ACR–SIIM · Local acceptance testing
How many cases does your acceptance test need?
The practice parameter requires local acceptance testing before an AI tool goes live, and leaves the metrics and sample sizes to you. This sizes the test before you collect the cases — and produces the dated, pre-specified metric record the parameter asks for.
The tool under test
Counts only — no images, no patient data.
Claimed performance and your test set
From the vendor’s labelling or 510(k) summary, and the cases you propose to test on.
Sensitivity
%
pos
·
Specificity
%
neg
Scanner mixLAT-03
The parameter requires the test set to span multiple manufacturers, models and protocols.
Acquisition types representedLAT-05
Acceptance marginLAT-06
The drop from claimed performance you would consider clinically meaningful. Set this before you look at any results.
pts