TBS iNsight (V4)

TBS iNsight (V4) is software that analyzes DXA (dual energy X-ray absorptiometry) spine images to calculate a Trabecular Bone Score (TBS) reflecting bone microarchitecture quality. It provides bone health assessment complementary to BMD measurements and optionally estimates 10-year fracture risk using the WHO FRAX tool, validated for patients aged 40-90 years. The software is used by physicians, radiologists, and DXA technicians in medical facilities to aid osteoporosis diagnosis and monitor treatment effects.

The primary advancement is replacement of BMI-based tissue thickness estimation with direct measurement of tissue thickness from DXA images. System architecture evolved from standalone software to a two-component system with a TBS Agent (client) on each DXA device and centralized server managing results and DICOM-PACS communication. Data security was enhanced with encryption for data at rest and in transit, plus role-based access control, whereas the predicate had no encryption or access controls.

Not stated in this summary.

TBS iNsight V4 maintains identical core functionality to its predicate (computing TBS from DXA image texture and providing complementary DXA analysis) with the same indications for use, regulatory class (II), product code (KGI), and target populations. Validation studies demonstrate the direct tissue thickness measurement algorithm produces correlation coefficients exceeding 0.99 with the predicate on cadaver specimens, meets or exceeds ISCD precision standards in 132 in vivo participants across multiple DXA systems, and achieves statistical equivalence in fracture risk assessment across 17,000 individuals in 14 international cohorts. The architectural and security improvements do not alter the device's fundamental diagnostic functionality or performance.