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NaviCam ProScan is an artificial intelligence (AI) assisted reading tool designed to aid small bowel capsule endoscopy reviewers in decreasing the time to review capsule endoscopy images for adult patients in whom the capsule endoscopy images were obtained for suspected small bowel bleeding. The clinician is responsible for conducting their own assessment of the findings of the AI-assisted reading through review of the entire video, as clinically appropriate. ProScan also assists small bowel capsule endoscopy reviewers in identifying the digestive tract location (oral cavity and beyond, esophagus, stomach, small bowel) of the image in adults. This tool is not intended to replace clinical decision making.

The NaviCam ProScan is artificial intelligence software that has been trained to process capsule endoscopy images of the small bowel acquired by the NaviCam Small Bowel Capsule Endoscopy System to recognize the various sections of the digestive tract and to recognize and mark images containing suspected abnormal lesions. NaviCam ProScan is intended to be used as an adjunct to the ESView software of the NaviCam Small Bowel Capsule Endoscopy System (both cleared in K221590) and is not intended to replace gastroenterologist assessment or histopathological sampling. NaviCam ProScan does not make any modification or alteration to the original capsule endoscopy video. It only overlays graphical markers and includes an option to only display these identified images. The whole small bowel capsule endoscopy video and highlighted regions still must be independently assessed by the clinician and appropriate actions taken according to standard clinical practice. The NaviCam ProScan software includes two main algorithms, as illustrated in Figure 1 below: - Digestive tract site recognition, which includes an image analysis algorithm and site segmentation algorithm to determine: oral and beyond, esophagus, stomach, and small bowel. Tract site is displayed as a color code on the video timeline with descriptions on the indicators at the bottom of the software user interface. - Small bowel lesion recognition, which includes the small bowel lesion image analysis algorithm with lesion region localization. Potential lesions are marked with a bounding box as illustrated in Figure 2 below, with the active video played at the top section of the figure, and ProScan-identified images in the lower section, which includes images with suspected lesions and individual images marking the transition in the digestive tract. The algorithm is functional only on those sections of the GI tract that were identified as "small bowel" by the digestive tract site recognition software function.

The NaviCam Small Bowel Capsule Endoscopy System is intended for visualization of the small bowel mucosa in adults. It may be used as a tool in the detection of abnormalities of the small bowel.

The NaviCam Small Bowel Capsule Endoscopy System is an endoscopic capsule imaging system intended to obtain images of the small bowel. It is comprised of the following components: 1. Capsule (AKES-11SW, AKES-11SI): The disposable, ingestible NaviCam Small Bowel Capsule is designed to acquire video images during the natural propulsion through the GI tract. The capsule transmits the acquired images via an RF communication channel to the NaviCam Data Recorder located outside the body. 2. Data recorder (AKR-1, AKRI-1): The Data Recorder is an external receiving and recording unit that receives and stores the acquired images from the capsule. 3. ESView Software: The ESView is a software application for processing, analyzing, storing, and viewing the acquired images collected from the NaviCam Data Recorder to create a video of the images. The software also includes a reporting function to create detailed clinical reports and a capsule endoscopy atlas. 4. Locator: The Locator is a handheld device that is used to turn the NaviCam Capsule on. It is also used for determining if the capsule is still in the body when the patient is not sure whether he/she expelled it.