Trial Information

Clinical Image Evaluation Study for Philips MammoDiagnost DR Full Field Digital Mammography System (FFDM)

The proposed research study is a prospective enriched reader trial in which patients who
meet the study's eligibility criteria, subject to certain constraints specified in this
protocol, will undergo both SF and the investigational Philips FFDM mammography. Two to five
sites will participate as image acquisition centers. Images will be read by 9 mammographers
reading the SF and Philips FFDM acquired images at various locations under the supervision
of study managers.

Per the new FDA Guidance document for FFDM (Class II Special Controls Guidance Document:
Full-Field Digital Mammography System), there is no longer a requirement for screen film
images for a comparison and a reader study to determine accuracy is not required. 10 images
acquired under protocols 2008-002a, 2010-002a and a European site will be read in a MQSA
type study. This record has been modified to support the new FDA Guidance document.

The reviewers will evaluate the cases, using soft copy and hard copy images, noting the
mammographic attributes for each case and documenting the findings on a clinical image
evaluation form, which is very similar to what is used for MQSA Accreditation.

The following attributes will be assessed: in order to provide an overall assessment of
whether these image sets collectively are of sufficient acceptable quality for mammography:

- Breast positioning, assessing coverage of the breast on craniocaudal(CC) and
medio-lateral oblique (MLO) views, separately;

- Exposure, assessing visualization of the adipose and fibroglandular tissues and
visualization of breast tissue underlying the pectoralis muscle, separately;

- Breast compression, assessing overlapping breast structures, uniformity of exposure of
fibroglandular tissues, adequacy of penetration of thicker portions of the breast,
exposure of thinner areas, and motion unsharpness;

- Image contrast for differentiation of subtle tissue density differences;

- Sharpness, assessing the edges of fine linear structures and tissues;

- Borders and benign calcifications;

- Tissue visibility at the skin line;

- Noise, i.e., noise obscuring breast structures or suggestive of structures not actually
present;

- Artifacts due to image processing, detector failure and other factors external to the
breast on hard-copy and soft-copy displays; and

- Overall clinical image quality