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 Unpublished clinical data	6.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.