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The Device is intended for introduction into the Naris (Nostril) and is is used in the introduction of various commercial or compounded enteral diets to appropriate sites along the Ailimentary tract of the patient.

The subject devices are weighted or unweighted, thermoplastic or elastomer tubes. The distal outlet of the tube may be closed in a spherical tip or opened and polished to facilitate passage through the mucosal tissues of the nose or esophagus. A series of side outlets may be perforated through the side wall of the tubing to allow for dispersion of the enteral diet around the distal end of the tube. A stainless steel stylet may or may not be included with the product for aid in placement

This is a 510(k) summary for a medical device submitted to the FDA, not a study report. Therefore, it does not contain the detailed information about acceptance criteria and a study proving those criteria are met in the way a structured clinical trial or performance study would.

Instead, this document focuses on establishing substantial equivalence to a predicate legally marketed device. The "acceptance criteria" here are implicitly related to demonstrating that the new device is as safe and effective as the predicate device.

Here's an attempt to answer your questions based on the provided text, recognizing the limitations of this type of submission:

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

This document does not present explicit "acceptance criteria" in a quantitative, measurable format like a performance study might (e.g., "device must achieve sensitivity of X%"). Instead, the primary "acceptance criterion" for a 510(k) is demonstrating substantial equivalence to a predicate device.

The "reported device performance" is essentially that the device is "equivalent in design and construction" to the predicate.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Sample size for test set: Not applicable. This document does not describe a performance or clinical study with a "test set" of patient data. It is a submission for regulatory clearance based on substantial equivalence.
• Data provenance: Not applicable.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

• Not applicable. No ground truth establishment for a test set is described.

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

• Not applicable. No adjudication method is described.

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 device is an enteral feeding tube, not an AI-assisted diagnostic device, and no MRMC study or AI component is mentioned.

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

• Not applicable. This device is an enteral feeding tube, not an algorithm.

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

• Not applicable. No patient data or ground truth determination is described in this 510(k) summary. The "ground truth" for this type of submission is the established safety and effectiveness of the predicate device.

8. The sample size for the training set

• Not applicable. No training set is mentioned as this is not a machine learning or AI device submission.

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

• Not applicable.

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