Ulthera Cellfina System System-Gebrauchsanweisung Seite 10

Ulthera, Inc.
providing a quantitative basis for the qualitative measure. Replicate slides were used to assess training effectiveness
and intra-rater reliability. All reliability measures were achieved. Both the powered study endpoints were met:

The primary endpoint of achievement of ≥1 point average reduction in the 0-5 point Cellulite Severity Scale
was met. The average improvement was 2.1 points (p<0.0001) at 3 months (n=55) and 2.0 points
(p<0.0001) at 1 year (n=50). There was no reduction in treatment effect at 2 years compared to 3 months.
The average improvement was 2.0 points (p<0.0001) at 2 years (n=52) with the 97.5% confidence limit of a
1.8 point improvement. The average improvement was 2.0 points (p<0.0001) at 3 years (n=45) with the
97.5% confidence limit of a 1.7 point improvement.

The powered secondary endpoint of improvement of one grade or more in severity (none, mild, moderate,
severe) in >60% of treated was met. 92.7% of treated subjects had improvement of 1 grade at 3 months
(n=55) and 94.0% at 1 year (n=50). At 2 years (n=52), 88.5% of treated subjects had improvement of 1
grade with a 95% confidence limit of 79.2%. At 3 years (n=45), 91.1% of treated subjects had improvement
of 1 grade with a 95% confidence limit of 81.6%
All additional secondary measures were also achieved or acceptable:

The secondary effectiveness measure of 80% or higher average rate of correct selection of blinded before
and after was achieved. The average rate of correct selection was 98% at 3 months (n=55) and 99% at 1
year (n=50). The average rate of correct selection at 2 years (n=52) was 98.1% with a 95% confidence limit
of 94.5%. The average rate of correct selection at 3 years (n=45) was 97% with a 95% confidence limit of
92.6%.

The secondary effectiveness measure of improvement in subject appearance according to a Global
Aesthetic Improvement Scale (GAIS) was achieved. 98% of the subjects had noticeable improvement by
the GAIS and 75% were characterized as having marked improvement or better at 3 months (n=55). 100%
of the subjects had noticeable improvement by the GAIS and 72% were characterized as having marked
improvement or better at 1 year (n=50). 100% of the subjects had noticeable improvement by the GAIS and
52% were characterized as having marked improvement or better at 2 years (n=52). 100% of the subjects
had noticeable improvement by the GAIS and 56% were characterized as having marked improvement or
better at 3 years (n=45).

The secondary measure of effectiveness of subject satisfaction with their appearance of cellulite according
to a 5 point Likert type scale achieved. Subject satisfaction was 85% at 3 months, 88% at 6 months, 94% at
1 year, 96% at 2 years, and 93% at 3 years.
a) Severity Scoring by the Independent Evaluators
Score
A. Number of Evident Depressions
0
1
2
3
B. Average Depth of Depressions
0
1
2
3
b) Cellulite Severity Grading (calculated values)
Severity Scale
(A+B-1 from Evaluator Scores)
1007270IFU Rev D
Cellfina
Table 2. Cellulite Severity Scoring
None
Mild (≤ 4 depressions)
Moderate (≥ 5 to ≤ 9 depressions)
Severe (≥ 10 depressions)
None
Mild (1-2mm)
Moderate (3-4mm)
Severe (5mm or greater)
0
1-2
3
4-5
®
System
Description
Classification
None
Mild
Moderate
Severe
User Manual
Severity Grade
0
1
2
3
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