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PD IEC TS 62791:2022 Ultrasonics. Pulse-echo scanners. Low-echo sphere phantoms and method for performance testing of grey-scale medical ultrasound scanners applicable to a broad range of transducer types, 2022
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- CONTENTS
- FOREWORD
- INTRODUCTION
- 1 Scope
- 2 Normative references
- 3 Terms and definitions
- 4 Symbols
- 5 General and environmental conditions
- 6 Equipment required [Go to Page]
- 6.1 General
- 6.2 Phantom geometries [Go to Page]
- 6.2.1 Low-contrast phantoms for assessing the ability to delineate tumour boundaries
- 6.2.2 High-contrast phantoms to evaluate scanner performance, tune scanner pre-sets, and detect defects in probes
- 6.2.3 Total internal reflection surfaces
- 6.2.4 Spatially random distribution of low-echo spheres
- 6.3 Ultrasonic properties of the tissue-mimicking (TM) phantoms
- 7 Data acquisition assuming a spatially random distribution of low-echo spheres [Go to Page]
- 7.1 Methodology [Go to Page]
- 7.1.1 General
- 7.1.2 Mechanical translation
- 7.1.3 Manual translation with cine-loop recording
- 7.2 Storage of digitized image data
- Figures [Go to Page]
- Figure 1 – Flow chart
- 7.3 Digital image files available from the scanner itself
- 7.4 Image archiving systems
- 8 Automated data analysis for quantifying low-echo sphere detectability [Go to Page]
- 8.1 General
- 8.2 Computation of mean pixel values (MPVs)
- Figure 2 – Schematic of the image plane nearest to the nth low-echo sphere and not influenced by the presence of an image boundary
- Figure 3 – Modification of Figure 2 showing a vertical image boundary (solid line) and a parallel dashed line, between which (MPV)ijk values are excluded from computation of SmBn or σBn in Formula (2)
- Figure 4 – Limiting case of Figure 3 where the vertical image boundaryis tangent to the imaged low-echo sphere
- Figure 5 – Modification of Figure 2 showing a 45° sector image boundary (solid line) and a parallel dashed line, between which (MPV)ijk values are excluded from computation of SmBn or σBn in Formula (2)
- 8.3 Additional restrictions for sector images [Go to Page]
- 8.3.1 Convex arrays
- Figure 6 – Limiting case of Figure 5 where the 45° sector imageboundary is tangent to the imaged low-echo sphere [Go to Page]
- 8.3.2 Phased arrays
- 8.4 Determination of the LSNRm-value for a given depth interval [Go to Page]
- 8.4.1 Preliminaries
- 8.4.2 Computation of LSNRmd for depth interval label d
- 8.4.3 Standard error corresponding to each LSNRmd-value
- 9 Visual assessments of images [Go to Page]
- 9.1 Image comparisons
- 9.2 Semi-quantitative image analysis
- Figure 7 – Usefulness of simple visual inspection of imagesof a standardized lowecho sphere phantom
- Figure 8 – Zones over which at least half of the spheres appear clearly outlined as a nearly full-size circle and are free of echoes (Zone 1) or an average of more than one sphere per slice can be discerned (Zone 2)
- Annex A (informative)Example of a phantom for performance testingin the 1 MHz to 7 MHz frequency range [Go to Page]
- Figure A.1 – End view of the phantom applicable for 1 MHz to 7 MHz showing the spatially random distribution of 3,2-mm-diameter, −6 dB spheres
- Figure A.2 – Top view of phantom with 3,2-mm-diameter, −6 dB spheres
- Annex B (informative)Illustrations of the computation of LSNRmd-valuesas a function of depth [Go to Page]
- Figure B.1 – Convex-array image of a prototype 4-mm-diameter,−20 dB sphere phantom for use in the 1 MHz to 7 MHz frequency range
- Figure B.2 – Auxiliary figures relating to Figure B.1
- Figure B.3 – Results corresponding to Figure B.1 and Figure B.2,demonstrating reproducibility
- Figure B.4 – Results corresponding to Figure B.1, Figure B.2 and Figure B.3
- Figure B.5 – One of 80 parallel, linear-array images of the phantom containing 4mmdiameter, −20 dB spheres, imaged at 4 MHz with the transmit focus at 3 cm depth
- Figure B.6 – Three successive images of the set of 80 frames addressed in Figure B.5, where imaging planes were separated by D/4 equal to 1 mm
- Figure B.7 – Results for the 4-cm-wide, 3-cm-focus, linear array addressedin Figure B.5 and Figure B.6 using all 80 image frames in two sets
- Figure B.8 – Results for the 4-cm-wide, 3-cm-focus, linear array addressedin Figure B.5, Figure B.6 and Figure B.7, using all 80 image framescorresponding to Figure B.7 in one set
- Annex C (informative)Sufficient number of data images to assurereproducibility of results [Go to Page]
- C.1 General
- C.2 Phantom with 3,2-mm-diameter, −20 dB low-echo sphere, having two spheres per millilitre
- Figure C.1 – One image obtained from a phantom containing 3,2-mm-diameter,−20 dB spheres by using a 4 MHz linear array focused at 3 cm depth
- Figure C.2 – Reproducibility result for two independent sets of 70 images with a mean number of low-echo sphere centres that is about 15 per 5 mm-depth interval
- Figure C.3 – Results obtained by combining both sets of 70 independentimages corresponding to Figure C.2 into a single, 140-image set
- Figure C.4 – Sector image (curved array) at 4,5 MHz with multiple transmit foci at 4 cm,8 cm and 12 cm depths; the −20 dB spheres are 3,2 mm in diameter
