CLINICAL EVALUATION REPORT
临床评估报告
For Product: XXXX
产品：XXXX
Document No. XXXXXXXX
文件编号
Version: 1.0
版本:
Date: 2022-02-13
日期:
Author:
作者:
Reviewed by:
审阅:
Approved by:
批准:
<Company>
<；公司>
Table of Content
目录
Page页码
1. General details总述 (3)
2. Description of the device and its intended application器械描述和预期用途.. 3
3. Intended therapeutic and/or diagnostic indications and claims
预期治疗和/或诊断说明和要求 (3)
4. Context of the evaluation and choice of clinical data types
评估背景和临床数据类型的选择 (3)
5. Summary of the clinical data and appraisal总结临床数据和评价 (4)
6. Data analysis数据分析 (5)
6.1. P erformance性能 (5)
6.2. S afety平安 (5)
苹果验证真伪6.3. P roduct Literature and Instructions for U产品文献和使用说明 (5)
7.Conclusions结论 (6)
1. General details 总述
State the proprietary name of the device and any code names assigned during device development. Identify the manufacturer(s) of the device.
描述器械的商品名，以及在器械研发过程中使用的任何编码。识别器械的生产商。小班语言活动
2. Description of the device and its intended application 器械描述和预期用途
Provide a conci physical description of the device, cross referencing to relevant ctions of the manufacturer’s technical information as appropriate. The description should cover information such as:
评职称个人总结materials, including whether it incorporates a medicinal substance (already on the market or new), tissues, or blood products;
the device components, including software and accessories;
mechanical characteristics; and
others, such as sterile vs. non-sterile, radioactivity etc.女人脱发怎么办
State the intended application of the device, single u/reusable; invasive/non invasive; implantable; duration of u or contact with the body; organs, tissues or body fluids contacted by the device.
Describe how the device achieves its intended purpo.
对该器械进行简明的物理描述，适当参照生产商技术信息的相关章节。此描述应包含的信息，如：
材料，包括是否含药〔已经上市的或全新的〕、组织或血液产品；
器械组成，包括软件和附件；
机械特征；和
其他，如灭菌，非灭菌，放射能等等。
描述器械的预期用途，一次性使用/屡次使用；侵入/非侵入；可植入；使用持续时间或与人体接触；器械接触的器官，组织或体液。
描述器械如何到达它的预期用途。
3. Intended therapeutic and/or diagnostic indications and claims预期治疗和/或
除了用英语怎么说诊断说明和要求
State the medical conditions to be treated, including target treatment group and dias.
Outline any specific safety or performance claims made for the device
描述使用时的医学条件，包括目标治疗群体和疾病。概述器械的任何特殊平安或性能要求。4. Context of the evaluation and choice of clinical data types评估背景和临床数约定成俗
据类型的选择
Outline the developmental context for the device. The information should include whether the device
is bad on a new technology, a new clinical application of an existing technology, or the result of incremental change of an existing technology.The amount of information will differ
according to the history of the technology. Where a completely new technology has been developed, this ction would need to give an overview of the developmental process and the points in the development cycle at which clinical data have been generated. For long standing technology, a shorter description of the history of the technology (with appropriate references) could be ud. Clearly state if the clinical data ud in the evaluation are for an equivalent device.Identify the equivalent device(s) and provide a justification of the equivalency, cross-referenced to the relevant non-clinical documentation that supports the claim.
概述器械的开展历史。内容应包括器械是否基于新技术，是否基于现有技术的新临床应用，或者是现有技术增量变化的结果。根据该技术的历史，信息量将有所不同。如果是一项全新技术开展起来，本章须概述开展过程和开展周期中产生临床数据的节点。如果是常规技术，须简短描述该技术的历史〔
须适当引用〕。明确指出，评估中使用的临床数据是否来自等同器械。识别等同器械，并给出等同的理由，参照相关非临床文献，以支撑观点。
State the Esntial Requirements relevant to the device in question, in particular, any special design features that po special performance or safety concerns (e.g. prence of medicinal, human or animal components) that were identified in the device risk management documentation and that required asssment from a clinical perspective.
陈述有关讨论的器械的根本要求，特别是，任何导致特殊性能或平安特性〔如药，人体或动物组织的使用〕的特殊设计已经在器械风险管理文件中被识别过，并从临床的角度进行了必要的评估。
Outline how the considerations were ud to choo the types of clinical data ud for the evaluation. Where published scientific literature has been ud, provide a brief outline of the arching/retrieval process, cross-referenced to the literature arch protocol and reports.
概述这些需要考虑的因素如何用来选择评估中用到的临床数据的类型。如果引用已出版的科学文献，请简要描述检索/回溯过程，参照文献检索草案和报告。
5. Summary of the clinical data and appraisal 总结临床数据和评价
Provide a tabulation of the clinical data ud in the evaluation, categorid according to whether the data address the performance or the safety of the device in question. (Note: many individual data ts will address both safety and performance.) Within each category, order the data according to the importance of their contribution to establishing the safety and performance of the device and in relation to any specific claims about performance or safety. Additionally, provide a brief outline of the data appraisal methods ud in the evaluation, including any weighting criteria, and a summary of the key results.
提供一张评估中用到的临床数据的表格，按照数据是否关系到讨论的器械的性能或平安来分类。〔注：许多单独的数据与平安、性能都相关。〕每个类别中，数据的排列依据它们对于该器械平安和性能的重要性，以及与性能和平安有关的任何特别要求的相关方面。此外，简要描述评估中使用的数据评价方法，包括任何权重标准，和重要结论的总结。
Include full citations for literature-bad data and the titles and investigation codes (if relevant) of any clinical investigation reports.
包括任何临床研究报告的基于文献的数据，题目和研究编码〔如果相关〕的完整引用信息。Cross-reference the entry for each piece of data to its location in the manufacturer’s technical documentation.
每条数据的记录与其在生产商技术文档中的位置应相互对应。
6. Data analysis数据分析
耳聋耳鸣的治疗6.1. Performance性能
Provide a description of the analysis ud to asss performance.
描述用于性能评估的分析方法。
Identify the datats that are considered to be the most important in contributing to the demonstration of the overall performance of the device and, where uful, particular performance characteristics. Outline why they are considered to be pivotal and how they demonstrate the performance of the device collectively (e.g. consistency of results, statistical significance, clinically significance of effects).
识别那些被认为是论证了器械总体性能和特殊性能特点的最重要的数据。概述这些数据为何被认为是关键数据，它们如何共同论证了器械的性能(比方结论的连贯性，统计的显著性，疗效的临床重要性)。
6.2. Safety平安
Describe the total experience with the device, including numbers and characteristics of patients expod to the device; and duration of follow-up of device recipients.
描述器械的全部使用经验，包括使用此器械的患者的数量和特点；以及跟踪器械使用情况的持续时间。
郦琼Provide a summary of device-related adver events, paying particular attention to rious adver events.
总结与器械有关的不良事件，特别注意严重不良事件。
Provide specific comment on whether the safety characteristics and intended purpo of the device requires training of the end-ur.
要特别讨论，是否会因为器械的平安特性和预期用途，须对最终用户进行培训。
6.3. Product Literature and Instructions for U产品文献和使用说明
State whether the manufacturer’s propod product literature and Instructions for U are consistent with the clinical data and cover all the hazards and other clinically relevant information that may impact on the u of the device.
