Performance Data - Dräger JM-103 Instructions Manual

Performance Data

The data in the following sections, as well as Appendix B, is provided to
demonstrate the performance of the Jaundice Meter. This series of
graphs shows 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) as explained in Sections 4 and 5. 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. Refer
to the graphics results provided in this appendix for the results of studies
at hospital sites. To address device performance in doctors' office
setting, a study of 201 infants was performed. Results showed similar
performance at doctors' offices as shown in Appendix B. The data for
the doctors' office setting contained no forehead measurements as all
measurements were taken at the sternum. This data correlated well with
prior sternum data (refer to page A-12). The serum bilirubin
measurements were taken using direct spectrophotometry in Clinical
Study A and specifically with the Beckman-Coulter Synchron LX-20 in
Hospital Study B. Both systems were used in the doctors' office study as
well.
Graph 1 – Hospital Study Site A All Patients, Forehead
Jaundice Meter Instructions for Use (MU01380)
DRAFT 20 June 2005
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