18 April, 2024
News
Crescom scores medical device registration for automated knee osteoarthritis severity quantitative AI software
18 April, 2024
News
Crescom, a company that specializes in development of musculoskeletal-data-based AI (artificial intelligence) analysis solutions, has announced clearance of class II medical device manufacture registration by Korea MFDS (Ministry of Food and Drug Safety) on April 5th, 2024 of MediAI-OA, the automated KL (Kellgren-Lawrence)-grade-based knee arthritis severity quantitative analysis AI software. (License Number: 24-247)
MediAI-OA is Korea’s first AI solution of its kind that offers quantitative analysis results of the KL grade, the standards used around the world to verify knee arthritis severity; the probability of osteophyte formation; the degree of reduction in knee joint space compared to the normal group.
As Knee arthritis is the most common musculoskeletal disease among the middle-aged or elderly population that could lead to physical dysfunction such as severe walking difficulties, continuous care is required to ensure timely and accurate treatment.
Analysis of X-ray images by the naked eye is the conventional method in most countries to diagnose knee arthritis; however, clinical study results show that it entails diagnosis subjectivity and sharp deviation among medical specialists, which may cause difficulty in a consistent, objective quantitative evaluation of the degree of narrowing of knee joint space associated with damage on knee arthritis cartilage.
In response to requests to resolve such discrepancies in clinical practice and to develop a quantitative analysis solution as commissioned by Korea HIRA (Health Insurance Review and Assessment Service) and Korea Ministry of Science and ICT, Crescom has developed the patent-based AI technology which automatically calculates the JSN (joint space narrowing) ratio and displays the ratio compared to the normal group standards as a percentage, and this technology also provides the KL grade as a probability that reflects and integrates several major disease indicators.
The results of the clinical test for Korea MFDS's medical device approval confirmed that the KL grade accuracy significantly increased when referring to MediAI-OA as the average kappa value from the reference standard was 0.88 when four doctors determined the KL grade with assistance from MediAI-OA while the average kappa value from the reference standard was 0.57 when the same doctors decided on the KL grade without MediAI-OA.
In recognition of this technological prowess, Crescom was selected for the government project supported by Korea HIRA for development of a knee arthritis insurance benefit review assistance system, which resulted in MediAI-OA. Korea HIRA has adopted this AI solution to assess development of knee arthritis and to determine insurability.
“As MediAI-OA is a pioneering AI solution for automated knee arthritis analysis in South Korea, it has taken several years to complete the whole process of clinical trials and class II medical device manufacture approval, but I’m very delighted we have finally cleared the medical device registration for the solution. We will work harder to make a contribution to a healthy life of all ages with other AI solutions we offer, that have been already cleared for medical device registration, such as MediAI-BA, the bone age analysis solution and MediAI-FX, wrist fracture analysis solution.”, says Jae Joon Lee, CEO of Crescom.
