IB Lab KOALA

ImageBiopsy Lab
Knee Osteoarthritis Labeling Assistant. Osteoarthritis is a paralyzing joint disease that can lead to joint replacement. Early detection as well as therapy can prevent unnecessary surgeries. Image Biopsy's lab module KOALA detects signs of knee osteoarthritis based on standard joint parameters and OARSI criteria of standing radiographs of the knee.
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Information source: Vendor
Last updated: December 1, 2023

General Information

General
Product name IB Lab KOALA
Company ImageBiopsy Lab
Subspeciality MSK
Modality X-ray
Disease targeted Knee osteoarthritis (OA)
Key-features Osteoarthritis detection, Kellgren & Lawrence classification, OARSI classification
Suggested use Before: stratifying reading process (non, single, double read), Without interference of a radiologist: AI-only diagnosis

Technical Specifications

Data characteristics
Population Any adult knee with suspician of knee osteoarthritis.
Input Standing, fixed-flexion AP radiographs of the knee
Input format DICOM
Output overlay, visual output report, text report in RIS (RIS-templates can be pre-defined)
Output format DICOM Secondary Capture, pdf, structured report
Technology
Integration Integration in standard reading environment (PACS), Integration RIS (Radiological Information System), Integration CIS (Clinical Information System), Integration via AI marketplace or distribution platform, Stand-alone third party application, Stand-alone webbased
Deployment Locally on dedicated hardware, Locally virtualized (virtual machine, docker), Cloud-based, Hybrid solution
Trigger for analysis Automatically, right after the image acquisition, On demand, triggered by a user through e.g. a button click, image upload, etc.
Processing time 10 - 60 seconds

Regulatory

Certification
CE
Certified, Class I , MDD
FDA 510(k) cleared , Class II
Intended Use Statements
Intended use (according to CE) IB Lab KOALA uses deep learning technology for detecting radiographic signs of knee osteoarthritis and augments the reporting workflow. The system is to be used by trained medical professionals including, but not limited to, orthopedists and radiologists. It should not be used in-lieu of full patient evaluation or solely relied upon to make or confirm a diagnosis.

Market

Market presence
On market since 08-2019
Distribution channels Nuance PIN, Eureka Clinical AI, Ambra Health, Philips Intellispace, syngo.via, Incepto, CARPL.ai, Osimis
Countries present (clinical, non-research use) 10
Paying clinical customers (institutes) 45
Research/test users (institutes) 5
Pricing
Pricing model Pay-per-use, Subscription
Based on Number of analyses

Evidence

Evidence
Peer reviewed papers on performance

  • Artificial-Intelligence-Aided Radiographic Diagnostic of Knee Osteoarthritis Leads to a Higher Association of Clinical Findings with Diagnostic Ratings (read)

  • Automated Knee Osteoarthritis Assessment Increases Physicians’ Agreement Rate and Accuracy: Data from the Osteoarthritis Initiative (read)

  • Artificial intelligence-based computer-aided system for knee osteoarthritis assessment increases experienced orthopaedic surgeons' agreement rate and accuracy (read)
Non-peer reviewed papers on performance
Other relevant papers

  • Association of AI-determined Kellgren–Lawrence grade with medial meniscus extrusion and cartilage thickness by AI-based 3D MRI analysis in early knee osteoarthritis (read)

  • Artificial intelligence in osteoarthritis: repair by knee joint distraction shows association of pain, radiographic and immunological outcomes (read)