Clinical Trial Assessment Principles of National Class III Medical Devices in China.

Yue Min, Jin-Tao Gao, Jing Wu, Bao Zhai, Dan Han, Bin Liu

Abstract read

In one paragraph

Article in Orthopaedic surgery, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper, 1 of them a synthesis that pooled it.

0numbers the graph read from it

0cells of the map it votes in

1citing papers in PubMed, 1 pooled it

–field-weighted citation impact

1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

1 citing paper in PubMed, 1 synthesis or guideline pooled it.

Methodologies for generating and evaluating clinical and performance evidence for high-risk and innovative medical devices andFrontiers in medical technology · 2026
Pooled it

4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

6 authors.

Yue MinCenter for Medical Device Evaluation, Center for Medical Device Evaluation NMPA, Beijing, China.

Jin-Tao GaoCenter for Medical Device Evaluation, Center for Medical Device Evaluation NMPA, Beijing, China.

Jing WuCenter for Medical Device Evaluation, Center for Medical Device Evaluation NMPA, Beijing, China.

Bao ZhaiCenter for Medical Device Evaluation, Center for Medical Device Evaluation NMPA, Beijing, China.

Dan HanCenter for Medical Device Evaluation, Center for Medical Device Evaluation NMPA, Beijing, China.

Bin LiuCenter for Medical Device Evaluation, Center for Medical Device Evaluation NMPA, Beijing, China.

Funding

Ministry of Science and Technology of the People's Republic of China 2018YFC1106700

6 · The paper itself

Abstract

Class III medical devices are defined as those which are implanted inside the human body and applied to maintain normal life and retain original tissue or organic functions. Because these devices are associated with high risk, their effectiveness and safety should be strictly monitored and clinically investigated. The aim of clinical investigation of these medical devices is to ensure the acceptability of their effectiveness and safety levels. On designing the clinical trial, the investigator should determine the indices to assess the effectiveness and safety of medical devices, select reasonable data-analyzing methods, and pay attention to several other issues. Although some guidelines on specific class III medical devices have illustrated those aspects in detail, there is still no comprehensive report that details all those principles and methodologies. This article aims to summarize the common features among the instruction principles and provide technological support for the clinical study of class III medical devices.

Indexed as

Clinical Trials as TopicEquipment SafetyResearch DesignChinaEquipment and SuppliesHumansAssessment indicesClass III medical deviceClinical trialData analysis

Identifiers

PMID31490619

DOI10.1111/os.12498

PMCPMC6819180

What OpenQuestion holds

Textmetadata

LicenceCC BY

Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.