Taiwan Biophotonic
Corporation (tBPC)

We take the development of people’s health as its responsibility.
oCareTM Wrist Pulse Oximeter

oCare Pro 100

It is the world’s first wearable pulse oximeter that works without a traditional fingertip probe which causes uncomfortable or thrombosis for patients. This device has demonstrated superior accuracy and usability through the data derived for numerous clinical trials.

Approved Certification

US FDA

US FDA 510(K)

NO. K183556
Taiwan FDA

Taiwan FDA

NO. 005860
CE

Europe CE Marking

NO. TW19/20044
TGA

Australia TGA

NO. DV-2017-MC-20124-1

Clinical Validation

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Clinical Performance:
The clinical performance data was collected in Taipei Medical University Hospital during 08/2018 ~ 10/2018 and received prior approvals from the Institutional Review Board (IRB) of the hospital and the Taiwan Food and Drug Administration (TFDA). This clinical validation was conducted following ISO 14155:2011, ISO 80601-2-61, and FDA guidance for pulse oximeters. The study was conducted as a comparative measurement, patients wore oCare Pro 100 to measure SpO2 levels and used CO-Oximeter to analyze SaO2 levels with an arterial blood sample at the same time. Data were collected from 15 human subjects with 8 males and 7 females of ages 20~40 years old.

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Summary I

A total of 215 pairs of SpO2 and SaO2 data was recorded from 15 human subjects during the controlled desaturation process approved for clinical investigation. The Arms value calculated is 2.68% (Arms < 4% ISO 80601-02-61), and it demonstrates that the SpO2 accuracy of the subject device is within ± 3%.

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Root-Mean-Squared Equation
  • SpO2i: SpO2 measured by the Subject Device during the arterial blood sampling i.
  • SRi : the SaO2 analyzed by the CO-Oximeter with the arterial blood sampling i.
  • n: total number of data pairs for this analysis.
  • Arms < 4% ISO 80601-02-61.

Figure 1: Scatter Plot

Figure 1. shows the Scatter plot of SpO2 levels measured by oCare Pro 100 versus SaO2 levels analyzed by the CO-Oximeter, with a significant R2 correlation of 0.95 on linear regression.

Item 70~100% 70~<80% 80~<90% 90~100%
# of points
215
56
79
80
Bias
1.63
1.37
2.00
1.44
Arms
2.68
2.84
2.97
2.23
Max difference
7.6
7.6
6.3
5.9
Min difference
0.0
0.0
0.0
0.0

Summary II

There are 95.81% (206/215) of data points have fallen within 95% limits of agreement, which indicates that SpO2 levels measured by oCare Pro 100 are in good agreement with the SaO2 levels measured by the CO-Oximeter. The precision is 2.13%, according to the standard deviation of the residual equation.

Sres
Sres: Standard deviation of the residuals
  • n : the number of data pairs in the sample.
  • SpO2i – SpO2fit,i : the difference between the ith SpO2 datum and the value of the fitted curve corresponding to the ith reference value.

Figure 2: Bland-Altman Plot

Figure 2. shows the Bland-Altman Plot of SpO2 levels measured by oCare Pro 100 and SaO2 levels analyzed by the CO-Oximeter where, X axis represents the SaO2 range of 70~100% and Y axis represents the difference of SpO2 and SaO2.

# of Points Sres (%) Std. Deviation Bias # of Points beyond the 95% LOA
215
1.91
2.13
1.63
9
  • LOA: Limit of Agreement.
  • Sres: Standard deviation of the residuals.