Olympus BF-UC180F - Clinical Measurement Accuracy with Hitachi Diagnostic Ultrasound System

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Appendix C: Acoustic Output Information in Accordance with the FDA Guidance: “Information for Manufacturers
ULTRASONIC BRONCHOFIBERVIDEOSCOPE BF-UC180F
 Acoustic measurement uncertainty
Clinical measurement accuracy with Hitachi diagnostic
ultrasound system
 When combined with SSD-5
Quantity Uncertainty (95% confidence)
W 8.07%
PII 12.87%
Pr 7.63%
Fc 2.39%
Measurement feature General
accuracy
Round-off accuracy
Distance in B-mode
3%
0.01 cm
0.1 cm
<10 cm distance
>10 cm distance
Area by trace in B-mode
6%
0.01 cm
2
0.1 cm
2
<100 cm
2
area
>100 cm
2
area
Circumference by trace
B-mode
6%
0.01 cm
0.1 cm
<10 cm distance
>10 cm distance
Area by ellipses in B-mode
5%
0.01 cm
2
0.1 cm
2
<100 cm
2
area
>100 cm
2
area
Volume in B-mode
7%
0.01 cm
3
<100 cm
3
area
Excrusion in M-mode
3%
0.01 cm
0.1 cm
<10 cm distance
>10 cm distance
Time interval in M-mode
3%
1ms
0.1 s
<1000 ms time
>1000 ms time
Velocity in Doppler mode 10% 0.1 cm/sec
Heart rate 1BPM or 5% 1 beat per minute