基准或类似产品

在临床评价计划（CEP）中，“基准或类似产品”这一章节旨在通过识别和描述市场上已存在的、与待评价器械具有可比性的产品，为临床评价提供重要的参照。本章的目的是提供在当前技术背景下，与待评价器械在设计、预期用途或技术特性等方面相近或可作为标杆的产品概况。这有助于评估者理解待评价器械的技术定位，并为后续的等同性论证（如适用）、性能与安全性可接受标准的设定，以及风险效益分析提供依据。

撰写本章节时，核心在于如何选择合适的对比产品，并以专业、精炼的方式呈现其关键信息，同时阐明其与待评价器械的关联性。

选择基准或类似产品的考量

选择哪些产品作为基准或类似产品，应基于明确且合理的标准。通常，应优先考虑那些在以下一个或多个方面与待评价器械具有显著相关性的产品：

• 预期用途和适应症： 选择那些预期用途、目标患者人群和临床应用场景与待评价器械高度一致或非常相似的产品。
• 技术特性和作用机理： 关注那些采用相似技术原理、关键设计或作用机制的产品。
• 材料和构造： 对于材料依赖性较强的器械，其主要材料的相似性也是一个重要的考量点。
• 市场代表性和公认度： 选择那些在目标市场（尤其是欧盟市场）上已有良好应用历史、被临床广泛接受、或能代表当前技术发展水平（State-of-the-Art）中成熟技术的产品。
• 法规状态： 通常选择已获得CE认证（依据MDR或MDD）或在其他主要监管区域（如FDA批准/许可）上市的产品。
• 等同性论证需求： 如果计划通过与某一已上市器械的等同性路径进行临床评价，则该“等同器械”将是在对应章节进行详细对比分析。

描述选定的基准或类似产品

对于每一个选定的基准或类似产品，应提供一段简洁而信息丰富的介绍。盲目罗列大量参数并不可取，关键在于提取并呈现那些对于理解该产品特性及其与待评价器械之可比性最为关键的信息。通常，对每个产品的描述包含以下方面：

首先，清晰标明该产品的准确名称、型号（如果适用）及其制造商。紧接着，简要说明其在主要市场的法规状态，例如是否已获得CE标志及其依据的法规（MDR/MDD），或在美国的FDA批准/许可情况。

核心内容在于阐述该产品的预期用途和适应症，这直接关系到其与待评价器械的临床可比性。随后，应聚焦于其关键的设计和技术特征。这部分内容需要根据器械的类型具体展开，例如： * 对于有源器械，可能涉及其工作原理、关键性能参数（如能量输出范围、频率等）。 * 对于无源植入物，则可能侧重于其主要结构材料、表面处理、机械性能指标等。 * 对于体外诊断试剂，则关注其检测原理、样本类型、主要分析性能（如灵敏度、特异性）等。

如果能够从公开渠道（如产品IFU、制造商官网、已发表文献、监管机构数据库等）获取到关于该产品已知的安全性和性能概况的总结性信息，且这些信息对于后续的比较分析具有实质意义，也应在此简要提及。例如，已知的临床应用效果、主要并发症发生率等。

阐明与待评价器械的关联性

在描述完每个基准或类似产品的基本情况后，阐明该产品为何被选中，以及它与正在进行临床评价的器械之间的具体关联。例如，它是作为等同性论证的前提（即“等同器械”）？还是代表了当前市场上同类产品的主流技术水平？或是因其某一特定设计或性能特点与待评价器械具有高度可比性？阐明这种关联性，能够帮助读者理解选择这些特定产品进行比较的逻辑和意义。

信息的组织与呈现

虽然在CEP的这一章节中，对每个基准或类似产品的核心特性进行系统化对比有时是必要的。例如，当比较多个产品在多个维度上的参数时，在CEP内部适当使用表格归纳这些具体参数（如材料、性能指标等）可以使信息一目了然。在逐一介绍完产品后，可以有一小段总结，提炼出从这些基准或类似产品中观察到的共性、差异性，及其对评价待评价器械的启示。

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In the Clinical Evaluation Plan (CEP), the “Benchmark or Similar Devices” chapter serves to provide a crucial frame of reference for the clinical evaluation by identifying and describing existing devices on the market that are comparable to the device under evaluation. The purpose of this chapter is to clearly delineate the landscape of products that are similar or can serve as benchmarks in terms of design, intended use, or technological characteristics within the current state of the art. This facilitates the evaluator’s understanding of the technological positioning of the device under evaluation and provides a basis for subsequent equivalence demonstrations (if applicable), the establishment of performance and safety acceptance criteria, and the benefit-risk analysis.

