title: Challenges and regulatory considerations in the acoustic measurement of high-frequency (>20 MHz) ultrasound.
abstract: This article examines the challenges associated with making acoustic output measurements at high ultrasound frequencies (>20 MHz) in the context of regulatory considerations contained in the US Food and Drug Administration industry guidance document for diagnostic ultrasound devices. Error sources in the acoustic measurement, including hydrophone calibration and spatial averaging, nonlinear distortion, and mechanical alignment, are evaluated, and the limitations of currently available acoustic measurement instruments are discussed. An uncertainty analysis of acoustic intensity and power measurements is presented, and an example uncertainty calculation is done on a hypothetical 30-MHz high-frequency ultrasound system. This analysis concludes that the estimated measurement uncertainty of the acoustic intensity is +73%/-86%, and the uncertainty in the mechanical index is +37%/-43%. These values exceed the respective levels in the Food and Drug Administration guidance document of 30% and 15%, respectively, which are more representative of the measurement uncertainty associated with characterizing lower-frequency ultrasound systems. Recommendations made for minimizing the measurement uncertainty include implementing a mechanical positioning system that has sufficient repeatability and precision, reconstructing the time-pressure waveform via deconvolution using the hydrophone frequency response, and correcting for hydrophone spatial averaging.
authors.affiliation: MSEE, SonoSite, Inc, 21919 30th Dr SE, Bothell, WA 98021-3904 USA., sam.nagle@sonosite.com.
authors.forename: Samuel M
authors.initials: SM
authors.lastname: Nagle
authors.forename: Guru
authors.initials: G
authors.lastname: Sundar
authors.forename: Mark E
authors.initials: ME
authors.lastname: Schafer
authors.forename: Gerald R
authors.initials: GR
authors.lastname: Harris
authors.forename: Shahram
authors.initials: S
authors.lastname: Vaezy
authors.forename: James M
authors.initials: JM
authors.lastname: Gessert
authors.forename: Samuel M
authors.initials: SM
authors.lastname: Howard
authors.forename: Mary K
authors.initials: MK
authors.lastname: Moore
authors.forename: Richard M
authors.initials: RM
authors.lastname: Eaton
mesh_terms: D016477:Artifacts; D054459:Elasticity Imaging Techniques / Q000592:standards*; D033161:Government Regulation; D007089:Image Enhancement / Q000592:standards*; D015203:Reproducibility of Results; D012680:Sensitivity and Specificity; D014481:United States
keywords: Food and Drug Administration track 3 clearance; acoustic measurement uncertainty; high-frequency ultrasound; hydrophone measurement errors; premarket notification