(79 days)
The Xpert™ Biliary Stent is intended for use in the palliation of malignant strictures in the biliary tree.
The Xpert™ Self-Expanding Transhepatic Biliary Stent System is indicated for use in the palliation of malignant strictures (neoplasms) in the biliary tree.
The Xpert™ Biliary Stent 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.
The provided text describes a 510(k) summary for a medical device called the Xpert™ Biliary Stent. It defines the device, its intended use, and states that substantial equivalence was confirmed through non-clinical testing to a predicate device (Xpert™ Biliary Stent K040667).
However, the document does not describe acceptance criteria for device performance, nor does it detail a study that proves the device meets such criteria. The information provided is primarily regulatory in nature, focusing on the substantial equivalence determination for market clearance.
Therefore, most of the requested information cannot be extracted from this document.
Here's an overview of what can and cannot be answered based on the provided text:
1. Table of acceptance criteria and the reported device performance:
This information is not provided in the document. The document states:
- "Substantial equivalence was confirmed through non-clinical testing."
- "The Xpert™ Biliary Stent is substantially equivalent to the predicate device."
It does not list specific performance criteria or results from these non-clinical tests.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
This information is not provided in the document. The filing mentions "non-clinical testing," but does not specify sample sizes or data provenance.
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 information is not provided in the document. No information about expert review or ground truth establishment is mentioned.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
This information is not provided in the document. No adjudication method is described.
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:
This information is not provided in the document. The Xpert™ Biliary Stent is a physical medical device (stent and delivery system), not an AI-assisted diagnostic tool for human readers. Therefore, an MRMC study comparing human readers with and without AI assistance is not applicable to this device and is not mentioned.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
This information is not provided in the document. As this is a physical medical device, not an algorithm, a "standalone algorithm" performance study is not applicable and not mentioned.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
This information is not provided in the document. The document only references "non-clinical testing" for substantial equivalence.
8. The sample size for the training set:
This information is not provided in the document. No training set is mentioned as the evaluation was based on non-clinical testing for substantial equivalence to a predicate device.
9. How the ground truth for the training set was established:
This information is not provided in the document. No training set or its ground truth establishment is mentioned.
§ 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.