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The Salem Sump™ Silicone Dual Lumen Stomach Tube with ENFit™ Connection is intended for gastric decompression and administration of nutrition, fluids, and medication. The device is intended for patients with age of two and older.

The proposed Salem Sump™ Silicone Dual Lumen Stomach Tube with ENFit™ Connection is a dual lumen gastrointestinal enteral access tube made of medical grade silicone. The dual lumen design allows for decompression and administration of fluids within the larger (main) lumen while simultaneously allowing air to enter the secondary (vent) lumen during suctioning. This prevents invagination of the stomach wall into the tube eyelets during gastric decompression. During the period that decompression is needed, delivery of nutritional fluids such as formula, hydration or medication may be delivered through the main catheter lumen. The Salem Sump Silicone Dual Lumen Stomach Tube with ENFit Connection contains an ISO 80369-3 compliant connector tethered to the Y-Shaft of the device. When nutritional fluid delivery is required, the male ENFit connector is inserted into the main lumen. The ENFit connector contains a female cap which helps the connector act as a lumen capping system when feeding or decompression is no longer required. Capping the lumen ends with the ENFit connector and the vent lumen cap helps aid in the prevention of gastric content leakage.

This document pertains to a 510(k) premarket notification for a medical device: the "Salem Sump™ Silicone Dual Lumen Stomach Tube with ENFit™ Connection." It does not describe an AI/ML medical device or any study that proves a device meets acceptance criteria related to AI/ML performance metrics (such as sensitivity, specificity, or human reader improvement with AI assistance).

The document is a submission to the FDA for a physical medical device, specifically a gastrointestinal tube. The acceptance criteria and "study" described are for non-clinical performance testing of this physical device, not for the performance of an algorithm or AI system.

Therefore, I cannot provide the information requested in your prompt because it is designed for an AI/ML device, and this document does not contain that type of information.

To elaborate on why the requested information cannot be found:

• Acceptance Criteria/Reported Performance (Table): The document lists various non-clinical tests (e.g., Functional Verification, Occlusion Verification, Tensile Strength, Biocompatibility). It states that the "results of the testing demonstrate that the proposed device continues to meet the requirements of the product specifications" but does not provide specific numerical acceptance criteria or reported performance values in a table format.
• Sample Size/Data Provenance/Experts/Adjudication/MRMC/Standalone Performance/Ground Truth/Training Set Details: These questions are entirely relevant to AI/ML device studies. This document explicitly states: "Clinical evaluations were not relied upon for evidence of safety of effectiveness, or for a determination of substantial equivalence." This means there was no clinical study, human reader study, or AI algorithm involved that would require the establishment of ground truth by experts, adjudication, or training/test sets as understood in the context of AI/ML.

The "study" referenced in this document is a series of laboratory tests on the physical properties and performance of the gastrointestinal tube.

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