ENGLISH OUS indications
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OTH-SEM-IFU-OUS-0359 Rev I
Table 10 Final results for individual anatomical locations
Total Patients in ITT
Population (182) / Total
Anatomical Locations (437)
Visible Pressure Ulcer
No Visible Pressure
Ulcer
SEM
Δ
≥ 0.6
42
261
SEM
Δ
< 0.6
6
128
Table 11
Range of SEM ∆ and confidence intervals using bootstrap method
Sensitivity
1
Specificity
1
SEM∆
n
%
95% CI
n
%
95% CI
≥0.6
42
87.4%
77.8%, 96.7%
124
33.0%
27.6%, 38.7%
1
Sensitivity and specificity analysis was performed following an analysis rule of 2 of 3
consecutive observations of a SEM delta of 0.6 or above (“SEM positive”) or SEM delta
less than 0.6 (“SEM negative”) from a five
-day window from study exit or when a
pressure ulcer is identified by visual skin assessment. This analysis rule was defined
before study analysis was performed.
Forty-eight (48) pressure injuries/ulcers developed in 36 subjects in the Intent-to-Treat
population (26% incidence in the ITT population) with several patients developing at least one
pressure injury/ulcer at separate anatomical sites.
Healthcare providers assessed 437 individual anatomical locations from 182 subjects in the ITT.
These locations were classed as shown in Table 10. Results were classified as:
•
True positives - a visible pressure injury/ulcer and a SEM delta of 0.6 or above
(“abnormal levels of SEM”).
There were 42 anatomical sites in this category.
•
True negatives - no visible pressure injury/ulcer and a SEM delta below 0.6
(“flat
values”). There wer
e 128 anatomical sites in this category.
•
False negatives - a visible pressure injury/ulcer and a SEM delta below 0.6
(“flat
values”). There were six anatomical sites in this category.
