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The WallFlex™ Enteral Duodenal Stent with Anchor Lock Delivery System is indicated for the palliative treatment of gastroduodenal obstructions caused by malignant neoplasms.

The proposed WallFlex™ Enteral Duodenal Stent with Anchor Lock Delivery System consists of two components: an implantable metal stent and a delivery system. The proposed stent is manufactured of Nitinol and has a 22mm body diameter with a 27mm distal flare diameter, and is offered in three lengths, 6cm, 9cm, and 12cm. The Anchor Lock Delivery System consists of a coaxial tubing assembly that constrains the stent on the delivery catheter shaft until the stent is released by retracting the exterior tube.

The provided text is a 510(k) summary for the WallFlex™ Enteral Duodenal Stent System with Anchor Lock Delivery System. It describes the device, its intended use, and its substantial equivalence to predicate devices. However, it does not contain detailed information about specific acceptance criteria or a dedicated study proving performance against such criteria.

The document states:

• "Clinical data in support of the proposed indication for the WallFlex™ Enteral Duodenal Stent with Anchor Lock Delivery System has been included in this premarket notification."
• "Boston Scientific Corporation has demonstrated that proposed WallFlex™ Enteral Duodenal Stent with Anchor Lock Delivery System is substantially equivalent to the currently marketed WallFlex™ Enteral Colonic Stent with Anchor Lock Delivery System and in terms of the proposed indication to Boston Scientific's Wallstent Enteral Endoprosthesis."

This indicates that the clinical data presented was likely used to demonstrate substantial equivalence to existing predicate devices, rather than a standalone study designed to meet specific quantitative acceptance criteria for a novel device performance.

Therefore, I cannot provide a table of acceptance criteria and reported device performance, nor can I answer many of the specific questions about sample sizes, ground truth, expert qualifications, or MRMC studies, as this information is not present in the provided 510(k) summary.

Here's what can be inferred or stated based on the available text:

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

   • Not provided. The document focuses on substantial equivalence rather than a new device meeting pre-defined acceptance criteria.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

   • Not provided. The document only states "Clinical data... has been included," without details on sample size or provenance.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):

   • Not provided. This information is generally not part of a 510(k) summary focused on substantial equivalence for a medical device like a stent.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

   • Not provided.

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 device is a medical implant (stent), not an AI-powered diagnostic tool engaging human "readers."

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

   • Not applicable. This is a medical implant, not an algorithm.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc):

   • Not explicitly stated for the "clinical data" mentioned. For a medical device like a stent, ground truth would likely refer to clinical outcomes (e.g., successful stent placement, patency, complication rates, patient survival, symptom relief) verified through clinical follow-up, imaging, and potentially pathology if biopsies were taken. The document, however, does not detail how this "clinical data" was acquired or what specific endpoints it measured.

8. The sample size for the training set:

   • Not applicable/Not provided. This device is hardware; there is no "training set" in the context of an AI algorithm. Clinical trials involve patient cohorts, but the size of any such cohort is not disclosed.

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

   • Not applicable/Not provided.

Summary of what's present in the document:

• The device is a WallFlex™ Enteral Duodenal Stent with Anchor Lock Delivery System.
• Its intended use is for the palliative treatment of gastroduodenal obstructions caused by malignant neoplasms.
• The submission is a 510(k) premarket notification claiming "substantial equivalence" to predicate devices (WallFlex™ Enteral Colonic Stent with Anchor Lock Delivery System and Wallstent Enteral Endoprosthesis).
• Clinical data was included to support the proposed indication, but no details of the study (design, sample size, outcome measures) are provided in this summary.
• The FDA's letter confirms the determination of substantial equivalence.

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