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U.S. Department of Health and Human Services

Recognized Consensus Standards: Medical Devices
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Part B: Supplementary Information Sheet (SIS)
FR Recognition List Number 059 Date of Entry 12/19/2022 
FR Recognition Number 5-138
Standard
AAMI  TIR66: 2017/(R)2020
Guidance for the creation of physiologic data and waveform databases to demonstrate reasonable assurance of the safety and effectiveness of alarm system algorithms
Scope/Abstract
This document is intended to define the nomenclature, ingredients, and principles for the development, annotation and use of physiologic waveform databases for developing and testing the performance of INTELLIGENT ALARM SYSTEM algorithms, and to test ALARM SYSTEMS incorporating such algorithms. This document also identifies issues that should be addressed in the design and development of these physiologic databases. It discusses many major pitfalls that should be avoided. Annexes that describe several publicly available databases in detail are included. The database profiles that are presented here are intended to serve as a guide in the design, development, acquisition and documentation of future physiologic databases that can be used in the development and evaluation of ALARM SYSTEMS and algorithms.

This document does not cover the use of databases beyond algorithm development and performance testing to ensure delivery of the stated ESSENTIAL PERFORMANCE.
Extent of Recognition
Complete standard
Rationale for Recognition
This standard is relevant to medical devices and is recognized on its scientific and technical merit and/or because it supports existing regulatory policies.

Regarding appropriate use of machine learning-based methods for automated annotation of databases referenced in Sub Clause 5.5:
As part of the sponsor's Declaration of Conformity to this recognition, supporting documentation of the conformity assessment results should include the verification and validation of relevant methods, including machine learning-based methods for automated annotation of databases.
Relevant FDA Guidance and/or Supportive Publications*
Appropriate Use of Voluntary Consensus Standards in Premarket Submissions for Medical Devices - Guidance for Industry and Food and Drug Administration Staff, issued September 2018.
FDA Technical Contacts
 Shawn Forrest
  FDA/OC/CDRH/OPEQ/OHTII/DHTIIA/
  301-796-5554
  shawn.forrest@fda.hhs.gov
 Christopher Scully
  FDA/OC/CDRH/OSEL/DBP/
  301-796-2928
  Christopher.Scully@fda.hhs.gov
Standards Development Organization
AAMI Association for the Advancement of Medical Instrumentation http://www.aami.org
FDA Specialty Task Group (STG)
General I (QS/RM)
*These are provided as examples and others may be applicable.
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