Journal article - Review
Challenges and regulatory considerations in the acoustic measurement of high-frequency (>20 MHz) ultrasound
Journal of ultrasound in medicine, v 32(11), pp 1897-1911
Nov 2013
PMID: 24154893
Featured in Collection : UN Sustainable Development Goals @ Drexel
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.
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Details
- Title
- Challenges and regulatory considerations in the acoustic measurement of high-frequency (>20 MHz) ultrasound
- Creators
- Samuel M Nagle (Corresponding Author) - SonoSite, Inc (United States, Bothell)Guru Sundar - FujiFilm VisualSonics (Canada)Mark E Schafer - Sonic Tech, Inc (United States, Lower Gwynedd)Gerald R Harris - United States Food and Drug AdministrationShahram Vaezy - United States Food and Drug AdministrationJames M Gessert - Acertara Acoustic Laboratories (United States, Longmont)Samuel M Howard - Onda Corporation (United States, Sunnyvale)Mary K Moore - SonoSite, Inc (United States, Bothell)Richard M Eaton - Medical Imaging & Technology Alliance (United States, Arlington)
- Publication Details
- Journal of ultrasound in medicine, v 32(11), pp 1897-1911
- Number of pages
- 15
- Resource Type
- Journal article
- Language
- English
- Academic Unit
- School of Biomedical Engineering, Science, and Health Systems
- Web of Science ID
- WOS:000326421700002
- Scopus ID
- 2-s2.0-84887232232
- Other Identifier
- 991019176801104721
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InCites Highlights
Data related to this publication, from InCites Benchmarking & Analytics tool:
- Collaboration types
- International collaboration
- Web of Science research areas
- Acoustics
- Radiology, Nuclear Medicine & Medical Imaging