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The AXIOS™ Stent is indicated for use to facilitate transgastric or transduodenal endoscopic drainage of symptomatic pancreatic pseudocysts ≥ 6 cm in size, and symptomatic 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 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 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™ 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.

The provided text is a 510(k) summary for a medical device (AXIOS™ Stent and Electrocautery-Enhanced Delivery System), establishing its substantial equivalence to a predicate device. It details the device's description, indications for use, and performance data from a clinical trial.

However, the request asks for information typically found in an AI/ML medical device submission, specifically concerning "acceptance criteria" and "study that proves the device meets the acceptance criteria" in the context of an AI/ML algorithm's performance. The document describes a medical device (a stent and delivery system), not an AI/ML algorithm. Therefore, many of the requested fields are not applicable to the content provided (e.g., number of experts to establish ground truth, adjudication methods, MRMC studies, standalone algorithm performance, training/test set sample sizes for an algorithm, etc.).

The "Performance Data" section in the document refers to a clinical trial evaluating the safety and effectiveness of the stent, not an AI/ML algorithm's performance.

Given this discrepancy, I will extract the relevant "performance data" provided for the stent and explain why other AI/ML-specific questions are not applicable to this document.

Acceptance Criteria and Study Proving Device Meets Criteria (Based on Provided Document)

This document describes the regulatory submission for a medical device: the AXIOS™ Stent and Electrocautery-Enhanced Delivery System. It is not an AI/ML-driven device, so the typical AI/ML-specific acceptance criteria and study design (like MRMC studies, ground truth establishment by experts for an algorithm, training/test sets for an algorithm, etc.) are not applicable here.

The "acceptance criteria" in this context would implicitly refer to demonstrating safety and effectiveness for its intended use, sufficient for FDA 510(k) clearance based on substantial equivalence to predicate devices, and in support of an expanded indication. The "study that proves the device meets the acceptance criteria" is the described clinical trial.

Here's the information extracted and contextualized based on the provided document:

1. Table of "Acceptance Criteria" (Clinical Endpoints) and Reported Device Performance

Note: These are not acceptance criteria for an AI/ML algorithm's performance but rather for the clinical efficacy and safety of a medical device (stent).

2. Sample Size and Data Provenance

• Sample Size (Clinical Trial): 40 patients (with 45 AXIOS™ stents implanted, as some subjects had multiple WON).
• Data Provenance: The document states "a prospective, single arm, multi-center trial." It does not specify the country of origin but implies a formal clinical investigation under an approved Investigational Device Exemption (IDE) per GCP and 21 CFR Parts 50, 56, and 812, which are U.S. regulations. Thus, it's a prospective, clinical trial data.

3. Number of Experts and Qualifications for Ground Truth

• Not Applicable (N/A): This is a clinical trial of a medical device (stent and delivery system), not an AI/ML algorithm requiring expert ground truth for image interpretation or similar AI-specific tasks. The "ground truth" here is the clinical outcome (WON resolution, adverse events), determined by medical professionals treating the patients and clinical assessments (radiographic imaging, physical exams) as part of the trial protocol.

4. Adjudication Method for the Test Set

• N/A: As this is a clinical trial, not an AI/ML algorithm's test set requiring human reader adjudication for performance metrics. Clinical endpoints are typically evaluated by blinded assessment where possible, and adverse events are adjudicated by a clinical events committee, but the specific details of that adjudication are not provided beyond the general statement of a "prospective, single arm, multi-center trial conducted per GCP."

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

• No (N/A): An MRMC study is relevant for evaluating the impact of an AI/ML algorithm on human reader performance (e.g., radiologists interpreting images). This document describes a clinical trial of a physical medical device (stent), not an AI/ML algorithm.

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

• N/A: This is not an AI/ML algorithm.

7. The Type of Ground Truth Used

• Clinical Outcomes and Radiographic Assessment: For the primary effectiveness endpoint, the "ground truth" was the "radiographic decrease of WON size to

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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.

Ask a specific question about this device

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 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.

Ask a specific question about this device

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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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 and Delivery System and the AXIOS Stent and Electrocautery Enhanced Delivery System are discussed below and presented in Table 5 - 1 . There have been no changes to the AXIOS Stent or the delivery systems; it is identical to the stent and delivery systems cleared in 510(k) K152572 and K150692.

AXIOS Stent:
The AXIOS Stent and Delivery System is designed to secure the apposition of tissue, minimize stent displacement and create a large access/drainage lumen.

AXIOS Non-Cautery 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.

AXIOS Electro-Cautery Enhanced Delivery System:
The stent is preloaded onto the AXIOS delivery catheter. The Electro-cautery Enhanced Delivery System consists of a catheter and an integrated handle with manual controls for positioning and deploying the AXIOS stent. The Electro-cautery Enhanced 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.

