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3.6.4. SEM200-008 – Results
Sensitivity and specificity data presented in Table 4 and Table 5 show how the SEM Scanner 200
compares to visual skin assessment in identifying patients with tissue at risk of developing pressure
ulcers at the heels or sacrum.
48 PUs developed in the Intent-to-Treat population (26% incidence in the ITT population) with
a number of patients developing at least 1 PU at separate anatomical sites. Therefore the 48
PUs developed on 36 patients.
In the 008 study, healthcare providers assessed 437 individual anatomical locations from 182
subjects in the ITT. These locations were classed as shown in Table 4. Results from the 008
clinical study results from each assessed anatomy were classed as:
• True positives - a visible pressure ulcer and a localized SEM delta of 0.6 or above
("abnormal levels of SEM"). Table 4 shows 42 anatomical sites in this category.
• True negatives - no visible pressure ulcer and a localized SEM delta below 0.6 ("flat
values"). Table 4 shows 128 anatomical sites in this category.
• False negatives - a visible pressure ulcer and a localized SEM delta below 0.6 ("flat
values"). Table 4 shows 6 anatomical sites in this category.
• False positives - no visible pressure ulcer and a localized SEM delta of 0.6 or above
("abnormal levels of SEM"). Table 4 shows 261 anatomical sites in this category.
Total Patients in ITT
Population (182) / Total
Anatomical Locations (437)
SEM Δ ≥ 0.6
SEM Δ < 0.6
Table 4. Final results for individual anatomical locations for SEM Scanner from the 008
In order to appropriately account for the within subject correlation in the estimates of the 95%
confidence intervals for sensitivity and specificity, the bootstrap method used. The bootstrap
method was applied by sampling, with replacement, from the original dataset. The sampling was
done on a per subject basis such that all records for a randomly chosen subject were
Visible Pressure Ulcer
42
6
study
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MULTI-LANG-0123 Rev D,
OTH-SEM-IFU-
ENGLISH (EU)
No Visible Pressure
Ulcer
261
128
January 2018
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