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The MagnaFlow® Magnetically Guided Enteral Feeding Tube functions as a conduit to facilitate enteral feeding, and may be used in pediatric, adult or elderly patients who cannot consume an adequate diet orally. Small bowel feeding may be indicated for patients with a functioning gut who require short- to moderate-term feeding support, such as post-trauma patients, post-surgical patients, burn patients, general trauma patients, high-risk patients prone to tube misplacement complications, and patients in whom malnutrition exists, or may result, secondary to an underlying disease or condition.

The MagnaFlow® Magnetically Guided Enteral Feeding Tube system is intended for direct placement in the small bowel. The catheter functions as a conduit for enteral feeding for patients who cannot consume an adequate diet orally. The catheter has a magnet embedded in the distal tip, which through the use of an external magnet aids in catheter placement. When the external magnet is in close proximity to the catheter tip, a reed switch (located proximal to tube tip magnet) closes, causing an LED light (in manifold) to illuminate. That light indicates when the external magnet has captured the tube distal portion. The external magnet can steer the catheter through the stomach pyloric sphincter into the duodenum.

The provided information pertains to a 510(k) premarket notification for a medical device called the MagnaFlow® Magnetically Guided Enteral Feeding Tube. This notification primarily focuses on establishing substantial equivalence to a predicate device already on the market (Flexiflo Magnetically Guided Enteral Feeding Tube, K972437).

Based on the provided text, there is no specific study described that proves the device meets acceptance criteria in the way typically expected for a diagnostic or AI-driven device. The document is a regulatory submission for a physical medical device (an enteral feeding tube) and focuses on describing its design, intended use, and substantial equivalence to a previously approved device. It does not detail clinical performance metrics, accuracy, sensitivity, or specificity as would be relevant for a diagnostic or AI device.

Therefore, many of the requested elements for describing "acceptance criteria and the study that proves the device meets the acceptance criteria" are not present in this document.

Here's an analysis based on the information available:

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

This information is not provided in the document. The submission focuses on describing the device and its equivalence to a predicate, not on specific performance metrics against defined acceptance criteria.

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

This information is not provided. As no such performance study is detailed, there's no mention of a test set, sample size, or data provenance.

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):

This information is not provided. This criterion is relevant for studies evaluating diagnostic accuracy, which is not the focus of this 510(k) summary.

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

This information is not provided.

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:

This information is not provided. This type of study is relevant for AI-assisted diagnostic devices, which the MagnaFlow® is not.

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

This information is not provided. The MagnaFlow® is a physical medical device, not an algorithm.

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

This information is not provided.

8. The sample size for the training set:

This information is not provided.

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

This information is not provided.

Summary of what is provided regarding the device's characteristics and equivalence:

• Device Trade Name: MagnaFlow® Magnetically Guided Enteral Feeding Tube
• Device Common Name: Enteral Feeding Tube
• Device Classification Name: Tube, Feeding at CFR 21 876.5980
• Legally Marketed Predicate Device: K972437: Flexiflo Magnetically Guided Enteral Feeding Tube
• Description of Device: The MagnaFlow® system is an enteral feeding tube for direct placement in the small bowel. It features a magnet embedded in the distal tip and a reed switch that closes to illuminate an LED light when an external magnet is in close proximity. This external magnet aids in steering the catheter through the stomach pyloric sphincter into the duodenum.
• Intended Use: Inserted orally or trans-nasally into the small bowel to provide nutrition, fluids, and medications. For pediatric, adult, or elderly patients who cannot consume an adequate diet orally. Indications include post-trauma, post-surgical, burn patients, general trauma, high-risk patients prone to tube misplacement, and malnourished patients.
• Technological Characteristics: The submission states that the proposed device has the "same fundamental technological characteristics of the predicate devices and similar design, packaging, sterilization and labeling." This is the primary "proof" for substantial equivalence in a 510(k) for this type of device – demonstrating that it is essentially the same as a device already cleared for market, rather than proving performance against novel acceptance criteria.

In conclusion, the provided text is a 510(k) summary for a physical medical device. It establishes substantial equivalence to a predicate device, which is the regulatory pathway for market clearance in this context. It does not contain the detailed performance study information typically associated with AI or diagnostic device submissions that would address the acceptance criteria as requested in the prompt.

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