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The GuardingCatheter - Infant Feeding Tube is a sterile, disposable silicone catheter intended to deliver nutritional media. The catheter is inserted into the stomach or intestine-small bowel through the nares or mouth for delivery of liquid nutritional diets to patients with a functional GI tract.

The GuardingCatheter - Infant Feeding Tube is a sterile, disposable silicone catheter intended to deliver nutritional media.

I am sorry, but the provided text from the FDA 510(k) K042112 document is a clearance letter for the "Marian Infant Feeding Tube (GuardianCatheter™-Infant Feeding Tube)." This letter confirms that the device is substantially equivalent to legally marketed predicate devices and outlines regulatory information.

However, this document does not contain any information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, expert qualifications, adjudication methods, or comparative effectiveness studies related to any AI/algorithm-based device.

The request asks for specific details about studies proving a device meets acceptance criteria, which is not present in this regulatory clearance letter for a physical medical device. Therefore, I cannot fulfill your request based on the provided input.

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The Infant Feeding tube is intended to be placed into the stomach to permit the introduction of fluids as directed by the physician. Intended for nasogastric or orogastric placement. Limited to less than 30 day placement. Not intended for transpyloric placement.

The Infant Feeding Tube is a small diameter tube of various sizes - 5,6, and 8 French, and lengths of 14.5", 35" and 41". It has an integral female luer fitting. There are 2 eyelets near the tip of the tube. It has marking along the shaft of the tubing and an integral radiopaque line. It is provided sterile.

The provided document is a 510(k) premarket notification for a medical device called "Infant Feeding Tube." This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than fulfilling specific acceptance criteria through a clinical study. Therefore, the information requested in the prompt, which is typically found in clinical study reports for devices proving new claims or safety/effectiveness, is largely not applicable or present in this document.

Here's an analysis based on the available information:

Acceptance Criteria and Device Performance

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

The document does not specify formal "acceptance criteria" in terms of performance metrics with thresholds (e.g., sensitivity, specificity, accuracy percentages) that would be met by a study. Instead, the "device performance" is demonstrated through a comparison of key attributes to predicate devices, showing that the proposed device shares the same intended use, design features, materials, and sterile packaging.

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

This document does not describe a clinical study with a "test set" sample size. The filing is based on demonstrating substantial equivalence to existing predicate devices.

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

Not applicable. No ground truth establishment by experts for a test set is mentioned.

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

Not applicable. No adjudication method described as no test set or clinical study was conducted.

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 a medical device for physical placement, not an AI or diagnostic imaging device that would involve human readers or AI assistance.

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

Not applicable. This device is a sterile physical feeding tube, not an algorithm.

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

Not applicable. The basis for clearance is substantial equivalence to predicate devices already on the market, not a direct demonstration of safety and effectiveness against a ground truth in a clinical study. The "ground truth" in this context is the regulatory acceptance of the predicate devices.

8. The sample size for the training set

Not applicable. There is no mention of a training set as this is not an AI/machine learning device.

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

Not applicable. There is no mention of a training set or its ground truth establishment.

Summary of the Document's Purpose:

The document (510(k) K020005) is a premarket notification to the FDA to demonstrate substantial equivalence of the ProMedic Infant Feeding Tube to previously cleared predicate devices (Vygon Infant Feeding Tubes - K925854, Klein-Baker - Neo-Care Feeding Tube - K861090, Knott Gastric tube - K971354). The study, in this case, is the comparison table itself, which systematically evaluates the proposed device against established predicate devices across various attributes like intended use, design, materials, and packaging. The "proof" is the detailed comparison showing no significant differences that would raise new questions of safety or effectiveness. The FDA's letter (JUL 1 6 2002) confirms this substantial equivalence determination.

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Ask a specific question about this device