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The ALIMAXX-B™ Uncovered Biliary Stent System is intended for palliation of malignant strictures in the biliary tree.

The ALIMAXX-B™ Uncovered Biliary Stent System is a sterile, single-use, self-expanding Nitinol stent that is supplied with the stent pre-loaded on the triaxial delivery catheter of the delivery system. The delivery system is available in two designs, one for endoscopic placement (working length is 185 cm) and another for transhepatic placement (working length is 80 cm).

The provided text describes a 510(k) submission for a medical device, the ALIMAXX-B™ Uncovered Biliary Stent System, with modifications to its endoscopic delivery system catheter. The submission primarily focuses on demonstrating substantial equivalence to a predicate device, rather than a clinical study evaluating diagnostic accuracy or a specific AI-driven medical device. Therefore, many of the requested categories (like AI improvement effect size, ground truth for training data, etc.) are not applicable in this context.

Here's an analysis based on the available information:

Acceptance Criteria and Device Performance

The submission states that "Design verification and design validation studies have been completed. The results demonstrate that the risks associated with the design modifications, as identified in Merit's ALIMAXX-B™ uncovered biliary stent system Clinical Risk Assessment (CRA), have met all of their pre-determined acceptance criteria."

However, specific numerical acceptance criteria (e.g., a required performance metric like sensitivity or specificity) and their corresponding reported device performance values are not provided in the text. The acceptance criteria relate to risk mitigation and design specifications rather than clinical performance metrics typically associated with AI or diagnostic devices.

The modifications are described as improving "visibility during stent placement" for the endoscopic delivery system catheter.

Study Details (Based on available information)

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

• Sample Size: Not specified. The document refers to "Design verification and design validation studies" but does not provide details on the sample size of any test sets used in these studies.
• Data Provenance: Not specified.

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

• Not applicable/Not specified. "Ground truth" in the context of device design verification and validation typically refers to engineering specifications, safety standards, and functional performance, rather than clinical diagnostic ground truth established by experts.

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

• Not applicable/Not specified. This typically applies to studies where expert consensus is used to establish ground truth for classification tasks.

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. This is a submission for a stent delivery system, not an AI-driven diagnostic or assistive device. An MRMC study is not relevant here.

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

• Not applicable. This device does not involve an algorithm.

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

• For "Design verification and design validation studies," the "ground truth" would be engineering specifications, safety standards, performance requirements, and clinical risk assessment criteria. The document explicitly states that the studies addressed "risks identified in Merit's Risk Assessment," indicating that adherence to a risk management framework and meeting predefined safety and performance parameters served as the ground truth.

8. The sample size for the training set:

• Not applicable. There is no AI or machine learning component requiring a training set.

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

• Not applicable.

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The Alveolus, ALIMAXX-B™ Uncovered Biliary Stent System is intended for palliation of malignant strictures in the biliary tree.

The ALIMAXX-B Uncovered biliary stent is a sterile, single-use, self-expanding Nitinol stent that is supplied with the stent pre-loaded on the delivery catheter. The delivery device is available for endoscopic placement (working length is 185 cm), and transhepatic placement (working length 80 cm).

The provided text is a 510(k) summary for the ALIMAXX-B™ Uncovered Biliary Stent System. It primarily focuses on demonstrating substantial equivalence to previously cleared devices rather than providing detailed acceptance criteria and a specific study proving the device meets them.

The submission refers to "physical test results for the delivery system as specified in the FDA 'Guidance for the Content of Premarket Notifications for Metal Expandable Biliary Stents' document (February 5, 1998)" to demonstrate that the device is suitable for its intended use. However, these specific tests and their acceptance criteria are not directly stated in the provided text, nor are the detailed results of such tests.

Therefore, much of the requested information cannot be extracted from the given document.

Here's a breakdown of what can and cannot be answered based only on the provided text:

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

• Cannot be provided based on the given text. The document states that physical test results were conducted "as specified in the FDA 'Guidance for the Content of Premarket Notifications for Metal Expandable Biliary Stents' document (February 5, 1998)" but does not list these specific criteria or the reported performance values.

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

• Cannot be provided based on the given text. The document does not describe a clinical study or a test set in the context of device performance. It only mentions "physical test results for the delivery system."

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 / Cannot be provided. There's no mention of a clinical test set or ground truth establishment by experts in the context of evaluating device performance in the provided document.

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

• Not applicable / Cannot be provided. No clinical test set where adjudication would be relevant is described.

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 physical medical stent, not an AI-assisted diagnostic tool. An MRMC study is not relevant to its evaluation.

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

• Not applicable. This device is a physical medical stent, not an algorithm.

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

• Not applicable / Cannot be provided. No clinical ground truth establishment is described for device performance. The "ground truth" for physical device performance would typically be defined by engineering specifications and validated through bench testing, which is referred to but not detailed.

8. The sample size for the training set

• Not applicable. The device is a physical stent; the concept of a "training set" is not relevant here as it would be for an AI/ML device.

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

• Not applicable. See point 8.

Summary based on the provided text:

The submission for the ALIMAXX-B™ Uncovered Biliary Stent System demonstrates "substantial equivalence" to predicate devices (Bard® LUMINEXX™, Cook® Zilver™, ABSOLUTE™ Biliary Self-Expanding Stent). The safety and effectiveness are supported by "summaries of physical test results for the delivery system as specified in the FDA 'Guidance for the Content of Premarket Notifications for Metal Expandable Biliary Stents' document (February 5, 1998)." However, specific acceptance criteria and the detailed results of these tests are not included in this 510(k) summary. The document does not describe any human-observer performance studies or data collection from patient cohorts in a way that would require statistical sample sizes, expert ground truth, or adjudication methods for performance evaluation.

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