Clinical Validation of Boneview for FDA Submission

Gleamer

Status: Completed

Conditions: Fracture

Treatments: Device: Diagnosis of fracture on X-Ray Radiographs

Study type: Observational

Funder types: Industry

Identifiers

NCT04532580

BCK-CEP

Details and patient eligibility

About

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).

Enrollment: 480 patients

Sex: All

Ages: 21+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

480 participants in 2 patient groups

AI- Aided performances

Treatment:

Device: Diagnosis of fracture on X-Ray Radiographs

AI- Unaided performances

Treatment:

Device: Diagnosis of fracture on X-Ray Radiographs