User's Manual

NaviCam Small Bowel Capsule Endoscopy System

User Manual P a g e |

ANKON Technologies Co., Ltd. AKQWO-YF-018 Rev A/1

Per Subject Analysis: Normal versus Abnormal

Abnormal rates (NaviCam 84/87 – PillCam 81/87) 96.55% – 93.10%,

Positive Percent Agreement (PPA) [95% CI]: 100.00% (95.47%, 100.00%)

Negative Percent Agreement (NPA) [95%CI] 50.00% (18.76%, 81.24%)

Overall Percent Agreement [95% CI] 96.55% (90.35%, 98.82%)

Overall percent agreement per Kappa analysis [95% CI] 0.6506 (0.2866, 1.0000)

Positive Predictive Value (PPV) [95% CI] 96.43% (90.02%, 98.78%)

Negative Predictive Value (NPV) [95% CI] 100.00% (43.84%, 10.00%

McNemar Test Results X2=3.0000, p=0.0833

These results demonstrate that the NaviCam SB System and PillCam SB System have good

diagnostic consistency.

There were no statistically significant differences in the diagnosis of vascular lesions (p=0.4497),

inflammatory lesions (p=0.3173, tumors/polyps/masses (p=0.2207), malabsorption (p=1.0000),

ulcers/ulcerations (p=0.7963), and other lesions (p=0.0863) between the NaviCam SB and

PillCam SB systems.

The video review time of the trial capsule was 1.63 min higher than that of the control capsule,

and the difference was statistically significant. The difference between the mean reading time of

the NaviCam SB with ProScan on and conventional reading (i.e., without ProScan feature on) was

-36.63 min (-46.29 min, -26.72 min) (95% CI), the difference was statistically significant. The

results of the analysis of the consistency of the interpretation of the images obtained by two or

more reviewers (FAS/PPS) show that the differences between the two groups are not

statistically significant.

The results of this study showed that the clinical performance of the NaviCam SB System with

the ProScan feature and PillCam SB System (with SBI) were similar, and that the NaviCam SB

System with ProScan feature on significantly reduced the physician's reading time compared to

the reading time of the NaviCam SB System without the ProScan on (21.47±8.05 vs. 58.10±45.28,

p<0.0001).