EC01-01 helped endoscopists find more colon polyps in a trial

In the maker's trial that China's CMDE reviewed, endoscopists using EC01-01 detected 94.7% of polyps, against 84.5% without it.

  • Not rated an organization

    Detection was measured in the maker's pre-market trial, and the report gives no outcome of care for any patient.

Depth runs from 1, a convenience or time saved, to 5, a life or a livelihood preserved.

Status
Intended benefit.
Evidence

foundstudiedreportedclaimed

An independent regulatory document supports the benefit.

Compared with

Endoscopists performing conventional colonoscopy in the parallel control group, with two experts' video review as the reference. Measured.

Without the system
84.5% polyp-level sensitivity
With it
94.7% polyp-level sensitivity
The system’s part
The parallel-controlled trial compared endoscopists with and without the software against an expert reference, so the gain in sensitivity is attributed to the software. The trial was the maker's own. The report does not say whether patients were randomized. It says that the polyp detection module uses deep learning.
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Benefit type
Improved Task Accuracy
System
EC01-01 (肠息肉电子下消化道图像辅助检测软件)
Made by
Xiamen Yingnuo Medical Technology Co., Ltd. (厦门影诺医疗科技有限公司)
Used by
Xiamen Yingnuo Medical Technology (prospective parallel-controlled trial with 1,020 subjects at four sites)
Where
Four trial sites in China that the report does not name
Stage
In a pilot
Date
, when the source was published
Kind
Aggregate result
Broad benefit
Identifying Objects, Actions, and Events, Monitoring Processes, Materials, or Surroundings
Collections
Scrutiny and findings
Last revised
1 November 2026

Sources

  1. Regulatory document, by authors with no tie to the system.

    Center for Medical Device Evaluation (CMDE), National Medical Products Administration, China. 医疗器械产品注册技术审评报告：肠息肉电子下消化道图像辅助检测软件 (technical review report for the registration of colon polyp detection-aid software for electronic lower gastrointestinal images), acceptance no. CQZ2200605, applicant 厦门影诺医疗科技有限公司. 2 November 2023. Section 三、临床评价概述 (clinical evaluation).

    医生在 AI 辅助下息肉检出敏感性（以息肉为单位）为 94.7%，医生独立检出敏感性 84.5%，两组率差为 10.5%（95CI：7.7%，13.3%） ，P<0.001，试验组优于对照组成立
    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。

Details

AI system

Reported configuration

Release V1

Workflow

The software cropped the endoscope's field of view, ran a deep learning detector and drew a box around each suspected polyp. Endoscopists performed colonoscopy with the software's boxes as an aid.

Follow-up

Conditions for replication

Patients are adults having colorectal endoscopy. The specified endoscope models and image processors are used in white-light mode. Endoscopists judge each mark and do not base a clinical decision on the software alone.

Entry details

Sector

Healthcare.

Purpose

Xiamen Yingnuo Medical Technology built EC01-01 to identify and show the areas of suspected polyps in images from adult colorectal endoscopy.

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). EC01-01 helped endoscopists find more colon polyps in a trial (AIBD-1066). Artificial Intelligence Benefits Database, edition of 1 November 2026. https://petervartanian.xyz/aibd/records/AIBD-1066.html (archived at https://doi.org/10.7910/DVN/AADSII, version 7.0)

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