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The Solar Compact is intended to record, store, view, and analyze pressure, impedance, and EMG data, gathered from anywhere in the gastrointestinal tract (pharynx, esophagus, stomach, 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 of the gastrointestinal tract.

An optional perfusion pump can also be used for automated balloon filling (for anorectal manometry studies). The filling lumen of the catheter can be connected to the perfusion pump.

The Solar Compact is indicated for use in adult to infants with common gastrointestinal conditions, for the monitoring and diagnosis of motility disorders of the GI tract.

The Solar Compact is a medical device for measuring gastrointestinal motility characteristics. The system consists of an electromechanical hardware device which connects to pressure catheters (air-charged or solid-state), and a PC software. Catheters provide measurements of pressure and impedance to the device from various sites along the gastrointestinal tract, which are then displayed and analyzed by the Laborie PC software. This provides the clinician with data that may aid in the diagnosis or management of various gastrointestinal disorders. Additionally, the system connects to provide EMG measurements of the muscles along the pelvic floor. Devices such as pressure catheters and surface electrodes are required to complete a gastrointestinal motility investigation, but they are not considered part of the Solar Compact device and not included standard with the system.

The device hardware consists of an external housing, pneumatics to inflate and deflate rectal balloons, and electronics to readout data from the pressure catheters and to control all other functions of the system. The device connects to a PC via Bluetooth to display measurements within the Laborie software. The Laborie software contains a patient database module, and an analysis module. The software displays measurements from the system as time-tracing based plots, Clouse Countour Plots (High Resolution Manometry), and as 3D plots. Clinicians can analyze the data provided by placing markers and using calculations within the software. The device does not provide an independent diagnosis.

The Solar Compact device is compatible with a number of of catheters for these aforementioned parameter measurements. For a full list of these compatible catheters please consult the instructions for use.

The provided text is an FDA 510(k) clearance letter and summary for a medical device called "Solar Compact (G4-1)". It contains information about the device's indications for use, technological characteristics, and comparison to predicate devices, but it explicitly states that "Clinical testing was not conducted and is not applicable for demonstrating substantial equivalence."

Therefore, I cannot provide the requested information about acceptance criteria and a study proving the device meets those criteria, as no such clinical study was performed or needed for this specific 510(k) clearance based on the provided document.

To clarify, the document focuses on demonstrating substantial equivalence to existing legally marketed devices (predicates) through non-clinical testing and comparison of technological characteristics. This pathway to market typically does not require a full clinical study with acceptance criteria like those outlined in the request, especially for devices that are considered well-understood or incremental improvements.

The document does mention "System verifications were conducted, including functional, electrical, lifetime verification testing, calibration and volume measurement, to ensure that the Solar Compact demonstrates by meeting requirements defined for the device." These "requirements defined for the device" are internal engineering and design specifications, not clinical acceptance criteria derived from a human study.

Therefore, since the document explicitly states "Clinical testing was not conducted and is not applicable," it's impossible to extract:

1. A table of acceptance criteria and reported device performance from a clinical study.
2. Sample size used for the test set and data provenance from a clinical study.
3. Number of experts used to establish ground truth or their qualifications from a clinical study.
4. Adjudication method from a clinical study.
5. MRMC study details or effect size from a clinical study.
6. Standalone performance details from a clinical study.
7. Type of ground truth used from a clinical study.
8. Sample size for the training set from a clinical study.
9. How the ground truth for the training set was established from a clinical study.

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