This document is a 510(k) submission for the AXIOS Stent and Delivery System, seeking to update its Indications for Use. The submission argues that no new performance data is required because the proposed changes align with existing clinical guidelines and previous IDE studies have already established safety and effectiveness for similar conditions.

Here's the breakdown of the information requested:

1. Table of Acceptance Criteria and Reported Device Performance

Note: This 510(k) submission is for a revised indication for use based on aligning with existing clinical guidelines and previously established safety and effectiveness through IDE studies. It is not a submission presenting new performance data against specific acceptance criteria for a new device or a significant modification requiring new performance testing.

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

This document does not describe a new test set or sample size for this specific 510(k) submission. The revision is based on:

• Data Provenance: Clinical guidelines from "Classification of acute pancreatitis- 2012: revision of the Atlanta classification and definitions by international consensus".
• Previous Studies: IDEs G110068 and G130266, which established safety and effectiveness for similar conditions. The sample sizes and data provenance for these IDE studies are not detailed in this document.

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

This document does not detail experts used for a new test set. The basis for the revised indication relies on:

• Clinical Guidelines: "Classification of acute pancreatitis- 2012: revision of the Atlanta classification and definitions by international consensus". This consensus would have been established by a group of medical experts in the field of pancreatitis. Their specific number and qualifications are not detailed here, but such guidelines are typically developed by leading specialists (e.g., gastroenterologists, interventional endoscopists, surgeons).

4. Adjudication Method for the Test Set

Not applicable, as no new test set is described or analyzed in this 510(k) submission. The revision is based on existing clinical consensus and previous IDE study findings.

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 stent and delivery system, not an AI-powered diagnostic or interpretive tool. Therefore, an MRMC study related to human reader performance with AI assistance is irrelevant.

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 algorithm.

7. The Type of Ground Truth Used

The "ground truth" for the revised indication is based on:

• Expert Consensus/Clinical Guidelines: The "Classification of acute pancreatitis- 2012: revision of the Atlanta classification and definitions by international consensus". This is a form of expert consensus derived from clinical research and practice.
• Outcomes Data from Previous IDEs: The safety and effectiveness were established via IDEs G110068 and G130266, which would have involved collecting patient outcomes data.

8. The Sample Size for the Training Set

Not applicable. This document does not describe a training set as it's not an AI/machine learning device. The previous IDE studies (G110068 and G130266) would have had patient cohorts, but their sizes for "training" purposes (if considered in the broader sense of informing device development) are not detailed here.

9. How the Ground Truth for the Training Set was Established

Not applicable. As noted above, there is no "training set" in the context of an AI/machine learning device. The "ground truth" for the device's efficacy and safety was established through the clinical outcomes and data collected during the IDE studies (G110068 and G130266). These studies would have involved clinical assessments, imaging, and potentially pathology or other diagnostic measures to define the conditions being treated and the success of the treatment.

Ask a specific question about this device

The AXIOS Stent and Delivery System is indicated for use to facilitate transgastric or transduodenal endoscopic drainage of symptomatic pancreatic pseudocysts ≥ 6 cm in size, with ≥ 70% fluid content that are adherent to the bowel wall. Once placed, the AXIOS Stent functions as a 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 resolution.

The AXIOS Stent and Delivery System is designed to secure the apposition of tissue, minimize stent displacement and create a large access/drainage lumen. The AXIOS Stent and Delivery System is provided sterile, disposable and intended for single patient use. 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.

This document is a 510(k) premarket notification for the AXIOS Stent and Delivery System. It explains that the device's labeling (Directions For Use - DFU) is being modified to align with a previously cleared version, and therefore, no new studies or acceptance criteria are being presented for the device itself.

The document states: "No additional verification or validation activities were required to support the DFU changes proposed in this submission for the AXIOS Stent with Delivery System. The MR data and clinical data that supported the proposed labeling modifications were also used to support the same labeling changes that were cleared for the AXIOS with Electrocautery Enhanced Delivery System per K150692."

Therefore, based on the provided text, there is no new study described within this specific submission that proves the device meets new acceptance criteria. The submission relies on previously conducted studies for the predicate device (K150692) to support the DFU changes.

As such, I cannot provide the requested information regarding acceptance criteria and a study from this document, as it explicitly states no new studies were required for this submission. The "Conclusion" also reinforces this, stating: "The modified DFU of the AXIOS Stent and Delivery System is substantially equivalent to the predicate devices."

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The AXIOS Stent with Electrocautery Enhanced Delivery System is indicated for use to facilitate transgastric or transduodenal endoscopic drainage of symptomatic pancreatic pseudocysts ≥ 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 resolution.

The AXIOS Stent with Electrocautery Enhanced Delivery System is intended for the endoscopic placement of a flexible. MR conditional, fully-covered, self-expanding braided Nitinol stent for transgastric or transduodenal endoscopic drainage of symptomatic pancreatic pseudocysts. The AXIOS Stent with Electrocautery Enhanced Delivery System is comprised of two main components: (1) AXIOS Stent and (2) Electrocautery Enhanced Deliverv System.

