(106 days)
The Xceed Nitinol Self-Expanding Transhepatic Biliary Stent System is intended for use in the palliation of malignant neoplasms in the biliary tree.
The Abbott Vascular Devices Xceed Nitinol Self-Expanding Transhepatic Biliary Stent System is comprised of a delivery system and a self-expanding stent. The delivery system is an over the wire (OTW) system designed to deliver the self-expanding stent to the biliary tree.
This document is a 510(k) summary for the Xceed Nitinol Self-Expanding Transhepatic Biliary Stent System. It primarily focuses on demonstrating substantial equivalence to a predicate device rather than providing a detailed study report with specific acceptance criteria and performance metrics typically found for AI/imaging devices.
Therefore, many of the requested details, such as specific acceptance criteria for a device's performance, sample sizes for test sets (especially with AI/imaging context), number of experts, adjudication methods, MRMC studies, standalone performance, and ground truth establishment are not present in this document. This is a medical device approval summary, not a clinical trial report for an AI or diagnostic imaging device.
However, based on the provided text, here's what can be extracted and what cannot:
1. A table of acceptance criteria and the reported device performance:
This document does not specify quantitative acceptance criteria for device performance in the manner requested (e.g., sensitivity, specificity thresholds). Instead, it relies on demonstrating substantial equivalence to an existing predicate device (Cordis Nitinol Stent and Delivery System (K980823)).
| Acceptance Criteria (Implied by Substantial Equivalence) | Reported Device Performance |
|---|---|
| Same intended use | "Xceed Nitinol Self-Expanding Transhepatic Biliary Stent System has the same intended use as the predicate device." |
| Biocompatibility | "Results of scientific testing have ensured that all materials are biocompatible..." |
| No new adverse effects | "...no new adverse effects were introduced..." |
| Appropriate physical properties for intended use | "...and physical properties are appropriate for the intended use." |
2. Sample size used for the test set and the data provenance:
- Test Set Sample Size: Not specified. The document mentions "Nonclinical testing was conducted" but does not provide details on the sample size or type of tests in a way that aligns with an AI/imaging device performance study.
- Data Provenance: Not applicable in the context of an AI/imaging study. The testing referenced is likely bench testing and potentially animal studies for device mechanics and biocompatibility, not clinical data from specific countries.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable/Not specified. This is a medical device (stent) approval document, not a diagnostic imaging or AI study where experts would establish ground truth for a test set of images.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable/Not specified.
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:
- No. This is a physical medical device (stent), not an AI or imaging diagnostic tool. An MRMC study is not relevant to this type of device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is a physical medical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not applicable in the context of diagnostic AI/imaging. The "ground truth" for a device like a stent would be its physical properties, biocompatibility, and functional performance in in-vitro or animal models, not a diagnostic outcome from a patient. The document states "Results of scientific testing have ensured that all materials are biocompatible, no new adverse effects were introduced and physical properties are appropriate for the intended use."
8. The sample size for the training set:
- Not applicable. This is not an AI device, so there is no "training set."
9. How the ground truth for the training set was established:
- Not applicable. There is no training set.
§ 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.