(89 days)
The Peripheral AVE Biliary Stent System is intended for use in patients who are eligible for percutaneous transluminal angioplasty (PTA) to maintain patency of a biliary duct which is occluded by tumor.
The Peripheral AVE Bilairy Stent System is indicated for palliative treatment of biliary duct strictures caused by malignant tumors.
The Peripheral AVE Bilairy Stent System consists of a balloon-expandable intraluminal stent premounted onto the balloon of an over-the-wire delivery catheter. The Peripheral AVE Bilairy 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 Peripheral AVE Bilairy Stent System is provided enclosed in a sterile package.
Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state acceptance criteria in a quantitative, pass/fail format with specific thresholds. Instead, the "acceptance criteria" are implied by the purpose of each test, which is to demonstrate "substantial equivalence" to a predicate device or to verify internal specifications. The reported performance is the conclusion of each study, stating whether substantial equivalence was achieved or if specifications were met.
| Acceptance Criteria (Implied from Purpose) | Reported Device Performance (Results) |
|---|---|
| Balloon Performance Study: | |
| - Compare minimum burst pressure to predicate. | - The test proved substantial equivalence. |
| - Compare deflation times to predicate. | |
| Two Plane Crush Strength Study: | |
| - Determine and compare radial strengths to predicate (graphical representation of force to crush to 50% deployed diameter). | - The test proved substantial equivalence. |
| Dimensional Verification and Stent Uniformity at Nominal Deployment: | |
| - Verify that processed stents meet diameter specifications after deployment. | - The results conclude that the stents tested meet the labeled specifications for stent diameter and stent length. |
| - Verify that processed stents meet length specifications after deployment. | |
| Biocompatibility: | |
| - Meet biocompatibility standards. | - The materials employed in the Peripheral AVE Biliary Stent Delivery System passed all biocompatibility tests. |
| Sterilization (SAL): | |
| - Achieve an SAL of 10^-6. | - The Sterility Assurance Level or SAL for the validated AVE stent systems is 10^-6. |
| Pyrogen Testing: | |
| - Be "pyrogen free" (LAL testing in compliance with FDA guidelines). | - The Peripheral AVE Biliary Stent System is labeled "pyrogen free". LAL testing is performed daily, in compliance with FDA guideline... as part of Peripheral AVE's product release criteria. |
2. Sample sizes used for the test set and the data provenance
The document does not specify the sample sizes used for any of the performance tests (Balloon Performance, Crush Strength, Dimensional Verification).
The data provenance is not explicitly stated as retrospective or prospective, nor does it mention a country of origin. However, given the nature of the tests (benchtop comparisons and verification), the data is most likely generated in a laboratory setting by the manufacturer, Peripheral AVE, to support their 510(k) submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not applicable and therefore not mentioned in the provided document. The studies conducted are primarily benchtop engineering and material science tests, not clinical studies requiring expert interpretation of patient data to establish ground truth.
4. Adjudication method for the test set
This information is not applicable and therefore not mentioned in the provided document. Adjudication methods are relevant for clinical studies where multiple reviewers assess ambiguous data. The tests described are objective, quantitative measurements.
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 mentioned, as this device is a physical medical device (a stent), not an AI-powered diagnostic tool requiring human-in-the-loop performance evaluation.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable. The device is a physical stent and does not involve an algorithm or AI.
7. The type of ground truth used
The "ground truth" for the benchtop performance tests is the measured physical properties and performance characteristics of the Peripheral AVE Biliary Stent System and the predicate device (PALMAZ™ Balloon-Expandable Stent), as well as predefined specifications.
- For the Balloon Performance Study and Crush Strength Study, the ground truth for comparison was the measured performance of the predicate device.
- For the Dimensional Verification, the ground truth was the labeled specifications for stent diameter and length.
- For Biocompatibility, Sterilization, and Pyrogen Testing, the ground truth refers to adherence to established industry standards and regulatory guidelines (e.g., ANSI/AAMI/ISO 11137-1994, FDA guidelines for LAL testing).
8. The sample size for the training set
This information is not applicable. The device is a physical medical device; there is no "training set" in the context of machine learning or AI. The tests conducted are design verification and validation tests rather than algorithm training.
9. How the ground truth for the training set was established
This information is not applicable for the reasons stated in 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.