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The AMT Decompression Tubes are used to allow decompression of gasses from a patient's stomach when the patient is using an AMT Button, AMT One Step Button, BARD Button, Surgitek One Step Button, Microvasive One Step Button, AMT Replacement Buttons, or other similar button feeding device that has an anti-reflux valve incorporated. By inserting the proper size decompression tube into the button feeding port, the decompression tube will open the anti-reflux valve, allowing patient stomach decompression without damaging the anti-reflux valve. Opening the anti-reflux valve relieves gaseous pressure in the patient's stomach by allowing the gas to escape through the decompression tube providing comfort to the patient. Other uses are not recommended.

Decompression device attached to a 12" piece of PVC tubing with a 16 French connector on the other end. The Decompression part is injection molded of Polyethylene in various diameters (French sizes) and Lengths (in cm), either right angle or straight. The proper length is determined by the length of the gastrointestinal button (ie: One Step Button, AMT Button) placed in the patient. By inserting the decompression tube, the gastrointestinal button's internal anti reflux valve is opened, allowing a pathway for patient stomach gasses to escape (decompression). The devices are sold in various sizes, packaged individually with Directions For Use, non-sterile, single user, and disposable.

The provided text does not contain acceptance criteria or a study that proves the device meets specific acceptance criteria in the way typically found for medical device software or AI.

Instead, this document is a 510(k) summary for a medical device called "AMT Decompression Tubes." The basis for its clearance is substantial equivalence to predicate devices already on the market, not through a performance study against predefined acceptance criteria.

Therefore, I cannot populate the table or answer the questions as requested because the foundational information (acceptance criteria and study results) is not present in the provided text.

The closest one can get to "acceptance" is the FDA's determination of substantial equivalence. The document explicitly states:

"13. Safety and Effectiveness of the device: The AMT Decompression Tubes are as safe and effective as other predicate devices cited above." and "The AMT Decompression tubes are identical in design and manufacture, using the same materials and processes used in 510(k) K920894 of Applied Medical Technology, Inc."

This means the "device performance" is considered equivalent to the predicate devices due to identical design, manufacture, materials, and processes, rather than through a new, independent performance study meeting specific metrics.

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