IB Lab LAMA
IB Lab GmbHIB Lab LAMA is a software tool that automatically analyzes full leg X-rays to measure discrepancies in limb length and assess knee alignment. It uses AI deep learning technology to provide precise geometric measurements to assist healthcare professionals in evaluating leg deformities and alignment issues, thereby supporting diagnosis and treatment planning.
Intended Use
IB Lab LAMA is a fully-automated radiological image processing software device intended to aid users in the measurement of limb-length discrepancy and quantitative knee alignment parameters on uni- and bilateral AP full leg radiographs of individuals at least 22 years of age. It should not be used in-lieu of full patient evaluation or solely relied upon to make or confirm a diagnosis. The software device is intended to be used by healthcare professionals trained in radiology. IB Lab LAMA is not indicated for use on radiographs on which Ankle Arthroplasties and/or Unicompartmental Knee Arthroplasties are present.
Technology
IB Lab LAMA uses deep learning technology with convolutional neural networks (CNNs) for classification, landmark detection, and segmentation on full leg X-ray images to compute precise geometric length and angle measurements. It operates software on OTS hardware supporting Linux and Docker environments. Measurements are presented in reports readable on cleared DICOM viewers.
Performance
Performance testing included product verification through unit, integration, and system testing, and a standalone clinical study comparing measurements by IB Lab LAMA to ground truth established by board-certified musculoskeletal radiologists. Data from 189 bilateral AP lower extremity radiographs (325 legs) showed strong agreement in length and angle measurements, with high sensitivity (95.05%) and specificity (99.8%) for arthroplasty detection and a failure rate of ~2.8%. Repeatability testing showed no differences between repeated runs, supporting accuracy and reliability.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
12/6/2022
6 months - 2
FDA Approval
6/16/2023
Other devices from IB Lab GmbH
- KOALA2019 • 510K
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