What is 3D-SHAPER® ?
3D-SHAPER® software introduction
3D-SHAPER® is a stand-alone medical software intended to assist healthcare professionals in the diagnosis and monitoring of bone disorders, in the assessment of fracture risk and in the establishment of a treatment plan.
3D-SHAPER® incorporates model-based algorithms to compute a 3D map of the cortical and trabecular compartments from a standard hip DXA scan, to measure and monitor bone thickness and density.
3D-SHAPER® works automatically and allows physicians to benefit from the 3D mapping and analysis of patients’ cortical and trabecular bone, in clinical routine as well as retrospectively. It does not require additional radiation to the patient.
3D-SHAPER® is considered as a class IIa medical device in compliance with the European Directive 93/42/EEC. Wherever registration towards local authority is not completed, 3D-SHAPER® should solely be used for investigational use.
3D-SHAPER® is indicated for the diagnosis and monitoring of bone health, bone disorders such as primary or secondary osteoporosis and for the monitoring of treatment effects.
3D-SHAPER® is intended to be used exclusively by healthcare professionals, properly trained by the manufacturer or by the manufacturer qualified partners.
Technical specifications
Independent & automated computing unit
3D-SHAPER® is loaded on a dedicated computing unit (small box: 10x10x4cm) that ensures stable, smooth and automatic image processing independently from the DXA scanner/associated computer workflow.
3D-SHAPER® Computing unit can be connected to a medical center network to ensure remote connectivity to the software interface and patients’ 3D analysis. With network connectivity, healthcare professionals who are eligible to access 3D-SHAPER® can do so remotely, from any other computer that is logged onto the network. If the DXA scanner is not connected to a network, 3D-SHAPER® computing unit can then also be connected locally.
Galgo Medical SL
Certified by BSI to ISO 13485:2012 under certificate number MD 656038.
3D -SHAPER®
Computer Workflow
DXA scanner
DXA workstation
Medical center network
3D -SHAPER® device
Report
Compatible DXA scanners
The majority of DXA scanners currently in use are compatible with 3D-SHAPER®
Compatible DXA scans
3D-SHAPER® software allows physicians to perform 3D analysis of the hip from standard anteroposterior hip DXA scans acquired with compatible DXA scanners. Operators should follow recommendations provided by their DXA scanner and related software manufacturer – after a successfully passed daily quality control, to perform and analyze the hip DXA scan.
The 3D analysis can then be performed using 3D-SHAPER®.
Features
3D-SHAPER®
3D-SHAPER® automatic detection module ensures fluid workflow as every new hip DXA scan is automatically detected.
3D-SHAPER® retrospective analysis module ensures easy and fast research and location of scans to load them and perform the 3D analysis. The analysis of several scans can be launched simultaneously.
Automatic 3D analysis: the 3D registration model onto the patient DXA scan is made automatically so there is no need for specific selection of region of interest or points positioning to generate the patient-specific 3D mapping of the hip. Segmentation of cortical and trabecular compartments is also performed automatically and simultaneously. Measurements of density and thickness are computed and instantly displayed on normative curves.
3D visualizations and slices: it is possible to visualize the entire 3D model and inner slices on the bone by using the mouse and computer orientation pad. Grey level scale can be adjusted as well to visualize the trabecular compartment into each bone view of the cortex.
Follow-up 3D analysis: once a patient has been scanned several times, a monitoring 3D analysis is computed. Changes that are significant are highlighted by a specific color mapping on the 3D hip visualization to identify changes that occurred on the bone, ie. Increase or decrease of the density and thickness. The points are also positioned on each reference curve to verify quantitative changes at the cortical and trabecular compartments.
Automatic report generation: once the 3D analysis is performed, a report is generated and can be exported in pdf. Comments can be added directly from 3D-SHAPER® interface and the report header can be personalized with the medical center details. In case of follow-up examination, both daily analysis and follow-up analysis are displayed on the report (with 3D visualizations of the hip and reference curves with 3D measurements).
Network connectivity: 3D-SHAPER® computed unit can be connected to a medical center network to allow remote access from any computer logged onto the network. All automations are maintained and this allows physicians to obtain their patients’ 3D analysis from their office or from their laptop if travelling or working outside the medical center, as long as such laptop is logged onto the network.
