American National ANSI/AAMI EC57:1998/(R)2003 Standard Testing and reporting performance results of cardiac rhythm and ST-segment measurement algorithms AAMI Association for the Advancement of Medical Instrumentation ANSI/AAMI EC57:1998 AmericanNationalStandard (Revision of AAMI ECAR:1987) Testing and reporting performance results of cardiac rhythm and ST segment measurement algorithms Corrected copy Developed by Association for the Advancement of Medical Instrumentation Approved 29 October 1998 by American National Standards Institute, 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 AAMl Recommended Practice 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 practice does not AAMl recommended practices are subject to periodic review, and users are cautioned to obtain the latest editions. CAUTION NOTICE: This AAMI recommended practice may be revised or withdrawn at any time. AAMI procedures writing AAMl. Published by Association for the Advancement of Medical Instrumentation 1110 N. Glebe Road, Suite 220 Arlington, VA 22201-5762 1999bytheAssociationforthe AdvancementofMedical Instrumentation All Rights Reserved This publication is subject to copyright claims of AAMl. No part of this publication may be reproduced or distributed in any draft should be submitted to AAMl. It is illegal under federal law (17 U.S.C. s 101, et seq.) to make copies of all or any part Advancement of Medical Instrumentation. Violators risk legal action, including civil and criminal penalties, and damages Director, Technical Publishing, at AAMl, 1110 N. Glebe Road, Suite 220, Arlington, VA 22201. Phone: (703) 525-4890, Ext. 239; Fax: (703) 525-1067 Printed inthe United States of America ISBN1-57020-116-1 Contents Page Committee representation .... v Foreword ... vi General ... 1.1 1.3 Exclusions. Definitions of abbreviations 2 3 Algorithm testing .. 2 3.1 Databases.... 2 3.1.1 2 General description of availabledatabases Records to be excluded during testing 3.1.2 3 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 Requirements for all arrhythmia algorithms . 3.5.3. Requirements for algorithms with optional capabilities. 5 .6 Simulated test patterns ..... Automated analysis ... 7 4.1 Use of standard databases , 4.2 Use of annotation files . 8 4.3 Beat-by-beat comparison.... 9 4.3.1 General description.... 9 Method for beat-by-beat comparison .. 4.3.2 9 4.3.3 Heart rate, and heart rate or RR interval variability... 10 4.3.3.1 Heart rate measurement.. 10 4.3.3.2 Heart rate variability or RR interval variability measurement from databases ... 10 4.3.3.3 12 4.4 Run-by-run comparison.. 14 4.4.1 General description.. 14 Terms and symbols , 4.4.2 15 Run sensitivity summary matrix 4.4.3 15 4.4.4 Run positive predictivity summary matrix. 16 4.5 VF and AF comparisons .. 16 4.6 ST comparison.. 17 Annex Rationale and additional guidance.. 22 A Tables Requirements for all arrhythmia algorithms .. 1 55 2 Requirements for algorithms with optional capabilities, 3 Beat label classifications... 9 12 4 AHA and MIT-BIH database labels distributed for use by HRV algorithms 5 13 Example of noise floor calculation results ... Example of HRV test results .. 14 6 7 Run sensitivity summary matrix 15 Run positive predictivity summary matrix. 8 15 A.1 Records to be included in a complete test. 23 A.2 Example of a line-format, beat-by-beat performance report ..... 26 Condensed beat-by-beat summary matrix containing 11 elements . A.2.1 26 A.2.2 Summary table (matrix format) of beat-by-beat comp