BoneXpert is a medical software device running on a Windows PC.
BoneXpert is CE marked under the European Medical Device Directive 93/42/EEC and is placed on the EU market under the transitional provisions of Article 120 of the Medical Device Regulation (EU) 2017/745.
The intended use of BoneXpert is to perform autonomous bone age assessment according to the Greulich-Pyle and Tanner-Whitehouse 3 methods from digital paediatric hand radiographs. BoneXpert also assesses the cortical thickness of the metacarpals, expressed as the Bone Health Index (BHI), and estimates Percent Adult Height. The hand radiograph must be provided as a DICOM file.
BoneXpert is intended for patients up to 21 years of age and for use by healthcare professionals, for example in radiology, endocrinology and orthopaedics. BoneXpert results must not be used as the sole basis for diagnosis. Clinical decisions should always be made in conjunction with the patient’s full clinical and diagnostic context.
BoneXpert is licensed through an annual license fee based on an estimate of the number of annual analyses made.
The Instructions for Use are available in the Help menu of BoneXpert. A paper copy can be requested free of charge from .
Performance
| Range of application | Bone age range | Greulich-Pyle: 0-19 years for males and 0-18 years for females Tanner-Whitehouse 3: 2-16.5 years for males and 2-15 years for females |
| Patient age | Up to 21 years | |
| Ethnicities | Caucasian, African-American, Hispanic, and Asian | |
| Disorders | Healthy children, short stature (e.g. growth hormone deficiency, Turner syndrome, small for gestational age), precocious puberty | |
| Contraindication | Contraindicated for use in children with achondroplasia | |
| Bone Age | Bone age scales | Greulich-Pyle (GP), including carpal bone age for younger children, and Tanner-Whitehouse 3 (TW3) |
| Bone age precision, SD | 0.08 years (GP) and 0.17 years (TW3) when taking a new X-ray (validated for boys aged 4-14 years and girls aged 3-12 years) | |
| Bone age accuracy | 0.62 years (GP bone age relative to a single manual rater) 0.50 years (TW3 bone age relative to a single manual rater) 0.41 years (GP bone age relative to the average of infinitely many raters, model-based estimate) |
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| Large deviations | 1.7% of GP bone ages deviate by more than 1.5 years from the average of 3 raters (6.4% for manual raters) | |
| Bone age sensitivity to image quality | <0.20 years | |
| Images accepted for analysis | 99% (images without severe abnormal anatomy or excessive post-processing) | |
| Adult height | Percent Adult Height | Bayley-Pinneau tables or the BoneXpert adult height prediction model (2009) |
| Bone Health Index | BHI precision SD | 1.4% at age 10 years |
| BHI sensitivity to image quality (accuracy) | <5.5% (95% conf) |