The subject premarket notification describes modifications to the cleared AXIOS Delivery System to add electrocautery to facilitate precise access to anatomic targets as well as the staged placement of the currently cleared AXIOS Stent. The AXIOS Stent with Electrocautery Enhanced Delivery System incorporates the same identical implantable stent that is preloaded within the current AXIOS Delivery System (K123250). Both the AXIOS Stent and Delivery System were originally cleared under 510(k) K123250 and most recently under 510(k) K140561.

As with the non-cautery AXIOS devices, the Electrocautery Enhanced AXIOS Delivery System is compatible with commercially-available 0.035-inch endoscopic guidewires and intended to be used in the gastrointestinal tract in conjunction with commercially available echoendoscopes. The Electrocautery Enhanced Delivery System has been modified to connect with an off-the- shelf electrosurgical unit or generator that is compliant to IEC 60601-1-2 and IEC 60601-2-2. The generator must be installed and put into service according to the EMC information provided in the generator manufacturer's guidance and declaration for electromagnetic compatibility.

Cables and patient return electrodes that are specified by generator manufacturer must be used for connection.

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

Here's an analysis of the acceptance criteria and study findings for the AXIOS™ Stent with Electrocautery Enhanced Delivery System, based on the provided document:

Acceptance Criteria and Device Performance

The document does not explicitly present a table of formal acceptance criteria with numerical targets (e.g., sensitivity > X%, specificity > Y%). Instead, it describes various tests and their outcomes, indicating that the device "meets product design specifications" and "perform[s] in accordance with its intended use."

However, we can infer some performance metrics and safety outcomes that serve as de facto acceptance criteria from the "Summary of Clinical Tests Performed" section.

Table 1: Inferred Acceptance Criteria and Reported Device Performance

Study Information

The document describes several types of studies: Nonclinical Bench Performance, Biocompatibility, Electromagnetic Compatibility/Electrical Safety, Animal Testing, and a Clinical Study.

1. Sample sizes used for the test set and data provenance:

• Clinical Study (Effectiveness and Safety): The document states a "prospective multi-center, single-arm clinical study." It mentions "subjects" and provides percentages, but an exact number for the clinical test set (i.e., the number of patients in the study) is not explicitly given. It mentions "In subjects treated PP" (likely referring to Pancreatic Pseudocyst, but the full phrase is cut off), implying the entire study group.

  • Data Provenance: Not specified, but "multi-center" suggests data from multiple locations, likely within one or more countries, but specific countries are not mentioned. It is a prospective study.

• Animal Study: "The study animals" were used. A specific number is not provided, but it evaluated the 06x08mm and 20x10mm stent models.

  • Data Provenance: Not specified, but it was a controlled animal study (porcine model).

• Ex-Tissue Model: Not specified how many tissue samples were used, but it involved "porcine tissue."

  • Data Provenance: Porcine tissue (ex-vivo).

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

• For the Clinical Study: The ground truth for outcomes (e.g., pseudocyst resolution, stent patency, adverse events) would typically be established by the treating physicians and study investigators, who are implied to be medical professionals (endoscopists, gastroenterologists). However, the number and specific qualifications of experts establishing "ground truth" (e.g., specific years of experience, board certification) are not explicitly stated in this document.
• For the Animal Study: "Histological evaluation... was performed." The qualifications of the individuals performing the histological evaluation are not stated.

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

• The document does not mention a specific adjudication method using multiple experts for the clinical or animal study outcomes (e.g., 2+1, 3+1 consensus). Clinical trial data generally involves verification by investigators, but formal independent adjudication by multiple blinded readers is not described.

4. If a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was done, and if so, what was the effect size of how much human readers improve with AI vs without AI assistance:

• No MRMC comparative effectiveness study was done. This device is a stent and delivery system, not an AI-powered diagnostic tool that assists human readers in interpreting medical images. Therefore, the concept of "human readers improve with AI vs without AI assistance" is not applicable here.

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

• This question is not applicable as the device is an interventional medical device (stent and delivery system), not an algorithm or AI system.

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

• Clinical Study: The ground truth for effectiveness was based on clinical outcomes data (pseudocyst resolution, stent patency, stent position, successful implantation/removal) and safety outcomes data (adverse events, complications). These would likely be assessed by treating physicians and investigators.
• Animal Study: The ground truth involved histopathological evaluation of tissues, gross evaluation of implant sites, and direct observation of device performance (successful access, stent deployment, patency, migration).
• Ex-Tissue Model: The ground truth involved measurement of thermal damage on porcine tissue.

