User's Manual

NaviCam Small Bowel Capsule Endoscopy System
User Manual P a g e |
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ANKON Technologies Co., Ltd. AKQWO-YF-018 Rev A/1
Per Finding Analysis:
There were no statistically significant differences between the 2 capsules in the detection of
vascular lesions (p=0.2087), inflammatory lesions (p=0.6831), tumors/polyps/masses
(p=1.0000), ulcers/ulcerations (p=0.3938), and other lesions (p=0.4669).
Safety Results:
One case of capsule retention occurred where both NaviCam and PillCam capsules were retained.
The incidence of adverse events was 1.15%. No abdominal pain, abdominal distention, nausea,
vomiting, headache, obstruction, or other adverse events occurred.
In conclusion, the NaviCam SB System and PillCam SB System had a diagnostic overall percent
agreement rate of 89.66% (81.50%, 94.46%), and an overall percent agreement Kappa of 0.6652
(0.4653, 0.8652). The results of this comparative study indicate that NaviCam Small Bowel
Capsule Endoscopy System performs similarly to the PillCam SB3 Capsule Endoscopy System
and provides an effective non-invasive method for the detection of small bowel diseases.
(2) Retrospective Evaluation to Compare Small Bowel Video Reading by AKE-1 (NaviCam
SB) Capsule Endoscopy System with ProScan Feature and PillCam SB3 Capsule System
with SBI Feature”
The goal of this retrospective evaluation was to compare the performance of the NaviCam SB
System ESView software with the ProScan feature to this of the PillCam SB System with the SBI
feature. The recordings/images used in this study were previously obtained in the prospective
study (study (1)) and were analyzed by two independent reviewers for visual comparison of the
findings and analysis using ESView software with ProScan and Rapid software with SBI in
comparison to the conventional reading previously performed for both systems.
Capsule endoscopy videos of 87 subjects were used and included in both the Full Analysis Set
(FAS) and Per Protocol Set (PPS) analyses.
The primary endpoint of the study was to evaluate the performance of the NaviCam SB System
with the ProScan software feature in comparison with the PillCam SB System SBI feature (per
patient analysis). Secondary study endpoints included per findings analysis, image review time,
and image review time of NaviCam reading with and without the ProScan feature on.