Evaluation of statistical equivalence using limits of agreement and associated sample size calculation*

Autor:	David M. Whipple, Charles Ho, Stan C. Lin
Rok vydání:	1998
Předmět:	Statistics and Probability Substantial equivalence Food and drug administration Medical device Sample size determination Statistics Limits of agreement Equivalence (measure theory) Confidence interval Mathematics Large sample
Zdroj:	Communications in Statistics - Theory and Methods. 27:1419-1432
ISSN:	1532-415X 0361-0926
DOI:	10.1080/03610929808832167
Popis:	In this article, the Food and Drug Administration's (FDA) medical device substantial equivalence provision will be briefly introduced and some statistical methods useful for evaluating device equivalence are discussed. A sample size formula is derived for limits of agreement, which may be used to assess statistical equivalence in certain medical device situations. Simulation findings on the formula are presented, which can be used to guide sample size selections in common practical situations. Examples of the sample size procedure are given.
Databáze:	OpenAIRE
Externí odkaz:	https://explore.openaire.eu/search/publication?articleId=doi_________::d411946fb2ed6bfbd87f8d5ff101b86b https://doi.org/10.1080/03610929808832167 Zobrazit plný text záznamu