(111 days)
The Solar GI system is intended to record, store, view and analyse pressure, EMG, swallow and respiration and various auxiliary input device data on-line anywhere in the gastrointestinal tract (pharynx, esophagus, stomach, duodenum, sphincter of oddi, small bowel, colon and anorectal area including rectum and pelvic floor) to assist in the diagnosis and evaluation of gastrointestinal and swallowing disorders. Designated catheters and accessories are required for measurement in each specific area.
Not Found
The provided text is a 510(k) premarket notification letter from the FDA regarding the "Solar GI including CIM-AUX Module". It indicates that the device has been found substantially equivalent to legally marketed predicate devices. However, the document does not contain any information about acceptance criteria, device performance studies, sample sizes, expert qualifications, or ground truth establishment.
Therefore, I cannot answer your request based on the provided input. The document is primarily a regulatory approval letter and not a performance study report.
§ 876.1725 Gastrointestinal motility monitoring system.
(a)
Identification. A gastrointestinal motility monitoring system is a device used to measure peristalic activity or pressure in the stomach or esophagus by means of a probe with transducers that is introduced through the mouth into the gastrointestinal tract. The device may include signal conditioning, amplifying, and recording equipment. This generic type of device includes the esophageal motility monitor and tube, the gastrointestinal motility (electrical) system, and certain accessories, such as a pressure transducer, amplifier, and external recorder.(b)
Classification. Class II (performance standards).