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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.

IB Lab LAMA uses deep learning technology to provide precise fully-automated geometric length and angle measurements of the lower limb on full leg X-ray images. The outputs aid healthcare professionals who are interested in the analysis of leg-length discrepancy and knee alignment in adult patients with suspected or present deformities of the lower extremities. IB Lab LAMA provides the following measurements: - mechanical axis deviation . - full leg length . - femur length ● - tibia length - leg length discrepancy ● - hip knee ankle angle - anatomical tibiofemoral angle - anatomical mechanical angle - joint-line convergence angle - mechanical lateral proximal femoral angle - mechanical lateral distal femoral angle - mechanical medial proximal tibia angle - mechanical lateral distal tibia angle ● The user does not interact directly with IB Lab LAMA except or reject the generated report findings via cleared third party medical viewers. The measurements are compared to fixed predetermined norm-ranges, based on standard state of the art clinical practices hard-coded into the software. Outputs are summarized in reports that can be viewed on any cleared medical DICOM viewer. IB Lab LAMA operates in a Linux environment and can be deployed on any operating system that supports the third-party software Docker. The integration environment has to support IB Lab LAMA data input and output requirements. The device does not interact with the patient directly, nor does it control any life-sustaining devices.

IB Lab KOALA is a radiological fully-automated image processing software computed (CR) or directly digital (DX) images intended to aid medical professionals in the measurement of minimum joint space width; the assessment of the presence or absence of sclerosis, joint space narrowing, and osteophytes based OARSI criteria for these parameters; and, the presence or absence of radiographic knee OA based on Kellgren & Lawrence Grading of standing, fixed-flexion radiographs of the knee. It should not be used in-lieu of full patient evaluation or solely relied upon to make or confirm a diagnosis. The system is to be used by trained professionals including, but not limited to, radiologists, orthopedics, physicians and medical technicians.

The Knee OsteoArthritis Labeling Assistant (KOALA) software provides metric measurements of the ioint space width and indicators for presence of radiographic features of osteoarthritis (OA) on posterior-anterior-posterior (PA/AP) knee X-ray images. The outputs aid clinical professionals who are interested in the analysis of knee OA in adult patients, either suffering from knee OA or having an elevated risk of developing the disease. Outputs are summarized in a KOALA report that can be viewed on any FDA approved DICOM viewer workstation. KOALA operates in a Linux environment and can be deployed to be compatible with any operating system supporting the third-party software Docker. The integration environment has to support KOALA data input and output requirements. The device does not interact with the patient directly, nor does it control any life-sustaining devices.