DC-OPGAI-01 helped dentists find more tooth decay on X-rays

In the maker's trial that China's CMDE reviewed, 12 dentists using DC-OPGAI-01 detected caries with a tooth-level sensitivity of 82.40%, against 67.43% without it.

  • Not rated an organization

    Dentists read stored radiographs in the maker's pre-market trial, and no patient's care depended on the software.

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

The same 12 dentists reading the same radiographs without the software. Measured.

Without the system
67.43% tooth-level sensitivity
With it
82.40% tooth-level sensitivity
The system’s part
Each dentist read every case with and without the software in a randomized crossover design, so the gain is attributed to the software. The trial was the maker's own. The report says that the product uses deep learning, and it does not state the reference standard.
Not yet checked
LimitsCosts and harmsLearns from dataLater outcome

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Benefit type
Improved Task Accuracy
System
DC-OPGAI-01 (龋病口腔曲面体层图像辅助检测软件)
Made by
Beijing Yuyi Ganlan Information Technology Co., Ltd. (北京羽医甘蓝信息技术有限公司)
Used by
Beijing Yuyi Ganlan Information Technology (retrospective reader trial with 12 dentists and 402 subjects at three sites)
Where
Three trial sites that the report does not name, for a registration in China
Stage
Tested in a laboratory
Date
, when the source was published
Kind
Aggregate result
Broad benefit
Identifying Objects, Actions, and Events
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：龋病口腔曲面体层图像辅助检测软件 (technical review report for the registration of dental caries panoramic radiograph detection-aid software), acceptance no. CQZ2400448, applicant 北京羽医甘蓝信息技术有限公司. 13 February 2025. Section 三、临床评价概述 (clinical evaluation).

    组间差值为 14.97%，95%置信区间为（7.28%，22.66%），下限优于优效界值 0，优效性假设成立
    经综合评价，认为该产品上市带来的受益大于风险，综合剩余风险可接受。

Details

AI system

Reported configuration

Release 1 (full version 1.0.0)

Workflow

The software analyzed panoramic radiographs with deep learning and marked the positions of teeth with suspected caries. Twelve dentists read 402 stored cases with and without the marks in a randomized crossover design.

Follow-up

Conditions for replication

Patients are adults aged 18 or over. Trained dental clinicians make the diagnosis and do not base a clinical decision on the software alone.

Entry details

Sector

Healthcare.

Purpose

Beijing Yuyi Ganlan Information Technology built DC-OPGAI-01 to identify teeth with suspected caries on panoramic radiographs of adults.

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). DC-OPGAI-01 helped dentists find more tooth decay on X-rays (AIBD-0962). Artificial Intelligence Benefits Database, edition of 1 November 2026. https://petervartanian.xyz/aibd/records/AIBD-0962.html (archived at https://doi.org/10.7910/DVN/AADSII, version 7.0)

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