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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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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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