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The AXIOS Stent and Delivery System & AXIOS Stent and Electrocautery Enhanced Delivery System are 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.

Non-Cautery Enhanced Delivery System: The stent is preloaded within the AXIOS delivery catheter. The Delivery System consists of a catheter and an integrated handle with manual controls for positioning and deploying the AXIOS stent. The Delivery System is designed to be used in the gastrointestinal tract in conjunction 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.

Electrocautery Enhanced Delivery System: 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 510(k) submission for the AXIOS Stent and Delivery System. The focus of this submission is to reinstate a passivation/etching manufacturing step that had previously been removed. Because the change involves reinstating a prior manufacturing step and the device is being claimed as substantially equivalent to previously cleared versions, the performance data presented is primarily bench testing to confirm that the reinstation of this step does not negatively impact the device's performance or safety.

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

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state "acceptance criteria" values in a quantitative format for each test. Instead, it states that the device "successfully passed all pre-defined product specifications and is equivalent to the predicate passivated AXIOS stent for the tests performed." This implies that the acceptance criteria for each test were met, resulting in a "Pass" outcome.

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

The document does not specify the exact sample sizes for each bench test conducted (e.g., number of stents tested for fatigue, corrosion, etc.). It only lists the types of tests performed.

The data provenance is from bench testing performed to verify design and validation requirements after reinstating a manufacturing step. The document does not specify if these tests were conducted internally by Boston Scientific or by an external laboratory. It does not refer to patient data (retrospective or prospective), as this submission is focused on a manufacturing change for an already cleared device.

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

Not applicable. This submission concerns bench testing of a physical device for manufacturing changes, not diagnostic or interpretive tasks requiring expert ground truth establishment.

4. Adjudication method for the test set

Not applicable. This submission concerns bench testing of a physical device, not a diagnostic study requiring adjudication.

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 submission is for a medical device (stent and delivery system), not an AI-powered diagnostic tool.

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

Not applicable. This submission is for a medical device (stent and delivery system), not a software algorithm.

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

For the bench testing, the "ground truth" would be the pre-defined product specifications and performance characteristics of the predicate device. The tests were designed to verify that the modified device met these engineering and material standards. For example, for "Deployed Stent Saddle Length," the ground truth would be the specified design length within allowable tolerances.

8. The sample size for the training set

Not applicable. This submission focuses on bench testing a physical device after a manufacturing change, not on training a machine learning algorithm.

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

Not applicable. There is no training set for a machine learning algorithm in this submission.

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