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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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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 is intended for the endoscopic placement of the selfexpanding nitinol stent for maintaining luminal patency in esophageal strictures. The flexible Agile Stent and through-the scope Delivery System allow for stent placement through direct visualization. The Agile™ Esophageal Stent System is supplied sterile.

The Agile™ Stent is a flexible. MR conditional, self-expanding, braided nitinol stent. The proximal and distal ends of the stent have a flare which is larger in diameter than the stent body. The stent wires at each end of the flare are looped. A suture is threaded within the looped ends of both the proximal and distal stent flares to aid in repositioning during initial placement. The proposed Agile Stent is both fully and partially covered in a silicone covering.

The Agile™ Stent comes preloaded and constrained in the delivery system. The delivery system consists of two coaxial shafts compatible with a minimum 3.7mm working channel of a therapeutic gastroscope. The exterior tube is used to constrain the stent before deployment and to reconstrain the stent after partial deployment. The delivery system has radiopaque and visual markers to aid the user in accurate stent placement. There are three visual markers on the delivery system handle to aid in the placement of the stent under endoscopic visualization and four radiopaque markers on the interior of the delivery system to aid in placement of the stent under fluoroscopic visualization.

The provided document describes the Agile Esophageal Stent System, a medical device intended for maintaining esophageal luminal patency in esophageal strictures. The information does not detail diagnostic or AI/ML-based performance. Instead, it focuses on the engineering and biocompatibility validation of the stent system itself. Therefore, many of the requested fields related to AI/ML model performance, such as MRMC studies, ground truth establishment for training/test sets, and sample sizes for training sets, are not applicable.

Here's an analysis based on the available information:

Acceptance Criteria and Study to Prove Device Meets Acceptance Criteria

The acceptance criteria for the Agile Esophageal Stent System are implicitly defined by the successful completion of a series of biocompatibility and bench tests, along with demonstrating substantial equivalence to predicate devices. The study proving the device meets these criteria involved performing these tests and comparing the results to pre-defined specifications or to predicate device performance.

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not explicitly state the numerical sample size for each bench test or biocompatibility test. It reports "Pass" for each test, indicating that the tested samples met the pre-defined criteria. The tests are bench tests performed on the device components or complete systems, and biocompatibility tests conducted in vitro and in vivo (e.g., animal models). The provenance of this data is from the manufacturer's (Boston Scientific Corporation) internal testing. These are prospective tests conducted on the newly designed device.

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

Not Applicable. This request is relevant for AI/ML validation where expert consensus establishes ground truth for diagnostic accuracy. Given this is a physical medical device (stent), the "ground truth" is established by engineering specifications, material science standards, and biocompatibility guidelines, rather than expert interpretation of medical images or data.

4. Adjudication Method for the Test Set

Not Applicable. Adjudication methods (e.g., 2+1, 3+1) are used to resolve disagreements among human readers or experts in diagnostic studies to establish a consensus ground truth. This is not relevant for the bench and biocompatibility testing of a physical device.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and the effect size of how much human readers improve with AI vs without AI assistance

Not Applicable. This is a physical medical device (stent), not an AI-based diagnostic tool that assists human readers.

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

Not Applicable. This is a physical medical device (stent), not a standalone algorithm.

7. The type of ground truth used

The "ground truth" for this device's performance is based on:

• Engineering specifications and standards: For mechanical properties, dimensions, deployment accuracy, etc.
• Biocompatibility standards (e.g., ISO 10993): For material safety tests.
• Comparison to predicate devices: For comparative bench testing, the performance of the predicate devices serves as a benchmark for what is considered acceptable.

8. The sample size for the training set

Not Applicable. This document describes a physical medical device, not an AI/ML model that requires a training set.

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

Not Applicable. As there is no AI/ML model, there is no training set or associated ground truth.

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