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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.

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.

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.

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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The Peripheral AVE Biliary Stent System is intended for use in patients who are eligible for percutaneous transluminal angioplasty (PTA) to maintain patency of a biliary duct which is occluded by tumor.

The Peripheral AVE Bilairy Stent System is indicated for palliative treatment of biliary duct strictures caused by malignant tumors.

The Peripheral AVE Bilairy Stent System consists of a balloon-expandable intraluminal stent premounted onto the balloon of an over-the-wire delivery catheter. The Peripheral AVE Bilairy 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 Peripheral AVE Bilairy Stent System is provided enclosed in a sterile package.

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:

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

The document does not explicitly state acceptance criteria in a quantitative, pass/fail format with specific thresholds. Instead, the "acceptance criteria" are implied by the purpose of each test, which is to demonstrate "substantial equivalence" to a predicate device or to verify internal specifications. The reported performance is the conclusion of each study, stating whether substantial equivalence was achieved or if specifications were met.

2. Sample sizes used for the test set and the data provenance

The document does not specify the sample sizes used for any of the performance tests (Balloon Performance, Crush Strength, Dimensional Verification).

The data provenance is not explicitly stated as retrospective or prospective, nor does it mention a country of origin. However, given the nature of the tests (benchtop comparisons and verification), the data is most likely generated in a laboratory setting by the manufacturer, Peripheral AVE, to support their 510(k) submission.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This information is not applicable and therefore not mentioned in the provided document. The studies conducted are primarily benchtop engineering and material science tests, not clinical studies requiring expert interpretation of patient data to establish ground truth.

4. Adjudication method for the test set

This information is not applicable and therefore not mentioned in the provided document. Adjudication methods are relevant for clinical studies where multiple reviewers assess ambiguous data. The tests described are objective, quantitative measurements.

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

There was no MRMC comparative effectiveness study mentioned, as this device is a physical medical device (a stent), not an AI-powered diagnostic tool requiring human-in-the-loop performance evaluation.

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 and does not involve an algorithm or AI.

7. The type of ground truth used

The "ground truth" for the benchtop performance tests is the measured physical properties and performance characteristics of the Peripheral AVE Biliary Stent System and the predicate device (PALMAZ™ Balloon-Expandable Stent), as well as predefined specifications.

• For the Balloon Performance Study and Crush Strength Study, the ground truth for comparison was the measured performance of the predicate device.
• For the Dimensional Verification, the ground truth was the labeled specifications for stent diameter and length.
• For Biocompatibility, Sterilization, and Pyrogen Testing, the ground truth refers to adherence to established industry standards and regulatory guidelines (e.g., ANSI/AAMI/ISO 11137-1994, FDA guidelines for LAL testing).

8. The sample size for the training set

This information is not applicable. The device is a physical medical device; there is no "training set" in the context of machine learning or AI. The tests conducted are design verification and validation tests rather than algorithm 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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