今天我們先說一下一份報(bào)告摘要的具體內(nèi)容
Test report summaries的內(nèi)容和格式
應(yīng)包括：（如下）
1. Test(s) performed
You should identify the tests performed. If the testing was conducted as recommended by a FDA guidance document or FDA-recognized consensus standard. we recommend that you state such in the test report summary.
說明已執(zhí)行的測試是否是按照FDA指導(dǎo)文件或FDA認(rèn)可的共識(shí)標(biāo)準(zhǔn)進(jìn)行檢測。
You should provide test objectives in the test report summary if a complete test report is not provided within the premarket submission.
如果在上市前提交的文件中未提供完整的檢測報(bào)告，則應(yīng)在檢測報(bào)告摘要中提供檢測目的。
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).
測試方法的簡要描述，包括測試樣品的信息，測試樣本量的選擇和具體的測試方法，其中：
1) 測試樣品的信息：比如它是否是最終完成的設(shè)備，以及該樣品是否是整個(gè)設(shè)備，一個(gè)部分或組件，或設(shè)備的屬性(例如，設(shè)備的材料組成/屬性或包裝)等
2) 測試樣本量的選擇：例如，大小或配置的簡短討論，以及樣本如何代表臨床相關(guān)的最壞情況。
3) 具體的測試方法：如果是FDA認(rèn)可的標(biāo)準(zhǔn)，通常不用描述具體的測試方法；如果認(rèn)可的標(biāo)準(zhǔn)里有幾種方法可以選擇，需要說明一下選擇了哪個(gè)及選擇的理由。
4. Pre-defined pass/fail criteria (when applicable)
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.
預(yù)先制定通過/失敗的標(biāo)準(zhǔn)（如適用），可以是FDA認(rèn)可的標(biāo)準(zhǔn)里面的，如果沒有，也可以是制造商自己制定。
5. Results summary
1) Provide an appropriate summary of data (in tabular and/or text format).including a summary from any analyses performed. For example: 提供適當(dāng)?shù)臄?shù)據(jù)摘要（以表格和/或文本格式），包括對(duì)所執(zhí)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. 對(duì)于定量評(píng)估，提供適當(dāng)?shù)膮R總參數(shù)，例如：正常數(shù)據(jù)的平均值、標(biāo)準(zhǔn)偏差、最小值和最大值；或每個(gè)數(shù)據(jù)分析計(jì)劃的匯總參數(shù)。
? 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. 對(duì)于屬性或定性數(shù)據(jù)，按類別提供對(duì)觀察到的特征數(shù)量的適當(dāng)總結(jié)（例如，特征存在/總觀察，特征缺失/總觀察）。如果適用，包括統(tǒng)計(jì)信息，例如置信度/可靠性水平。
2) Specify whether the acceptance criteria (if applicable) were met.說明是否滿足驗(yàn)收標(biāo)準(zhǔn)（如果適用）。
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. 簡要解釋不符合驗(yàn)收標(biāo)準(zhǔn)的研究結(jié)果，和/或可能影響研究結(jié)果、結(jié)論或數(shù)據(jù)完整性的方案偏差，并描述如何解決由此產(chǎn)生的問題。
測試結(jié)果：數(shù)據(jù)、數(shù)據(jù)分析和方案偏差的描述（PS:其中統(tǒng)計(jì)信息，例如置信度/可靠性水平提問較多）。
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.
討論和結(jié)論：提供一個(gè)從測試結(jié)果得出的結(jié)論的討論
測試報(bào)告摘要的這一部分可用于提供有關(guān)進(jìn)行的測試和/或觀察到的測試結(jié)果的附加信息（例如，用于執(zhí)行測試的方法的合理性、驗(yàn)收標(biāo)準(zhǔn)的臨床/科學(xué)工程基礎(chǔ)、異常和異常 結(jié)果）。請注意，如果方法和/或驗(yàn)收標(biāo)準(zhǔn)是直接從 FDA 認(rèn)可的共識(shí)標(biāo)準(zhǔn)或指導(dǎo)文件中直接獲得的，則通常不需要對(duì)其進(jìn)行論證。如果需要，對(duì)測試方法或驗(yàn)收標(biāo)準(zhǔn)的討論可以包括測試如何與臨床實(shí)踐中或文獻(xiàn)中描述的設(shè)備使用相關(guān)。例如，跟蹤測試通常使用模擬目標(biāo)解剖結(jié)構(gòu)的夾具。對(duì)所用跟蹤測試夾具的討論或論證將解決測試如何與指定解剖位置的預(yù)期最壞情況臨床使用相關(guān)。對(duì)于為表征目的而進(jìn)行的非臨床工作臺(tái)性能測試，結(jié)論應(yīng)說明結(jié)果與設(shè)備預(yù)期性能之間的關(guān)系。如上所述，關(guān)于測試結(jié)果如何支持整體提交的簡短討論可以包含在測試報(bào)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.
我們建議您確定每個(gè)完整的測試報(bào)告的位置(例如，附錄和/或頁碼)，并為其提供摘要(如果適用)。
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.
匯總表（可選）
作為每個(gè)非臨床工作臺(tái)性能測試的書面敘述的替代方案，可以提供表格摘要來組織測試報(bào)告摘要中推薦的信息（參見下面的示例）。如果使用匯總表，仍建議提供對(duì)結(jié)果/結(jié)論的敘述性討論。
