Prior to clinical application, reliability of percutaneous ventricular assist devices(pVAD) requires to be tested systematically. Currently, there's a lack of dedicated reliability testing equipment and methodologies for pVAD. Considering the structural and functional aspects of percutaneous ventricular assist devices, this study conducts research on pVAD reliability test engineering. Test setups, clinical conditions, failure modes, effects analysis, and evaluation models have been investigated. A highly feasible methodological approach for percutaneous ventricular assist device reliability assessment has been formed. This study offers valuable insights into standardizing their reliability evaluation in clinical settings.

目的:以临床准入和应用评估衔接为导向,研究用于人工智能医疗器械确认测试的第三方数据库即人工智能医疗器械测评数据库评估方法.方法:根据人工智能医疗器械产品安全有效评价方法、测评数据库的数据分布特性和产品确认方法,结合产品测评方式和测评环境进行分析.结果:给出测评数据库基本要素,数据库建设、更新、维护的通用要求和权威性、科学性、规范性、多样性、封闭性、动态性等专用要求.结论:人工智能医疗器械测评数据库需符合数据库建设的通用要求以及权威性、科学性、规范性、多样性、封闭性、动态性等专用要求.

人工智能医疗器械安全有效性评价是当前国际医疗器械监管领域的研究热点之一,开展国际监管比较分析有助于完善我国人工智能医疗器械监管要求,明晰发展方向.基于全球主要医疗器械监管机构和国际协调组织近年来发布的人工智能医疗器械文件,比较分析了中外监管要求.我国对于人工智能医疗器械的监管已取得阶段性成果,在上市前评价、变更控制、信息透明、生存周期质控、真实世界监测、新技术评价等方面与国际先进水平基本相当,在重点产品评价方面处于领先水平.今后还需进一步加强人工智能新技术、持续学习、真实世界性能、可解释性等监管科学研究,推进法规制订修订、指导原则体系构建、创新平台合作、国际监管协调等工作.

We describe a multicenter study using the European Spine Phantom (ESP) to compare the accuracy, linearity and precision of QCT measurements of spine vBMD between different brands of scanner, different models of the same brand and identical units of the same model. Ten scans of the same ESP with repositioning were performed on forty CT scanners from five manufacturers in different hospitals across China, all calibrated with the Mindways QCT system. The three ESP vertebral bodies simulating low (L1), medium (L2) and high (L3) vBMD and their average (L1-3 vBMD) were compared with phantom values. Linearity was assessed using the standard error of the estimate derived from linear regression. Precision errors were expressed as the standard deviation of the ten measurements on each scanner. Median (IQR) vBMD over all forty CT scanners compared with phantom values were: L1: 52.2 (49.9−56.4) vs 51.0; L2: 104.4 (101.2−108.6) vs 102.2; L3: 201.4 (195.0−204.9) vs 200.4; L1-3: 119.3 (116.6−123.2) vs 117.9 mg/cm3. Statistically significant differences in L1-3 vBMD were found between different brands (p= 0.005) and between different models of the same brand and identical units of the same model (both p< 0.001). Cross-calibration using linear regression gave a good fit for all forty systems with a median standard error of the estimate of 1.7 mg/cm3. The median precision error for L1-3 vBMD was 0.61 mg/cm3. Statistically significant differences in spine vBMD measurements between different scanners reinforce the importance of cross-calibration in multi-center studies. Cross-calibration can be reliably performed using linear regression equations.

乳腺癌早筛查、早诊断能显著提高生存率,基于人工智能(Artificial Intelligence,AI)的乳腺X射线图像辅助诊断系统对于乳腺癌筛查有重要意义.AI辅助诊断系统的算法模型测试和评估需要大量精确标注的数据.本文就测试数据库构建的相关要求进行探讨,包括总体要求、伦理要求、数据分布要求、数据采集及质控要求、数据脱敏与数据清洗要求、数据标注及质控要求等,为数据集构建者和相关使用者提供参考.

