(29 days)
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.
| Test | Acceptance Criteria (Inferred from text) | Reported Device Performance |
|---|---|---|
| Balloon Burst | Performance comparable to the predicate device | "To compare the stent/delivery system of the subject device and the predicate device." (Implies comparable performance was observed or demonstrated) |
| Balloon Deflation Time | Performance comparable to the predicate device | "To compare the stent/delivery system of the subject device and the predicate device." (Implies comparable performance was observed or demonstrated) |
| Crossing Profile | Performance comparable to the predicate device | "To compare the stent/delivery system of the subject device and the predicate device." (Implies comparable performance was observed or demonstrated) |
| Diameter versus Inflation Pressure | Compliance curves comparable to the predicate device | "To create and compare the compliance curves for the subject device and the predicate device." (Implies comparable curves were obtained) |
| Stent Free Area | Dimensional data comparable to the predicate device | "To compare the stent dimensional data for the subject device and the predicate device." (Implies comparable data was obtained) |
| Stent Length | Dimensional data comparable to the predicate device | "To compare the stent dimensional data for the subject device and the predicate device." (Implies comparable data was obtained) |
| Stent Recoil | Dimensional data comparable to the predicate device | "To compare the stent dimensional data for the subject device and the predicate device." (Implies comparable data was obtained) |
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.
§ 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.