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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%
1 ms
0.1 s
<1000 ms time
>1000 ms time
Velocity in Doppler mode
10%
0.1 cm/sec
1 beat per minute