(21 days)
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.
| Test | Purpose | Reported Performance |
|---|---|---|
| Balloon Burst | To compare the stent/delivery system of the subject device and the predicate device. | Not explicitly stated, but the conclusion is that the two devices are substantially equivalent. |
| Bond Strength | To compare the stent/delivery system of the subject device and the predicate device. | Not explicitly stated, but the conclusion is that the two devices are substantially equivalent. |
| Balloon Deflation Time | To compare the stent/delivery system of the subject device and the predicate device. | Not explicitly stated, but the conclusion is that the two devices are substantially equivalent. |
| Crossing Profile | To compare the stent/delivery system of the subject device and the predicate device. | Not explicitly stated, but the conclusion is that the two devices are substantially equivalent. |
| Diameter versus Inflation Pressure | To create and compare the compliance curves for the subject device and the predicate device. | Not explicitly stated, but the conclusion is that the two devices are substantially equivalent. |
| Stent Free Area | To compare the stent dimensional data for the subject device and the predicate device. | Not explicitly stated, but the conclusion is that the two devices are substantially equivalent. |
| Stent Length | To compare the stent dimensional data for the subject device and the predicate device. | Not explicitly stated, but the conclusion is that the two devices are substantially equivalent. |
| Crush Strength | To compare the stent dimensional data for the subject device and the predicate device. | Not explicitly stated, but the conclusion is that the two devices are substantially equivalent. |
| Stent Recoil | To compare the stent dimensional data for the subject device and the predicate device. | Not explicitly stated, but the conclusion is that the two devices are substantially equivalent. |
| Stent Expansion | To compare the stent dimensional data for the subject device and the predicate device. | Not explicitly stated, but the conclusion is that the two devices are substantially equivalent. |
| Biocompatibility | To ensure the material used in the stent is safe for biological contact. | "The material used in the Medtronic AVE Stent passed all biocompatibility tests." |
| Sterilization | To ensure the sterilization method is effective. | "The Medtronic AVE Stent is provided sterile." and validated according to ANSI/AAMI/ISO 11137 - 1994, Method I, with a SAL of 10-6. "Labeled pyrogen free." |
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.
§ 876.5010 Biliary catheter and accessories.
(a)
Identification. A biliary catheter and accessories is a tubular flexible device used for temporary or prolonged drainage of the biliary tract, for splinting of the bile duct during healing, or for preventing stricture of the bile duct. This generic type of device may include a bile collecting bag that is attached to the biliary catheter by a connector and fastened to the patient with a strap.(b)
Classification. Class II (special controls). The device, when it is a bile collecting bag or a surgical biliary catheter that does not include a balloon component, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.