TBS iNsight (V4)
Medimaps Group SATBS iNsight (V4) is a software tool that processes bone density images from DXA scans to calculate a Trabecular Bone Score (TBS). This score helps clinicians assess bone quality and fracture risk, complementing standard bone density measurements. The software improves the accuracy of evaluating osteoporosis and bone health, aiding in diagnosis and treatment monitoring.
Intended Use
TBS iNsight is a software provided for use as a complement to both DXA analysis and clinical examination. It computes the antero-posterior spine DXA examination file and calculates a score (Trabecular Bone Score - TBS) related to bone microarchitecture. The software aids in the diagnosis of osteoporosis and fracture risk assessment and includes optional 10-year fracture risk estimation based on FRAX adjusted by TBS.
Technology
TBS iNsight analyzes DXA spine images and computes the Trabecular Bone Score using an adapted experimental variogram method (a modified fractal-like algorithm) on the image texture. Version 4 replaces BMI-based thickness estimation with direct tissue thickness measurements from DXA scans, enhancing accuracy. The software includes a client-server architecture with encrypted communication for integration with PACS and clinical workflows.
Performance
Performance testing included software verification and validation, cybersecurity assessments, and clinical association studies validating strong correlation between TBS outputs and bone microarchitecture parameters from microCT. The software shows high reproducibility and precision across multiple DXA systems and populations. Clinical data demonstrate equivalence to predicate software in fracture risk prediction and treatment monitoring utility.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
10/4/2024
3 months - 2
FDA Approval
1/17/2025
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