目的 从技术审评的角度明确CT肺结节测评数据库的构建要求.方法 本文基于国内外AI医疗器械监管要求的调研,结合多项AI医疗器械的技术审评工作经验,提出CT肺结节测评数据库的构建要求.结果 CT肺结节测评数据库应具备权威性、科学性、规范性、多样性、封闭性和动态性等特点,方能满足AI CT肺结节辅助检测/诊断软件的确认要求.结论 本文前瞻性地提出CT肺结节测评数据库的构建要求,不仅可以指导相关责任方筹建符合技术审评要求的测评数据库,而且可以为探索CT肺结节测评数据库取代或部分取代临床评价的可行性提供参考.

随着我国人口老龄化的加剧,骨骼健康问题越来越受到人们的关注.骨质疏松症为最常见的骨骼健康问题,是一种以骨量低、骨组织微结构损坏导致骨脆性增加、易发生骨折为特征的全身性骨病 [1].骨质疏松症常发生在老年男性和绝经后女性人群中,是造成老年患者骨折而致残和致死的主要原因之一.对高危人群进行早期筛查与诊断并及时治疗,可有效降低骨质疏松症带来的危害.临床医生主要依据骨密度测量结果 和相关危险因素来诊断骨质疏松症并评估骨折风险,目前常用的骨密度测量设备包括双能X线骨密度测量仪、定量CT骨密度分析系统和超声骨密度仪.本文对这三种设备的技术及临床应用进展进行介绍和对比分析.

糖尿病是威胁人类健康的慢性疾病之一.2012年统计数据显示,我国糖尿病患者约1亿人,患病率为9.7％.良好地控制血糖水平能够减少糖尿病慢性并发症,改善预后[1-4].血糖监测方式主要包括生化血糖检测、自我血糖监测、持续葡萄糖监测(continuous glucose monitoring,CGM)、无创血糖监测等.生化血糖检测主要是检测静脉血糖水平,结果准确,可用于临床诊断,但操作复杂,检测时间长[5-6];自我血糖监测主要是通过便携式血糖仪检测毛细血管血糖水平,患者可以在家庭中使用,但只能提供单点血糖信息;CGM可提供连续、全面的血糖信息,反映血糖水平波动的趋势,并发现隐匿性高血糖和低血糖,避免自我血糖监测中的频繁采血,改善患者生活质量,在临床实践中可为血糖控制的改善提供有力支持,但该方法仍为有创检测方法,需要指血校正,有生理性延迟[7];无创血糖监测主要检测体液(如泪液、汗液)中的葡萄糖水平,但因其测量精度不确定、血糖相关性弱、无法检测睡眠中高血糖/低血糖而未被广泛重视[8].目前CGM因具有连续监测的技术优势,应用前景广阔.

本文通过调研植入式视网膜电刺激系统国内外应用现状及监管情况,明确了此种罕见病治疗设备的监管政策及注册审评考虑.主要明确了临床前研究、临床试验、随机文件的相关要求,有助于该类产品尽快获得上市应用,使罕见病患者受益.

真实世界数据日益得到广泛重视.本文从医疗器械技术审评角度出发,结合我国相关医疗器械临床评价相关要求,探讨真实世界证据在医疗器械上市前临床评价中的作用,旨在为今后我国真实世界证据在该领域的应用提供参考.

Pediatric medical devices cannot meet the existing medical needs now. In consideration of the difficulty that clinical trials conducted in pediatric population, reasonable extrapolation of adult device data to pediatric population can maximize the use of existing data, as well as reduce unnecessary clinical trials in pediatric populations. It can also help accelerate the development and marketing of pediatric medical devices and ensure the clinical demand of pediatric devices. We analyzed the related guiding principles in America, and explored the extrapolation of medical device data to pediatric population in China from the perspective of medical device technology evaluation, hoping to provide reference in promoting China's data extrapolation.

医疗器械临床评价是评价医疗器械安全有效性的重要方法和手段.在医疗器械注册申报过程中,很多注册申请人对医疗器械的临床评价、系统综述与循证医学的关系混淆不清甚至混为一谈,错误地理解了医疗器械临床评价的要求,降低了工作效率.本文介绍了系统综述、循证医学、医疗器械上市前临床评价的概念,并从医疗器械审评角度探讨了三者之间的关系,以期指导注册申请人更好地做好医疗器械上市前临床评价工作.

