ENGLISH OUS indications
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OTH-SEM-IFU-OUS-0359 Rev I
Clinical interpretation
Clinical interpretation of the Provizio SEM Scanner scans begins by collecting a set of
measurements described in Section 5 performed on each anatomical site under assessment. After
the set of measurements have been collected, the SEM
value will be displayed.
A SEM
equal to or greater than 0.6 at an anatomical site suggests the detection of deep and
early stage pressure induced injuries/ulcers.
The SEM
value should be considered in conjunction with other measures of standard of care
and clinical judgement.
The standard of care should be followed to reduce the risk of developing pressure
injuries/ulcers. Readings from the Provizio SEM Scanner can be used to support increased
intervention but should never be the basis for decreasing intervention.
Deriving SEM Scanner Delta (∆) Values
The measurement technology of the Provizio SEM Scanner is the same as the SEM Scanner 200
and the clinical evaluation results of the SEM Scanner 200 are applicable to the Provizio SEM
Scanner System.
Clinical study (SEM200-
008 or “008”) (reference: Okonkwo H. et al. (2020). A blinded clinical
study using a subepidermal moisture biocapacitance measurement device for early detection of
pressure injuries. Wound Repair and Reg.) results from 182 study subjects with 437 anatomical
locations were used to derive clinical validity of the SEM
values. The 008 clinical study was a
prospective, blinded study comparing the SEM Scanner to the current Standard of Care, Visual
Skin Assessment (VSA), in identifying patients with tissue at increased risk of developing pressure
injuries/ulcers at the heels or sacrum. Provizio SEM Scanner assesses the electrical capacitance of
skin and tissue below the electrode when placed on the patient’s skin. VSA seeks to identify
pressure injuries/ulcers (Stage 1 and beyond) once they are visible at the skin level.
8.1.1
SEM200-008
–
Study Population
In the 008 Study there were 12 unique clinical-trial sites in the United States and United Kingdom
that were included in the study. Each had their own Principal Investigator. Subjects in the 008-study
received standard-of-care interventions for pressure ulcer prevention and management. These
