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The Sandoz Nutrition #082302 NFG Tube is intended for use with patients who require both enteral feeding and gastric suction simultaneously. The Sandoz Nutrition #082304 NF Tube is intended for use with patients who require only enteral feeding. Indications for such medical and post-surgical treatments may include surgical problems, prolonged artificial ventilation, central nervous system trauma, and others. The placement of the device in patients can be accomplished intraoperatively at laparotomy using standard surgical techniques.

A Nasojejunal Feeding Tube with or without Gastric Drainage.

This document, K961664, is a 510(k) premarket notification for a medical device: a nasojejunal feeding tube. The purpose of a 510(k) submission is to demonstrate that the device is "substantially equivalent" to a legally marketed predicate device, not necessarily to prove its absolute safety and effectiveness through extensive clinical trials as might be required for a PMA (Premarket Approval).

Therefore, the submission does not contain the typical "acceptance criteria" and a detailed "study" as you might expect for a new diagnostic or AI-powered device. Instead, it focuses on demonstrating equivalence to a predicate device.

Here's an analysis based on the provided text, addressing your points where applicable:

Acceptance Criteria and Device Performance (Based on Substantial Equivalence Logic)

Since this is a substantial equivalence submission, the "acceptance criteria" are implied to be at least equivalent performance regarding safety and effectiveness as the predicate device. The "reported device performance" is essentially the claim that the modified device performs similarly to the predicate.

Addressing Your Specific Points:

1. A table of acceptance criteria and the reported device performance
   See table above. The "acceptance criteria" are not explicitly stated in a quantitative manner as this is a medical device and not a diagnostic/AI product. The criteria are implicitly tied to the safety and performance of the predicate device.

2. Sample sized used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
   Not applicable / Not provided. This submission does not describe a test set or clinical study in the traditional sense for evaluating performance. The argument for substantial equivalence relies on material equivalence, design similarity, and the existing safety record of the predicate device.

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 / Not provided. No ground truth establishment is described as there is no specific performance test set.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
   Not applicable / Not provided. No test set or expert adjudication 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 is a physical medical device (feeding tube), not a diagnostic or AI product. Therefore, an MRMC study is not relevant or described.

6. If a standalone (i.e., algorithm only without human-in-the loop performance) was done
   Not applicable. This is a physical medical device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
   Not applicable. No specific "ground truth" or clinical outcomes data is presented to prove performance of this specific modification. The "ground truth" for the predicate device's safety and effectiveness is assumed to be established through its 5 years of marketing without complaints regarding materials.

8. The sample size for the training set
   Not applicable / Not provided. There is no training set mentioned, as this is not an AI or machine learning device.

9. How the ground truth for the training set was established
   Not applicable / Not provided. No training set is mentioned.

In summary: This 510(k) submission for a nasojejunal feeding tube demonstrates substantial equivalence to a predicate device by highlighting:

• Identical intended use (delivering enteral formula post-pylorically, and gastric drainage for one model).
• Identical materials for new and existing components.
• Identical lengths, diameters, and connectors to the predicate.
• The minor changes (grasping rings, bolus tip) are designed to "assist in surgical palpation on manipulation of the tube tip during placement" and don't negatively affect safety or effectiveness, especially since their materials and bonding are the same as the predicate device which has a 5-year complaint-free history regarding materials.
• Placement confirmation can still be achieved via radiography due to radiopaque features.

The "study" in this context is the comparison between the proposed device and the predicate device, emphasizing their similarities and arguing that the minor differences do not introduce new risks or alter fundamental performance, thus meeting the criteria for substantial equivalence. No clinical trials or performance studies are detailed in this summary.

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