Considerations for simulation-based evaluation of noninvasive blood pressure monitors.
Noninvasive blood pressure (NIBP) simulators can potentially be used to evaluate the measurement accuracy of NIBP monitors. The simulated waveforms and their associated reference blood pressures should be based on physiologic waveforms and reference blood pressures obtained during actual NIBP measurement. For comparability, the minimum sample size for a simulation-based evaluation should be based on the same statistical characteristics as those used in clinical evaluation protocols. The minimum sample size has been determined to be 44 for paired-data waveforms and 84 for unpaired-data waveforms. For a mixture of paired-data and unpaired-data waveforms, their relative contributions to the total sample size can sbe easily determined. For comparability, the requirements and assessment criteria for a simulation-based evaluation should in general emulate or follow those of the clinical protocols. Although the considerations addressed in this article are intended primarily for evaluation of auscultatory and oscillometric blood pressure monitors, their underlying principles can be applied to evaluation of NIBP monitors that use other measurement methods.
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