Specification of acoustic output level and measurement uncertainty in ultrasonic exposimetry.
This manuscript was written to bring together the pertinent statistical procedures for specifying acoustic output values and measurement uncertainties of ultrasound devices, and to present them in a way that would be clear and convenient to the reader. Implementations of these procedures are illustrated in several examples: measurement of ultrasonic power of a single transducer, measurement of the power output of a transducer model, and measurement of the power output of an ultrasound scanner series. This manuscript is intended to be helpful to ultrasound device manufacturers who need to specify these quantities when applying for Food and Drug Administration (FDA) approval to market their new devices. It also is intended to be helpful to ultrasound users who need to interpret these values in order to meaningfully evaluate the relative risks and benefits of performing ultrasound examinations on their patients.
Ziskin
Marvin C
MC
Center for Biomedical Physics, Temple University Medical School, Philadelphia, PA 19140, USA. ziskin@temple.edu
D018795:Device Approval / Q000592:standards; D008954:Models, Biological; D015233:Models, Statistical; D011829:Radiation Dosage; D011874:Radiometry / Q000295:instrumentation / Q000379:methods* / Q000592:standards; D015203:Reproducibility of Results; D018570:Risk Assessment / Q000379:methods*; D012680:Sensitivity and Specificity; D014463:Ultrasonography / Q000295:instrumentation / Q000379:methods* / Q000592:standards