This Standard provides a framework for assessing the relevance and adequacy of completed V&V activities that establish credibility of a computational model. The credibility should be commensurate with the degree to which the computational model is relied on as evidence of device performance, functional characteristic, and\/or safety to support a decision, and the consequences of that decision being incorrect.<\/p>\n
| PDF Pages<\/th>\n | PDF Title<\/th>\n<\/tr>\n | ||||||
|---|---|---|---|---|---|---|---|
| 4<\/td>\n | CONTENTS <\/td>\n<\/tr>\n | ||||||
| 6<\/td>\n | FOREWORD <\/td>\n<\/tr>\n | ||||||
| 8<\/td>\n | ASME V&V Committee Roster <\/td>\n<\/tr>\n | ||||||
| 9<\/td>\n | CORRESPONDENCE WITH THE V&V COMMITTEE <\/td>\n<\/tr>\n | ||||||
| 12<\/td>\n | 1 EXECUTIVE SUMMARY 2 INTRODUCTION 2.1 Motivation <\/td>\n<\/tr>\n | ||||||
| 13<\/td>\n | 2.2 Purpose 2.3 Scope 2.4 Overview of the Risk-Informed Credibility Assessment Framework Figure 2.4-1 Process Diagram of the Risk-Informed Credibility Assessment Framework <\/td>\n<\/tr>\n | ||||||
| 14<\/td>\n | 3 CONTEXT OF USE 4 MODEL RISK 4.1 Model Influence <\/td>\n<\/tr>\n | ||||||
| 15<\/td>\n | 4.2 Decision Consequence Figure 4.2-1 Schematic of How Model Influence and Decision Consequence Determine Model Risk <\/td>\n<\/tr>\n | ||||||
| 16<\/td>\n | 5 MODEL CREDIBILITY Tables Table 5-1 Verification, Validation, and Applicability Activities and Their Associated Credibility Factors <\/td>\n<\/tr>\n | ||||||
| 17<\/td>\n | 5.1 Verification 5.1.1 Code Verification <\/td>\n<\/tr>\n | ||||||
| 18<\/td>\n | 5.1.2 Calculation Verification 5.2 Validation 5.2.1 Computational Model <\/td>\n<\/tr>\n | ||||||
| 19<\/td>\n | 5.2.2 Comparator <\/td>\n<\/tr>\n | ||||||
| 22<\/td>\n | 5.3 Applicability of the Validation Activities to the COU <\/td>\n<\/tr>\n | ||||||
| 23<\/td>\n | 5.3.1 Relevance of the QOIs 5.3.2 Relevance of the Validation Activities to the COU Figure 5.3-1 Illustrative Examples of Three COUs Relative to the Validation Points for a Two-Parameter (X1, X2) Computational Model <\/td>\n<\/tr>\n | ||||||
| 24<\/td>\n | 6 THE PLAN 7 CREDIBILITY ASSESSMENT <\/td>\n<\/tr>\n | ||||||
| 25<\/td>\n | Figures Figure 7-1 Example Workflow for Assessing Computational Model Credibility <\/td>\n<\/tr>\n | ||||||
| 26<\/td>\n | 8 DOCUMENTATION AND EVIDENCE <\/td>\n<\/tr>\n | ||||||
| 27<\/td>\n | MANDATORY APPENDIX I REFERENCES <\/td>\n<\/tr>\n | ||||||
| 28<\/td>\n | MANDATORY APPENDIX II GLOSSARY <\/td>\n<\/tr>\n | ||||||
| 30<\/td>\n | Table A-1-1 A Sample PIRT NONMANDATORY APPENDIX A PHENOMENA IDENTIFICATION AND RANKING TABLE A-1 INTRODUCTION TO PIRT A-2 COMPILING THE PIRT A-2.1 Classification of Phenomena A-2.2 Knowledge\/Confidence Levels <\/td>\n<\/tr>\n | ||||||
| 31<\/td>\n | Table A-2.2-1 An Example Gradation of Knowledge\/Confidence Level and Importance Table A-2.2-2 A Sample PIRT Including a Mitigation Column A-3 REFERENCES <\/td>\n<\/tr>\n | ||||||
| 32<\/td>\n | Figure B-1-1 Elements of the ASME V&V 40 Risk-Informed Credibility Assessment Framework Illustrated in Nonmandatory Appendix B NONMANDATORY APPENDIX B EXAMPLES OF RISK-INFORMED CREDIBILITY ASSESSMENT CONCEPTS B-1 INTRODUCTION B-2 EXAMPLES <\/td>\n<\/tr>\n | ||||||
