a specification of methods, including the appropriate statistical tools, used for the examination of the analytical and clinical performance of the device and of the limitations of the device and information provided by it;
sonrú ar na modhanna, lena n-áirítear na huirlisí iomchuí staidrimh, arna n-úsáid don scrúdú ar fheidhmíocht anailíseach agus chliniciúil na feiste agus ar theorainneacha na feiste agus na faisnéise a sholáthraítear léi;