ASME VV 40 2018
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ASME VV-40 – 2018 Assessing Credibility of Computational Modeling through Verification and Validation: Application to Medical Devices
| Published By | Publication Date | Number of Pages |
| ASME | 2018 | 61 |
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.
PDF Catalog
| PDF Pages | PDF Title |
|---|---|
| 4 | CONTENTS |
| 6 | FOREWORD |
| 8 | ASME V&V Committee Roster |
| 9 | CORRESPONDENCE WITH THE V&V COMMITTEE |
| 12 | 1 EXECUTIVE SUMMARY 2 INTRODUCTION 2.1 Motivation |
| 13 | 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 |
| 14 | 3 CONTEXT OF USE 4 MODEL RISK 4.1 Model Influence |
| 15 | 4.2 Decision Consequence Figure 4.2-1 Schematic of How Model Influence and Decision Consequence Determine Model Risk |
| 16 | 5 MODEL CREDIBILITY Tables Table 5-1 Verification, Validation, and Applicability Activities and Their Associated Credibility Factors |
| 17 | 5.1 Verification 5.1.1 Code Verification |
| 18 | 5.1.2 Calculation Verification 5.2 Validation 5.2.1 Computational Model |
| 19 | 5.2.2 Comparator |
| 22 | 5.3 Applicability of the Validation Activities to the COU |
| 23 | 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 |
| 24 | 6 THE PLAN 7 CREDIBILITY ASSESSMENT |
| 25 | Figures Figure 7-1 Example Workflow for Assessing Computational Model Credibility |
| 26 | 8 DOCUMENTATION AND EVIDENCE |
| 27 | MANDATORY APPENDIX I REFERENCES |
| 28 | MANDATORY APPENDIX II GLOSSARY |
| 30 | 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 |
| 31 | 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 |
| 32 | 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 |
| 33 | Table B-1-1 Mapping of Examples to Selected Credibility Factors Table B-1-2 Mapping of Examples to Device Type and Modeling Approach |
| 34 | Figure B-2.1.1-1 Illustration of a Centrifugal Blood Pump Design B-2.1 Example 1: Assessing Hemolysis in Centrifugal Blood Pumps |
| 36 | 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 |
| 39 | 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 |
| 40 | 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 |
| 41 | Figure B-2.2.4.2-1 Model Risk Matrix for Example 2 |
| 42 | B-2.3 Example 3: Stability and Adjustability of Hospital Beds |
| 43 | Figure B-2.3.1-1 Schematic of a Hospital Bed |
| 45 | B-2.4 Example 4: Radiofrequency-Induced Temperature Rise in Patients During Magnetic Resonance Imaging |
| 46 | Figure B-2.4.1-1 Physical Test Set-Up and Computational Model Representation of a Gel Phantom Inside an MRI |
| 48 | B-2.5 Example 5: Evaluation of the Locking Mechanism Strength of a Posterior-Stabilized Total Knee Arthroplasty Design |
| 49 | Figure B-2.5.1-1 Schematic of a Posterior-Stabilized TKA Assembly |
| 50 | 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 |
| 51 | Figure B-2.5.4-1 Impact of Benchtop Testing (BT) on Model Influence and Therefore Overall Model Risk |
| 53 | Figure B-2.6.1-1 The ASTM Cage B-2.6 Example 6: Interbody Fusion Devices |
| 54 | Figure B-2.6.1-2 Typical Compressive Load-Displacement Plot of a Fusion Cage |
| 56 | 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 |
| 57 | 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 |
| 58 | Table B-2.6.5.1.3-1 Equivalency of Input Parameters Table B-2.6.5.2-1 Relevance of the QOIs |
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