(109 days)
The FLEXILOG 3000 system is to be used for the recording, display and analysis of pH and pressure data from the upper gastrointestinal tract in ambulant subjects. It provides information that aids in the diagnosis and management of motility disorders. The FLEXILOG 3000 also has a limited stationary manometry capability to aid sensor placement prior to an ambulatory study.
The FLEXILOG 3000 system is a multi channel, multi parameter, ambulatory recording system with stationary capability. It is comprised of a recorder that supports data collection on up to 24 channels. The data collected is determined by up to 5 plug-in parameter modules. At present only pH (4 channel) and pressure (3 channel) modules are available. Multiple modules of the parameters can be installed to give the required number of channels. In ambulatory mode, data is saved onto a PCMCIA card and subsequently uploaded to the computer. In stationary mode, data is transferred via a patient isolated RS232 outlet to the computers serial port. The signals, recorded or online, are displayed on the computer VDU via a Microsoft Windows based program, FLEXISOFT III. FLEXISOFT III provides display, analysis and report generation options. The FLEXILOG 3000 is compatible with pressure and pH catheters currently approved for sale in the U.S.A. and manufactured and marketed by third parties.
This is a 510(k) summary for a medical device called FLEXILOG 3000, which is a multi-channel, multi-parameter recording system for pH and pressure data from the upper gastrointestinal tract. This document describes the device, its indications for use, and a comparison to predicate devices. However, it does not contain any information about acceptance criteria, device performance metrics, or study details such as sample sizes, expert involvement, adjudication, MRMC studies, or standalone performance.
Therefore, I cannot fulfill your request for a table of acceptance criteria and reported device performance or any other study-related details based on the provided input. The document focuses on the description of the device and its similarity to predicates rather than presenting performance data from a clinical or technical study.
§ 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).