What happened
Wuhan EndoAngel Medical Technology built EA PC-LGI, software that uses deep learning to mark suspected polyps on a separate monitor during colonoscopy. It also recognizes the cecum and times the withdrawal of the scope. 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 parallel-controlled trial at three institutions in China. Patients had colonoscopy with or without the software, and experts reviewed the recorded videos to set the reference. Polyp-level sensitivity was 84.97% with the software and 72.07% without it, and specificity was non-inferior. CMDE wrote that “医生在本产品辅助下能够一定程度上提高息肉检出率” (with the product's help, doctors can raise the polyp detection rate to a certain extent). On 20 April 2023, it judged that benefits outweigh risks and recommended approval. NMPA announced the approval on 12 May 2023 and wrote that the product helps by “reducing missed detections”. A paper on the trial, which EndoAngel funded, reports that 1,293 patients took part at centers in Shanghai, Beijing and Wuhan in 2021.
Sources
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Peer-reviewed study, by an evaluator that the makers or users commissioned.
Zhang H, Wu Q, Sun J, Wang J, Zhou L, Cai W, Zou D. A computer-aided system improves the performance of endoscopists in detecting colorectal polyps: a multi-center, randomized controlled trial. Frontiers in Medicine 10:1341259, 24 January 2024. doi:10.3389/fmed.2023.1341259. A sponsor-initiated study funded by Wuhan ENDOANGEL Medical Technology.
The sensitivity of the endoscopists in the two groups was 84.97% (95% Confidence Interval [CI], 82.76-87.17%) and 72.07% (95% CI, 69.43-74.71%), the difference in sensitivity between the two groups was 12.89% (95% CI, 9.46-16.33%)
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Regulatory document, by authors with no tie to the system.
医生在 AI 辅助下息肉检出敏感性(以息肉为单位)为 84.97%(95CI:82.76%,87.17%) ,优于医生独立检出敏感性 72.07%(95CI:69.43%,74.71%)
临床试验结果显示,医生在本产品辅助下能够一定程度上提高息肉检出率。
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Regulatory document, by authors with no tie to the system.
National Medical Products Administration (NMPA), China. Computer Aided Detection Software for Intestinal Polyps in Lower Gastrointestinal Endoscopy Approved for Marketing. NMPA English website, 12 May 2023.
Compared with similar products already marketed at home and abroad, this product uses deep learning technology, perceptual hash algorithm, and other technologies to assist doctors in operation control while identifying polyps, further ensuring the quality of proctoscopy, reducing missed detections, and improving the standardization of examination operations.
Details
AI system
- Reported configuration
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Release V1.0
- Workflow
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The software took video from the endoscope's image processor and marked suspected polyps with boxes on a separate monitor. Endoscopists at three centers performed colonoscopy with or without the software, and experts reviewed the recorded videos as the reference.
Follow-up
- Conditions for replication
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Patients are adults having colonoscopy in a medical institution. The endoscope and image processor are specified models 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
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Healthcare.
- Purpose
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Wuhan EndoAngel Medical Technology built EA PC-LGI to mark suspected polyps in real time during adult colonoscopy and to monitor the cecum, withdrawal time and withdrawal speed.
References
- Other identifiers
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Chictr: ChiCTR2100041988.
28 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, category mappings.
Cite this record
Peter H. Vartanian. (2026). EA PC-LGI helped endoscopists find more polyps in a Chinese trial (AIBD-1069). Artificial Intelligence Benefits Database, edition of 1 November 2026. https://petervartanian.xyz/aibd/records/AIBD-1069.html (archived at https://doi.org/10.7910/DVN/AADSII, version 7.0)