GE Senographe SecondLook Operator's Manual page 25

GE Healthcare
Revision 1
SecondLook Digital is intended to be used by a radiologist as follows: The radiologist must first review
the mammogram in the normal manner and only afterward consult the CAD marks to determine if
SecondLook Digital has marked any areas of concern that were not observed on the initial review. To
view the CAD marks prior to the initial unassisted review of the mammogram risks the so-called
satisfaction-of-search error, in which the radiologist's vigilance for other areas on the mammogram may
be lowered by virtue of seeing one or more areas highlighted by SecondLook Digital. The absence of a
CAD mark at a lesion initially detected without the assistance of SecondLook Digital should not be used
by the radiologist to override the decision to further evaluate the lesion.
SecondLook Digital is designed to mark areas with the mammographic appearance of cancer; however,
many of the marked areas will not contain a malignancy, and it is up to the radiologist to decide, using
conventional clinical judgment and reviewing the mammogram itself, if the area is suspicious enough to
warrant further work-up. SecondLook Digital is not a diagnostic device, as the CAD marks are intended
to be used to assist only in detection and not in interpretation. Therefore, SecondLook Digital can assist
a radiologist in detecting areas of concern that would have been missed without its use, but used
properly it cannot cause a radiologist to miss areas of concern that would have been detected without
SecondLook Digital.
SecondLook Digital was developed by leaders in the fields of image processing and artificial intelligence.
Below is a description of how SecondLook Digital's Computer-Aided Detection (CAD) works.
1. The GEMS Senographe full-field digital mammograms are processed by the system. Image
processing is used to identify all the potential cancerous locations in the image.
2. These locations are analyzed using radiologic and proprietary measures as well as a feature
selection process to determine the most likely locations to be cancer.
3. The most likely locations are evaluated in the context of the patient, and highlighted with CAD marks
displayed overlying the mammograms on the review workstation used by the radiologist for softcopy
reading.
It is important to remember that SecondLook Digital will not necessarily mark what a radiologist would
work-up. This is an important consideration as every radiologist works-up different areas based on her
or his own criteria.
SecondLook Digital does not function on its own, but always with a radiologist. Therefore, if SecondLook
Digital highlights a mass or microcalcifications in one view only, the radiologist can look for it in the other
view to determine if there is a lesion that warrants work-up.
CAD.fm
Senographe SecondLook Digital CAD System
Page no. 25
Operator Manual 5189820-5-C-1EN