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The NGT is intended for gastric decompression, gastric suction, administration of nutritional supplements and medication, and to monitor core temperature.

The NGT Nasogastric Tube is made of a plastic material, contains three lumens, a main suction lumen, a smaller vent lumen, and a still smaller temperature thermistor lumen. The primary suction lumen is used for drainage, the second vent lumen provides an air inlet as a mechanism to break suction minimizing the potential for tube blockage secondary to mucosal tissue invagination into the side holes of the primary lumen. The device is intended to be used with a standard suction source to facilitate drainage.

The provided 510(k) summary for K022558 focuses on demonstrating substantial equivalence of the NGT Nasogastric Thermistor device to predicate devices. It states that "Bench testing was performed on the NGT to demonstrate equivalency." However, the summary does not provide any specific acceptance criteria or detailed results of this performance testing.

Therefore, I cannot populate the table or answer most of the questions as the required information is not available in the given text.

Here's a breakdown of what can be extracted and what cannot:

1. Table of Acceptance Criteria and Reported Device Performance:

2. Sample size used for the test set and the data provenance:

• Sample size: Not provided.
• Data provenance: Not provided (the document only mentions "Bench testing," which implies laboratory-based testing, but no details on data origin or type are given).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• Not applicable. This device is a medical tube with a temperature sensor, not an AI/Software as a Medical Device (SaMD) requiring expert-established ground truth for interpretation of images or other complex data. The document describes bench testing for equivalency, not a study involving expert review of results.

4. Adjudication method for the test set:

• Not applicable. (See answer to #3)

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:

• Not applicable. This is not an AI/SaMD device.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:

• Not applicable. This is a physical medical device, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):

• Not applicable in the conventional sense for a physical device. For "bench testing," ground truth would typically refer to known physical properties, measurements from calibrated reference instruments, or specified performance standards for gastric suction and temperature sensing. The document does not specify these.

8. The sample size for the training set:

• Not applicable. This is a physical medical device, not an machine learning model requiring a training set.

9. How the ground truth for the training set was established:

• Not applicable. (See answer to #8)

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