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The New Microvasive® Biliary Stent and Delivery System is intended for delivery of the stent to the biliary tract for drainage of the bile ducts, for splinting of a bile duct during healing, or for providing bile duct patency in a stricture or past a stone.

The New Microvasive® Biliary Stent and Delivery System is a device intended for delivery of a stent to the biliary tract. The stent is of the Amsterdam type, made of Flexima material, and is available in diameters from 7 to 11.5 Fr and lengths from 5 to 15 cm. The delivery system has a preloaded stent, a working length of 200 cm, and is compatible with a 0.035 inch guidewire.

The provided document is a 510(k) summary for a medical device, the New Microvasive® Biliary Stent and Delivery System. It focuses on demonstrating substantial equivalence to predicate devices rather than proving performance against specific acceptance criteria through a clinical study for a new AI/software-as-a-medical-device (SaMD) product.

Therefore, most of the requested information regarding acceptance criteria, study details, expert involvement, and ground truth for a performance study is not applicable or not present in this type of submission.

Here's a breakdown of the information that can be extracted and what cannot:

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

• Not Applicable. This document does not present acceptance criteria for a performance study in the way an AI/SaMD submission would. Instead, it demonstrates "substantial equivalence" based on descriptive and technological characteristics compared to predicate devices. The "performance characteristics" mentioned refer to laboratory testing for safety and basic function, not clinical efficacy or diagnostic accuracy.

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

• Not Applicable. No clinical test set or data provenance is mentioned as this is a device based on substantial equivalence, not a new performance evaluation study.

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. No ground truth establishment by experts is mentioned in the context of a performance study.

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

• Not Applicable. No adjudication method for a test set is mentioned.

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 a comparative effectiveness study involving human readers or AI assistance.

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

• Not Applicable. This is a physical medical device, not an algorithm, so "standalone performance" in that context is not relevant.

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

• Not Applicable. No ground truth is established in the context of a performance study. For this device, "ground truth" for its design and safety is implicitly based on established engineering principles and biocompatibility standards for similar devices already on the market.

8. The sample size for the training set

• Not Applicable. This is not a machine learning or AI device, so there is no "training set."

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

• Not Applicable. As there is no training set, this question is not applicable.

Information that is available from the document related to "performance" in the context of this 510(k) submission:

The document states:

• Performance Characteristics: "Laboratory testing regarding characteristics was performed on New Microvasive® Biliary Stent and Delivery System to verify its safety and performance."
• Biocompatibility: "A biocompatibility assessment was performed on the patient- and fluid-contact materials of the New Microvasive® Biliary Stent and Delivery System with satisfactory results."
• Sterilization & Pyrogenicity: "The New Microvasive® Biliary Stent and Delivery System will be sterilized using ethylene oxide gas using the AAMI protocol for ethylene oxide sterilization. Pyrogenicity testing will be performed on a periodic basis to monitor bacterial endotoxin levels."

The "study" that "proves" the device meets acceptance criteria in this 510(k) context is primarily through:

1. Bench Testing/Laboratory Testing: Mentioned for "characteristics" relating to safety and performance (specific details not provided in the summary).
2. Biocompatibility Assessment: To ensure the materials are safe for patient contact.
3. Sterilization Validation: Using the AAMI protocol for ethylene oxide sterilization.
4. Pyrogenicity Testing: To monitor bacterial endotoxin levels.
5. Substantial Equivalence Argument: The core of the 510(k) is the comparison in design, materials, and intended use to the predicate devices (Solopas™ Percuflex Biliary Stent and Flexima™ Biliary Drainage Catheter), implying that because the predicate devices are safe and effective, and the new device is substantially similar, it too will be safe and effective.

The provided document is a regulatory submission for a physical medical device (a biliary stent) seeking clearance based on substantial equivalence, not a clinical study report for an AI/SaMD product. Therefore, the specific questions about AI/SaMD study design are not addressed.

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