Belun SpO2 Accuracy Comparison to Arterial Blood CO-Oximetry
Condition: Hypoxia
MeSH terms: Hypoxia
Study type: Observational

Summary: 
      This study was a comparative, single-center, non-randomized study conducted to evaluate the
      SpO2 accuracy per standards and guidelines identified above for SpO2 accuracy for pulse
      oximetry equipment over the range of 70-100% SaO2 under non-motion conditions. Arterial blood
      sampling measured by functional SaO2 CO-Oximetry, was used as the basis for comparison.
      Testing was conducted under normal office environment conditions.
    

Detailed description: 
      Pulse oximetry monitoring is considered a standard physiological measurement and is used by
      clinicians in everyday situations to estimate arterial oxygen saturation. A pulse oximeter is
      a device that measures the oxygen saturation of arterial blood non-invasively. In general,
      pulse oximeters use two wavelength absorption spectrophotometry to measure oxygen saturation
      based on the amount of reflected or scattered radiation. The wavelengths are selected to
      provide the best separation of absorbencies of oxy-hemoglobin (O2Hb) and deoxy-hemoglobin
      (HHb) states. The ratio of the two absorbencies is used to calculate the oxygen saturation
      (SpO2) value. Because an arterial sample of blood is not required to make the measurement,
      the pulse oximeter can provide non-invasive real time information. The clinical use of pulse
      oximeters has reduced the frequency and necessity of invasive arterial blood sampling, and
      has helped to improve patient safety by providing information to clinicians about patients'
      oxygenation status.

      The purpose of this study was to evaluate the SpO2 accuracy performance of the Belun Ring
      Oximeter placed on the index fingers during non-motion conditions over the range of 70-100%
      SaO2 to arterial blood samples assessed by CO-Oximetry for an SpO2 validation.

      The primary goal, was to show the SpO2 accuracy performance for the investigational device
      below. As a secondary goal, the pulse rate accuracy performance for the Belun ring was
      calculated.

      It was expected that the Accuracy Root Mean Square (ARMS) performance would meet the required
      specification of ARMS 3.5% or lower in non-motion conditions for the range of 70 - 100% SaO2
      thereby demonstrating an acceptable SpO2 accuracy performance specification. For the pulse
      rate accuracy, the desired goal was to have an accuracy performance of an ARMS of 3.

      No risks or adverse device effects were expected. There were no contraindications for use in
      the proposed study / study population.

      The study was conducted in accordance to the code of federal regulations for non-significant
      medical device studies and applicable ISO 14155 (2nd edition 2011-02-01), applicable sections
      of ISO 80601-2-61, second edition 2017-12, Corrected version 2018-02, and Pulse Oximeters -
      Premarket Notifications Submissions [510(k)s] Guidance For Industry and Food and Drug
      Administration Staff (issued: March 4, 2013).
    

Intervention name(s): Pulse Oximeter
Intervention type(s): Device
Intervention description(s): The investigational device will be placed on the finger of the left or right hand per the instructions for use. Simultaneous data collection will be set up for the system under test and control oximeter.
Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        The study population will include 10 to 15 healthy non-smoking (or has refrained from
        smoking for 2 days) competent adults, ages 18 to 50 years. 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.