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The methodological quality of subject-specific finite element analysis papers depends on the rigor of the study design and detailed description of key elements, while assessment instruments are often confined to clinical trials or quasi-experiments. This study aims to present an instrument for methodological quality assessment of single-subject finite element analysis used in computational orthopaedics (MQSSFE). Based upon existing instruments and relevant review papers, a pilot version was developed consisting of 37 items with 6 domains, including study design and presentation of findings, subject recruitment, model reconstruction and configuration, boundary and loading conditions (simulation), model verification and validation, and model assumption and validity. We interviewed four experts in the field to assess the face validity and refined the instrument. The instrument was tested for interrater reliability among two assessors on nine finite element study papers. Also, the criterion validity was evaluated by comparing the similarity of the MQSSFE and the modified Down and Black instrument. The intraclass correlation coefficient was 0.965, while the MQSSFE was significantly moderately correlated with the modified Down and Black instruments (r = 0.61). We believed that MQSSFE was adequately appropriate, reliable, and valid for assessing the methodological quality for finite element studies used in computational orthopaedics. The instrument could facilitate quality assessment in the systematic reviews of finite element models and checklists for fidelity.
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