Accuracy Validation of the Cadwell Pulse Oximetry System
Condition: Anoxia
MeSH terms: Hypoxia
Study type: Observational

Summary: 
      The purpose of this study is to evaluate the SpO2 accuracy and performance of the Cadwell
      Pulse Oximetry system during non-motion conditions over the range of 70-100% SaO2 as compared
      to arterial blood samples assessed by CO-Oximetry for SpO2 validation. The end goal is to
      show the SpO2 accuracy performance of the Cadwell Pulse Oximetry System. It is expected that
      the Accuracy Root Mean Square (Arms) performance of the Cadwell Pulse Oximetry System will
      meet a specification of 3 or better in non-motion conditions for the range of 70-100% SaO2
      thereby demonstrating an acceptable SpO2 accuracy performance specification.
    

Detailed description: 
      The SpO2 accuracy performance of the Cadwell Pulse Oximetry systems will be evaluated during
      non-motion conditions over the range of 70-100% SaO2 and compared to arterial blood samples
      assessed by COOximetry. A minimum of 10 healthy adult subjects, ranging in pigmentation from
      light to dark, will be enrolled in the study to meet the study design requirements defined by
      ISO 80601-2-61 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 devices will be
      placed on fingers for the test sites. Simultaneous data collection will be set up for each of
      the systems under test.

      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.
      Next the CO-Oximeter data will be reviewed to make sure it does not contain any anomalous
      values such as elevated COHb, MetHb or inconsistent 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 on at least 10 subjects for the range of
      67% to 100% SaO2. 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 or better showing
      equivalence to the Gold Standard Reference CO-Oximetry providing documentation to support
      SpO2 accuracy claims for the investigational device.
    

Intervention name(s): Disposable Sensor; Reusable Sensor; Control Pulse Oximetry
Intervention type(s): Device; Device; Device
Intervention description(s): Two adhesive based Pulse Oximeter Probes, S0136J-L were connected to the Cadwell Pulse Oximetry and then placed on each subject to evaluate the SpO2 accuracy performance during steady state non-motion conditions.; Two soft reusable Pulse Oximeter Probes, Model S0080D-S were connected to the Cadwell Pulse Oximetry and then placed on each subject to evaluate the SpO2 accuracy performance during steady state non-motion conditions.; A Clinimark Control Pulse Oximetry system was also placed on the subject to evaluate the stability of the draws.
Other intervention name(s): Model S0136J-L; Model S0080D-S; Reference Co-Oximeters, ABL80 Flex OSM (Radiometer): # 302125, 307205 IL682 (Instrumentation Laboratories): # 012511B (ILH), #012511A (ILG)
Observational model: Case-Only
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Following Salus Independent Review Board (IRB) approval for the Study Procedure Title:
        "Accuracy Validation of the Cadwell Pulse Oximetry System", Clinimark Study ID# PR
        2016-177, eleven healthy adult volunteer subjects were enrolled into the study. The
        demographics for the study included five males and six females (age: 21-46yrs, weight:
        118-220lbs, height: 60-74", BMI: 20.9-30.7). For the demographics based on race, the
        subject pool included one Black / African-American, three Asians (one of Indian descent),
        and seven White. The ethnicity for the group is four Hispanic, and seven Non-Hispanic /
        Non-Latino. The skin pigmentation / tones ranged from light to dark meeting the requirement
        of at least 2 darkly pigmented or 15 % of the subject pool whichever is larger.
      
Biospecimen description: 
      Arterial blood samples were drawn during simultaneous data collection from the test devices.
      The blood was immediately analyzed by Reference CO-Oximetry providing functional SaO2 for the
      basis of the SpO2 accuracy comparison.
    
Keywords: pulse oximetry