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The Medtronic AVE Bridge™ Stent is intended to maintain patency of a bile duct which is occluded by a malignant tumor.
The Medtronic AVE Bridge™ Stent System (Hi-Flex) -- Biliary Indication is intended to maintain patency of a biliary 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. Radiopaque markers are 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 75 cm or 120 cm. The device is provided in a sterile package. Size range: 6.0 to 10.0 mm Diameters; 20mm, 40mm, 60mm Lengths.

Based on the provided text, the Medtronic AVE Stent Delivery System is a medical device, and the document describes its 510(k) submission. However, the text does not contain a study that proves the device meets specific acceptance criteria in the format typically used for AI/software devices.

This document is a 510(k) summary for a physical medical device (a stent delivery system), not a software or AI-based device. The "performance testing" described is for comparing physical characteristics of the stent and its delivery system to a predicate device, focusing on substantial equivalence.

Therefore, I cannot provide the requested information in the format of AI-related acceptance criteria and study details because the document does not describe such a study for an AI/software device.

Instead, I can extract the information relevant to this physical medical device's performance testing and conclusions regarding substantial equivalence:

Acceptance Criteria and Device Performance (for a physical medical device, not AI/software):

Explanation for AI/Software-Specific Questions (Not Applicable to this Document):

The following points refer to information typically found in submissions for AI/software devices. Since this document is for a physical medical device, these details are not present in the provided text.

1. Sample sized used for the test set and the data provenance: Not applicable. The document describes physical testing, not a dataset for an AI model.
2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for an AI model is not relevant here. The ground truth for the physical tests would be measured physical properties.
3. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. This refers to expert consensus in AI model validation.
4. 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: Not applicable. This is for AI-assisted diagnostic tools.
5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is for AI algorithm performance.
6. The type of ground truth used (expert consensus, pathology, outcomes data, etc): For the physical tests, the "ground truth" is typically the measured physical properties of the device components and comparisons against engineering specifications or predicate device performance.
7. The sample size for the training set: Not applicable. No AI model is described.
8. How the ground truth for the training set was established: Not applicable. No AI model is described.

In summary, the provided document describes a 510(k) submission for a physical stent delivery system, where "performance testing" focuses on establishing substantial equivalence to a predicate device based on physical and material characteristics, biocompatibility, and sterility, rather than the validation of an AI or software algorithm.

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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.

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The Medtronic AVE Stent Delivery System - For Use In Biliary Indication device is intended to maintain patency of a bile 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 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 90cm. The device is provided in a sterile package.

The Medtronic AVE Stent Delivery System did not provide acceptance criteria in a quantitative format with reported performance. Instead, the submission relies on demonstrating substantial equivalence to a predicate device through performance testing. The study focuses on direct comparisons between the subject device and the predicate device for various physical and mechanical properties.

Here's a breakdown of the requested information based on the provided text:

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

The submission does not present acceptance criteria in a quantitative table format. Instead, it describes performance testing conducted to demonstrate substantial equivalence to a predicate device. The general acceptance criterion seems to be that the subject device performs comparably to the predicate device for the listed tests.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document does not specify sample sizes for each of the performance tests conducted. It refers to "performance testing" being conducted but provides no details on the number of units tested for each parameter. The data provenance is also not mentioned; it's a submission for a medical device by Medtronic AVE, Inc. in Santa Rosa, California, but details on where the tests were conducted or the origin of any 'data' beyond the tests are absent. These appear to be bench tests, not clinical studies involving patients.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This section is not applicable. The study involves demonstrating the physical and mechanical performance of a medical device against a predicate device, not establishing a ground truth for a diagnostic algorithm or interpretation. There are no "experts" involved in judging test results in the clinical sense mentioned here.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This section is not applicable for the same reasons as point 3. There is no adjudication method described as this is not a study requiring human interpretation or consensus.

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 done. This submission is for a medical device (stent delivery system), not an AI-assisted diagnostic tool.

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

This section is not applicable as this is a medical device (stent delivery system), not an algorithm or AI system.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

The "ground truth" in this context is the performance and characteristics of the predicate device (Peripheral AVE Stent Delivery System - For Use In Biliary Indication) and established engineering/performance standards for medical devices, coupled with the results from the specific performance tests conducted on the subject device. The goal is to show the subject device performs equivalently.

8. The sample size for the training set

This section is not applicable as the submission describes a physical medical device, not a machine learning model. There is no concept of a "training set" here.

9. How the ground truth for the training set was established

This section is not applicable for the same reasons as point 8.

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