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The InSight Model S980000 Gastrointestinal Motility System is intended for use by gastroenterologists, surgeons, and medically trained personnel as an aid in documenting and diagnosing digestive motility disorders. It may be used for esophageal, biliary, and anorectal motility studies. The system includes analysis software, but requires skilled interpretation by a physician to make a diagnosis.

The Accessory Model MII, when used in conjunction with a pH probe, can he used as an aid in differentiating acid vs. non-acid reflux events. In addition, the Accessory Model MIT is intended to measure motor function of the proximal gastrointestinal tract including swallow effectiveness and directional bolus transport by means of intraluminal impedance recording,

The Accessory Model MII component of the InSight Gastrointestinal Motility System is not intended for use in biliary studies.

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I am sorry, but based on the provided document, there is no information available regarding acceptance criteria, study details, sample sizes, ground truth establishment, or expert involvement for a device performance study.

The document is a 510(k) clearance letter from the FDA for the Sandhill Scientific InSight Model S980000 with Accessory Model MII. It states that the device is substantially equivalent to legally marketed predicate devices. It outlines the indications for use but does not contain a study report or data about performance.

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