GE Healthcare
Senographe SecondLook Digital CAD System
Revision 1
Operator Manual 5189820-5-C-1EN
CAD.fm
Page no. 33
ROSE-DS
The second supplemental study, ROSE-DS, was conducted to assess the performance of SecondLook
Digital. An original PMA and a PMA supplement for the Second Look Analog system were previously
approved by the FDA’s Office of Device Evaluation for use with screen-film mammography. For
SecondLook to process GEMS Senographe full-field digital mammography, a new optional system
component was developed, SecondLook Digital.
SecondLook Digital and Second Look Analog were developed with common Computer-Aided Detection
algorithms for the system performance with GEMS Senographe full-field digital mammography and
screen-film mammography to be consistent. In the ROSE-DS study, the performance of SecondLook
Digital was assessed with 45 GEMS Senographe full-field digital mammography cancer cases and
compared to the Screen-Detected Study and Normal Study from ROSE-S1, which assessed the
performance of Second Look Analog with screen-film mammography from 906 screen-detected cancer
cases and 153 normal cases.
The results of the ROSE-DS study showed that the sensitivity of SecondLook Digital on GEMS
Senographe full-field digital mammography cases was statistically no different than the sensitivity of
Second Look Analog on screen-film mammography cases, while the false positive rate of SecondLook
Digital (2.03 false positive marks per case) was statistically improved from the false positive rate of
Second Look Analog (2.94 false positive marks per case). Thus, the results indicate that the
enhancement of a radiologist’s effectiveness in detecting breast cancer with SecondLook Digital with
input from a the GEMS Senographe full-field digital mammography system will at least be statistically no
different than the enhancement demonstrated with Second Look Analog.
Conclusions drawn from the studies:
• The use of the Second Look Analog system led to a clinically significant reduction in missed cancers
of at least 28.4% (95% CI 23.4% - 33.7%).
• A retrospective study of 374 cancer cases showed that 23.0% (95% CI, 19.0% - 27.3%) of women
diagnosed with breast cancer, who had prior screening mammograms within 9 - 24 months of
diagnosis, could have had their cancers discovered earlier, by an average of 15.1 months, with the
use of Second Look Analog.
• The use of the Second Look Analog system led to an insignificant increase in the number of work-
ups recommended by radiologists reading screening mammograms from 16.6% (95% CI 15.5% -
17.8%) unaided to 17.2% (95% CI 16.0% - 18.4%) aided by the system.
• The sensitivity of SecondLook Digital with input from the GEMS Senographe full-field digital
mammography system was statistically no different than the sensitivity of Second Look Analog with
input from screen-film mammography.
• The false positive rate of SecondLook Digital with input from the GEMS Senographe full-field digital
mammography system was statistically improved from the false positive rate of Second Look Analog
with input from screen-film mammography, with a reduction in false positive marks per case from
2.94 with Second Look Analog to 2.03 with SecondLook Digital.
• The study with SecondLook Digital did not assess the impact of this system on reduction in missed
cancers, percent of women who could have had their cancers discovered earlier, and work-up rate.
In summary, the SecondLook system will enhance a radiologist’s effectiveness in detecting breast
cancer.
