(28 days)
The Aurora 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 stent design incorporates radiopaque markers to aid in stent placement during fluoroscopy. The delivery system is designed to deliver the stent to the stricture site. Once positioned at the stricture site, the sheath is withdrawn and the stent is released.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. Two catheter mounted radiopaque markers aid in visibility during fluoroscopy.
The provided text describes a 510(k) summary for the Medtronic AVE Bridge Aurora Biliary Stent System, focusing on its substantial equivalence to a predicate device rather than presenting detailed acceptance criteria and a study to prove meeting those criteria.
Therefore, many of the requested points cannot be answered directly from the provided text, as it does not contain information about:
- Specific quantitative acceptance criteria for device performance.
- A detailed study protocol (sample sizes for test sets, training sets, data provenance, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth establishment for specific performance metrics).
However, I can extract information related to the overall regulatory approval process and the type of evidence submitted.
Here's what can be inferred or directly stated based on the given documents:
1. A table of acceptance criteria and the reported device performance
- Acceptance Criteria (Inferred): The primary "acceptance criteria" for 510(k) clearance is demonstrating substantial equivalence to a legally marketed predicate device. This means the new device is as safe and effective as the predicate. The document states: "The Aurora is substantially equivalent to the currently cleared and marketed device and meets the clinical needs of the physicians."
- Reported Device Performance: The document explicitly states: "Preclinical testing was conducted to confirm the safe and effective performance of this device as well as the biocompatibility of the device." However, specific quantitative results of this preclinical testing are not provided in this summary. The device's technological characteristics are mentioned as being similar to the predicate, with the improvement of "increased visibility under fluoroscopy."
| Acceptance Criteria (Inferred from 510(k) Process) | Reported Device Performance (Summary) |
|---|---|
| Substantial equivalence to a predicate device (Bridge SE - K011080, K014205) in terms of safety and effectiveness for the palliation of malignant neoplasms in the biliary tree. | - "The Aurora is substantially equivalent to the currently marketed Bridge SE." |
- "The subject and predicate stents are technologically similar and are intended for palliation of malignant neoplasms in the biliary tree."
- "Constructed of biocompatible materials."
- "Delivered via a sheathed delivery system."
- "The subject device offers increased visibility under fluoroscopy."
- "Preclinical testing was conducted to confirm the safe and effective performance of this device as well as the biocompatibility of the device." |
| Meeting clinical needs of physicians. | - "The Aurora... meets the clinical needs of the physicians." |
| Device safety and effective performance. | - "Preclinical testing was conducted to confirm the safe and effective performance of this device as well as the biocompatibility of the device." (No specific metrics or quantitative data provided in this summary). |
| Biocompatibility. | - "The subject and predicate stents are constructed of biocompatible materials." - "Preclinical testing was conducted to confirm the... biocompatibility of the device." |
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 given 510(k) summary. The document mentions "Preclinical testing" but does not detail the nature, size, or provenance of any test sets. This summary focuses on substantial equivalence and device description.
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 given 510(k) summary. There is no mention of a "test set" in the context of expert review for performance evaluation.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- This information is not provided in the given 510(k) summary.
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 is not applicable as the device is a Biliary Stent System, not an AI-powered diagnostic device designed to assist human readers. The provided documentation does not suggest any MRMC study was conducted.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- This is not applicable as the device is a Biliary Stent System. It is an implantable medical device, not a standalone diagnostic algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- This information is not explicitly stated as the details of "preclinical testing" are not elaborated. For an implantable stent, "ground truth" for performance would typically be based on established engineering benchmarks, material science properties, biocompatibility testing (in vitro/in vivo), and potentially animal studies or historical clinical data from predicate devices. It is not framed in terms of expert consensus on diagnostic images.
8. The sample size for the training set
- This information is not provided in the given 510(k) summary. (Moreover, "training set" is typically associated with machine learning or AI models, which is not the nature of this device.)
9. How the ground truth for the training set was established
- This information is not provided in the given 510(k) summary (and again, the concept of a "training set" as commonly understood in AI/ML is not applicable here).
Summary of what is known:
The provided documents are a 510(k) summary for a medical device (a biliary stent), not an AI/ML device. Therefore, the questions related to AI/ML specific rigorous study designs (like MRMC, training/test sets, expert ground truth, adjudication) are not addressed in this type of regulatory submission. The clearance is based on substantial equivalence to existing predicate devices and general "preclinical testing" demonstrating safe and effective performance and biocompatibility, without disclosing specific quantitative results or study methodologies in this public summary.
§ 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.