Literature Screening Criteria
During the initial screening phase (reading titles and abstracts), only peer-reviewed literature published in English or Chinese that includes relevant clinical data will be included in the analysis. The specific inclusion and exclusion criteria are as follows:
| Inclusion Criteria | Exclusion Criteria |
|---|---|
| 1. Peer-reviewed literature | 1. In vitro, preclinical, laboratory (including animal in vivo) studies |
| 2. Literature published in scientific, peer-reviewed journals | 2. Narrative reviews, abstracts, case reports, published article comments, emails |
| 3. Independent review literature | 3. Literature without quantitative outcome data |
| 4. Published controlled clinical trials | 4. Duplicate studies: data from the same cohort with similar time spans previously published |
| 5. Significant clinical experience data for comparator devices (only contributory data included; other data see Exclusion Criterion 5) | 5. Clinical trials of different technologies/devices (non-comparator devices) |
| 6. Unpublished clinical data | 6. Literature published in languages other than English/Chinese |
| 7. Literature in English or Chinese |
Note: For literature screening in compliance with EU MDR requirements, only English literature needs to be included.
Note on Ethical Constraints: For indications where randomized controlled trials (RCTs) or placebo-controlled studies are ethically prohibited (e.g., emergency treatments where withholding intervention would endanger patients), case reports and case series of any sample size should be retained as valid clinical evidence for that specific indication. This is consistent with MDR Article 61(1) which requires the level of clinical evidence to be "appropriate in view of the characteristics of the device and its intended purpose", and MDCG 2020-6 Section 6.5e which allows a lower level of clinical evidence to be justified as sufficient in exceptional cases. MDCG 2020-6 Appendix III (Rank 9) explicitly recognizes individual case reports as clinical data under MDR Article 2(48). Exclusion Criterion 2 (case reports) should therefore be applied with professional judgment when ethical constraints exist for specific indications.