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The FLEXILOG LS is used for the location of the lower and/or upper esophageal sphincter and the measuring of the nares to esophageal sphincter distance. This procedure being carried out prior to the accurate placement of a pH sensitive catheter for an ambulatory pH study to quantify gastroesophageal reflux.

The FLEXILOG LS, Esophagea1 Sphinctor Locator, is to be used for the manometric location of the lower and upper esophageal sphincters. That is the measurement of the distance from the nares to the sphincter.

The FLEXILOG LS is a single channel, pressure monitoring system comprising of a module of electronics that provides transducer excitation, amplification and transmission of the signal to a computer via an optically isolated RS232 connector. The pressure signal is displayed on the computer VDU via a Microsoft Windows display program. The program does not provide any analysis or data saving options.

The electronics module is designed to be compatible with catheter tip perfused pressure transducers currently available in the US market.

The provided document is a 510(k) premarket notification for the FLEXILOG LS Esophageal Sphincter Detector. It does NOT contain information about acceptance criteria or a study proving that a device meets such criteria.

The document includes:

• Trade Name: FLEXILOG LS
• Common Name: Esophageal Sphincter Detector
• Classification Name: Monitor, esophageal motility and tube
• Indications for Use: For the location of the lower and/or upper esophageal sphincter and the measuring of the nares to esophageal sphincter distance, prior to accurate placement of a pH sensitive catheter for an ambulatory pH study to quantify gastroesophageal reflux.
• Description: A single-channel pressure monitoring system that provides transducer excitation, amplification, and signal transmission to a computer via an optically isolated RS232 connector. The pressure signal is displayed on a computer VDU without analysis or data saving options.
• Technological Characteristics: Similar to predicate devices (FLEXILOG LS Lower Esophageal Sphincter Detector, RMS III, the LES Locator, Digitrapper MKIII, Digitrapper MD) but with electronics in a standalone box, not integrated with ambulatory pH recorders, and not requiring connection to a pH recorder. Displays data on a computer screen.
• Testing: Only a general statement is provided: "The FLEXILOG LS has been shown to accurately measure and display pressure." No specific study details, methodology, sample sizes, ground truth establishment, or acceptance criteria are given.
• Predicate Devices: Oakfield Instruments Limited, FLEXILOG LS; Sandhill Medical Inc., RMS III; Biolab, The LES Locator; Synectics Medical Limited, Digitrapper MKIII; Synectics Medical Limited, Digitrapper MD PC Polygraph HR.

Therefore, I cannot provide the requested table or answer the specific questions about acceptance criteria, study details, sample sizes, ground truth, or MRMC studies, as this information is not present in the provided text.

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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.

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The FLEXILOG LS is used for the location of the lower esophageal sphincter and the measuring of the nares to lower esophageal sphincter distance. This procedure being carried out prior to the accurate placement of a pH sensitive catheter for an ambulatory pH study to quantify gastroesophageal reflux.

The FLEXILOG LS is a single channel, pressure monitoring system comprising of a module of electronics that provides transducer excitation, amplification and transmission of the signal to a computer via an optically isolated RS232 connector. The pressure signal is displayed on the computer VDU via a Microsoft Windows display program. The program does not provide any analysis or data saving options. The electronics module is designed to be compatible with catheter tip and water perfused pressure transducers currently available in the US market.

This document is a 510K submission for the FLEXILOG LS device, a Lower Esophageal Sphincter Detector. The provided text outlines the device's description, indications for use, and technological characteristics, along with a claim of substantial equivalence to predicate devices. However, it does not contain the detailed study information required to answer your questions about acceptance criteria, specific performance metrics, sample sizes, ground truth establishment, or specialized studies like MRMC or standalone performance evaluations.

The only statement related to performance and testing is: "The FLEXILOG LS has been shown to accurately measure and display pressure." This sentence is too vague to extract specific acceptance criteria or study details.

Therefore,Based on the provided text, I cannot answer your questions as the document does not contain the detailed study results, acceptance criteria table, sample sizes, ground truth information, or specific study types (e.g., MRMC, standalone) you are looking for. The document only states that "The FLEXILOG LS has been shown to accurately measure and display pressure," which is a general claim and not specific performance data.

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