Fracture
Conditions
Keywords
fracture, artificial intelligence, x-rays radiographs
Brief summary
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).
Interventions
DEVICEDiagnosis of fracture on X-Ray Radiographs
Diagnosis of fracture on X-Ray Radiographs with and without the assistance of Boneview Software
Sponsors
Gleamer
Study design
Observational model
CASE_CONTROL
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* 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.
Exclusion criteria
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| measurement of diagnosis performances via calculation of sensitivity, specificity, NPV, PPV | 1 month | calculation of sensitivity, specificity, NPV, PPV and comparison between the two cohorts |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time needed for diagnosis via measurement of the time before submission of the diagnosis | 1 month | measurement of the time and comparison between the two cohorts |
Countries
United States
Outcome results
None listed