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6mmx8mm and 8mmx8mm stents: The AXIOS™ Stent and Electrocautery-Enhanced Delivery System is indicated for use to facilitate transgastric or transduodenal endoscopic drainage of symptomatic pancreatic pseudocysts ≥ 6 cm in size, that are adherent to the gastric or bowel wall and are free of solid debris. The stent is intended for implantation up to 60 days and should be removed upon confirmation of pseudocyst resolution.

10mmx10mm and 15mmx10mm stents: The AXIOS™ Electrocautery-Enhanced-Stent and Delivery System is indicated for use to facilitate transgastric or transduodenal endoscopic drainage of symptomatic pancreatic pseudocysts ≥ 6 cm in size and walled-off necrosis ≥ 6 cm in size 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 and Electrocautery-Enhanced Delivery System is indicated for use to facilitate transguodenal endoscopic drainage of the gallbladder in patients with acute cholecystitis who are at high risk for surgery.

20mmx10mm and 15mmx15mm stents: The AXIOS™ Electrocautery-Enhanced Stent and Delivery System is indicated for use to facilitate transgastric or transduodenal endoscopic drainage of symptomatic pancreatic pseudocysts ≥ 6 cm in size and walled-off necrosis ≥ 6 cm in size 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.

AXIOS™ Stent:

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

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™ 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.

This FDA 510(k) summary (K233318) for the Boston Scientific AXIOS Stent and Electrocautery-Enhanced Delivery System does not contain information about a study proving the device meets specific acceptance criteria in the context of an AI/human-in-the-loop performance evaluation.

Instead, this document focuses on demonstrating substantial equivalence to a previously cleared predicate device (DEN230019, K22011 "AXIOS Stent and Electrocautery-Enhanced Delivery System"). The core of the evidence presented is related to bench testing for use with a different Electrosurgical Unit (ESU), specifically the ERBE VIO 3.

Therefore, I cannot provide the requested information regarding acceptance criteria and performance data for an AI-based system, sample sizes for test and training sets, expert qualifications, or adjudication methods, as these details are not present in the provided text.

Based on the text, here's what can be extracted regarding the performance testing that was performed:

Summary of Device Acceptance Criteria and Performance (as per the provided document):

The document describes performance testing conducted to demonstrate equivalent settings for the AXIOS devices when used with a specific Electrosurgical Unit (ESU). The "acceptance criteria" in this context refer to demonstrating equivalence in performance with the new ESU compared to the ESU used during the original clearance, rather than a clinical performance metric like sensitivity or specificity for a diagnostic device.

1. Table of "Acceptance Criteria" and Reported Device "Performance"

2. Sample Size Used for the Test Set and Data Provenance:

• Sample Size: Not specified. The study states "bench testing" was performed.
• Data Provenance: Not specified, but implied to be laboratory/bench data generated by Boston Scientific Corporation for this submission. The testing was based on "original clearance testing."

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:

• Not applicable. This was bench testing evaluating device function with a new ESU, not a clinical study requiring expert assessment for "ground truth" on patient outcomes or diagnoses.

4. Adjudication Method for the Test Set:

• Not applicable. This was bench testing.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:

• No. This document focuses on demonstrating substantial equivalence through bench testing of the device with a different ESU, not a clinical comparative effectiveness study involving human readers or AI assistance.

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

• Not applicable. This device is a medical stent and delivery system, not an AI algorithm.

7. The type of ground truth used:

• Bench Test Results / Engineering Specifications. The "ground truth" for this testing was established by comparing the performance with the new ESU to the baseline performance established with the previously tested ESU (300D ESU), likely against pre-defined engineering specifications for power output, current, impedance, or other relevant electrical and mechanical properties.

8. The sample size for the training set:

• Not applicable. This is not an AI/machine learning device.

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

• Not applicable. This is not an AI/machine learning device.

In summary, the provided FDA 510(k) summary focuses on demonstrating that a change (compatibility with a new ESU) to an already cleared device does not alter its safety or effectiveness. The study described is a bench test aimed at showing equivalence in the device's technical performance with the new ESU. It does not involve AI, human readers, or clinical ground truth derived from expert consensus or pathology.

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