In the test report summary, you should briefly describe the test methods used for the conducted bench tests, or reference an established method that was followed, such as any FDA-recognized consensus standards that were used for the conducted testing. You should also provide a description of the test sample that was tested (whether it is a final, finished device or not), and whether that sample is the entire device, a part or component, or an attribute of the device (e.g., the device's material composition/properties or packaging). In addition to the description of the test sample, you should include a brief discussion on sample selection (e.g., size or configuration) and how the samples represented a clinically relevant worst-case scenario(s).

测试方法的简要描述，包括测试样品的信息，测试样本量的选择和具体的测试方法，其中：

1) 测试样品的信息：比如它是否是最终完成的设备，以及该样品是否是整个设备，一个部分或组件，或设备的属性(例如，设备的材料组成/属性或包装)等

2) 测试样本量的选择：例如，大小或配置的简短讨论，以及样本如何代表临床相关的最坏情况。

3) 具体的测试方法：如果是FDA认可的标准，通常不用描述具体的测试方法；如果认可的标准里有几种方法可以选择，需要说明一下选择了哪个及选择的理由。

In the test report summary, you should briefly

We recommend that your test report summary include an identification of the acceptance criteria, when applicable, that were pre-defined and that were applied during testing. When a non-clinical bench performance test that is conducted for characterization purposes does not have acceptance criteria, you should still provide a description of the assessment criteria that you used to allow for interpretation of the data, for example, the visual inspection criteria utilized for coating integrity testing when assessing voids or cracks.

预先制定通过/失败的标准（如适用），可以是FDA认可的标准里面的，如果没有，也可以是制造商自己制定。

1) Provide an appropriate summary of data (in tabular and/or text format).including a summary from any analyses performed. For example: 提供适当的数据摘要（以表格和/或文本格式），包括对所执行的任何分析的摘要。例如：

̵ For quantitative assessments, provide appropriate summary parameters such as: the mean, standard deviation, minimum, and maximum for normal data; or summary parameters per the data analysis plan. 对于定量评估，提供适当的汇总参数，例如：正常数据的平均值、标准偏差、最小值和最大值；或每个数据分析计划的汇总参数。

̵ For attribute or qualitative data, provide an appropriate summary of the number of observed characteristics by category (e.g., characteristic present/total observations, characteristic absent/total observations). Include statistical information such as confidence/reliability level, if applicable. 对于属性或定性数据，按类别提供对观察到的特征数量的适当总结（例如，特征存在/总观察，特征缺失/总观察）。如果适用，包括统计信息，例如置信度/可靠性水平。

2) Specify whether the acceptance criteria (if applicable) were met.说明是否满足验收标准（如果适用）。

3) Provide a brief explanation of study results that do not meet acceptance criteria, and/or protocol deviations that may have impacted the study results, conclusions, or data integrity, and describe how the resulting concerns were resolved. 简要解释不符合验收标准的研究结果，和/或可能影响研究结果、结论或数据完整性的方案偏差，并描述如何解决由此产生的问题。

测试结果：数据、数据分析和方案偏差的描述（PS:其中统计信息，例如置信度/可靠性水平提问较多）。

Your test report summaries should provide a discussion of the conclusions drawn from the test results. This section of the test report summary can be used to provide additional information regarding the testing conducted and/or observed test results(e.g., justification for the methods used to perform the testing, clinical/scientific engineering basis for the acceptance criteria, outlying and anomalous results). Note that a justification for methods and/or acceptance criteria is generally not needed if they were directly obtained from a FDA-recognized consensus standard or guidance document. A discussion of the test methods or acceptance criteria, if needed, can include how the testing relates to the use of the device in clinical practice or as described in literature. For example, tracking tests typically use a fixture that simulates the target anatomy. A discussion or justification for the tracking test fixture used would address how the testing relates to expected worst-case clinical use for the indicated anatomical location. For non-clinical bench performance tests that are conducted for characterization purposes, the conclusions should address the relationship between the results and the intended performance of the device. As noted above, a brief discussion of how the test results support the overall submission can be included in the test report summary or another location in your submission.

讨论和结论：提供一个从测试结果得出的结论的讨论

测试报告摘要的这一部分可用于提供有关进行的测试和/或观察到的测试结果的附加信息（例如，用于执行测试的方法的合理性、验收标准的临床/科学工程基础、异常和异常 结果）。请注意，如果方法和/或验收标准是直接从 FDA 认可的共识标准或指导文件中直接获得的，则通常不需要对其进行论证。如果需要，对测试方法或验收标准的讨论可以包括测试如何与临床实践中或文献中描述的设备使用相关。例如，跟踪测试通常使用模拟目标解剖结构的夹具。对所用跟踪测试夹具的讨论或论证将解决测试如何与指定解剖位置的预期最坏情况临床使用相关。对于为表征目的而进行的非临床工作台性能测试，结论应说明结果与设备预期性能之间的关系。如上所述，关于测试结果如何支持整体提交的简短讨论可以包含在测试报告摘要或您提交的其他位置。

We recommend that you identify the location (e.g., appendix and/or page number) for each complete test report for which a summary is provided, if applicable.

我们建议您确定每个完整的测试报告的位置(例如，附录和/或页码)，并为其提供摘要(如果适用)。

As an alternative to a written narrative for each non-clinical bench performance test, a tabulated summary can be provided to organize the information recommended in a test report summary (see below for example). If a summary table is used, it is still recommended that a narrative discussion of the results/conclusions be provided as described above in Section IL.A.6, when needed.

汇总表（可选）

作为每个非临床工作台性能测试的书面叙述的替代方案，可以提供表格摘要来组织测试报告摘要中推荐的信息（参见下面的示例）。如果使用汇总表，仍建议提供对结果/结论的叙述性讨论。