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The ManoScan Motility with Impedance Visualization System obtains a high resolution mapping of pressures and impedance levels within organs of the human gastrointestinal tract. These include the pharynx, upper esophageal sphincter (UES), esophagus, lower esophageal sphincter (LES), stomach, sphincter of oddi, small bowel, colon, duodenum and anorectal organs. It is used in a medical clinical setting to acquire pressures, impedance levels and video and store the corresponding data. The system also provides visualization and analysis tools and information. The real time data as well as the analysis information can be viewed for diagnostic and analysis purposes with an intention of assisting in the diagnosis and evaluation of gastrointestinal and swallowing disorders. The device is intended for use by gastroenterologists, surgeons and medically trained personnel.

The ManoScan Motility with Impedance Visualization System is used to acquire gastrointestinal tract data in order to present a high-resolution mapping of pressures with Impedance levels within tubular organs. It includes the ability to acquire, display and replay video data captured from within the gastrointestinal tract organs. The ManoScan Motility with Impedance Visualization can be used with either or both of the video with Impedance data capture features disabled.

The System is used in a medical clinical setting to sense pressure and Impedance levels, acquire and store the corresponding data and enable viewing or analyzing in real time or anytime after the data is acquired and stored. Accordingly, the System provides visualization and analysis tools that can be used for evaluation of the data and analytic diagnosis.

The system includes a catheter probe that can be configured with a variety of pressure sensing element with Impedance sensor channels. During the clinical procedure, the catheter is inserted transorally or via rectal intubation and pressure with Impedance levels from inside the gastrointestinal tract are monitored. Data collection can include acquisition of data from different segments of the GI tract, including the pharynx, upper esophageal sphincter (UES), esophagus, lower esophageal sphincter (LES), stomach, sphincter of oddi, small bowel, colon, duodenum and anorectal area. Real-time data is sampled from each sensing channel via the interface electronics and made available to the software during each sample period. The software displays the data in real-time to support the clinical procedure.

The Sierra Scientific Instruments ManoScan Motility with Impedance Visualization System is a device used to acquire gastrointestinal tract data, presenting a high-resolution mapping of pressures and impedance levels within tubular organs. The system is intended to aid in the documentation, diagnosis, and evaluation of motility, digestive tract, and swallowing disorders.

Here's an analysis of the acceptance criteria and the study that proves the device meets those criteria, based on the provided 510(k) summary:

1. Table of Acceptance Criteria and Reported Device Performance:

The 510(k) summary indicates that the device's acceptance criteria are based on meeting or exceeding the performance characteristics of its predicate devices. The study performed involved bench-top verification tests.

2. Sample Size Used for the Test Set and Data Provenance:

• Test Set Sample Size: Not explicitly stated as a numerical sample size. The "test set" for performance evaluation consisted of bench-top verification tests to assess pressure with impedance accuracy, noise, and repeatability.
• Data Provenance: The data is from non-clinical bench-top testing conducted by Sierra Scientific Instruments, Inc. No specific country of origin for the data is mentioned beyond the company's location in Los Angeles, CA, USA. The study was non-clinical and therefore neither retrospective nor prospective in the human subject sense.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:

• Number of Experts: Not applicable. The "ground truth" for the bench-top tests was established by objective measurements and comparisons against the performance of predicate devices, not by human expert assessment.
• Qualifications of Experts: Not applicable, as expert consensus was not used for the bench-top testing.

4. Adjudication Method for the Test Set:

• Adjudication Method: Not applicable. The "test set" involved objective measurements against established engineering and performance benchmarks, and comparison to predicate device specifications, rather than a clinical interpretation requiring adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, If so, What Was the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance:

• MRMC Study: No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The submission explicitly states: "No formal clinical testing has been performed, nor is any believed to be necessary."
• Effect Size: Not applicable, as no MRMC study was conducted.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:

• Standalone Study: Yes, in essence, the "bench-top verification tests" can be considered a form of standalone performance evaluation for the device's technical specifications (accuracy, noise, repeatability) in a controlled environment. However, this is not an algorithm-only standalone study for diagnostic performance in the same way an AI device might be evaluated. This device is a measurement system, and its standalone performance relates to its ability to acquire and display accurate data. The system is designed to provide "visualization and analysis tools and reports that can be viewed for diagnostic purposes by appropriately trained medical personnel," implying a human-in-the-loop for diagnosis, even though the system's core measurement capabilities were tested in standalone bench-top settings.

7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.):

• Ground Truth Type: For the bench-top verification tests, the ground truth was based on objective physical measurements using calibrated instruments and comparison to the established performance characteristics/specifications of the predicate devices. For example, pressure accuracy would be verified against known pressure inputs from a calibrated pump, and noise/repeatability would be measured against engineering specifications.

8. The Sample Size for the Training Set:

• Training Set Sample Size: Not applicable. This device is a hardware and software system for acquiring and presenting physiological data. It does not appear to involve machine learning or AI models that require a "training set" for diagnostic classification in the conventional sense. The software's "analysis and diagnostic tools" are based on algorithms designed to process the acquired pressure and impedance data, not on learned patterns from a training set.

9. How the Ground Truth for the Training Set Was Established:

• Ground Truth for Training Set: Not applicable, as no training set was used for machine learning or AI algorithm development. The software's functionality is based on established biophysical principles and data processing algorithms.

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The Motility Visualization System obtains a high resolution mapping of pressures within tubular organs of the gastrointestinal tract. These organs include the esophagus from the pharyngeal region to the stomach, the proximal gut (stomach/duodenum), and the anus/recturn. It is used in a medical clinical setting to sense the pressures and store the corresponding data. The system also provides analysis information. The real time data as well as the analysis information can then be viewed by a physician for diagnostic and analysis purposes.

The Motility Visualization System (MVS) obtains a high resolution mapping of pressures within tubular organs of the gastrointestinal tract. It is used in a medical clinical setting to sense the pressures along the gastrointestinal tract and stores the corresponding data. The system also provides analysis information. The real time data as well as the analysis information can be viewed by a physician for diagnostic and analysis purposes.

The system includes a catheter probe with 36 pressure sensing elements. During the clinical procedure, the catheter is inserted transnasally and pressures inside the upper esophageal sphincter (UES), esophagus, lower esophageal sphincter (LES), and proximal gut are measured as the patient typically swallows small amounts of water. Alternatively, the catheter may be inserted in the anus/rectum for measurement of contractile pressures in that region. Real-time data is sampled from each sensing element via the MVS interface electronics and made available to the MVS software during each sample period. The software displays the data in real-time to support the clinical procedure.

The software also supports operational utility functions such as providing the user an interface for operating the pressure calibration system. It obtains the catheter sensor and calibration chamber data during the calibration process and determines the correction factors to be used in subsequent data collection.

The MVS supports physician diagnosis and analysis by means of a playback function, which replays a stored session using previously recorded data instead of real-time data. The MVS also indicates estimated parameters such as LES location, LES resting pressure, LES relaxation, LES residual pressure inversion point (PIP) location, UES pressure, and motility metrics such as peristaltic wave amplitude, duration and velocity.

The provided text refers to a 510(k) Summary for the Motility Visualization System (MVS). It describes the device, its intended use, and claims substantial equivalence to a predicate device (K011472 - Medtronic, Polygraf ID and Polygram 98 software). However, it does NOT contain details about acceptance criteria, specific studies, sample sizes, ground truth establishment, or expert involvement as requested.

Therefore, I cannot populate the requested table and answer the study-specific questions based on the provided text. The document is primarily a descriptive summary for regulatory submission, not a study report.

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