(21 days)
The Cordis S.M.A.R.T.™ Nitinol Stent Transhepatic Biliary System is intended for use in the palliation of malignant neoplasms in the biliary tree.
The Cordis S.M.A.R.T.™ Nitinol Stent Transhepatic Biliary System is a system consisting of a self-expanding, open mesh, nitinol stent preloaded onto a sheathed delivery catheter. The delivery system is designed to deliver the stent to the stricture site via transhepatic access. Once positioned at the stricture site, the sheath is withdrawn and the stent is released. Upon release, the stent expands and conforms to the inner lumen of the biliary duct.
This document is a 510(k) submission for a medical device (Cordis S.M.A.R.T.™ Nitinol Stent Transhepatic Biliary System) and focuses on demonstrating substantial equivalence to a predicate device through preclinical testing, rather than reporting on a clinical study with detailed acceptance criteria and performance metrics for an AI-powered device. Therefore, much of the requested information cannot be extracted from this document.
Here's what can be extracted and a clear statement about what information is not present:
1. A table of acceptance criteria and the reported device performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Substantial Equivalence to Predicate Device: The device should be substantially equivalent to the currently marketed Cordis S.M.AR.T.™ Nitinol Stent Transhepatic Biliary System. | Equivalence confirmed: "The equivalence was substantially equivalent to the predicate device. The equivalence was confirmed through pre-clinical testing." |
| Biocompatibility: All materials used in the device should be biocompatible. | Biocompatible: "All materials used in the Cordis S.M.AR.T.™ Nitinol Stent Transhepatic Biliary System are biocompatible." |
| Intended Use: Device is intended for palliation of malignant neoplasms in the biliary tree. | Meets Intended Use: The device description and indications for use align with this. |
| Performance Standards: (No specific FDA performance standards established.) | N/A |
2. Sample size used for the test set and the data provenance:
- Not Applicable. This document describes a traditional medical device (stent) and its submission for substantial equivalence based on pre-clinical testing, not an AI/ML device that would typically involve a "test set" in the context of data. The "pre-clinical testing" mentioned would refer to bench testing and potentially animal studies, but no specific sample sizes or data provenance (country of origin, retrospective/prospective) for a "test set" are provided in relation to an AI algorithm.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not Applicable. As this is not an AI/ML device submission, there is no mention of experts establishing ground truth for a test set in this context.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not Applicable. This information is relevant for AI/ML device studies, not for this type of medical device submission.
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:
- Not Applicable. This is a traditional medical device (stent) and not an AI-assisted diagnostic or therapeutic device. Therefore, no MRMC study or assessment of human reader improvement with AI assistance was conducted or reported.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not Applicable. This device is a physical medical implant (stent), not an algorithm.
7. The type of ground truth used:
- For the purposes of establishing substantial equivalence for this device, the "ground truth" would be the performance and characteristics of the predicate device (Cordis S.M.A.R.T.™ Nitinol Stent Transhepatic Biliary System) and established engineering/biocompatibility standards. Pre-clinical testing would have likely involved assessments of mechanical properties, deployment characteristics, and biocompatibility, directly compared to the predicate or to defined specifications. The document does not detail the specific methodology of this "pre-clinical testing."
8. The sample size for the training set:
- Not Applicable. This is not an AI/ML device, so there is no training set in the context of machine learning.
9. How the ground truth for the training set was established:
- Not Applicable. As there is no training set for an AI/ML algorithm, this question is not relevant.
§ 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.