What happened
Tencent Healthcare (Shenzhen) built MY-CJ-01, software that uses deep learning to mark suspected polyps in real time during colonoscopy. The Center for Medical Device Evaluation (CMDE) of China's National Medical Products Administration reviewed the company's application for Class III registration. The trial was the maker's own, a prospective randomized superiority trial at two centers that enrolled 296 patients and analyzed 265. CMDE reports that group B outperformed group A on first-pass polyp detection, with a lower 95% confidence bound of 13.67% for the difference. The polyp miss rate was 44.67% in group A and 23.39% in group B. The report does not say how each group used the software. Group B presumably used it in the first examination, since CMDE counted its advantage as the product's superiority. The polyp detection rate was 62.50% in group A and 63.57% in group B, and withdrawal took slightly longer with the software. On 18 May 2023, CMDE judged that “该产品的上市为适用人群带来的受益大于风险” (marketing the product brings its intended patients more benefit than risk). It recommended approval, which NMPA announced on 1 June 2023.
Sources
-
Regulatory document, by authors with no tie to the system.
A 组息肉漏检率为 44.67% (95%CI:39.07%~50.42%),B 组息肉漏检率为23.39% (95%CI:18.92%~28.54%)
根据申请人提供的申报资料,经综合评价,在目前认知水平上,认为该产品的上市为适用人群带来的受益大于风险。
-
Regulatory document, by authors with no tie to the system. Context or contrary evidence.
National Medical Products Administration (NMPA), China. Computer-aided Detection Software for Electronic Endoscope for Colon Polyps Approved for Marketing. NMPA English website, 1 June 2023.
Recently, the innovative product computer-aided detection software for electronic endoscope for colon polyps of Tencent Healthcare (Shenzhen) Co., Ltd. is approved by China NMPA.
Details
AI system
- Reported configuration
-
Release V2 (full version V2.0.0_build001)
- Workflow
-
The software took the video stream from the endoscope's image processor and marked suspected polyps with a deep learning algorithm on a separate video client. Patients at two centers were randomized to two groups in a prospective superiority trial.
Follow-up
- Conditions for replication
-
Patients are adults having colonoscopy in a medical institution. The endoscope is a specified model used in white light mode. Endoscopists judge polyps from the images and the patient's condition and do not decide on the marks alone.
Entry details
- Sector
-
Healthcare.
- Purpose
-
Tencent Healthcare (Shenzhen) built MY-CJ-01 to mark suspected polyps in real time in the video of adult colonoscopies for endoscopists.
29 more questions not yet checked
model, provider, role, configuration, inputs and outputs, autonomy, human oversight, beneficiaries, reach, distribution and access, duration, every measurement question, every money question, ownership and control, dependencies, cross-border connections, geopolitical implications, replication attempts, availability, institutional decision, grounds, action and result, success criterion, every evidence question, observed or intended, alternative assessments, related entries, other identifiers, category mappings.
Cite this record
Peter H. Vartanian. (2026). MY-CJ-01 raised first-pass polyp detection in Tencent's trial (AIBD-1068). Artificial Intelligence Benefits Database, edition of 1 November 2026. https://petervartanian.xyz/aibd/records/AIBD-1068.html (archived at https://doi.org/10.7910/DVN/AADSII, version 7.0)