(85 days)
The Esophageal Manometry Analysis Module has been designed to analyze intragastroesophageal pressure data throughout the gastrointestinal tract. The Esophageal Manometry Analysis Module has been designed for the same intended use (analyze intragastroesophageal pH data) in both pediatric and adult populations. The product is to be used on patients in the hospital environment under supervision of a trained physician.
The Polygram Software for Windows (K946322) was designed to record and handle/store physiological parameters. After a recording, the user is able to review the tracings on the computer screen and print the signal tracings or just parts of them. When reviewing the data on the computer screen, the user is able to mark certain segments and calculate certain parameters from the selected signal segments. These parameters are minimum value, maximum value, and the length of the selection. By adding the Esophageal Manometry Analysis Module to the Polygram Software for Windows, the user can also have all the pressure data analyzed in terms of physiological properties, comparison with normal values, etc. The analyzed data can thereafter be viewed on screen or printed out on a separate paper.
The provided document is a 510(k) summary for the "Esophageal Manometry Analysis Module" from 1996. It describes the general functionality of the software but does not contain the specific information requested in your prompt regarding acceptance criteria, performance studies, sample sizes, ground truth establishment, or expert involvement.
Therefore, I cannot populate the table or answer the specific questions about device performance and study methodology based on this document. The document primarily focuses on describing the module's intended use and general features.
Here's what I can infer from the document, though it doesn't directly answer your questions:
- Device Name: Esophageal Manometry Analysis Module
- Intended Use: To analyze intragastroesophageal pressure data throughout the gastrointestinal tract in both pediatric and adult populations.
- Operating Environment: Hospital environment under the supervision of a trained physician.
- Functionality:
- Records and stores physiological parameters (from Polygram Software).
- Allows review of tracings, marking of segments, and calculation of parameters (min, max, length of selection).
- Analyzes pressure data in terms of physiological properties and comparison with normal values.
- Allows viewing and printing of analyzed data.
To provide the requested information, you would need a more detailed performance study report or a different section of the 510(k) submission that specifically addresses the clinical validation and acceptance criteria.
§ 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).