Appendix A: Clinical Performance Summary; Introduction; Study Design - Dräger JM-103 Instructions Manual

Introduction

The Jaundice Meter has been the subject of clinical studies in Japan and
the United States. The following is a summary review of two clinical
studies in the US and a later study in the doctors' office setting.
Because 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, correlates with the serum bilirubin
concentration sufficiently to warrant its use as a screening tool.
The data in the following sections is provided to demonstrate results of
the JM-103 clinical studies, in comparison to total serum bilirubin. The
JM-103 reports values over a range of 0-20 mg/dL estimated bilirubin.
Appendix A pages A2 - A18 illustrate results of hospital site studies.
Appendix B pages B3 - B8 illustrate results of physicians' office site
studies.
The following is a summary of the study protocols:

Study Design

Selection Criteria
The patient selection criteria used for the studies included infants less
than 30 days old and weighing greater than 1000 grams. Although the
selection criteria was established as "less than 30 days of age," the
infants in the hospital studies were primarily NICU and newborn infants
unless their medical condition required a longer duration of care. 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.
Jaundice Meter Instructions for Use (MU01380)
DRAFT 20 June 2005
Clinical Performance Summary
Appendix A
Page A - 1