KOALA
IB Lab GmbHKOALA is an automated software that helps medical professionals analyze knee X-rays by measuring joint space width and identifying radiographic signs of osteoarthritis. It assists clinicians in evaluating knee health and aids diagnosis, improving efficiency and accuracy in managing osteoarthritis cases.
Intended Use
KOALA is a fully-automated image processing software device of computed or direct digital knee X-ray images intended to aid medical professionals in measuring joint space width and assessing radiographic features of knee osteoarthritis, including sclerosis, joint space narrowing, and osteophytes based on OARSI criteria. It is not to be used in lieu of full patient evaluation or diagnosis on its own.
Technology
KOALA uses computer vision and machine learning algorithms trained on knee radiographs to provide high accuracy detection and measurement of osteoarthritis symptoms. It accepts DICOM-compliant computed or direct digital knee X-ray inputs, runs on a Linux server environment using Docker, and outputs measurements and grading summaries for clinical review.
Performance
Software verification and validation demonstrated correct function. Clinical validation was performed on 6597 knee radiographs from 1149 individuals with ground truth established by expert adjudication. KOALA showed high sensitivity and specificity for detecting radiographic features of osteoarthritis and accurate joint space width measurements with strong agreement against reference standards.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
8/5/2019
3 months - 2
FDA Approval
11/5/2019
Other devices from IB Lab GmbH
- IB Lab LAMA2023 • 510K
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