When composing this chapter, the core lies in selecting appropriate comparator devices and presenting their key information in a professional and concise manner, while also articulating their relevance to the device under evaluation.

Considerations for Selecting Benchmark or Similar Devices

The selection of devices as benchmarks or comparators should not be arbitrary but based on clear and justifiable criteria. Typically, priority should be given to products that demonstrate significant relevance to the device under evaluation in one or more of the following aspects:

• Intended Use and Indications: Select products whose intended use, target patient population, and clinical application scenarios are highly consistent or very similar to those of the device under evaluation.
• Technological Characteristics and Mechanism of Action: Focus on products that employ similar technological principles, key designs, or mechanisms of action.
• Materials and Construction: For devices where materials are a critical aspect, the similarity of principal materials is also an important consideration.
• Market Representation and Acceptance: Choose products that have a well-established history of use in the target market (especially the EU market), are widely accepted clinically, or represent mature technologies within the current state-of-the-art (SOTA).
• Regulatory Status: Generally, select products that have already obtained CE marking (under MDR or MDD) or are marketed in other major regulatory jurisdictions (e.g., FDA cleared/approved).
• Equivalence Demonstration Needs: If the clinical evaluation pathway involves demonstrating equivalence to a device already on the market, then that “equivalent device” will be compared with the device under evaluation in the relevant chapter.

Describing Selected Benchmark or Similar Devices

For each selected benchmark or similar device, a concise informative profile should be presented. A mere laundry list of numerous parameters is not advisable; the key is to extract and present the information most critical for understanding the device’s characteristics and its comparability to the device under evaluation. Typically, the description for each device should include the following aspects:

Begin by clearly stating the accurate name of the product, model number (if applicable), and its manufacturer. Following this, briefly outline its regulatory status in key markets, such as whether it has obtained a CE mark and the regulation it conforms to (MDR/MDD), or its FDA clearance/approval status in the United States.

The core content should focus on articulating the product’s intended use and indications for use, as this directly relates to its clinical comparability with the device under evaluation. Subsequently, the description should center on its key design and technological features. This part needs to be elaborated based on the type of device, for example: * For active devices, this might involve their operating principles, key performance parameters (e.g., energy output range, frequency). * For passive implants, the focus might be on their main structural materials, surface treatments, mechanical performance indicators. * For in-vitro diagnostic devices, attention would be on their detection principles, sample types, and main analytical performance characteristics (e.g., sensitivity, specificity).

If summary information regarding the known safety and performance profile of the product can be obtained from public sources (such as product IFUs, manufacturer websites, published literature, regulatory agency databases), and this information is substantively relevant for subsequent comparative analysis, it should also be briefly mentioned here. For instance, known clinical application outcomes, or rates of major complications.

Articulating Relevance to the Device Under Evaluation

After describing the basic situation of each benchmark or similar device, clearly articulate why that product was selected and its specific relationship to the device undergoing clinical evaluation. For example, is it a predicate for an equivalence claim (i.e., an “equivalent device”)? Does it represent the mainstream technological level of similar products currently on the market? Or is it highly comparable to the device under evaluation due to a specific design or performance characteristic? Clarifying this relationship helps the reader understand the logic and significance behind choosing these particular devices for comparison.

Organizing and Presenting Information

While a systematic comparison of the core characteristics of each benchmark or similar device is sometimes necessary within this CEP chapter, for instance, when comparing multiple products across several parameters, appropriately using internal tables to summarize these specific parameters (such as materials, performance indicators) can make the information readily understandable. After introducing each product individually, a brief summary can distill commonalities, differences observed among these benchmark or similar devices, and their implications for evaluating the device under evaluation.