When comparing a subject device to a predicate/equivalent device, there are a number of factors which need to be considered like device type, clinical condition, reporting results, IVD device, etc. When comparing some devices doing intermediate statistics may be appropriate such as comparing material fatigue testing. Other devices like comparing software only applications analysing CT scans may require intermediate to advanced statistics where comparison of the results are done. For IVDs it may be statistics like % Change Value or %CV which could be <5% CV or <10% CV or could be regression analysis where r >0.90. I could recommend looking at some 510(k) Summaries for your device type as there is sometimes type of testing and analysis performed. Another method is to understand the clinical process with the device and conduct a literature review or clinical trial review to understand type of results expected from a clinical perspective.
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Richard Vincins RAC
Vice President Global Regulatory Affairs
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Original Message:
Sent: 13-Apr-2021 17:54
From: Anonymous Member
Subject: Performance Testing to Predicate
This message was posted by a user wishing to remain anonymous
For a diagnostic device, if you are unable to compare directly to your predicate, so you are only comparing values, such as sensitivity and specificity, how alike must these values be? I understand that the acceptance criteria for a diagnostic study would require that the lower bound of the 95% confidence interval be greater than the performance goal. Is that acceptable? Is there a right answer or does it depend on clinical meaningfulness?