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The Medtronic AVE Stent Delivery System - For Use In Biliary Indication device is intended to maintain patency of a biliary duct which is occluded by a malignant tumor.

Device Description

The device consists of a balloon expandable intralumenal stent premounted onto the balloon of an over-the-wire delivery catheter. The device has two radiopaque platinum markers mounted on the stent to aid in the placement of the stent during fluoroscopy. The delivery system is compatible with 0.035inch guidewires and has a useable length of 75cm to 120cm. The device is provided in a sterile package.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the Medtronic AVE Stent Delivery System, based on the provided 510(k) summary:

1. Table of Acceptance Criteria and Reported Device Performance:

The provided 510(k) summary does not explicitly state acceptance criteria in terms of numerical thresholds or performance targets for a device. Instead, the "acceptance criteria" are implied through the purpose of the performance testing, which is to demonstrate substantial equivalence to a predicate device. The performance is "reported" implicitly by stating that the tests were conducted and the conclusion reached was that the devices are substantially equivalent.

Therefore, the table will reflect the purpose of each test as the "acceptance criteria" (i.e., comparability to the predicate), rather than specific quantitative metrics. The "Reported Device Performance" is the stated outcome of meeting these comparative goals.

Acceptance Criteria (Purpose of Test)	Reported Device Performance (Conclusion)
Mechanical Performance (Stent Delivery System):
To compare the minimum burst pressure of the subject device and the predicate device.	Performance testing confirmed that the subject device's balloon burst pressure is comparable to the predicate device, supporting substantial equivalence.
To compare the deflation times of the subject device and the predicate device.	Performance testing confirmed that the subject device's balloon deflation times are comparable to the predicate device, supporting substantial equivalence.
To create and compare the compliance curves for the subject device and the predicate device.	Performance testing confirmed that the subject device's diameter versus inflation pressure (compliance curves) are comparable to the predicate device, supporting substantial equivalence.
To create and compare the balloon bond strength for the subject device and the predicate device.	Performance testing confirmed that the subject device's balloon bond strength is comparable to the predicate device, supporting substantial equivalence.
To create and compare the crossing profile for the subject device and the predicate device.	Performance testing confirmed that the subject device's balloon crossing profile is comparable to the predicate device, supporting substantial equivalence.
Biocompatibility:
To ensure the materials used in the device are biocompatible.	The material used in the Medtronic AVE Stent Delivery System passed all biocompatibility tests.
Sterilization:
To validate the sterilization method and achieve a Sterility Assurance Level (SAL) of 10⁻⁶.	The sterilization method aligns with ANSI/AAMI/ISO 11137 - 1994, Method I, achieving an SAL of 10⁻⁶.
To ensure the device is pyrogen-free.	The Medtronic AVE Stent Delivery System is labeled pyrogen-free, with daily LAL testing performed in compliance with FDA guidance as part of product release criteria.
Overall Equivalence:
To prove substantial equivalence to the predicate device.	The performance testing and comparison prove the two devices (subject and predicate) are substantially equivalent.

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

The document does not explicitly state the numerical sample size for each performance test (e.g., how many balloons were tested for burst pressure). It generally refers to "performance testing" being conducted. The data provenance is not specified beyond the fact that the testing was conducted by Medtronic AVE, Inc. It does not indicate the country of origin of the data or whether it was retrospective or prospective, though it's implied to be a prospective, lab-based performance study for regulatory submission.

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

This information is not applicable as the study described is a performance equivalency study for a medical device (stent delivery system), not a study involving human-in-the-loop performance, diagnostic accuracy, or clinical evaluation by experts. The "ground truth" here is based on engineering and material science standards for device functionality and safety, as compared to a predicate device.

4. Adjudication Method for the Test Set:

This information is not applicable for the reasons stated in point 3. There are no human judgments or diagnoses being adjudicated.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and If So, What Was the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance:

This information is not applicable. The provided document describes the 510(k) summary for a stent delivery system, which is a physical medical device. It does not involve any AI or human readers for diagnostic interpretation.

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

This information is not applicable. The device is a physical stent delivery system, not an algorithm.

7. The Type of Ground Truth Used:

The "ground truth" for this device's performance testing is engineering specifications, material science standards, and direct comparison to the predicate device's established performance characteristics. For biocompatibility, the ground truth is established by passing standardized biocompatibility tests. For sterilization, it's achieving specific Sterility Assurance Levels and passing pyrogenicity tests.

8. The Sample Size for the Training Set:

This information is not applicable. This is a physical device, and its approval pathway (510(k)) focuses on substantial equivalence to a predicate device based on performance testing, not on machine learning model training.

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

This information is not applicable for the reasons stated in point 8.

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