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Determining the sample size required to establish whether a medical device is non-inferior to an external benchmark

OBJECTIVES: The use of benchmarks to assess the performance of implants such as those used in arthroplasty surgery is a widespread practice. It provides surgeons, patients and regulatory authorities with the reassurance that implants used are safe and effective. However, it is not currently clear ho...

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Detalles Bibliográficos
Autores principales:	Sayers, Adrian, Crowther, Michael J, Judge, Andrew, Whitehouse, Michael R, Blom, Ashley W
Formato:	Online Artículo Texto
Lenguaje:	English
Publicado:	BMJ Publishing Group 2017
Materias:	Research Methods
Acceso en línea:	https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5652499/ https://www.ncbi.nlm.nih.gov/pubmed/28851772 http://dx.doi.org/10.1136/bmjopen-2016-015397

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