This section uses simple steps to help SaMD manufacturers through the approach to generating evidence for the clinical evaluation of a SaMD and provides links to techniques, definitions and sources that are available to help a SaMD manufacturer generate appropriate evidence. Note: The examples used are not intended to be comprehensive. All data sources and statistical methods should be tailored to the specific SaMD and its intended use. Clinical Evaluation Valid Clinical Association Analytical Validation Clinical Validation ① ② ③ Does use of your SaMD’s Is a valid clinical Does your SaMD correctly accurate, reliable, and precise association between your process data to generate output data achieve your intended SaMD output and your accurate, reliable, and precise purpose in your target population SaMD’s targeted clinical output data? in the context of clinical care? condition? Figure 12 - Clinical Evaluation Clinical Association: ① Examples of existing evidence Is there a valid clinical association between Literature searches your SaMD output, based on the inputs and Original clinical research algorithms selected, and your SaMD’s Professional society guidelines targeted clinical condition? Examples of generating new evidence Step 1: Verify that the association between Secondary data analysis the SaMD output and the targeted clinical Perform clinical trials condition is supported by evidence. All SaMD should demonstrate a valid clinical association. Note: Question: How do I evidence”? “generate You can verify by using existing evidence or you can verify by generating new evidence. Analytical Validation: ② Verification confirmation through – Does your SaMD meet technical provision of objective evidence that requirements? specified requirements have been fulfilled. Step 1: Generate evidence that shows Source: Section 2.7 [6] that the output of your SaMD is technically what you expected. Validation confirmation through – provision of objective evidence that the Note: All SaMD should demonstrate requirements for a specific intended use or analytical validation. application have been fulfilled. Source: [6] Question: How do I “generate Section 2.8 evidence”?
This section uses simple steps to help SaMD manufacturers through the approach to generating evidence for the clinical evaluation of a SaMD and provides links to techniques, definitions and sources that are available to help a SaMD manufacturer generate appropriate evidence. Note: The examples used are not intended to be comprehensive. All data sources and statistical methods should be tailored to the specific SaMD and its intended use. Clinical Evaluation ① Valid Clinical Association ② Analytical Validation ③ Clinical Validation Is a valid clinical association between your SaMD output and your SaMD’s targeted clinical condition? Does your SaMD correctly process data to generate accurate, reliable, and precise output data? Does use of your SaMD’s accurate, reliable, and precise output data achieve your intended purpose in your target population in the context of clinical care? Figure 12 - Clinical Evaluation Examples of existing evidence Literature searches Original clinical research Professional society guidelines Examples of generating new evidence Secondary data analysis Perform clinical trials ① Clinical Association: Is there a valid clinical association between your SaMD output, based on the inputs and algorithms selected, and your SaMD’s targeted clinical condition? Step 1: Verify that the association between the SaMD output and the targeted clinical condition is supported by evidence. Note: All SaMD should demonstrate a valid clinical association. Question: How do I “generate evidence”? You can verify by using existing evidence or you can verify by generating new evidence. Verification – confirmation through provision of objective evidence that specified requirements have been fulfilled. Source: [6] Section 2.7 Validation – confirmation through provision of objective evidence that the requirements for a specific intended use or application have been fulfilled. Source: [6] Section 2.8 ② Analytical Validation: Does your SaMD meet technical requirements? Step 1: Generate evidence that shows that the output of your SaMD is technically what you expected. Note: All SaMD should demonstrate analytical validation. Question: How do I “generate evidence”?
imdrf-tech-170921-samd-n41-clinical-evaluation.docx