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The LifeStent /XL Biliary Stent System consists of a self-expanding stent that is provided loaded into an over-the-wire catheter that acts as a delivery system. The stent is a permanently implanted device used to maintain patency of a major bile duct obstructed by tissue of an impinging tumor, The flexible, self-expanding stent is made by laser cutting an open lattice design into a nitinol tube. The subject device is supplied in lengths of 20-120 mm and diameter of 5 mm. A delivery system comprised of a dilator (inner shaft) and a sheath to enhance trackability, which are linked together by means of a handle. The dilator terminates distally in an atraumatic catheter tip and originates proximally in a luer hub designed to accept a 0.035" guidewire. The self-expanding stent is constrained within the space between the dilator and the sheath. Deployment is initiated by rotating the thumbwheel in the direction of the handle arrow while holding the handle in a fixed position until complete deployment of the stent is achieved.

AI/ML Overview

The provided text describes a 510(k) premarket notification for a medical device, the LifeStent® / XL Biliary Stent System. The submission aims to demonstrate substantial equivalence to legally marketed predicate devices, not to prove the device meets specific acceptance criteria through clinical studies with ground truth.

Therefore, many of the requested categories in the prompt (such as sample size for test set, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance, type of ground truth, training set sample size, and how training set ground truth was established) are not applicable to this type of regulatory submission as described.

The submission focuses on non-clinical performance testing to demonstrate that the modified device (a 5mm stent diameter for the existing stent system) performs as safely and effectively as its predicate devices.

Here's a breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't provide a table of specific acceptance criteria with numerical targets. Instead, it states that the results of non-clinical tests demonstrate that the technological characteristics and performance criteria fulfill the same specifications as the predicate devices.

Acceptance Criteria Category	Reported Device Performance
Overall Objective	Fulfills the same specifications as the predicate devices, performing as safely and effectively.
Deployment Testing	Results are deemed equivalent to predicate devices.
Expansion Force Testing	Results are deemed equivalent to predicate devices.
Compression Force Testing	Results are deemed equivalent to predicate devices.
Dimensional Testing	Results are deemed equivalent to predicate devices.
Corrosion Testing	Results are deemed equivalent to predicate devices.

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

Sample Size: Not specified quantitatively. The testing was non-clinical.
Data Provenance: Not applicable as it's non-clinical testing.

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

Not applicable. This submission relies on non-clinical engineering and materials testing, not expert-adjudicated clinical ground truth.

4. Adjudication Method for the Test Set:

Not applicable. This was non-clinical engineering testing, not a clinical study requiring adjudication.

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 medical device submission for a physical stent, not an AI/imaging device.

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

No. This is a medical device submission for a physical stent, not an AI/imaging device.

7. The Type of Ground Truth Used:

Not applicable. The "ground truth" for this submission are the established performance specifications and characteristics of the legally marketed predicate devices, against which the modified device's non-clinical performance was compared.

8. The Sample Size for the Training Set:

Not applicable. There is no "training set" as this is not an AI/machine learning device.

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

Not applicable. There is no "training set" or corresponding ground truth.

Summary of the Study that Proves the Device Meets the Acceptance Criteria:

The "study" described is a series of non-clinical performance tests conducted to demonstrate substantial equivalence to predicate devices.

Reference Document: FDA guidance document, "Guidance for the content of premarket notifications for metal expandable Biliary Stents," dated February 5th, 1998, and internal risk assessment procedures.
Tests Performed:
- Deployment Testing
- Expansion Force Testing
- Compression Force Testing
- Dimensional Testing
- Corrosion Testing
Conclusion: The results of these tests demonstrated that the technological characteristics and performance criteria of the 5mm LifeStent® / XL Biliary Stent System fulfill the same specifications as the predicate devices and therefore perform as safely and as effectively as the legally marketed predicate device.

This type of submission (510(k) for a modified device) typically relies on demonstrating that the changes do not raise new questions of safety or effectiveness when compared to the predicate, often through non-clinical bench testing.

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