Hologic ThinPrep Operator's Manual page 18

G2.3 Analytical performance of Integrated Imager
Within-instrument Reproducibility
Analytical performance was evaluated by reviewing the content of the 22 fields of view (FOVs)
presented by the Integrated Imager. Evaluations were carried out by cytotechnologists. No
pathologist reviewed the FOV. Full slide reviews were not carried out for this evaluation.
Within-instrument reproducibility results were collected by three (3) cytotechnologists who
performed review of slides three (3) times on the same instrument with a washout period of a
minimum of 14 days.
The 260 slides used in this study were previously prepared from ThinPrep specimens and had an
adjudicated cytology diagnosis.
The highest ranked diagnosis from review of 22 FOVs and number of abnormal FOVs were
recorded for each of three runs for both TIS review and I2 review.
In Table 16, the within-instrument results are summarized for each diagnostic category of slides
(according to adjudicated truth results). For each grouping, the following metrics are reported:

% Abnormal
The proportion of slides for which any abnormal FOVs were observed.
(For NILM or UNSAT slides, the % Normal column is used to record the proportion that are
not abnormal).

% Category+
The proportion of slides for which at least one FOV was observed with content of the slide's
true category or higher.

% N/A
The proportion of slides in that category that are excluded from analysis (slide not able to be
imaged by imager or missing data)

Abnormal FOV, % zero
The proportion of slides for which zero abnormal FOV were observed.

Abnormal FOV, Median
The median number of abnormal FOV observed (out of 22 total).
MAN-05359-001 -001 Rev. 001 page 14 of 32