Search Results

The Medtronic AVE Bridge™ Stent is intended to maintain patency of a bile duct which is occluded by a malignant tumor.

The Bridge™ Stent 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 imbedded on 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 75cm to 120cm. The device is provided in a sterile package.

Here's an analysis of the acceptance criteria and study information for the Medtronic AVE Bridge™ Stent Delivery System, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The provided 510(k) summary does not explicitly state quantitative acceptance criteria for each test (e.g., "Balloon Burst must be > X psi"). Instead, it focuses on demonstrating substantial equivalence to a predicate device through direct comparison. The "acceptance criteria" can be inferred as achieving comparable performance to the predicate device in the specified tests.

Summary of Study Findings: "The performance testing and comparison of the Peripheral AVE Stent Delivery System and the Medtronic AVE Bridge™ Stent prove the two devices are substantially equivalent."

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

The 510(k) summary does not specify the sample size for the test set used in the performance testing. It also does not explicitly mention the data provenance (e.g., country of origin, retrospective or prospective). However, the testing conducted appears to be bench testing, which is typically performed in a laboratory setting. This type of testing would not involve human subjects or clinical data in the traditional sense.

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

N/A. This information is not applicable because the testing involved physical device performance comparisons (bench testing) rather than clinical evaluations requiring expert interpretation for ground truth.

4. Adjudication Method for the Test Set

N/A. This information is not applicable as the testing involves objective physical measurements and comparisons, not subjective interpretations 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

N/A. This is not an AI-based device. The device is a physical medical implant (stent) and a delivery system. The provided documentation does not include any information about AI or human-in-the-loop performance.

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

N/A. This is not an AI-based device.

7. The Type of Ground Truth Used

The "ground truth" for this device's performance testing is based on objective physical measurements and established engineering standards/specifications as applied to the predicate device. The performance of the new device is compared directly to the measured performance of the predicate device.

8. The Sample Size for the Training Set

N/A. There is no "training set" in the context of this device's submission, as it is not an AI/machine learning device. The "training" for such a device would refer to manufacturing processes and quality control, not data training.

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

N/A. As there is no training set as understood in AI/machine learning, this question is not applicable.

Ask a specific question about this device