IR-CT-AO flagged aortic dissections in a prospective trial in China

In the maker's prospective trial of 485 subjects that China's CMDE reviewed, Infervision's IR-CT-AO flagged aortic dissection with 87.83% sensitivity and 97.64% specificity.

  • Not rated an organization

    The report does not say that the prompts guided care in the maker's pre-market trial.

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

Preset targets, with a three-physician expert panel's reading as the reference. Measured.

Without the system
Targets of 80% for sensitivity and for specificity
With it
87.83% sensitivity and 97.64% specificity
The system’s part
Not isolated. The trial measured the software's triage calls against an expert panel and set them against targets of 80%. It did not compare doctors' diagnoses or the timing of care with and without the software. The trial was the maker's own. The report says that the product uses deep learning.
Not yet checked
LimitsCosts and harmsLearns from dataLater outcome

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Benefit type
Improved Task Accuracy
System
IR-CT-AO (主动脉夹层CT造影图像辅助评估软件), models IR-CT-AO (A) and IR-CT-AO (B)
Made by
Infervision Medical Technology Co., Ltd. (推想医疗科技股份有限公司)
Used by
Infervision Medical Technology (prospective trial with 485 subjects)
Where
Trial centers 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
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：主动脉夹层CT造影图像辅助评估软件 (technical review report for the registration of aortic dissection CT angiography image assessment-aid software), acceptance no. CQZ2302385, applicant 推想医疗科技股份有限公司. 5 August 2024. Section 三、临床评价概述 (clinical evaluation).

    主动脉夹层分诊的灵敏度为 87.83%， 95%置信区间为[82.30%， 92.13%]， 下限高于目标值 80%
    综上，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 1.0.3.0)

Workflow

The software segmented and named the aorta on CT angiography with deep learning and flagged suspected aortic dissection. Three physicians with more than 10 years of cardiothoracic imaging experience read each case independently, and the majority view served as the reference.

Follow-up

Conditions for replication

Patients are adults with risk factors, pain or signs that suggest aortic dissection. CT angiography slices are 2 mm or thinner, as in the trial. Trained physicians use the prompt and do not base a clinical decision on it alone.

Entry details

Sector

Healthcare.

Purpose

Infervision Medical Technology built IR-CT-AO to flag suspected aortic dissection on CT angiography of adults so that trained physicians can triage and assess them.

30 more questions not yet checked

model, provider, role, configuration, inputs and outputs, autonomy, human oversight, AI contribution, 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). IR-CT-AO flagged aortic dissections in a prospective trial in China (AIBD-1087). Artificial Intelligence Benefits Database, edition of 1 November 2026. https://petervartanian.xyz/aibd/records/AIBD-1087.html (archived at https://doi.org/10.7910/DVN/AADSII, version 7.0)

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