{"id":198131,"date":"2024-10-19T12:36:47","date_gmt":"2024-10-19T12:36:47","guid":{"rendered":"https:\/\/pdfstandards.shop\/product\/uncategorized\/aami-tir66-2017\/"},"modified":"2024-10-25T05:09:59","modified_gmt":"2024-10-25T05:09:59","slug":"aami-tir66-2017","status":"publish","type":"product","link":"https:\/\/pdfstandards.shop\/product\/publishers\/aami\/aami-tir66-2017\/","title":{"rendered":"AAMI TIR66 2017"},"content":{"rendered":"

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.<\/p>\n

PDF Catalog<\/h4>\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n
PDF Pages<\/th>\nPDF Title<\/th>\n<\/tr>\n
2<\/td>\nTitle page <\/td>\n<\/tr>\n
3<\/td>\nAAMI Technical Information Report
Copyright information <\/td>\n<\/tr>\n
4<\/td>\nContents <\/td>\n<\/tr>\n
5<\/td>\nGlossary of equivalent standards <\/td>\n<\/tr>\n
6<\/td>\nCommittee representation <\/td>\n<\/tr>\n
8<\/td>\nForeword <\/td>\n<\/tr>\n
9<\/td>\nIntroduction <\/td>\n<\/tr>\n
10<\/td>\n1 Scope
2 Normative references
3 * Terms and definitions <\/td>\n<\/tr>\n
16<\/td>\n4 Database requirements
4.1 General
4.2 Database alignment with the intended application of the algorithm <\/td>\n<\/tr>\n
17<\/td>\n4.3 Population
4.4 * Study design
4.5 Engineering requirements
4.6 Annotation requirements <\/td>\n<\/tr>\n
18<\/td>\n4.7 * Archive requirements
5 Waveform acquisition and synthesis
5.1 Data integrity
5.2 Handling missing values <\/td>\n<\/tr>\n
19<\/td>\n5.3 * Defining excluded values
5.4 Database annotation process <\/td>\n<\/tr>\n
20<\/td>\n5.5 * Annotators and adjudicators
5.6 Annotation rules for human annotation <\/td>\n<\/tr>\n
22<\/td>\n6 Application of waveform databases to testing <\/td>\n<\/tr>\n
23<\/td>\n7 Use of a database for algorithm development
8 Alarm system algorithm optimization and tuning <\/td>\n<\/tr>\n
25<\/td>\nFigure 1 \u2014 Example of an ROC analysis plot <\/td>\n<\/tr>\n
26<\/td>\nAnnex A (informative) Rationale and additional guidance <\/td>\n<\/tr>\n
28<\/td>\nAnnex B (informative) Known data sets (either publically available free of charge, or available at a cost) <\/td>\n<\/tr>\n
29<\/td>\nBibliography <\/td>\n<\/tr>\n
32<\/td>\nTerminology\u2014Alphabetized index of defined terms <\/td>\n<\/tr>\n<\/table>\n","protected":false},"excerpt":{"rendered":"

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<\/b><\/p>\n\n\n\n\n
Published By<\/td>\nPublication Date<\/td>\nNumber of Pages<\/td>\n<\/tr>\n
AAMI<\/b><\/a><\/td>\n2017<\/td>\n33<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n","protected":false},"featured_media":198135,"template":"","meta":{"rank_math_lock_modified_date":false,"ep_exclude_from_search":false},"product_cat":[2654],"product_tag":[],"class_list":{"0":"post-198131","1":"product","2":"type-product","3":"status-publish","4":"has-post-thumbnail","6":"product_cat-aami","8":"first","9":"instock","10":"sold-individually","11":"shipping-taxable","12":"purchasable","13":"product-type-simple"},"_links":{"self":[{"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product\/198131","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product"}],"about":[{"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/types\/product"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/media\/198135"}],"wp:attachment":[{"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/media?parent=198131"}],"wp:term":[{"taxonomy":"product_cat","embeddable":true,"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product_cat?post=198131"},{"taxonomy":"product_tag","embeddable":true,"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product_tag?post=198131"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}