TY - JOUR T1 - Creation of objective performance criteria among medical devices JF - BMJ Surgery, Interventions, & Health Technologies DO - 10.1136/bmjsit-2021-000106 VL - 4 IS - 1 SP - e000106 AU - Laura Elisabeth Gressler AU - Danica Marinac-Dabic AU - Susan dosReis AU - Philip Goodney AU - C. Daniel Mullins AU - Fadia Shaya Y1 - 2022/08/01 UR - http://sit.bmj.com/content/4/1/e000106.abstract N2 - Objectives Objective performance criteria (OPC) may serve as a tool to expedite the approval process and continue active surveillance of class III medical devices. Thus far, published guidance on the creation of OPC has been clinical area-specific. This study aimed to capture reflections from key stakeholders on the creation of OPC that may serve as a precursor for a formalized conceptual framework within the USA.Design Reflections from key stakeholders and guidance from an advisory committee were captured to gain an understanding of the elements that are crucial to the generation of OPC.Setting A non-probability sampling method using the purposive sampling strategy was employed to identify relevant stakeholders for engagement in semi-structured, open-ended, concept elicitation discussions.Participants Stakeholders involved in the generation of OPC.Main outcome measures Elements and themes regarding the priorities of, experiences with, roles within and perceived challenges associated with OPC creation captured through a phenomenological approach.Results A total of 27 participants were engaged to represent the following contributors: representatives of registries, health systems, health technology assessment bodies, clinicians, device application reviewers, payers, patients, patient representatives, patient caregivers, device manufacturers, data coordinators, data analysts and data informaticians. Consensus was achieved on the five core elements: (1) identification of medical devices, (2) engagement of key stakeholders, (3) selection of data source, (4) performance of appropriate statistical analyses and (5) reporting of findings. The engagement of key stakeholders (38%) was cited most frequently as the most important core element. Access to meaningful and high-quality data sources (47%) was the most frequently mentioned challenge.Conclusions The reflections from the participants identified five elements to be considered when generating an OPC within class III medical devices and may provide the needed foundation for the development of official guidance on OPC generation.Data may be obtained from a third party and are not publicly available. Not applicable. ER -