(24 days)
The Bridge SE Biliary Self-Expanding Stent Delivery System is indicated for use in the palliation of malignant neoplasm in the biliary tree.
The subject device is a system consisting of a single-lumen, tubular, self-expanding nickel-titanium ("nitinol") stent pre-loaded 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 Once positioned at the stricture site, the sheath is withdrawn and the stent is released.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. The device has two radiopaque markers to aid in stent placement during fluoroscopy.
The provided document is a 510(k) summary for the Bridge SE Biliary Self-Expanding Stent Delivery System. This type of regulatory submission establishes substantial equivalence to a predicate device, rather than performing a de novo clinical study with specific acceptance criteria or an MRMC study. Therefore, the information requested about acceptance criteria, specific study details, and AI-related metrics is not directly applicable or available in this document.
However, I can extract information regarding the device description, indications for use, and technological characteristics to explain how the device is considered to meet substantial equivalence criteria without the detailed study information you requested.
Here's an analysis based on the provided text, addressing only the applicable points:
1. A table of acceptance criteria and the reported device performance
The concept of explicit "acceptance criteria" and "reported device performance" in the context of a de novo clinical trial is not present here because this is a 510(k) submission. Instead, the "acceptance criteria" for a 510(k) submission are met by demonstrating substantial equivalence to a legally marketed predicate device. The "performance" is demonstrated through nonclinical testing and comparison to the predicate.
| Acceptance Criteria (for 510(k) Substantial Equivalence without explicit performance metrics) | Reported Device Performance (based on substantial equivalence narrative) |
|---|---|
| Intended Use: Device is for the same intended use as the predicate. | Palliation of malignant neoplasm in the biliary tree. |
| Technological Characteristics: Device has similar technological characteristics to the predicate. | Same materials (nitinol), same delivery method (sheathed delivery catheter via transhepatic access). Minor differences (additional stent sizes, longer catheter) are not considered to impact safety or effectiveness. |
| Safety and Effectiveness: Differences in technological characteristics do not raise new questions of safety or effectiveness. | Preclinical testing conducted to confirm safe and effective performance and biocompatibility. |
2. Sample size 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 510(k) summary. A 510(k) summary primarily focuses on demonstrating substantial equivalence through comparison to a predicate device and often relies on bench testing and existing knowledge of similar devices, rather than a prospective clinical trial with a defined test set of patients.
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 as this document does not describe a clinical study involving human readers or expert-established ground truth in the way a diagnostic algorithm study would.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not provided as there is no described clinical study in the document that would require an adjudication method for a test set.
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
An MRMC comparative effectiveness study was not performed or described in this 510(k) summary. This document pertains to a medical device (stent and delivery system), not an AI-assisted diagnostic tool or an imaging modality requiring a reader study.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This concept is not applicable to the Bridge SE Biliary Self-Expanding Stent Delivery System, as it is a physical medical device (stent) and not an algorithm or AI system.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The concept of "ground truth" in the context of diagnostic accuracy for an algorithm is not applicable here. The assessment for this device relies on preclinical testing to confirm performance and biocompatibility, and the comparison to an already cleared predicate device. For stent efficacy, "outcomes data" or clinical follow-up would typically be part of a full clinical trial, but this 510(k) relies on the established safety and efficacy of the predicate device for its substantial equivalence claim.
8. The sample size for the training set
This information is not provided as this is not a study involving a training set for an algorithm.
9. How the ground truth for the training set was established
This information is not provided as this is not a study involving a training set for an algorithm.
§ 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.