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Ultraflex™ Esophageal NG Stent System (non-covered) is intended for maintaining esophageal luminal patency in esophageal strictures caused by intrinsic and/or extrinsic malignant tumors only.

Ultraflex™ Esophageal NG Stent System (covered) is intended for maintaining esophageal luminal patency in esophageal strictures caused by intrinsic and/or extrinsic malignant turnors only, and occlusion of concurrent esophageal fistula.

The proposed Ultraflex Esophageal NG Stent System allows for the placement of a self-expanding metallic stent within the esophagus. The systems consist of a flexible delivery catheter preloaded with an expandable stent. The stent is offered either bare or covered and with either a proximal release or distal release delivery system. The stent may be placed fluoroscopically using radiopaque markers as a guide or endoscopically using the visual marker on the delivery catheter. The proposed device incorporates an updated Magnetic Resonance (MR) Conditional statement in the Directions for Use.

The Ultraflex™ Esophageal NG Stent System (K130004) is substantially equivalent to its predicates because it has identical design and materials, and the only change is an updated MR Conditional statement in the Directions for Use (DFU). This updated statement ensures compatibility with 1.5 and 3.0 Tesla MRI use, aligning with ASTM standard F 2503-08.

Here's a breakdown of the information:

1. Table of Acceptance Criteria and Reported Device Performance:

2. Sample Size Used for the Test Set and Data Provenance:

   • Sample Size: Not explicitly stated as a "test set" in the context of human data. The performance data section refers to "Magnetic Resonance testing."
   • Data Provenance: The document does not specify the country of origin or whether the data was retrospective or prospective. It implies laboratory testing rather than human clinical data.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:

   • Not applicable. The "ground truth" here is defined by the technical standard ASTM F 2503-08 for MR Conditional labeling, not by expert medical opinion on a patient dataset.

4. Adjudication Method for the Test Set:

   • Not applicable. The evaluation is based on adherence to a technical standard and laboratory testing, not on human adjudication of cases.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:

   • No. This study is focused on the MR safety labeling of a medical device, not on diagnostic performance or the effectiveness of human readers with or without AI assistance.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done:

   • Not applicable. This device is a stent, not an AI algorithm. The performance evaluation relates to its physical properties and interaction with an MR environment.

7. The Type of Ground Truth Used:

   • Technical Standard Compliance: The "ground truth" for the device's MR compatibility is established by adherence to the ASTM F 2503-08 standard for MR Conditional labeling.

8. The Sample Size for the Training Set:

   • Not applicable. There is no training set mentioned, 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 training set for this device.

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