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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 davs and should be removed upon confirmation of pseudocyst 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 deploving the AXIOS Stent. 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 describes a medical device, the AXIOS Stent and Electrocautery-Enhanced Delivery System, and its performance. However, it does not involve an AI/ML algorithm, and therefore the acceptance criteria and study information related to AI/ML performance metrics (such as effect size for human readers with AI assistance, type of ground truth, training set size, etc.) are not applicable here.

The document focuses on demonstrating substantial equivalence to a predicate device (K181905) through engineering performance data (bench testing) rather than clinical study data involving AI/ML.

Here's a breakdown of the available information based on your request, with an emphasis on what is not present due to the nature of this device submission:

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

The document provides a table summarizing the types of bench tests performed and their results. The "acceptance criteria" are implied by the "Pass" result for each test, indicating that the device met the pre-defined product specifications for these engineering parameters. Specific numerical acceptance criteria values are not provided, only the pass/fail outcome.

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

• Sample Size: Not specified for the bench tests. For medical devices, bench testing typically involves a sufficient number of samples to ensure statistical confidence in the results, but the exact N is not disclosed in this summary.
• Data Provenance: Not applicable as this relates to engineering bench testing of physical device components, not clinical data sets.

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 applicable. This device is not an AI/ML diagnostic tool requiring expert interpretation for ground truth establishment. The "ground truth" for the performance tests are engineering specifications verified through physical measurement and functional testing.

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

Not applicable. This is not a clinical study involving human interpretation or adjudication of cases.

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 is not an AI/ML powered device, and no MRMC study was conducted or mentioned.

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

Not applicable. There is no algorithm to test in a standalone configuration.

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

The "ground truth" for these tests are the pre-defined product specifications and engineering requirements for the device's physical and functional characteristics. This is established through engineering design, material science, and manufacturing standards.

8. The sample size for the training set

Not applicable. This is not an AI/ML device, so there is no training set.

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

Not applicable. As there is no AI/ML component, there is no training set or associated ground truth establishment process.

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The AXIOS Stent and Electrocautery Enhanced Delivery System 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 contains information about the AXIOS Stent and Electrocautery-Enhanced Delivery System, specifically an FDA 510(k) summary for a new version of the device (K192043). However, it does not describe a clinical study that proves the device meets specific acceptance criteria based on human or expert evaluation. Instead, it describes bench testing against predefined product specifications to demonstrate substantial equivalence to a predicate device.

Therefore, many of the requested items (sample sizes for test sets, data provenance, number of experts, adjudication methods, MRMC studies, standalone algorithm performance, training set details) are not applicable or cannot be answered from the provided document as it does not detail a clinical performance study with human readers or AI.

Here's a breakdown of what can be extracted:

1. Table of Acceptance Criteria and Reported Device Performance:

The document describes "pre-defined product specifications" for bench tests as the acceptance criteria. The device is reported to have met these criteria.

Regarding the other requested information:

• 2. Sample size used for the test set and the data provenance: This information is not provided in the document. The tests performed were bench tests on the device itself, not clinical tests on a patient population.
• 3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. The "ground truth" for the bench tests would be the established product specifications for physical properties, not expert-derived medical diagnoses.
• 4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. Adjudication methods are typically used for clinical studies involving interpretation of medical images or patient outcomes, not for bench testing of device specifications.
• 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: No MRMC study was mentioned. The device is a medical stent and delivery system, not an AI diagnostic tool that assists human readers.
• 6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. The device is a physical medical device, not a standalone AI algorithm.
• 7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): For the bench tests, the ground truth was the pre-defined product specifications for mechanical and physical properties of the device (e.g., specific dimensions, force resistance, MR compatibility).
• 8. The sample size for the training set: Not applicable. This document describes a physical medical device, not an AI model 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 an AI model.

Summary from the document:

The provided text focuses on the technical characteristics and bench testing of a medical device (AXIOS Stent and Electrocautery-Enhanced Delivery System) to demonstrate substantial equivalence to a previously cleared predicate device. The "acceptance criteria" here refer to predefined product specifications for the physical device, and the "study" is a series of bench tests. No clinical studies involving human readers, AI, or patient outcomes for the purpose of establishing device performance against clinical acceptance criteria are described in this document.

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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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