American National Standard ANSI/AAMI EC57:2012/ (R)2020 Testing and reporting performance results of cardiac rhythm and ST segment measurement algorithms AAMI reckandha sateaw n Hezlth Tedtekeem American National Standard ANSI/AAMI EC57:2012/(R)2020 (Revision of ANSI/AAMI EC57:1998/(R)2008) Testing and reporting performance results of cardiac rhythm and ST segment measurement algorithms Developedby Association for the Advancement of Medical Instrumentation Approved 18 December 2012 and reaffirmed 9 October 2020 by AmericanNationalStandardsInstitute,Inc. Abstract: This recommended practice establishes a method for testing and reporting the performance of algorithms used to detect cardiac rhythm disturbances, including the ST segment. Keywords: arrhythmia database, arrhythmia monitoring, ST segments, heart rate variability AAMlRecommendedPractice This Association for the Advancement of Medical Instrumentation (AAMl) recommended practice implies a consensus of those substantially concerned with its scope and provisions. The existence of an AAMl recommended obtain the latest editions. the date of publication. Interested parties can obtain current information on all AAMl documents by calling or writing AAMI. developed by AAMl are voluntary, and their application is solely within the discretion and professional judgment of andregulations. Publishedby AAMI 901 N. Glebe Road, Suite 300 Arlington, VA 22203 www.aami.org 2013by the Associationfor the Advancement of Medical Instrumentation All Rights Reserved strictly prohibited by law. It is llegal under federal law (17 U.S.C. $ 101, et seq.) to make copies of all or any part of Advancement of Medical Instrumentation. Violators risk legal action, including civil and criminal penalties, and reprint request form at www.aami.org or contact AAMl, 901 N. Glebe Road, Suite 300, Arlington, VA 22203. Phone:+1-703-525-4890;Fax:+1-703525-1067. ISBN1-57020-478-0 Contents Page Glossary of equivalent standards. Committee representation... Foreword. vii Scope.. 1.1 General... 1.2 Inclusions. 1.3 Exclusions... Definitions of abbreviations... Algorithm testing .... 3 3.1 Databases . 3.1.1 General description of available databases 3.1.2 Records to be excluded during testing .... 3.2 Testing requirements. 3.3 Test environment. 3.4 Multiple-lead analysis . 3.5 Requirements for the evaluation report . 3.5.1 Required statistics.... 3.5.2 Requirementsforall arrhythmiaalgorithms 3.5.3. Requirements for algorithms with optional capabilities 3.6 Simulated test patterns..... Automated analysis . 4 4.1 Use of standard databases. 4.2 Use of annotation files. 4.3 Beat-by-beat comparison.. General description . 4.3.1 Method for beat-by-beat comparison. 4.3.2 10 Heart rate, and heart rate or RR interval variability 4.3.3 10 4.3.3.1 Heart rate measurement.. 4.3.3.2 Heart rate variability or RR interval variability measurement from databases. 11 4.3.3.3 Heart rate variability or RR interval variability measurement of test patterns. 12 4.4 Run-by-run comparison 14 4.4.1 General description . 14 4.4.2 Terms and symbols . 15 4.4.3 Run sensitivity summary matrix. 16 4.4.4 Run positive predictivity summary matrix. 16 4.5 VF and AF comparisons .... 16 Annex 22 A Rationale and additional guidance Tables Table 1-Requirements for all arrhythmia algorithms... Table 2-Requirements for algorithms with optional capabilities . .6 Table 3Beat label classifications... Table 4-AHA and MIT-BIH database labels distributed for use by HRV algorithms 12 Table 5—Example of noise floor calculation results .... 13 Table 6—example of HRV test results .14 Table 7-Run sensitivity summary matrix.. Table 8-Run positive predictivity summary matrix ... .15 Table A.1-Records to be included in a complete test ..23 Table A.2-Example of a line-format, beat-by-beat performance report .... Table A.2.1- -Condensed beat-by-beat summary matrix containing 11 elements, ..26 Table A.2.2-—Summary table (matrix format) of beat-by-beat comparison. -Example of a li