3D Analysis Workflow
3D Analysis
3D Monitoring Analysis
3D analysis workflow is computed automatically and does not require any human intervention apart from a visual check of the mask positioning, to ensure the analysis is valid.
Let’s review the different steps computed by 3D-SHAPER in order to gain a deeper understanding of the image post-processing and measurements calculation.
3D analysis workflow consists in the following steps:
1. The loading of the data (labelled “IMPORT”),
2. The proximal femur mask creation (labelled “MASK”),
3. The statistical model registration (labelled “REGISTRATION”),
4. The clinical measurements calculation (labelled “ANALYSIS”),
5. The comparison of current and previous clinical parameters (labelled “FOLLOW-UP”).
1. Import
This step consists in the loading of the 2D image of the hip, that is, when selected from “study storage” folder, displayed in 3D-SHAPER main interface.
Example initial view after loading the input DXA image.
2. Mask
This step consists in the creation of the proximal femur mask that will be used for the 3D registration process. At this step, the patient-specific 3D model is not yet computed, but this step is critical for the proper execution of the registration, as it will define the proper region of interest used to project and register the model.
Example proximal femur mask with highlighted key points.
The mask is characterized by three key points – landmarks – that are positioned automatically by 3D-SHAPER®:
- Lower pelvis-femur intersection (P): it is the intersection point between the distal and medial contour of the femur.
- Upper pelvis-femur intersection (Q): it is the intersection point between distal contour of the pelvis and the distal contour of the femur.
- Femoral neck basis under the lesser trochanter (S): it is the point on the medial contour of the femur where the lesser trochanter ends.
Mask Visual Check:
In rare cases or in case of artefacts, the positioning of the landmarks may be altered directly impacting the quality of the mask. Tools are available in 3D-SHAPER® to manually adjust landmarks positioning and to edit the mask.
3D-SHAPER® users do not need to verify the workflow by entering each step window. Only a visual check shall be done once the 3D analysis is performed and report generated. To this purpose, a copy of the registered mask is added directly in the examination report. This allows physicians to visually verify the proper mask creation. In case of abnormality observed during the visual check, operators or physicians using 3D-SHAPER® would need to enter the workflow step, to correct it and re-launch the 3D analysis.
Please refer to the complete user manual for further explanation on how to adjust landmarks positioning and mask.
3. Registration
This step consists in the registration of the statistical model (see 3D-DXA Technology website to learn more) onto the patient hip DXA scan, using the mask previously defined.
At this step, the patient-specific 3D model is created and the cortex is analyzed.
At this step, the patient-specific 3D model is created and the cortex is analyzed.
3D reconstruction resulting proximal femur simulated projection.
Note: This projected image is the one printed automatically on each 3D analysis report, that should be visually checked by physicians to ensure proper workflow execution and validity of the 3D analysis. The blur mask should be as on the illustration.
4. Analysis
This step consists in the calculation of the 3D measurements of:
- Cortical surface bone mineral density (cortical sBMD), expressed in mg/cm2: this represents the multiplication of the cortical volumetric bone mineral density by the cortical thickness.
- Trabecular volumetric bone mineral density (trabecular vBMD), expressed in mg/cm3.
- Integral volumetric bone mineral density (integral vBMD), expressed in mg/cm3: this represents the sum of the cortical and trabecular compartments.
Each measurement is positioned automatically on dedicated reference curves (women from 40 to 90, Spanish Caucasian data). Values, T-scores (comparison to the young population, expressed in standard deviation (SD)) and Z-scores (comparison to the same age population, expressed in standard deviation (SD)) are indicated on each graph.
Proximal femur cortical thickness and clinical parameters.
5. Follow-up
This step consists in comparing the 3D analysis to previous ones. A specific color-coding highlights changes, that are significant (higher than least significant change (LSC), in %) compared to baseline analysis. Measurements at each time point are also plotted on the reference curves. Changes higher than the LSC are indicated with a “*” in the measurements table.
Proximal femur follow-up.
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