在植入式骶神经刺激系统临床试验的技术审评中,应主要关注以下方面:临床试验基本原则、临床试验医疗机构要求和临床试验方案设计要素.

X射线计算机体层摄影(CT)设备属大型医学影像设备,开展临床试验面临着诸多困难,急需审评机构明确CT设备临床评价的要求.CT设备临床评价可按照采集模式、重建方法和后处理功能划分为3个独立功能模块,采用不同的临床路径进行评价;成熟且风险已知的CT设备通常不需要进行临床试验;技术改进型CT设备的临床评价,支持性资料应与企业宣称的预期用途、技术风险及技术成熟程度相适应;如果非临床研究资料和样本临床图像可以证明产品的安全有效性,则不需要临床试验证据;进口产品可以利用上市后临床经验数据进行评价.明确CT设备临床评价要求,有助于指导该类产品生产企业准备适当的临床评价资料,减少不必要的临床试验,使其产品尽快获得上市应用,并使患者受益.

Deep brain stimulation (DBS) therapy develops rapidly in clinical application. The structures of deep brain stimulator and magnetic resonance imaging (MRI) equipment are introduced, the interactions are analyzed, and the two compatible problems of radio frequency (RF) heating and imaging artifact are summarized in this paper.

Active implantable medical device develops rapidly in recent years. The clinical demands and current application are introduced, the technical trends are discussed, and the safety risks are analyzed in this paper.

Objective To assess the immune efficacy of dendritic cells(DCs) combined with cytokine induced killer(CIK) cells on malignant tumors.Methods Peripheral blood mononuclear cells were isolated from 158 patients with malignant tumors.The attached cells were induced by IL-4,GM-CSF,and TNF-α,and then confirmed as DCs by flow cytometry;the suspension cells were induced by CD3 monoclonal antibody,INF-γ,and IL-2,and then confirmed as CIK cells by flow cytometry.DCs were transfused back to the patients on the 7th day,8th day,9th day,and 10th day.CIK cells were transfused back to the patients on the 11th day,12th day,13th day,and 14th day.After 4 weeks,lymphocyte subsets was determined by flowcytometry;cytokine production was determined by ELISA,which reflecting the immune function of patients.Adverse reactions was observed at the same time.Results The levels of CD3+,CD4+,CD8+ and the ratio of CD4+/CD8+ increased significantly compared with those before treatment(P0.05).The levels of IL-2,INF-γ and IL-7 increased significantly compared with those before treatment(P0.01).Except 27 cases appeared fever,the rest patients had no obvious side effects.Conclusion DC-CIK cells combination therapy malignant tumor is safe and effective,and can improve immune function.

This paper aims to discuss the issues needed to be considered during the process of defining the registered product standards and industry standards of digital mammographic X-ray camera system. Meanwhile, for the future reference of establishment of standards, it adds the additional technical requirements not only from the features of device's structure, but also from the risk of clinical use.

<正>我国第二次残疾人抽样调查显示全国听力语言残疾人口达2 780万人,占全部残疾人总数的27%。耳聋严重影响人的认知发育、言语交流、教育就业,聋人的听力康复引起了全社会的关注。人工耳蜗能帮助重度或极重度聋患者恢复言语听、说能力,是这类患者目前惟一有效的康复治疗手段;

Objective As China′s technological development and social progress,China′s enterprises have begun to produce cochlear implant which has high risk in installation and application.While,currently there is not yet the corresponding state or industry level standards,nor is the international conversion demonstrate standard.The evidence of safety and effectiveness submitted by companies vary widely,and they are quite different from the existing requirements of the technical review.This article aims to do preliminary study on safety and efficacy evaluation in order to establish national and industrial standards to objectively evaluate the cochlear implant safety and efficacy.Methods Systematic analysis of the foreign history and status of safety and efficacy evaluation of cochlear implant were performed,with the indication of the current problems in safety and efficacy evaluation and the reference standard of similar products.Results The systemic recommendations of the safety and efficacy standards of cochlear implant system werw provided.Conclusion From the perspective of medical device regulation,it is imperative and possible to develop the reasonable and scientific safety and effectiveness evaluation for cochlear implant with the effort of experts,enterprises and users.