Appendix A: Clinical Performance Summary; Introduction; Selection Criteria - Konica Minolta JM-103 User Manual

Introduction

The Jaundice Meter (JM-103) has been the subject of three clinical
studies. One study in Japan, the other two studies in the United States.
The following information is a summary of results from the two US
studies.
The purpose of the JM 103 is to measure the yellowness of
subcutaneous tissue in the neonate. This measurement can be correlated
to serum bilirubin concentration and is therefore an aid in the
management of neonatal jaundice. Since this device performs
measurement through the use of light it is non-invasive and painless for
the infant. The objective of the clinical studies was to confirm that the
device measurement, displayed in units of estimated bilirubin
concentration, does correlate with the serum bilirubin concentration
sufficiently well to warrant its use as a screening tool.
The following is a summary of the study protocols:

Selection Criteria

The patient selection criteria used for the study included infants less
than 30 days old and weighing greater than 1000 grams. The test was
performed on infants who were determined by their physician to require
a serum bilirubin test. A tabulation of weight distribution is provided in
graph 22 Infant Weight Distribution. Error plots by weight are provided
in graphs 23 Clinical Study Site A Birthweight Error Plot, Forehead and
24 Clinical Study Site A Birthweight Error Plot, Sternum.
Demographics of Patient Population
All patients meeting the above criteria were included in the study. There
was significant effort to ensure that there was sufficient representation
of all skin pigmentation to verify that the JM 103 could be used across
all populations with consistent results. The demographics of the patient
population included Caucasian, African-American, and other.
Jaundice Meter (JM-103) User Manual (usr070rb)
Clinical Performance Summary
Appendix A
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