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The Agile Esophageal Stent System is intended for maintaining esophageal luminal patency in esophageal strictures caused by intrinsic and/or extrinsic malignant tumors, and occlusion of concurrent esophageal fistulas.

The Agile Esophageal Stent System consists of a self-expanding esophageal metal stent and a delivery system. The Agile Esophageal Stent is available partially or fully covered with silicone covering and in three diameter sizes: 14mm, 18mm and 23mm. The 14mm and 18mm diameter stents are pre-loaded on a 10.5Fr delivery system and the 23mm diameter stent is pre-loaded on an 18.5Fr delivery system. The 10.5Fr delivery system has a single central lumen to accommodate a 0.035" (0.89 mm) guidewire. The 18.5Fr delivery system has a single central lumen to accommodate a 0.038" (0.97mm) guidewire.

The provided text, K233837, is an FDA 510(k) clearance letter for the Boston Scientific Agile Esophageal Stent System. This document does not contain information about acceptance criteria or a study proving the device meets those criteria in the context of an AI/ML-driven medical device.

Instead, this document is a Traditional 510(k) submission for a non-software medical device (an esophageal stent system). The text explicitly states that the proposed device is "identical to the predicate Agile Esophageal Stent System (K180144 and K211960) in intended use, indications for use, classification, principles of operation, technical characteristics, performance, and materials." This means the submission is based on substantial equivalence to a previously cleared device, not on new performance studies with specific acceptance criteria that would typically be seen for an AI/ML device.

Therefore, I cannot provide the requested information as it is not present in the given document. The document confirms:

• Device Name: Agile Esophageal Stent System
• Regulation Number: 21 CFR 878.3610 (Esophageal Prosthesis)
• Regulatory Class: Class II
• Product Code: ESW
• Predicate Devices: K180144 and K211960 (Agile Esophageal Stent System and Agile Esophageal OTW Stent System, respectively)
• Basis for Clearance: Substantial equivalence to previously cleared predicate devices, an "identical" comparison in design, material, chemical composition, fundamental technology, principle of operation, sterilization, packaging, shelf-life, and manufacturing process.

The document discusses "Non-Clinical and/or Clinical Tests Summary & Conclusions," but it does so in the context of confirming the substantial equivalence to the predicate, implying that the tests performed (if any beyond confirming identical characteristics) were to demonstrate this equivalence, not to meet new, specific performance acceptance criteria for a novel AI/ML algorithm.

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