BoneXpert is a software-only medical device running on a Windows PC. The software also exists as an integrated part of larger software systems.

BoneXpert conforms to the European Community Directive for Medical Devices EC 1993/42, as indicated by the CE mark.

Caution: Not approved for clinical use in USA.

The intended use of BoneXpert is to perform an automatic determination of bone age and bone health index (BHI), and to predict adult height from the bone age. The bone age determination can replace the conventional manual rating. The hand radiograph must be provided as a DICOM file.

BoneXpert is licensed through an annual license fee, based on an estimate of the number of analyses made per year. A free trial period is offered for the BoneXpert Server version; contact Visiana for more information, at .

Performance

Range of application Bone age range 0-19 years for boys and 0-18 years for girls (GP bone age ranges)
Ethnicities Caucasian, African-American, Hispanic, and Asian in USA and Japan
Disorders Healthy children, short stature (e.g. Turner and GHD), pubertes praecox, tall stature, CAH, SHOX, Klinefelter
Bone Age Bone age scales Greulich-Pyle (GP), Tanner-Whitehouse (TW2, TW3, TWJapan) and Fels
Bone age precision, SD 0.00 years when rerating the same image
0.16 years or less when taking a new X-ray
Bone age accuracy, SD 0.63 years (GP bone age relative to average manual rater)
0.59 years (TW3 bone age, relative to an excellent rater)
Bone age sensitivity to image quality  <0.20 years (95% conf)
Accuracy of adult height prediction, SD 3.3 cm (healthy Caucasian boys aged 10-15 years)
2.7 cm (healthy Caucasian girls aged 8-13 years)
Bone Health Index BHI precision SD 1.4% at age 10 years
BHI sensitivity to image quality (accuracy) <5.5% (95% conf)