Aperio GT 450 DX User’s Guide, Revision B © Leica Biosystems Imaging, Inc. 2022
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Appendix A: Performance Information
Clinical Performance
Clinical performance is based on the concordance between the Aperio GT 450 DX and traditional light microscopy.
Clinical performance of the Aperio GT 450 DX is based on available scientific literature as, to date, no clinical performance
studies, data from routine diagnostic testing or other clinical performance data is available for the Aperio GT 450 DX. A
systematic literature search was performed to identify relevant literature which supports the clinical performance of the
Aperio GT 450 DX.
The clinical performance, measured in terms of concordance of pathology findings between the Aperio GT 450 DX and
traditional light microscopy has been demonstrated by Hanna et al. 2020, who demonstrated that the Aperio GT 450 DX had a
major diagnostic concordance of 100% and a minor diagnostic concordance of 98.8%.
Overall, based on the clinical performance evidence available, the Aperio GT 450 DX is able to perform as per its intended
purpose in a clinical setting.
Results from the clinical performance studies reported in the literature are shown below.
Performance
Outcome
Comparator
Results
Reference
Concordance
Glass slide microscopy
Major diagnostic concordance
100% (254/254)
Minor diagnostic concordance
98.8% (251/254)
Hanna et al. 2020
1
1 Hanna MG, Parwani A, Sirintrapun SJ:
Whole Slide Imaging: Technology and Applications
. Adv Anat Pathol, 27: 251-259, 2020
10.1097/pap.0000000000000273
