AAMI TIR66 2017

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AAMI TIR66:2017 – Guidance for the creation of physiologic data and waveform databases to demonstrate reasonable assurance of the safety and effectiveness of alarm system algorithms

Published By	Publication Date	Number of Pages
AAMI	2017	33

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Provides guidance to manufacturers that change existing or create new alarm system algorithms as to how to create evidence that demonstrates a reasonable assurance of the safety and efficacy of the algorithm. This document also provides guidance to authorities having jurisdiction for the assessment of such evidence.

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PDF Pages	PDF Title
2	Title page
3	AAMI Technical Information Report Copyright information
4	Contents
5	Glossary of equivalent standards
6	Committee representation
8	Foreword
9	Introduction
10	1 Scope 2 Normative references 3 * Terms and definitions
16	4 Database requirements 4.1 General 4.2 Database alignment with the intended application of the algorithm
17	4.3 Population 4.4 * Study design 4.5 Engineering requirements 4.6 Annotation requirements
18	4.7 * Archive requirements 5 Waveform acquisition and synthesis 5.1 Data integrity 5.2 Handling missing values
19	5.3 * Defining excluded values 5.4 Database annotation process
20	5.5 * Annotators and adjudicators 5.6 Annotation rules for human annotation
22	6 Application of waveform databases to testing
23	7 Use of a database for algorithm development 8 Alarm system algorithm optimization and tuning
25	Figure 1 — Example of an ROC analysis plot
26	Annex A (informative) Rationale and additional guidance
28	Annex B (informative) Known data sets (either publically available free of charge, or available at a cost)
29	Bibliography
32	Terminology—Alphabetized index of defined terms


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Standard Title	AAMI TIR66:2017 – Guidance for the creation of physiologic data and waveform databases to demonstrate reasonable assurance of the safety and effectiveness of alarm system algorithms
Published Code	AAMI
Publication Date	2017
Pages Count	33

AAMI TIR66 2017

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