CE脊柱移植物封闭系统临床评估报告Clinical Evaluation Report -template (MEDDEV.2.7.1 Rev4).docx

Inion Oy Clinical Evaluation Report PAGE 21 Inion Spinal Graft Containment System (S-1TM/S-2TM) Confidential Company Name Clinical Evaluation Report PAGE 1 Product Name Confidential Clinical Evaluation Report Product Name Evaluators: Name, Title Name, Title Name, Title Reviewed by: Name, Title Name, Title Approved by: Name, Title Name, Title Table of contents TOC \o 2-3 \h \z \t Heading 1;1 Executive summary 4 1. Scope of the clinical evaluation 5 1.1 Device description 5 1.1.1 Components 6 1.1.2 Materials 11 1.1.3 Mechanical characteristics 11 1.1.4 Principles of operation 12 1.1.5 Chemical characteristics 12 1.2 Intended purpose of the device 12 1.3 Changes since the last report 14 1.4 Relevant regulations 14 2. State of the art 16 3. Identification of relevant clinical data 23 3.1 Literature search strategy 23 3.1.1 Clinical literature search 24 3.1.2 Data selection of clinical literature search results 26 3.1.3 Adverse event database search 27 4. Summary and appraisal of the clinical data 28 4.1 Criteria for suitability 28 4.2 Criteria for data contribution 29 4.3 Selection criteria 29 5. Data analysis 31 5.1 Performance 31 5.2 Safety 37 5.3 PMS data 41 5.4 Requirement on acceptable benefit/risk profile 46 5.5 Requirement on acceptability of side effects 47 5.6 Product documentation and instructions for use 47 6. Conclusions 47 7. Next clinical evaluation 48 8. Dates and signatures 49 9. Qualification of the responsible evaluator 50 10. Declaration of interests 50 11. References 51 12. Appendices 54  LIST OF TABLES TOC \h \z \t Block Text;1 \c Kuva Table 1. List of implants, Inion S-1TM System 7 Table 2. List of implants, Inion S-2TM System 8 Table 3. List of accessory instruments, Inion S-1 and Inion S-2 systems 9 Table 4. Change Log - Clinical Evaluation Inion Spinal Graft Containment System? 14 Table 5. International standards