(72 days)
The Medtronic AVE Bridge™ FX Biliary Stent Delivery System is intended to maintain patency of a bile duct, which is occluded by a malignant tumor.
The Bridge FX Stent Delivery System consists of a balloon-expandable intralumenal, 316L stainless steel stent pre-mounted onto the balloon of an over-the-wire delivery catheter. The device is available in diameters ranging from 6-10 mm and in several lengths including 20, 30, 40, and 60 mm. The delivery system has two radiopaque marker bands to aid in the placement of the stent during fluoroscopy. The delivery system is compatible with 0.035" guidewires and has useable lengths of 80 and 130 cm. The device is provided in a sterile package.
The provided text is a 510(k) summary for the Medtronic AVE Bridge FX Stent Delivery System. It describes the device, its intended use, and states that preclinical testing was conducted to confirm its safe and effective performance. However, this document does not contain information about acceptance criteria or a detailed study proving the device meets specific performance criteria in the way typically expected for an AI/CADe device.
The 510(k) process for a device like this stent typically relies on demonstrating "substantial equivalence" to a legally marketed predicate device rather than presenting extensive clinical performance studies with acceptance criteria in the format requested. The "performance" section mentions "Preclinical testing was conducted to confirm the safe and effective performance of the Bridge FX. The device passed biocompatibility testing." This is a high-level summary and doesn't provide the granular detail needed for the requested table and study information.
Therefore, many sections of your request cannot be fulfilled based on the provided text. I will indicate where information is "Not provided in the text."
Here's a breakdown of the available information:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not provided in the text. (Typically for a stent, this would involve criteria related to deployment success, patency rates, complication rates, etc., which are often derived from clinical studies or meta-analyses of related devices). | "Preclinical testing was conducted to confirm the safe and effective performance of the Bridge FX." |
| "The device passed biocompatibility testing." |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample size for test set: Not provided in the text. The term "preclinical testing" suggests laboratory or animal studies, not human clinical trials with a test set in the traditional sense for evaluating diagnostic performance.
- Data provenance: Not provided in the text.
- Retrospective or prospective: Not provided in the text.
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)
- Not applicable as the text describes preclinical testing of a physical medical device (stent), not an AI/CADe system requiring expert-established ground truth for image interpretation.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable for the type of preclinical testing 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
- No. This is a physical medical device (stent), not an AI/CADe system, so an MRMC study is not relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This is a physical medical device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- For "preclinical testing," ground truth would be established through laboratory measurements, engineering specifications, and potentially animal model outcomes (e.g., successful stent deployment, patency in a simulated vessel, biocompatibility assessment using standard assays). The specific details are not provided in the summary.
8. The sample size for the training set
- Not applicable for the type of preclinical testing described. The device is a physical stent, not an AI model requiring a training set of data.
9. How the ground truth for the training set was established
- Not applicable for the type of preclinical testing described.
§ 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.