(212 days)
The AVE Bridge™ Stent System is intended for use in patients to maintain patency of a biliary duct which is occluded by tumor. The AVE Bridge™ Stent System is indicated for palliative treatment of biliary duct strictures caused by malignant tumors. This device is not intended for intravascular use.
The AVE Bridge™ Stent System consists of a balloon-expandable intraluminal stent premounted onto the balloon of an over-the-wire delivery catherer. The AVE Bridge™ 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 AVE Bridge™ Stent System is provided enclosed in a sterile package.
The provided text describes a 510(k) premarket notification for the AVE Bridge™ Stent System, focusing on demonstrating substantial equivalence to a predicate device, the PALMAZ™ Balloon-Expandable Stent. The document details performance testing conducted to support this claim, rather than establishing new acceptance criteria or proving the device meets those criteria in a de novo fashion.
Here's an analysis of the provided information relative to your request:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly define acceptance criteria in terms of specific thresholds for the AVE Bridge™ Stent. Instead, the "acceptance criteria" for the studies were to demonstrate substantial equivalence to the predicate device (PALMAZ™ Balloon-Expandable Stent). The reported device performance is presented as a comparison to this predicate.
| Study Title | Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|---|
| AVE Bridge™ Stent vs JJIS Palmaz™ Balloon-Expandable Stent - Balloon Performance Study | Demonstrate substantial equivalence in minimum burst pressure and deflation times compared to PALMAZ™ Balloon. | "The test proved substantial equivalence." |
| AVE Bridge™ Stent vs JJIS Palmaz™ Balloon-Expandable Stent - Two Plane Crush Strength Study | Demonstrate substantial equivalence in radial strength (force to crush to 50% deployed diameter) compared to PALMAZ™ Balloon. | "The test proved substantial equivalence." |
| AVE Bridge™ Stent Dimensional Verification and Stent Uniformity at Nominal Deployment | Meet specified diameter and length after deployment. | "The results conclude that the stents tested meet the labeled specifications for stent diameter and stent length." |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify the sample sizes used for any of the non-clinical performance tests (Balloon Performance, Two Plane Crush Strength, Dimensional Verification).
The data provenance is industrial testing conducted by Arterial Vascular Engineering, Inc. and is retrospective to the submission date. There is no mention of country of origin for data; it's implied to be from the manufacturer's testing in the USA.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not provided in the document. The studies are non-clinical, mechanical performance tests, not studies requiring expert interpretation or ground truth establishment in the medical sense (e.g., diagnosis from imaging).
4. Adjudication Method for the Test Set
This information is not applicable and therefore not provided, as the tests are non-clinical mechanical performance tests, not clinical studies requiring adjudication of outcomes or interpretations.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
This information is not applicable and therefore not provided. The submission is for a medical device (stent) based on non-clinical performance testing for substantial equivalence, not an AI or imaging diagnostic device that would typically involve MRMC studies.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
This information is not applicable and therefore not provided. The AVE Bridge™ Stent System is a physical medical device, not an algorithm.
7. Type of Ground Truth Used
For the Balloon Performance Study and Two Plane Crush Strength Study, the "ground truth" was essentially the performance of the predicate device (PALMAZ™ Balloon-Expandable Stent), against which the AVE Bridge™ Stent was compared for substantial equivalence in mechanical properties.
For the Dimensional Verification and Stent Uniformity at Nominal Deployment study, the "ground truth" was the labeled specifications for stent diameter and stent length.
8. Sample Size for the Training Set
This information is not applicable and therefore not provided. As noted, this is a physical medical device, not an AI model, and therefore does not have a "training set" in the context of machine learning. The non-clinical performance studies are akin to validation/test sets for mechanical properties.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable and therefore not provided, as there is no "training set" in this context.
§ 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.