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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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