Clinical Evaluation Systematic Literature Review - Apec-ahc.org

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Evaluation of Type III Study Ref No Design • All studies analyzed as below • Not all parameters included . Ref Study Name Level of Evidence 10 XX Retrospective Comparative study Study Design Selection Criteria Clear? Subjects with similar state of disease? Were controls Randomly selected from population? Groups Comparable at baseline? Adequate controls for potential confounders? Blinded outcome Assessors? Yes Yes Yes Yes NA No Yes Evaluation of Type IV Study Ref No Design • All studies analyzed as below • Not all parameters included . Ref Study Name Level of Evidence 10 XX Retrospective Comparative study Study Design Selection Criteria Clear? Subjects with similar state of disease? Were controls Randomly selected from population? Groups Comparable at baseline? Adequate controls for potential confounders? Blinded outcome Assessors? Yes Yes Yes Yes NA No Yes Matching Appropriate? Matching Appropriate? 26
Clinical Evaluation Stage 2 Example 8 studies identified from XXX Database 3 studies identified from XXX search 1 study identified from secondary search 109 studied identified from the XXX search engine 13 potential studies identified from searches, analyzed and included in review 25 studies included 8 National Knee arthroplasty registers included 100 studies excluded: No clinical outcomes were reported studies on kinematics studies not on knee product Methodological Quality of Included Studies • Non-randomized prospective comparative studies (Level II) were the largest group of cases (48%) obtained from the searches • The second largest group obtained from the searches were either retrospective or prospective case series Level IV (40%). • Follow-up of the clinical outcomes • No control groups or randomization of cases. • Two Level III, case-control studies were included • One Level I randomized control trial (RCT) 27
Page 1 and 2: Clinical Evaluation Systematic Lite
Page 3 and 4: Clinical Evidence - Key Definitions
Page 5 and 6: Effects of Unnecessary Clinical Tri
Page 7 and 8: Effects of Unnecessary Clinical Tri
Page 9 and 10: FDA Submissions Requiring Clinical
Page 11 and 12: MEDDEV. 2.7.1 Rev 3 • Clinical Ev
Page 13 and 14: Data Generated Through Literature S
Page 15 and 16: Data from Clinical Investigations
Page 17 and 18: Qualifications of Evaluators • As
Page 19 and 20: Risk Analysis Requirements • Noti
Page 21 and 22: Methodology for Systematic Review
Page 25: Ref No Evaluation of Type I Study
Page 29 and 30: Evidence of Clinical Performance
Page 31 and 32: Survivorship - Overall • Survivor
Page 33 and 34: Qualifications of Evaluators in Exa
Page 35 and 36: Risk Analysis For The Intervention
Page 37 and 38: Clinical Evaluation Stage 2 MEDDEV
Page 41 and 42: Clinical Evaluation Stage 2 Example
Page 43 and 44: Evidence of Clinical Performance
Page 45 and 46:
Survival Data • Data from all 30
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Clinical Evaluation Systematic Literature Review - Apec-ahc.org

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