was told by auditor that our device "performance claims had yet established for the function of cavity cleanness claimed in intended use"
reading through the guidance, it still seems fairly vague to me as to what is performance claim "Behavior of a medical device or response of the subject(s) to that medical device in relation to its intended use, when correctly applied to appropriate subject(s)."
is it the statistical efficacy of its intended use?
reading through the guidance, it still seems fairly vague to me as to what is performance claim "Behavior of a medical device or response of the subject(s) to that medical device in relation to its intended use, when correctly applied to appropriate subject(s)."
is it the statistical efficacy of its intended use?