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The AXIOS Stent is indicated for use to facilitate transgastric or transduodenal endoscopic drainage of symptomatic pancreatic pseudocysts ≥6cm in size, and symptomatic Walled Off Necrosis ≥6cm in size, with ≥70% fluid content, that are adherent to the gastric or bowel wall. Once placed, the AXIOS stent functions as an access port allowing passage of standard and therapeutic endoscopes to facilitate debridement, irrigation and cystoscopy. The stent is intended for implantation up to 60 days and should be removed upon confirmation of pseudocyst or Walled Off Necrosis resolution.

The AXIOS Stent is a flexible, MR conditional, fully-covered self-expanding braided nitinol stent, which comes preloaded into the delivery system. The AXIOS stent is designed with two flanges on each end to prevent migration and to enable tissue plane apposition and a "saddle" in between the flanges to span the tissue implant distance.

The AXIOS Electrocautery Enhanced Delivery System consists of a catheter and an integrated handle with manual controls for positioning and deploying the AXIOS Sten. The AXIOS Electrocautery Enhanced Delivery System is designed to be used in the gastrointestinal tract with commercially available echoendoscopes with a 3.7 mm diameter or larger working channel and is compatible with commercially available 0.035-inch insulated endoscopic guidewires.

The Electrocautery Enhanced Delivery System connects with an off-the-shelf electrosurgical unit or generator that is compliant to IEC 60601-1-2 and IEC 60601-2-2.

The AXIOS Stent and Electrocautery Enhanced Delivery System is provided sterile, disposable and intended for single use.

The provided text describes a medical device, the AXIOS Stent and Electrocautery Enhanced Delivery System, and its acceptance criteria as evaluated through bench testing, animal testing, and a clinical literature review.

Here's the information extracted and organized:

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

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

• Bench Testing: The sample sizes for each specific bench test are not provided in the document.
• Animal Testing: The sample size for animal testing is not specified. The provenance (country/retrospective/prospective) is also not specified, though it implies a prospective study as it states "The proposed device performed as intended."
• Clinical Literature Review: The sample size is not explicitly stated as it's a review of existing literature, not a new clinical study. The provenance and details of the studies reviewed (e.g., country of origin, retrospective/prospective nature of those individual studies) are not provided.

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)

This information is not provided in the document. The bench tests rely on objective physical measurements, and the animal testing and clinical literature review do not mention expert involvement for establishing ground truth in the way a diagnostic imaging study might.

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

This information is not applicable and therefore not provided in the document. The tests described (bench, animal, literature review) do not typically involve adjudication of results in the expert consensus sense.

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

There is no mention of a multi-reader multi-case (MRMC) comparative effectiveness study, nor is there any AI component described for this device. The device is a physical stent and delivery system.

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

Not applicable. The device is a physical medical implant and delivery system, not an algorithm.

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

• Bench Testing: Ground truth is established by engineering specifications and physical measurement standards.
• Animal Testing: Ground truth is established by direct observation of device performance, and potentially histological examination or other animal physiology assessments to verify safety and function.
• Clinical Literature Review: Ground truth is derived from the reported outcomes and findings of the clinical studies included in the review, presumably based on clinical endpoints like stent migration, drainage efficacy, etc.

8. The sample size for the training set

Not applicable. This document describes the performance data for a medical device (stent), not a machine learning algorithm that requires a training set.

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

Not applicable, as there is no training set for a medical stent device.

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