Patient-Assisted Compression in 3D - Impact on Image Quality and Workflow

The study population will consist of adult asymptomatic women presenting for screening 2D
mammography. One breast of each subject will be identified as the "breast of interest," which
will undergo study-specific 3D imaging consisting of two-view (craniocaudal and mediolateral
oblique) PA compression and image acquisition, followed by two-view technologist-controlled
(TC) compression and image acquisition. The breast of interest will be randomly assigned to
either the first breast imaged during the exam or the second breast imaged. TC compression
and imaging, and procedures performed on the subject's other breast will be conducted per
standard of care.

Following image acquisition, 3D image quality evaluation will be conducted by Mammography
Quality Standards Act-qualified readers. Prior to the reading session, images will be
de-identified and the following information will be removed from the DICOM header to blind
readers to the compression mode used during acquisition: time stamp, compression force, and
breast thickness. The image sets will also be randomized for presentation during the image
attribute reviews. Two (2) readers will evaluate each PAC and TC compression image set
collected from each subject's breast of interest and assess the acceptability of image
attributes, as defined in the Guidance for Industry and FDA Staff - Class II Special Controls
Guidance Document: Full-Field Digital Mammography System (2012). A third reader will provide
adjudication, if there is disagreement for a given image set's overall clinical image
quality.

Workflow data, including the incidence of technologist intervention during acquisition and
need for repeat image acquisition, will also be collected.

The proportion of PAC image sets that are of equal or higher acceptability than TC image sets
will be calculated. A 95% confidence interval will be calculated using asymptotic method with
continuity correction. The proportion of image sets indicated for repeated image acquisition
when using PA mode or TC mode will be summarized. Other endpoint data will be summarized
using descriptive statistics. No statistical hypothesis is being tested in this study.

Inclusion Criteria:

1. Are women aged 40 years or older;

2. Are asymptomatic and scheduled for screening mammography;

3. Have left and right breasts;

4. Have breast sizes compatible with the dimensions of a 24 x 31 cm image detector,
without anatomical cut-off;

5. Are documented as non-pregnant based on the investigator's medical judgment and in
consideration of local clinical practice standards for evidence of non-pregnancy;

6. Are able and willing to comply with study procedures; and

7. Are able and willing to provide written informed consent to participate.

Exclusion Criteria:

1. Are women aged 40 years or older;

2. Are asymptomatic and scheduled for screening mammography;

3. Have left and right breasts;

4. Have breast sizes compatible with the dimensions of a 24 x 31 cm image detector,
without anatomical cut-off;

5. Are documented as non-pregnant based on the investigator's medical judgment and in
consideration of local clinical practice standards for evidence of non-pregnancy;

6. Are able and willing to comply with study procedures; and

7. Are able and willing to provide written informed consent to participate.