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 BoneXpert is a software-only medical device running on a PC under Windows XP or Vista. 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: In USA, BoneXpert has the status of an investigational device, i.e. it is not for clinical use.
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
Performance
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Range of
application
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Bone age range
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2.5-17 years for boys and 2-15 years for girls (GP bone age ranges)
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Ethnicities
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Caucasian, African-American, Hispanic, and Asian in USA, Japan and China
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Disorders
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Healthy children, short stature (e.g. Turner and GHD), pubertes praecox, tall stature, CAH
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Bone age
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Bone age scales
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Greulich-Pyle (GP), Tanner-Whitehouse (TW2, TW3, TWJapan, TW-China), Fels, and a Chinese GP
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Bone age precision, SD
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0.00 years when rerating the same image
0.18 years or less when taking a new X-ray
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Bone age accuracy, SD
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0.72 years (GP bone age relative to typical manual rater)
0.65 years (TW3 bone age, relative to an excellent rater)
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Sensitivity to image quality
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<0.20 years (95% conf)
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Accuracy of adult height prediction, SD
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3.3 cm (healthy Caucasian boys aged 10-15 years)
2.7 cm (healthy Caucasian girls aged 8-13 years)
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Bone Health index
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BHI precision SD
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1.4% at age 10 years
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BHI sensitivity to image quality (accuracy)
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<2.5% (95% conf)
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