(302 days)
The Ano-Rectal Manometry (ARM) Option to Laborie's PC-based urodynamic systems is intended to be used in quantifying ano-rectal pressures. Using the same transducers as for urodynamics but with a different measuring range, the ARM Option can be used for performing standard ano-rectal manometric measurements.
Ano-rectal Manometry Option Device, Model UDS-ARM
The provided document is a 510(k) clearance letter from the FDA for a device called "Ano-rectal Manometry Option Device, Model UDS-ARM" and its Indications for Use statement. This document confirms the device's substantial equivalence to a predicate device but does not contain any information regarding specific acceptance criteria, performance studies, sample sizes, expert qualifications, or ground truth methodologies.
The letter is a regulatory approval document and focuses on stating that the device is substantially equivalent to a pre-amendments device, allowing it to be marketed. It does not include the detailed technical or clinical study data that would typically contain the information requested in your prompt.
Therefore, I cannot provide the requested information based solely on the text provided. To answer your questions, one would need access to the actual 510(k) submission (K963064) which would contain the performance data and methodology used to demonstrate substantial equivalence.
§ 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).