(109 days)
The ARM-1 is interdad to enable the Urolab equipment to measure and record the functioning of a patient's anorectal. function.
Ano-Rectal Manometry Option (ARM-1)
I am sorry, but the provided text does not contain information regarding acceptance criteria, device performance, study details (sample sizes, data provenance, ground truth establishment, expert qualifications, adjudication methods), or multi-reader multi-case comparative effectiveness studies. The document is an FDA 510(k) clearance letter for a medical device called "Ano-Rectal Manometry Option (ARM-1)", indicating that the device is substantially equivalent to a legally marketed predicate device. It specifies the indications for use but does not delve into the technical validation studies.
§ 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).