vi
Tables
Table 2-1. Summary of Regulatory Policy for CDS Software Functions. ..................................................................9
Table 3-1. Definitions for Device and Medical Device in Canada...........................................................................25
Table 3-2. Questions to Consider When Defining an IVD Intended Purpose........................................................27
Table 3-3. Example of Intended Use Element Break Down. ...................................................................................28
Table 3-4. Example of Claims and Benefits List. .....................................................................................................28
Table 3-5. Steps for Classifying IVD Devices in the US..........................................................................................28
Table 3-6. FDA Device Risk Classifications. ...........................................................................................................30
Table 3-7. FDA Software Device Levels of Concern...............................................................................................33
Table 3-8. Information to Include in Technical Documentation for Trained Algorithms in IVD SaMD. ..............36
Table 3-9. Data Sources for Information to Support Clinical Association and Scientific Validity...........................37
Table 4-1. The Type and Frequency of Reporting to Competent Authorities Based on Risk Class in the EU. .......60
Table 5-1. Guidelines and Standards for Generation of SaMD Clinical Evidence and Clinical Evaluation. ..........70
Table 6-1. Probability. ..............................................................................................................................................79
Table 6-2. Qualitative and Semi-Quantitative Probability.......................................................................................79
Table 6-3. Example Severity Scale...........................................................................................................................79
Table 6-4. Example Risk Matrix. .............................................................................................................................80
Table 6-5. Typical Hazards of In Vitro Diagnostic Software. ..................................................................................81
Table 6-6. Example Software Risk Assessment........................................................................................................82
Table 6-7. Examples of Diagnosis and Factors to Consider in the Severity Assessment..........................................84
Table 8-1. Acronyms. .............................................................................................................................................106
Table 10-1. Examples of Usability Goals................................................................................................................139
Table 10-2. Heuristics Report Example. ................................................................................................................145
Table 10-3. System Usability Score (SUS). ............................................................................................................150
Table 10-4. Acceptance Criteria Examples.............................................................................................................153
Table 10-5. Acceptance Criteria Matrix.................................................................................................................155
Table 13-1. Clauses Applicable to Health Software Labeling in CEN-ISO/TS 82304-2:2020. ...........................193
Table 13-2. Comparison of Requirements to Different Economic Operators........................................................194
Table 14-1. Telemedicine Reimbursement in France.............................................................................................208
Table 14-2. The PICOS Framework.......................................................................................................................215
Tables
Table 2-1. Summary of Regulatory Policy for CDS Software Functions. ..................................................................9
Table 3-1. Definitions for Device and Medical Device in Canada...........................................................................25
Table 3-2. Questions to Consider When Defining an IVD Intended Purpose........................................................27
Table 3-3. Example of Intended Use Element Break Down. ...................................................................................28
Table 3-4. Example of Claims and Benefits List. .....................................................................................................28
Table 3-5. Steps for Classifying IVD Devices in the US..........................................................................................28
Table 3-6. FDA Device Risk Classifications. ...........................................................................................................30
Table 3-7. FDA Software Device Levels of Concern...............................................................................................33
Table 3-8. Information to Include in Technical Documentation for Trained Algorithms in IVD SaMD. ..............36
Table 3-9. Data Sources for Information to Support Clinical Association and Scientific Validity...........................37
Table 4-1. The Type and Frequency of Reporting to Competent Authorities Based on Risk Class in the EU. .......60
Table 5-1. Guidelines and Standards for Generation of SaMD Clinical Evidence and Clinical Evaluation. ..........70
Table 6-1. Probability. ..............................................................................................................................................79
Table 6-2. Qualitative and Semi-Quantitative Probability.......................................................................................79
Table 6-3. Example Severity Scale...........................................................................................................................79
Table 6-4. Example Risk Matrix. .............................................................................................................................80
Table 6-5. Typical Hazards of In Vitro Diagnostic Software. ..................................................................................81
Table 6-6. Example Software Risk Assessment........................................................................................................82
Table 6-7. Examples of Diagnosis and Factors to Consider in the Severity Assessment..........................................84
Table 8-1. Acronyms. .............................................................................................................................................106
Table 10-1. Examples of Usability Goals................................................................................................................139
Table 10-2. Heuristics Report Example. ................................................................................................................145
Table 10-3. System Usability Score (SUS). ............................................................................................................150
Table 10-4. Acceptance Criteria Examples.............................................................................................................153
Table 10-5. Acceptance Criteria Matrix.................................................................................................................155
Table 13-1. Clauses Applicable to Health Software Labeling in CEN-ISO/TS 82304-2:2020. ...........................193
Table 13-2. Comparison of Requirements to Different Economic Operators........................................................194
Table 14-1. Telemedicine Reimbursement in France.............................................................................................208
Table 14-2. The PICOS Framework.......................................................................................................................215