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The VIABIL™ Biliary Endoprosthesis is indicated for the treatment of malignant biliary strictures.

The predicate VIABIL "" Biliary Endoprosthesis is a flexible, self-expanding stent with an inner tubular lining that is radially compressed and secured onto the distal end of a delivery catheter. The catheter provides a means for implanting the VIABIL " Biliary Endoprosthesis at the target site in the biliary tract. There are two principle components of the device: the endoprosthesis and the delivery catheter. Two catheter lengths are available: a 40 cm working length catheter for percutaneous delivery of the endoprosthesis, and a 195-cm working length catheter for endoscopic delivery. The endoprosthesis is available in two diameters (8 mm and 10 mm), and four lengths (4 cm, 6 cm, 8 cm, and 10 cm).

The provided text does not contain information about acceptance criteria or a study proving device performance against such criteria. The document is a 510(k) summary for a medical device (VIABIL™ Biliary Endoprosthesis) and primarily focuses on establishing substantial equivalence to a predicate device.

Therefore, I cannot populate the requested table and answer the specific questions about acceptance criteria, study details, sample sizes, expert qualifications, or ground truth establishment.

The document states: "A variety of tests, assessments, and comparisons demonstrate that the VIABIL™ Biliary Endoprosthesis is substantially equivalent to its predicate in terms of composition, design, intended use, and performance attributes." However, it does not provide the details of these tests, assessments, or comparisons, nor does it quantify any performance metrics against pre-defined acceptance criteria.

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The VIABIL Biliary Endoprosthesis is indicated for the treatment of malignant biliary strictures.

The VIABIL Biliary Endoprosthesis is a flexible, selfexpanding stent-graft that is radially compressed and secured onto the distal end of a delivery catheter. The catheter provides a means for implanting the VIABIL Biliary Endoprosthesis at the target site in the biliary tract. There are two principle components of the device: the Biliary Endoprosthesis and the Delivery Catheter. Two catheter lengths are available: a 75 cm working length catheter for percutaneous delivery of the endoprosthesis, and a 195 cm working length catheter for endoscopic delivery. The endoprosthesis is available in two diameters (8 mm and 10 mm), and four nominal lengths (4 cm, 6 cm, 8 cm, and 10 cm).

The provided text is a Premarket Notification Summary for the VIABIL Biliary Endoprosthesis, and thus focuses on demonstrating substantial equivalence to predicate devices rather than establishing novel acceptance criteria or showing device performance against such criteria. As such, the information typically found in a study proving acceptance criteria for a new device is not fully present.

However, based on the provided text, here's an attempt to extract and infer the requested information, with notable limitations due to the nature of the document:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly define specific numerical acceptance criteria (e.g., success rates, patency rates, complication rates) with corresponding target values. Instead, it relies on demonstrating substantial equivalence to predicate devices. The "performance" assessment is qualitative, stating that the device is "substantially equivalent" to predicates.

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

• Sample Size for Test Set: The document simply states "The results of the clinical study with the VIABIL Biliary Endoprosthesis demonstrated the safety and effectiveness of the device..." It does not specify the sample size of the clinical study.
• Data Provenance: The document does not specify the country of origin for the clinical study data or whether it was retrospective or prospective. It only mentions "clinical testing" and a "clinical study." The comparison to a "historical control" suggests that the predicate device's data was used retrospectively for comparison.

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

This information is not provided in the document. As this is a medical device for treatment, the "ground truth" would likely be based on clinical outcomes assessed by treating physicians and follow-up imaging, rather than expert consensus on diagnostic images.

4. Adjudication Method for the Test Set

This information is not provided in the document.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC comparative effectiveness study, as typically described for AI systems evaluating human reader improvement with AI assistance, was not performed or mentioned. The clinical study was likely a standard clinical trial for a medical device.

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

This question is not applicable to this device. The VIABIL Biliary Endoprosthesis is a physical medical device (a stent-graft), not an algorithm or AI system. Therefore, "standalone" algorithm performance is not a relevant concept for this product. The device's performance is intrinsically linked to its implantation by a human operator.

7. The Type of Ground Truth Used

The "ground truth" for evaluating the device's performance would primarily be:

• Clinical Outcomes: Regarding safety (e.g., adverse events, complications) and effectiveness (e.g., successful stent deployment, patency of the biliary tract, relief of stricture, patient survival). This would be derived from patient follow-up data.
• Historical Control Data: For comparison, the performance of the predicate device based on its historical clinical outcomes likely served as a benchmark for equivalence.

8. The Sample Size for the Training Set

This question is not applicable to this device. As a physical medical device, there is no "training set" in the context of machine learning or AI algorithms. The device undergoes design, manufacturing, and preclinical testing, followed by clinical studies.

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

This question is not applicable as there is no "training set" for a physical medical device in this context.

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