Yitu_AICare_Bone_Age met its bone-age error target in China's review

What happened

Hangzhou Yitu Healthcare Technology built Yitu_AICare_Bone_Age, software that locates ossification centers on hand and wrist X-rays with deep learning and calculates bone age by the TW3 method. China's Center for Medical Device Evaluation (CMDE) reviewed the company's application for Class III registration as a priority device. The trial was the maker's. It was prospective and enrolled 1,000 subjects at four clinical institutions. An expert panel's TW3-RUS and TW3-Carpal bone ages served as the gold standard. The report says that the software's mean absolute error against the panel reached the preset target. It gives no figures. CMDE judged that the product “能够有效提高医师阅片效率” (can effectively improve doctors' reading efficiency) when its clinical performance meets clinical needs. On 15 March 2021, it found that the benefits outweigh the risks and recommended registration. The trial did not time the reading. CMDE warns that accuracy may be lower for people aged 0.5 to 6 and 13 to 18, who were few in the trial. It adds that accuracy may be lower for ethnic minorities, because the algorithm work was mainly based on Han Chinese people.