Clinical Validation of Boneview for FDA Submission
The goal of this clinical validation is to assess comparative performances of physicians with and without the assistance of BoneView for the diagnosis of fractures on radiographs. The performances are evaluated in terms of accuracy (primary endpoint with the pair specificity/sensitivity and the secondary endpoint PPV/NPV) and in terms of time needed for diagnosis (secondary endpoint with the measurement of time on each case).
- Eligible Ages
- Over 21 Years
- Eligible Genders
- Accepts Healthy Volunteers
- Anonymized standard X-ray exams of extremity/pelvis/rib cage/dorsolumbar spine not containing or containing fracture(s).
- Adult patient, with minimum age of 21 years old.
- Exams with one or more images including a body part not concerned by the intended use of BoneView (skull and cervical spine)
- Cases with one or more images being used for model design and development.
- Exams with one or more images being of poor quality (lossy), which prevent a proper interpretation by the readers.
- Cases not containing a medically relevant number of views for correct diagnosis.
- Study Type
- Observational Model
- Time Perspective
|AI- Aided performances||
|AI- Unaided performances||
Study ContactNor-Eddine Regnard, MD