A Study to Collect Imaging Data for the Validation of the Intelligent Ultrasound's ScanNav Anatomy Peripheral Nerve Block (PNB) - US v1.0
Condition: Ultrasound Imaging of Anatomical Structures
Study type: Observational

Summary: 
      This is a single-center, prospective study to be undertaken at University of Oregon,
      Portland, USA. The aim is to evaluate the clinical performance of ScanNav Anatomy PNB when
      highlighting anatomical structures during UGRA scanning. Specifically, we aim to assess and
      quantify the correct/incorrect highlighting of anatomical structures associated with ScanNav
      Anatomy PNB during UGRA scanning.
    

Detailed description: 
      Background:

      The American Society of Regional Anesthesia and Pain Medicine (ASRA) has published
      evidence-based assessment of ultrasound-guided regional anesthesia (Neal et al., 2010)
      concluding that ultrasound guidance is superior or equal to other non-ultrasound nerve
      localization techniques. A subsequent publication from ASRA (Neal et al., 2016), has
      strengthened their position of ultrasound guidance being superior than other methods,
      including for the reduction of local anesthetic systemic toxicity. However, ultrasound-guided
      regional anesthesia (UGRA) is a difficult technique to master. A key activity of UGRA is
      ultrasound image interpretation (Sites et al., 2009) which ScanNav Anatomy PNB is designed to
      support. The data collected during this study will be assessed by a panel of intended users
      (experts in UGRA) to evaluate the performance and safety of ScanNav Anatomy PNB device
      highlighting.

      Statistical Methodology:

      Validation analyses will be conducted once the data collection has been complete. The
      collected scans will be processed, and the device output will be generated post hoc. Device
      output will be presented with raw ultrasound side-by-side. A panel of at least three expert
      anesthesiologists will review and evaluate each processed scan. The majority view of the
      panel will be used to evaluate each endpoint for any given structure ScanNav Anatomy PNB is
      intended to highlight.

      Data collection and scan processing:

      40 different subjects will be scanned. The dataset will be balanced to contain approximately
      equal numbers of subjects with BMI<30 and BMI>= 30 kg/m2.

      All data collection will be performed with FDA cleared general purpose ultrasound machine,
      ScanNav Anatomy PNB device will not be used during data collection.

      Data characteristics for scan subjects (e.g., age and BMI) will be reported. Ultrasound scans
      for all 9 supported anatomical regions will be collected from both sides of each subject.

      90 x 10s clips per supported anatomical region will be generated, consisting of:

        -  80 x 10s scene clips: the block view (chosen by the expert scanner) together with the
           preceding 10 seconds of ultrasound scanning will be recorded (without the use of ScanNav
           Anatomy PNB)

        -  10 x 10s non-scene clips: 10 second ultrasound scans will be recorded at non-optimum
           block views, chosen by the expert scanner to represent plausible scanning errors
           (without the use of ScanNav Anatomy PNB) Scenes and non-scenes will be analyzed
           separately. Unmodified ultrasound video and highlighted video (color overlay produced by
           ScanNav Anatomy PNB generated post-hoc) will be presented side-by-side to independent
           experts for data analysis.

      Data analysis:

      Every clip will be presented to a minimum of 3 independent expert reviewers. All clips from a
      single anatomical region will be reviewed by the same 3 reviewers. Experts may review more
      than one anatomical region, but not necessarily all anatomical regions. Thus, a range of
      experts will review all anatomical regions.

      Reviewers will be asked structured questions to assess the highlighting of safety critical
      anatomical structures (see definitions later in document) and the performance of ScanNav
      Anatomy PNB output for each individual clip.

      The majority opinion (at least 2/3) will be obtained to establish the overall panel opinion
      (e.g., yes/yes/no = yes) for each structure on each clip.

      Data will be evaluated and presented by structure in each anatomical region and overall
      (i.e., total for each class; nerve, artery etc.).

      Inter-rater agreement between the reviewers will be reported on an anatomical region basis.

      Data will be presented as frequencies and presented as percent of total clips analyzed.

      Data analysis will include stratification by subject age, BMI, and ultrasound machine to
      ensure consistency across these variables.
    

Intervention name(s): Ultrasound scans
Intervention type(s): Device
Intervention description(s): Each subject will be randomly allocated to an ultrasound machine and an expert scanner who will perform the ultrasound scans of all supported anatomical regions.
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Potential study subjects will be healthy volunteers, chosen to provide a variety of ages
        and BMIs. Subjects will be screened to ensure approximate equal numbers in coverage for BMI
        (<30, 30-39) category.