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The AVE Bridge™ Stent System is intended for use in patients to maintain patency of a biliary duct which is occluded by tumor. The AVE Bridge™ Stent System is indicated for palliative treatment of biliary duct strictures caused by malignant tumors. This device is not intended for intravascular use.

The AVE Bridge™ Stent System consists of a balloon-expandable intraluminal stent premounted onto the balloon of an over-the-wire delivery catherer. The AVE Bridge™ Stent System has two radiopaque platinum markers imbedded in the inner shaft (at each end of the stent) to aid in the placement of the stent during fluoroscopy. The delivery system is compatible with 0.035" guidewires and has a useable length of 75 cm to 90 cm. The AVE Bridge™ Stent System is provided enclosed in a sterile package.

The provided text describes a 510(k) premarket notification for the AVE Bridge™ Stent System, focusing on demonstrating substantial equivalence to a predicate device, the PALMAZ™ Balloon-Expandable Stent. The document details performance testing conducted to support this claim, rather than establishing new acceptance criteria or proving the device meets those criteria in a de novo fashion.

Here's an analysis of the provided information relative to your request:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly define acceptance criteria in terms of specific thresholds for the AVE Bridge™ Stent. Instead, the "acceptance criteria" for the studies were to demonstrate substantial equivalence to the predicate device (PALMAZ™ Balloon-Expandable Stent). The reported device performance is presented as a comparison to this predicate.

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

The document does not specify the sample sizes used for any of the non-clinical performance tests (Balloon Performance, Two Plane Crush Strength, Dimensional Verification).
The data provenance is industrial testing conducted by Arterial Vascular Engineering, Inc. and is retrospective to the submission date. There is no mention of country of origin for data; it's implied to be from the manufacturer's testing in the USA.

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

This information is not provided in the document. The studies are non-clinical, mechanical performance tests, not studies requiring expert interpretation or ground truth establishment in the medical sense (e.g., diagnosis from imaging).

4. Adjudication Method for the Test Set

This information is not applicable and therefore not provided, as the tests are non-clinical mechanical performance tests, not clinical studies requiring adjudication of outcomes or interpretations.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

This information is not applicable and therefore not provided. The submission is for a medical device (stent) based on non-clinical performance testing for substantial equivalence, not an AI or imaging diagnostic device that would typically involve MRMC studies.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

This information is not applicable and therefore not provided. The AVE Bridge™ Stent System is a physical medical device, not an algorithm.

7. Type of Ground Truth Used

For the Balloon Performance Study and Two Plane Crush Strength Study, the "ground truth" was essentially the performance of the predicate device (PALMAZ™ Balloon-Expandable Stent), against which the AVE Bridge™ Stent was compared for substantial equivalence in mechanical properties.
For the Dimensional Verification and Stent Uniformity at Nominal Deployment study, the "ground truth" was the labeled specifications for stent diameter and stent length.

8. Sample Size for the Training Set

This information is not applicable and therefore not provided. As noted, this is a physical medical device, not an AI model, and therefore does not have a "training set" in the context of machine learning. The non-clinical performance studies are akin to validation/test sets for mechanical properties.

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

This information is not applicable and therefore not provided, as there is no "training set" in this context.

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