(88 days)
The Ohmega system is intended to record, store, view and analyse pH, impedance, pressure and various auxiliary input data 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
I am sorry, but based on the provided text, there is no information about acceptance criteria or a study that proves the device meets specific acceptance criteria. The document is a 510(k) clearance letter from the FDA for the Ohmega device, indicating that it has been found substantially equivalent to legally marketed predicate devices.
The text does provide information about the device's intended use:
- Device Name: Ohmega
- Regulation Number: 21 CFR §876.1725 (Gastrointestinal motility monitoring system)
- Product Code: FFX
- Indications For Use: The Ohmega system is intended to record, store, view and analyze pH, impedance, pressure and various auxiliary input data 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.
However, it does not contain the detailed study information you requested, such as:
- A table of acceptance criteria and the reported device performance
- Sample size used for the test set and the data provenance
- Number of experts used to establish the ground truth for the test set and their qualifications
- Adjudication method
- Multi-reader multi-case (MRMC) comparative effectiveness study details
- Standalone performance
- Type of ground truth used
- Sample size for the training set
- How the ground truth for the training set was established
§ 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).