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The Novartis Nutrition COMPAT Jejunostomy Tube is a surgically placed small bowel feeding access port intended for single patient use. The device delivers enteral solutions and medications directly into the small intestine. When direct access to the small bowel lumen is necessary, the tube may be placed, and positioned within the small bowel using an appropriate technique. It may be permanently fixed to the skin of the outer abdomen using the arternal retainer provided and suture, or another appropriate fixation technique.

The Jejunostomy Tube is a surgically placed small bowel feeding access port intended for single patient use.

The provided text describes a 510(k) submission for the Novartis Nutrition COMPAT® Jejunostomy Tube Kit. This type of submission relies on demonstrating substantial equivalence to a legally marketed predicate device, rather than conducting new clinical trials to prove device performance against specific acceptance criteria.

Therefore, the document does not contain the information requested regarding acceptance criteria, a study that proves device performance against those criteria, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth details.

Instead, the submission focuses on comparing the new device's technological characteristics to those of the predicate device (Medical Innovations Corp. MIC Jejunostomy Tube #300-014). The key differences highlighted are:

• Length: 50cm for the new device vs. 30cm for the predicate.
• Radiopacity: Solid radiopaque silicone for the new device vs. clear with stripe for the predicate.
• Exit Ports: Side and open-end for the new device vs. open-end only for the predicate.
• Fixation: No "wings" or suture cuff for the new device vs. 2 soft "wings" and a Dacron cuff for the predicate.

The FDA's letter (K991668) confirms that the device was found substantially equivalent for the stated indications for use based on this comparison, not on performance data from a clinical study as would be described by the requested table and study details.

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