Hologic ThinPrep Imager Duo Operator's Manual page 31

Results of the clinical study for 22 slides with Reference Diagnosis of Cancer is also presented below where
"Positive" means HSIL+ (combined Cancer and HSIL).
Table 31: Performance of Laboratory Imager-Assisted Review Results vs. Laboratory
Manual Review Results for the Specimens with Reference Diagnosis of Cancer where Positive
Means HSIL+
ThinPrep Genesis
Imaged
*One Cancer slide has Manual result of NILM and Imaged result of ASC-US
Both ThinPrep Genesis Imaged and Manual have HSIL+ results for 21 out of 22 specimens (PPAs for both are 95.5% (21/22) and
difference is 0.0% with 95%CI: (-15.8%; 15.8%)).
There were five (5) slides determined to be UNSAT by adjudication consensus. Of the 15 total site reviews
for these slides by each method, one diagnosis was UNSAT in both Manual and TIS reviews. The majority
of site reviews (10 for Manual, 11 for TIS) were NILM.
H. Clinical Investigation Conclusions
•
For all sites combined for ASCUS+, the improvement in sensitivity of the Imager Review
method over the Manual Review method is statistically significant. This increase is 6.4%
with a 95% confidence interval of 2.6% to 10.0% for all sites combined. The differences
in sensitivity varied among the sites from –2.8% to +14.4%. For LSIL+ and HSIL+ the
sensitivity of the Imager Review method is equivalent to the Manual Review method.
•
For all sites combined for HSIL+, the improvement in specificity of the Imager Review
method over the Manual Review method is statistically significant. This increase is 0.2%
with a 95% confidence interval of 0.06% to 0.4% for all sites combined. The differences
in specificity varied among the sites from –0.1% to +0.7%. For ASCUS+ and LSIL+ the
specificity of the Imager Review method is equivalent to the Manual Review method.
•
Specimen adequacy can be determined using the method described in Bethesda System
2001 or by having the Cytotechnologist count the cells in the 22 fields of view presented
by the Imager.
•
The workload limit for the ThinPrep Imaging System has been established at 200 slides in
no less than an 8-hour workday. This workload limit of 200 slides includes the time spent
for manual review of slides that is not to exceed 100 slides in an 8 hour workday.
For these clinical sites and these study populations, the data from the clinical trial and clinical
support studies demonstrate that the use of the ThinPrep Imaging System to assist during primary
screening of ThinPrep Pap Test slides for all cytologic interpretations, as defined by the Bethesda
System, is safe and effective for the detection of cervical abnormalities.
Performance may vary from site to site as a result of differences in patient populations and reading
practices. As a result each laboratory using this device should employ quality assurance and control
systems to ensure proper use and selection of appropriate workload limits.
ThinPrep Genesis Manual
HSIL+
HSIL+
Not-HSIL+
Total
Not-HSIL+
21 0
0 1*
21 1
Total
21
1
22
MAN-08723-001 Rev. 001 page 27 of 28