Ulthera DeepSEE DS 4 - 4.5, Инструкция по эксплуатации

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Table 6.5 Masked Assessment Results of Ev aluable Subject Photos
N 54
Improvement 36 (~67%)
Incorrect 13 (24%)
No Change 5(9%)
In the sub-set of evaluable photos, there were 36 of 54 (~67%) subjects that
showed improvement by masked assessment of pre and post treatment
photographs at the primary endpoint of 180 days.
Table 6.5 provides CGAIS and Patient Assessments stratified by results of the
primary endpoint of masked assessment for the subject sub-set with the most
consistent photo quality.
Table 6.6 CGAIS and Patient Assessments Stratified by Masked Assessment Results for Sub-Set of Ev aluation
Photos at day 180.
Masked
Assessment
CGAIS Patient Satisfaction
Patient Reported
Improvement
Improved
(improved,
much
improved,
very much
improved
)
No
Change
Worse
Satisfied
(satisfied
& very
satisfied)
Neither
Satisfied
nor
Dissatisfied
Dissatisfied
(dissatisfied
& very
dissatisfied)
Yes No
Improvement n=36 27 (75%) 9 (25%) 0 (0%) 23 (64%) 9 (25%) 4 (11%) 32 (89%) 4 (11%)
Incorrect n=13 5 (38%) 7 (54%) 1 (8%) 8 (61%) 4 (31%) 1 (8%) 10 (77%) 3 (23%)
No Change n=5 3 (60%) 2 (40%) 0 (0%) 4 (80%) 0 (0%) 1 (20%) 4 (80%) 1 (20%)
TOTAL n=54 35 (65%) 18 (33%) 1 (2%) 35 (65%) 13 (24%) 6 (11%) 46 (85%) 8 (15%)
The results of the sub-set analysis demonstrate improvement of lines and wrinkles
based on masked assessment of pre and post treatment photographs in 36 of 54
evaluable subjects with the most consistent photo quality after one Ultherapy
treatment 180 days post-treatment.
Please note that treatment efficacy was achieved at the pre-set energy levels of
Level 4 for the 7 - 3.0 and 4 - 4.5 transducers and energy Level 3 for the 10 – 1.5
transducer. Changes in energy may impact efficacy.