BoneView BoneAge
- Reduces both inter- and intra-variability.
- Better estimates the Greulich and Pyle bone age than a general radiologist does.1
BoneView BoneAge function is a software intended to provide preliminary data to assist physicians in assessing the bone age, according to the Greulich and Pyle’s method, on children’s hand radiographs.
Anatomical areas of interest for Bone Age assessment:
- Left (and right) hand and wristHip: ≥ 10 years
Compatible radiographic view:
- Frontal
Age supported:
- ≥ 3 years old
- < 18 years old2
BoneView Output
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- CR / DX / DR Exams.
- A Body part algorithm will define which images can be processed.
- The result file provided by BoneView Bone Age is in an additional series in the original study. The result file is composed of a copy of the original image analyzed on which the bone age is assessed.
- Elements displayed on the result file:
- Chronological age (derived from DICOM tags).
- Sex of the patient (Male or Female, derived from DICOM tags).
- AI-based Greulich and Pyle Bone Age assessment: Bone age assessed based on the Greulich and Pyle method.
- Standard Deviation (SD): standard deviation based on the Brush Foundation study (Optional).
- 2 SD interval: defines a range of normal skeletal ages that would be expected to encompass the skeletal development of approximately 95% of patients at the patient’s chronological age and sex (Optional).
EU risk class and CE marking
BoneView has CE marking (CE 2797) and EU MDR class IIa.
Reimbursement status
None
Contraindications
- BoneView is not intended to be used for X-ray radiographs from the skull and cervical spine regions.
- BoneView is not intended to be used on other exam modalities than X-rays.
- BoneView is not intended to be used on lossy exams.
Target Population
- The intended patients are persons admitted to a hospital/health institution for X-rays examination: while patients don't directly interact with BoneView, the results from the X-ray radiograph they just underwent are processed via BoneView and will be used by the clinicians in their diagnosis.
Limitations
- BoneAge only provides preliminary data, the final diagnosis shall rely upon the physician’s expertise.
- BoneAge is intended for use as a concurrent reading aid during the interpretations of radiographs.
- Particular attention needs to be provided to the exam where:
- BoneView BoneAge has not received or analyzed all the images.
- BoneView BoneAge did not provide results on all the images.
- The results from BoneView BoneAge are different images from the original images.
- In the case of an update of the PACS or RIS solution, Gleamer shall be contacted to ensure the continued compatibility of BoneView BoneAge with the updated software.
1.
Nguyen T, Hermann AL, Ventre J, Ducarouge A, Pourchot A, Marty V, Regnard NE, Guermazi A. High performance for bone age estimation with an artificial intelligence solution. Diagn Interv Imaging. 2023 Jul-Aug;104(7-8):330-336. doi: 10.1016/j.diii.2023.04.003. Epub 2023 Apr 22. PMID: 37095034.
2.
Instructions for Use BoneView BoneAge, software version 2.5.x, dated 2024-04
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