BiOSENCY BORA Band SpO2 Validation Study
Condition: Hypoxia
MeSH terms: Hypoxia
Study type: Interventional

Summary: 
      The purpose of this clinical study is to validate the SpO2 accuracy of the BiOSENCY BORA
      BAND™ wristband Pulse Oximeter during non-motion conditions over the range of 70-100% SaO2 as
      compared to arterial blood samples assessed by CO-Oximetry. The end goal is to provide
      supporting documentation for the SpO2 accuracy validation of BORA BAND™ wristband Pulse
      Oximeter.

      It is required that the Accuracy Root Mean Square (ARMS) performance of the BORA BAND™
      wristband Pulse Oximeter will meet a specification of 3.5 or better in non-motion conditions
      for the range of 70 - 100% SpO2 thereby demonstrating an acceptable SpO2 accuracy performance
      specification.
    

Detailed description: 
      The SpO2 accuracy performance of BiOSENCY BORA BAND™ wristband Pulse Oximeter will be
      evaluated during non-motion conditions over the range of 70-100% SaO2 and compared to
      arterial blood samples assessed by CO-Oximetry. A minimum of 10 healthy adult male and female
      subjects, ranging in age and pigmentation from light to dark, will be enrolled in the study
      to meet the study design requirements defined by ISO 80601-2-61:2017 and by the FDA's
      Guidance for Pulse Oximeters (March 4, 2013). The subjects will have an arterial catheter
      placed in the radial artery to allow for simultaneous blood samples during stable plateaus of
      induced hypoxic levels. The investigational device will be placed on the wrist opposite for
      the test per the instructions for use. Simultaneous data collection will be set up for the
      system under test and control oximeter.

      For the data analysis, the control oximeter will be used to assess the stability of each data
      point. Data that is found to be unstable will be removed prior to the comparative analysis.
      The CO-Oximeter data will be reviewed to make sure it does not contain any anomalous values
      such as elevated, low or inconsistent COHb, MetHb, or tHb data. Anomalous values will be
      removed from the analysis prior to pairing of the SpO2 and SaO2 data. The statistical
      analysis is performed on a minimum of 200 data points collected from at least 10 subjects for
      the range of 70% to 100% SaO2 with allowance of ± 3% of the target range. Functional SaO2 as
      measured by Reference CO-Oximetry will be used as the basis for comparison. The Accuracy Root
      Mean Square (ARMS) calculation is used to determine the SpO2 accuracy performance. Success
      will be achieved with an ARMS of 3.5 or better showing equivalence to the Gold Standard
      Reference CO-Oximetry providing documentation to support SpO2 accuracy claims for the
      investigational device.

      The study population will include 10-15 healthy non-smoking (or has refrained from smoking
      for 2 days) competent adults, 18-50 years of age. The subject selection will be an equitable
      distribution of males and females of any race with varying skin tones including at least 2
      darkly pigmented subjects or 15% of the subject pool, whichever is larger. The subjects must
      understand the study and consent to participate by signing the Informed Consent Form. The
      subjects must be healthy showing no evidence of medical problems as indicated by
      satisfactorily completing the health assessment form.
    

Intervention name(s): BORA Band SpO2 Validation Study
Intervention type(s): Device
Intervention description(s): Qualified healthy volunteers will be enrolled into the study. Subjects will recline for the study. Reference sensor(s) will be placed on each subject to evaluate the SpO2 accuracy and performance. Shield material may be used between any adjacent finger sensors to prevent optical crosstalk.
Simultaneous data collection will be set up for device under test and the control pulse oximeter. The data from the test device will be collected by the sponsor or trained Clinimark Study staff. Data will be collected for 1 second intervals data analysis. The SpO2 accuracy of the test devices will be evaluated over the oxygen saturation range between 70-100%.
The investigational device will only be placed on the wrist. The control pulse oximeter may be alternated through fingers between subjects.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Device Feasibility
Keywords: Pulse oximetry