linux Virtual Machines, and programming language changed from LabVIEW to Python. All device inputs, outputs, user interface, indications for use, and core functionality remain identical. ECG signal requirements, file formats, supported electrode types, patient population, and intended users are unchanged.

Performance testing conformed to AAMI/ANSI EC 57:2012 (Testing and Reporting Performance Results of Cardiac Rhythm and ST Segment Measurement Algorithms) and IEC 60601-2-47:2012 (Medical Electrical Equipment, Part 2-47: Particular Requirements For The Basic Safety And Essential Performance Of Ambulatory Electrocardiographic Systems, Section 201.12.1.101 – Algorithm Testing).

The subject device is substantially equivalent to the predicate because intended use, indications for use, technological characteristics, usability, and principles of operation remain identical despite changes to operating system and programming language. ISO 14971 risk analysis and verification/validation testing confirmed that differences in execution environment and programming language do not introduce new questions of safety or effectiveness. Comparative performance testing demonstrated statistical equivalence for every measured parameter, with 95% confidence intervals within specified equivalence margins.