Performance Data - Konica Minolta JM-103 User Manual

Sample Size
The total number of infants in the sample population was 613.
Measurement Selection
One study followed a protocol where three measurements were taken,
each measurement was recorded and then the three measurements were
averaged. The second study took one measurement only. Estimated
bilirubin measurements taken during the studies ranged from 1.1 to 20.8
mg/dL.
Body Sites Tested
In both studies the measurements were taken on the forehead and
sternum each time the measurements were taken for a given patient.
Number of Clinical Sites
There were two clinical sites that participated in the study. Clinical
study site A with 513 patients studied. Clinical study site B with 100
patients studied.

Performance Data

The following data is provided to demonstrate the performance of the
JM 103 in the clinical use environment. This series of graphs show the
correlation of the estimated bilirubin concentration taken non-invasively
with the JM 103 to the actual serum bilirubin concentration measured
from a blood sample taken from the patient (TSB). The device operates
over a range of 0.0 – 20.0 mg/dL (0 – 340 µmol/L). The data include
graphs in the form of x-y plots where x is the total serum bilirubin
concentration measured and y is the JM 103 estimated bilirubin
measurement. Forehead and sternum were not combined because the
data would be too difficult to distinguish. The serum bilirubin
measurements were taken using direct spectrophotometry in Clinical
Study A and specifically with the Beakman-Colter Synchron LX-20by
in Clinical Study B.
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