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The Stomach Tube is intended for gastric decompression. It is used to drain undesirable contents from the stomach, or decompress the stomach. The device is available in sizes 6Fr to 22Fr for use in adults only.

The Stomach Tube is a sterile, single-use tube manufactured in various sizes from medical grade PVC. The Stomach Tube is intended for gastric decompression. It is used to drain undesirable contents from the stomach, or decompress the stomach. The tube is inserted into a patient's stomach through the patient's nose or mouth.

The Stomach Tube is supplied in French size ranging from 6 to 22, consists of main tube and connector. The stomach tube connector connects to suction device for suctioning, The tube is available in open tip and closed tip form. It is composed of biologically safe materials and supplied sterile and intended for single use only.

The Stomach Tube device, K162340, is a non-AI device. The provided text does not contain information about acceptance criteria and performances related to AI/ML technology. Therefore, the questions related to AI/ML technology (sample size for test set, data provenance, number of experts, adjudication method, MRMC study, standalone performance, ground truth type, training set sample size, how ground truth for training set was established) are not applicable.

Here's the information regarding the device's acceptance criteria and the study proving it meets them:

1. A table of acceptance criteria and the reported device performance

The provided text states that "The Stomach Tube meets all the pre-determined testing and acceptance criteria" but does not explicitly list the specific acceptance criteria and detailed performance results for each test. Instead, it broadly lists the types of tests conducted.

2. Sample sized used for the test set and the data provenance

Not applicable as this is not an AI/ML device. The performance testing refers to physical product testing. The document does not specify the sample size used for each physical test or the origin of the test data (e.g., specific country for collecting samples).

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

Not applicable as this is a non-AI/ML device. Ground truth is not established by human experts in this context; performance is determined by established engineering and biological testing methods.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable as this is a non-AI/ML device. Adjudication methods are typically relevant for human expert review in diagnostic studies, not for physical performance testing of a medical device like a stomach tube.

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 as this is a non-AI/ML device.

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

Not applicable as this is a non-AI/ML device.

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

For the non-clinical performance testing, the "ground truth" is based on established engineering standards and biological testing protocols. For instance:

• General performance testing (Dimensions, Leakage, Flow Rate, Tensile, Suction Tubing Collapse): The ground truth is determined by the specifications and tolerances defined in relevant engineering standards or internal company specifications for the device's physical properties and functional performance. It is measured objectively using instruments and procedures.
• Biocompatibility testing (Cytotoxicity, Irritation, Sensitization): The ground truth is established by the results of biological assays performed according to ISO 10993 standards, which assess the material's interaction with biological systems. The "truth" is whether the material elicits an adverse biological response according to the defined criteria of these standards.

8. The sample size for the training set

Not applicable as this is a non-AI/ML device.

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

Not applicable as this is a non-AI/ML device.

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