| 33<\/td>\n | Table B-1-1 Mapping of Examples to Selected Credibility Factors Table B-1-2 Mapping of Examples to Device Type and Modeling Approach <\/td>\n<\/tr>\n | ||||||
| 34<\/td>\n | Figure B-2.1.1-1 Illustration of a Centrifugal Blood Pump Design B-2.1 Example 1: Assessing Hemolysis in Centrifugal Blood Pumps <\/td>\n<\/tr>\n | ||||||
| 36<\/td>\n | Figure B-2.1.4.2-1 Model Risk Matrix for Example 1 Table B-2.1.4.2-1 Corresponding Risk Levels for the Credibility Factors That Address Rigor of Output Comparison and Agreement of Output Comparison, With the Addition of Validation Metric in Figure B-2.1.4.2-1 <\/td>\n<\/tr>\n | ||||||
| 39<\/td>\n | Table B-2.1.5.4-1 Credibility Factors Summary B-2.2 Example 2: Predicting the Performance of Flow Diverters in the Treatment of Brain Aneurysms <\/td>\n<\/tr>\n | ||||||
| 40<\/td>\n | Figure B-2.2.1-1 An Example of a Flow Diverter Placed in a Parent Vessel With a Side-Wall Aneurysm Figure B-2.2.1-2 The Flow Patterns Before and After the Placement of a Flow Diverter, Highlighting the Significant Reduction in Blood Flow Within the Aneurysm After Diverter Placement <\/td>\n<\/tr>\n | ||||||
| 41<\/td>\n | Figure B-2.2.4.2-1 Model Risk Matrix for Example 2 <\/td>\n<\/tr>\n | ||||||
| 42<\/td>\n | B-2.3 Example 3: Stability and Adjustability of Hospital Beds <\/td>\n<\/tr>\n | ||||||
| 43<\/td>\n | Figure B-2.3.1-1 Schematic of a Hospital Bed <\/td>\n<\/tr>\n | ||||||
| 45<\/td>\n | B-2.4 Example 4: Radiofrequency-Induced Temperature Rise in Patients During Magnetic Resonance Imaging <\/td>\n<\/tr>\n | ||||||
| 46<\/td>\n | Figure B-2.4.1-1 Physical Test Set-Up and Computational Model Representation of a Gel Phantom Inside an MRI <\/td>\n<\/tr>\n | ||||||
| 48<\/td>\n | B-2.5 Example 5: Evaluation of the Locking Mechanism Strength of a Posterior-Stabilized Total Knee Arthroplasty Design <\/td>\n<\/tr>\n | ||||||
| 49<\/td>\n | Figure B-2.5.1-1 Schematic of a Posterior-Stabilized TKA Assembly <\/td>\n<\/tr>\n | ||||||
| 50<\/td>\n | Figure B-2.5.3-1 Matrix of Proposed COUs for a Tibial Component Anterior Liftoff Model Figure B-2.5.3.4-1 Potential Interactions Among Modeling, Testing, and Predicate Evaluation for COU4 <\/td>\n<\/tr>\n | ||||||
| 51<\/td>\n | Figure B-2.5.4-1 Impact of Benchtop Testing (BT) on Model Influence and Therefore Overall Model Risk <\/td>\n<\/tr>\n | ||||||
| 53<\/td>\n | Figure B-2.6.1-1 The ASTM Cage B-2.6 Example 6: Interbody Fusion Devices <\/td>\n<\/tr>\n | ||||||
| 54<\/td>\n | Figure B-2.6.1-2 Typical Compressive Load-Displacement Plot of a Fusion Cage <\/td>\n<\/tr>\n | ||||||
| 56<\/td>\n | Table B-2.6.5.1.1-1 Model Risk Summary Table B-2.6.5.1.1-2 System Configuration: Minimum Level of Credibility Needed for the COUs <\/td>\n<\/tr>\n | ||||||
| 57<\/td>\n | Table B-2.6.5.1.1-3 System Properties: Minimum Level of Credibility Needed for the COUs Table B-2.6.5.1.2-1 Comparator Validation: Measurement Uncertainty <\/td>\n<\/tr>\n | ||||||
| 58<\/td>\n | Table B-2.6.5.1.3-1 Equivalency of Input Parameters Table B-2.6.5.2-1 Relevance of the QOIs <\/td>\n<\/tr>\n<\/table>\n","protected":false},"excerpt":{"rendered":" ASME VV-40 – 2018 Assessing Credibility of Computational Modeling through Verification and Validation: Application to Medical Devices<\/b><\/p>\n |