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The Express LD Biliary Premounted Stent System is indicated for the palliation of malignant neoplasms in the biliary tree.

The Express LD Biliary Premounted Stent System consists of: A 316L surgical grade stainless steel balloon expandable stent. The stent is premounted on an over the wire Stent Delivery System (SDS) equipped with a non-compliant balloon. The SDS balloon catheter has two radiopaque markers embedded in the shaft to aid in the placement of the stent. The SDS is compatible with 0.035 in (0.89 mm) guidewires. The SDS balloon has a maximum inflation pressure of 12 atm (1216 kPa) that can be used for initial stent placement and post stent dilatation. The Premounted Stent System is available in a variety of stent lengths with SDS balloons that expand them from 5 mm to 10 mm in diameter. The SDS balloon catheter is also offered in two shaft lengths.

The provided document is a 510(k) summary for a medical device called the "Express LD Biliary Premounted Stent System." It describes the device, its intended use, and compares it to predicate devices to establish substantial equivalence.

Based on the content, the study conducted is focused on bench testing and biocompatibility to demonstrate that the new device has similar performance and safety characteristics to previously cleared devices. It is not a study that involves AI, human readers, or image interpretation. Therefore, many of the requested categories related to AI performance metrics cannot be found or are not applicable.

Here's an analysis of the provided text in relation to your request:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of acceptance criteria with corresponding reported device performance in the typical pass/fail or quantitative metric sense for a clinical or image-based AI study. Instead, it lists the types of tests performed to demonstrate substantial equivalence to predicate devices. The "performance" is implied by the successful completion of these tests, confirming that the new device is "appropriate for its intended use" and "substantially equivalent."

Study Details

Given the nature of the device (a physical stent system) and the regulatory submission (510(k) for substantial equivalence), the "study" described is a series of engineering bench tests and biocompatibility assessments, not an AI or clinical performance study.

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

• Sample Size: Not specified in terms of number of units or test replicates for each specific bench test. The document states "Bench testing and biocompatibility were performed," implying an engineering validation rather than a statistical clinical trial.
• Data Provenance: Not applicable in the context of clinical data provenance (e.g., country of origin). The data is generated from laboratory testing (bench and biocompatibility tests) of the physical device. The tests are for design validation and do not involve patient data.

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

• Number of Experts: Not applicable. Ground truth for these types of tests are typically established by engineering specifications, international standards (e.g., ISO), and material science principles, not expert consensus on medical images or diagnoses.
• Qualifications of Experts: N/A

4. Adjudication Method (e.g., 2+1, 3+1, none) for the Test Set:

• Adjudication Method: Not applicable. This refers to the resolution of disagreements among human readers, which is not relevant to bench testing or biocompatibility assessment of a physical medical device.

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:

• MRMC Study: No. This is a comparison of a physical medical device to its predicates, not an AI system.
• Effect Size: Not applicable.

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

• Standalone Performance: Not applicable. The device is a physical stent, not an algorithm.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.):

• Type of Ground Truth: For the "bench testing" and "biocompatibility" studies, the "ground truth" would be the pre-defined engineering specifications, performance standards, and biological safety criteria that the device must meet to function as intended and be considered safe and effective, similar to the predicate devices. This is based on established scientific and engineering principles for medical device design and manufacturing.

8. The Sample Size for the Training Set:

• Sample Size: Not applicable. The stent system is a physical device, and this document does not describe the development or training of an AI model.

9. How the Ground Truth for the Training Set Was Established:

• Ground Truth Establishment: Not applicable. As there is no AI training set, there is no ground truth to establish for it.

In summary: The provided document describes a regulatory submission (510(k)) for a physical medical device (a stent system) based on "substantial equivalence" to existing predicate devices. The "study" refers to bench testing and biocompatibility assessments performed to ensure the new device functions similarly and safely. The request's questions are heavily geared towards the evaluation of Artificial Intelligence (AI) or image-based diagnostic devices, which do not align with the nature of this particular submission.

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