Performance Data; Table 12 Cross-Classification Of Graders - Clarity RetCam3 User Manual

146 Chapter 11
• Threshold ROP (at least 5 contiguous or 8 non-contiguous clock hours of stage 3 in
The reported study results are presented below.

Performance Data

The tables below depict the study outcomes.
the individualized data from each of the three independent Graders A, B, and C
respectively.
the referenced article.

Table 12 Cross-Classification of Graders

Table 12a: Cross-classification from Grader A versus BIO (35-37 Weeks PMA)
Type 2 pre-threshold ROP or
treatment-requiring ROP
Unknown
No ROP or Mild ROP
Total
Based on a review of the RetCam images, Grader A concluded that 31 sets of images had
Type 2 pre-threshold ROP or Treatment-requiring ROP including all 26 cases determined
by BIO to be Type 2 pre-threshold ROP or Treatment-requiring ROP. Grader A was unable
to make a determination for 6 sets of images. Eighty-three (83) sets of images were
concluded by Grader A to have no ROP or mild ROP.
Table 12b: Cross-classification from Grader B versus BIO (35-37 Weeks PMA)
Type 2 pre-threshold ROP or
treatment-requiring ROP
Unknown
No ROP or Mild ROP
Total
Based on a review of the RetCam images, Grader B concluded that 32 sets of images had
Type 2 pre-threshold ROP or treatment-requiring ROP including all 26 cases determined
by BIO to be Type 2 pre-threshold ROP or treatment-requiring ROP. Grader B was unable
to make a determination for 8 sets of images. Eighty (80) sets of images were concluded
by Grader B to have no ROP or mild ROP.
RetCam 3 and RetCam Shuttle User Manual
Zone 1 or 2, with Plus disease) at 35-37 weeks PMA.
Table 13 identifies the sensitivity and specificity for the population studied in
Grader A
Grader B
Screening for Retinopathy of Prematurity (ROP)
Table 12a,
Reference Standard: BIO
Type 2 pre-threshold ROP or
Treatment-requiring ROP
26
0
0
26
Reference Standard: BIO
Type 2 pre-threshold ROP or
Treatment-requiring ROP
26
0
0
26
Table 12b, and Table 12c contain
No ROP or Mild ROP
5
6
83
94
No ROP or Mild ROP
6
8
80
94
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