7. The sample size for the training set:

• Not applicable. This document describes the testing of a medical device (stent and delivery system), not a machine learning algorithm that requires a "training set." The device itself undergoes rigorous design verification and validation, but there isn't a "training set" in the AI/ML sense.

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

• Not applicable as there is no training set for this type of medical device submission.

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The AXIOS™ Stent and Delivery System is indicated for use to facilitate transenteric endoscopic drainage of symptomatic pancreatic pseudocysts ≥ 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 resolution.

The AXIOS™ Stent and Delivery System is an endoscopic device designed to deliver a fully-covered stent between a pancreatic pseudocyst and the gastrointestinal tract. The AXIOS™ Stent is a flexible, MR compatible, fully-covered self-expanding Nitinol stent preloaded within the AXIOS Delivery System. The AXIOS™ Delivery System is compatible with endoscopes equipped with a 3.7mm diameter or larger working channel. The AXIOS Stent and Delivery System is provided sterile, disposable and intended for use during a single patient procedure. The AXIOS Stent and Delivery System are sterilized by a validated method of sterilization via Ethylene Oxide (EO).

The provided document is limited to a 510(k) summary for the AXIOS™ Stent and Delivery System. This type of submission focuses on demonstrating substantial equivalence to a predicate device through non-clinical testing rather than detailed clinical studies with acceptance criteria, performance metrics, and human reader evaluations typical for AI/ML-based diagnostic devices.

Therefore, the information required to populate most of the sections of your request (acceptance criteria, detailed study design with sample sizes for test/training sets, expert qualifications, adjudication methods, MRMC studies, standalone performance, and ground truth establishment for AI/ML models) is not present in this document.

However, I can extract information related to non-clinical testing and the overall conclusion about device performance:

1. Table of Acceptance Criteria and Reported Device Performance:

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

• Not Applicable. This document describes non-clinical bench testing and biocompatibility testing, not human clinical trials or AI/ML model performance evaluation with test sets derived from patient data.

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. Ground truth, in the context of expert consensus for AI/ML, is not relevant to this type of device submission. The "ground truth" here is implied by predefined engineering specifications and regulatory standards met through non-clinical laboratory testing.

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

• Not Applicable. Adjudication methods are typically for clinical outcome or diagnostic agreement, which is not described for this non-clinical submission.

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. An MRMC study is not mentioned as this is a medical device for drainage, not an AI-based diagnostic tool.

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

• No. This is a hardware medical device; the concept of "standalone algorithm performance" does not apply.

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

• For the non-clinical testing, the "ground truth" was established by predetermined product specifications, performance characteristics, regulatory standards, and recognized consensus standards (e.g., for biocompatibility and sterilization). The direct comparison was against the predicate device (AXIOS™ Stent and Delivery System K123250) for substantial equivalence.

8. The sample size for the training set

• Not Applicable. This document does not pertain to an AI/ML device that requires a training set.

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

• Not Applicable. As above, no training set for an AI/ML model is described.

Ask a specific question about this device

The AXIOS Stent and Delivery System is indicated for use to facilitate transgastric or transduodenal endoscopic drainage of symptomatic pancreatic pseudocysts ≥ 6 cm in size, with ≥ 70% fluid content that are adherent to the bowel wall. Once placed, the AXIOS Stent functions as a 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 resolution.

The AXIOS Stent and Delivery System consists of two major components, the catheter-based delivery system and the implantable stent. The stent is a flexible, fully-covered. self-expanding Nitinol stent, which is preloaded within the catheter-based delivery system. The system is intended to cannulate the transgastric or transduodenal wall into a pancreatic pseudocyst for endoscopic drainage. The stent serves as a conduit for passive drainage of pseudocyst contents directly into the GI tract. The large lumen diameter provides a short path and may allow secure access to the pseudocyst interior for additional diagnostic or therapeutic procedures. The AXIOS Stent is designed with a duplicate "anchor" or "flange" on each end to achieve tissue apposition and prevent migration. The stent is radiopaque and is fully covered with silicone to prevent leakage, minimize tissue in-growth, and facilitate removal. The AXIOS Stent will be provided in two lumen diameters (10mm and 15mm) and one length (10mm). The AXIOS Delivery System consists of a catheter and an integrated handle with manual controls for positioning and deploying the AXIOS stent. The AXIOS Delivery System is sized to fit within commercially available echoendoscopes with a working channel of 3.7 mm diameter or larger. The Delivery System catheter is 138 cm in working length and attached directly to the endoscope handle. The AXIOS Delivery System requires an access site of at least 10 Fr. The AXIOS Stent and Delivery System is provided sterile, disposable and intended for use during a single patient procedure.

Acceptance Criteria and Device Performance for the AXIOS Stent and Delivery System

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for the AXIOS Stent and Delivery System were primarily drawn from the "Safety Endpoints" and "Effectiveness Endpoints" sections of the pivotal clinical study.

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