A pragmatic approach for dynamically incorporating predicate device data in prospective diagnostic test studies
Sign Up to like & getrecommendations! Published in 2022 at "Journal of Biopharmaceutical Statistics"
DOI: 10.1080/10543406.2022.2080690
Abstract: ABSTRACT Clinical studies are generally required to characterize the accuracy of new diagnostic tests. In some cases, historical data are available from a predicate device, which is directly relevant to the new test. If this… read more here.
Keywords: pragmatic approach; test; predicate device; new test ... See more keywords
Mineralization in a Critical Size Bone-Gap in Sheep Tibia Improved by a Chitosan-Calcium Phosphate-Based Composite as Compared to Predicate Device
Sign Up to like & getrecommendations! Published in 2022 at "Materials"
DOI: 10.3390/ma15030838
Abstract: Deacetylated chitin derivatives have been widely studied for tissue engineering purposes. This study aimed to compare the efficacy of an injectable product containing a 50% deacetylated chitin derivative (BoneReg-Inject™) and an existing product (chronOS Inject®)… read more here.
Keywords: predicate device; bone; bonereg; critical size ... See more keywords