- Figure C.5 – Reproducibility results for a multiple transmit-focus(4 cm, 8 cm and 12 cm) case corresponding to Figure C.4
- Figure C.6 – Reproducibility results for the case corresponding to Figure C.5,except that there is a single focus at a 10 cm depth
- Figure C.7 – Reproducibility results for the case corresponding to Figure C.5,except that there is a single transmit focus at 4 cm depth
- C.3 Phantom with 2-mm-diameter, −20 dB spheres and eight spheres per millilitre
- Figure C.8 – Image of a phantom containing 2-mm-diameter, −20 dB spheres, made with a curved array having a 1,5 cm radius of curvature, with its transmit focus at 3 cm depth
- Figure C.9 – Reproducibility results corresponding to Figure C.8
- Figure C.10 – Results using all 100 images in the image set that gave rise to Figure C.9
- Figure C.11 – Image of a phantom containing 2-mm-diameter, −20 dB spheres, made with a high-frequency (15 MHz) linear array and a transmit focus of 4 cm depth
- Figure C.12 – Reproducibility results corresponding to Figure C.11
- Figure C.13 – Results using all 200 images in the image set that gave rise to Figure C.12
- Annex D (informative)Example of a phantom for performance testingin the 7 MHz to 23 MHz frequency range [Go to Page]
- Figure D.1 – End- and top-view diagrams of the phantom containing 2-mm-diameter, low-echo spheres with a backscatter level −20 dB relative to the background,for use in the 7 MHz to 23 MHz frequency range
- Figure D.2 – Image of the phantom containing 2-mm-diameter, −20 dB spheres [7], [8] obtained with a paediatric transducer with a radius of curvature of about 1,5 cm
- Annex E (informative)Determination of low-echo sphere positionsto within D/8 in x-, y- and z-Cartesian coordinates [Go to Page]
- E.1 Procedure
- Figure E.1 – Diagram discussed in the second paragraph of 3)
- E.2 Argument for the choice of seven MPV nearest-neighbour sites for determining the centres of low-echo spheres
- Annex F (informative)Tests of total internal reflection produced by aluminaand plate-glass, plane reflectors [Go to Page]
- Figure F.1 – Average of 10 images obtained by using a phased array transducer
- Figure F.2 – Mean and standard deviation of pixel value plotted against depthfrom the two rectangular regions seen in Figure F.1
- Figure F.3 – Same as Figure F.2, but for data obtained after the transducer was rotated 180°, so the plate-glass reflector appeared on the right side of the image
- Figure F.4 – The percentage by which the mean pixel values resulting from reflections differ from the mean pixel values not involving reflections plotted against depth
- Figure F.5 – Image obtained using a wide-sector (153°),1 cm radius-of-curvature transducer
- Figure F.6 – Mean pixel value and its standard deviation plottedagainst depth from the two rectangular regions in Figure F.5
- Figure F.7 – Same as Figure F.6, only the transducer was rotated 180°,so the alumina reflector was on the right side of the B-mode image
- Figure F.8 – The percentage by which the mean pixel values resulting from reflections differ from the mean pixel values not involving reflections
- Annex G (informative)Results of a test of reproducibility of LSNRmd as a function of depthfor a phantom with 4-mm-diameter, −20 dB spheres,having two spheres per millilitre [Go to Page]
- Figure G.1 – Example image of the phantom, taken with a 4,2 MHz curved array
- Figure G.2 – Reproducibility results corresponding to the two 40-image data subsets,one of which is shown in Figure G.1
- Annex H (informative)Results for low-echo sphere concentration dependence of LSNRmdas a function of depth for phantoms with 3,2-mm-diameter,−20 dB spheres [Go to Page]
- Figure H.1 – Example of an image from the 75-image, 4 ml−1 dataset producing the results shown in Figure H.2
- Figure H.2 – Results for the phantom containing four3,2-mm-diameter, −20 dB low-echo spheres per millilitre
- Figure H.3 – Example of an image from the 140-image, two spheresper millilitre data set producing the results shown in Figure H.4
- Figure H.4 – Results for the phantom containing two3,2-mm-diameter, −20 dB low-echo spheres per millilitre
- Figure H.5 – Example of an image from the 180-image, one sphereper millilitre data set producing the results shown in Figure H.6
- Figure H.6 – Results for the phantom containing one3,2-mm-diameter, −20 dB low-echo sphere per millilitre
- Annex I (informative)Comparison of two different makes of scannerwith similar transducers and console settings [Go to Page]
- Figure I.1 – Results for System A scanner and 7CF2 3-D (swept convex array) transducer focused at 4 cm depth and operated at 4,5 MHz in 2-D mode
- Figure I.2 – Results for System B scanner with a 4DC7-3 3-D (convex array) transducer focused at 4 cm depth and operated at 4 MHz in 2-D mode
- Annex J (informative)Special considerations for 3-D probes [Go to Page]
- J.1 3-D probes operating in 2-D imaging mode
- J.2 2-D arrays operating in 3-D imaging mode for determining LSNRmd-values as a function of depth for reconstructed images
- J.3 Mechanically driven 3-D probes operating in 3-D imaging mode
- Bibliography [Go to Page]
