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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 Esophageal TTS Stent is intended for use in esophageal strictures caused by intrinsic and/or extrinsic malignant tumors.

The Esophageal TTS Stent consists of the implantable metallic stent and introducer system. The stent is made of Nitinol wire. It is a flexible, fine mesh tubular prosthesis that has 10 radiopaque markers; 4 in each end and 2 in the center. It has a body diameter of 18, 20 and 22mm, and a total length from 60 to 150mm. The surface of the body portion of the stent is covered with silicone. The Esophageal TTS Stent is provided in two configurations, either fully covered with silicone or with both heads not covered in silicone (bare). The introducer system accepts a 0.035 in (0.89 mm) or 0.038 in (0.97 mm) guidewire. The stent introducer system is passed over the guidewire and through an endoscope into the esophagus. The stent may be positioned appropriately using the X-ray markers for guidance under fluoroscopy.

The provided text is a 510(k) summary for the Esophageal TTS Stent. It describes the device, its intended use, and a comparison to predicate devices, along with performance data. However, it explicitly states that no clinical data or animal testing were performed to establish substantial equivalence.

Therefore, the study that proves the device meets acceptance criteria is not a clinical study involving human or animal subjects, but rather bench testing.

Here's a breakdown of the requested information based on the provided text:

1. A table of acceptance criteria and the reported device performance

The document states: "All samples met their acceptance criteria, demonstrating that when manufactured to specification, the device functions as intended and can be found substantially equivalent to the predicate device." However, the specific acceptance criteria for each test (e.g., a specific force range for the Deployment Force Test) are not detailed within this document. Only the types of tests conducted are listed.

2. Sample size used for the test set and the data provenance

• Sample size: The document states that bench testing was conducted on "both the 22mm diameter size and the 220cm length" of the device. It does not provide a specific number of units tested for each test.
• Data provenance: Not explicitly stated, but assumed to be internal testing conducted by the manufacturer, Taewoong Medical Co., Ltd., which is based in Korea. This is a retrospective evaluation of the device performance during its development and prior to submission.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. This device's substantial equivalence was established through bench testing, not a clinical study requiring expert assessment of patient data.

4. Adjudication method for the test set

Not applicable, as this was not a clinical study involving human judgment. The outcome of the bench tests would have been objective measurements against predetermined (but not specified in this document) specifications.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This is a medical device (stent) and not an AI/software product, so an MRMC study and AI assistance are not relevant to its performance evaluation as described.

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

Not applicable. This is a physical medical device, not an algorithm.

7. The type of ground truth used

The "ground truth" for the bench testing would be the engineering specifications and design requirements for the device. The tests validated that the manufactured device performed in accordance with these established technical criteria.

8. The sample size for the training set

Not applicable. This is a physical medical device and does not involve machine learning or a "training set" in the context of AI.

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

Not applicable, as no training set was used.

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