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Nelson Lu

Center for Devices and Radiological Health, US Food and Drug Administration



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Yunling Xu

Center for Devices and Radiological Health, US Food and Drug Administration



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44 – Trial Design and Analysis Issues in Medical Devices

On Weighted Performance Goals in Medical Device Single-Arm Clinical Studies

Sponsor: Section on Medical Devices and Diagnostics
Keywords: performance goal, medical device, subgroup

Nelson Lu

Center for Devices and Radiological Health, US Food and Drug Administration

Yunling Xu

Center for Devices and Radiological Health, US Food and Drug Administration

Under some circumstances, a pre-market application of medical devices may be supported by a single arm study where clinical endpoint is compared with a performance goal (PG). Occasionally, performance is expected to be different between two clinically defined subgroups of patients, and an approach based on a weighted PG is adopted. In this article, we discuss considerations of current practice where weights need to be pre-specified and fixed. We also propose an approach which relaxes the fix weights requirement.

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