(172 days)
The LifeStent Biliary Endoprosthesis is intended for the palliation of malignant neoplasms in the biliary tree.
The LifeStent Biliary Endoprosthesis is a permanently implanted device used to maintain patency of a major bile duct obstructed by tissue of an impinging tumor. The device is a balloon expandable stent made by laser cutting an open lattice design into a 316L stainless steel tube. The stent is designed to be manually crimped onto a PTA balloon catheter, inserted percutaneously to the diseased site, and deployed by balloon inflation. The stents are available with an expansion range of 4.0-7.0 mm at lengths of 13, 18, 26, 36, and 56 mm.
The provided document is a 510(k) summary for the LifeStent Biliary Endoprosthesis, which is a medical device. This type of document is for demonstrating substantial equivalence to a predicate device, not typically a study proving the device meets specific acceptance criteria in the way a clinical trial for a novel drug or high-risk device would. Therefore, the requested information, particularly regarding AI performance, ground truth, expert adjudication, and detailed statistical results, is not present in this type of regulatory submission for this device.
Based on the provided text, here's what can be extracted and what cannot:
1. Table of acceptance criteria and the reported device performance:
The document states that "Orbus protocols ensure that the LifeStent Biliary Endoprosthesis performs in a manner substantially equivalent to the predicate devices during in vitro tests such as deployment, expansion force testing, compression force testing, dimensions, expansion damage, and corrosion testing."
This implies that the "acceptance criteria" are related to achieving substantial equivalence in these in-vitro performance characteristics compared to the predicate devices. However, the exact numerical acceptance criteria (e.g., "expansion force must be within X% of predicate") and the specific reported performance values are not detailed in this summary. It only states that the device performs in a manner substantially equivalent.
| Acceptance Criteria Category | Reported Device Performance |
|---|---|
| Deployment | Substantially equivalent to predicate devices |
| Expansion Force Testing | Substantially equivalent to predicate devices |
| Compression Force Testing | Substantially equivalent to predicate devices |
| Dimensions | Substantially equivalent to predicate devices |
| Expansion Damage | Substantially equivalent to predicate devices |
| Corrosion Testing | Substantially equivalent to predicate devices |
| Material Properties | Identical to predicate devices |
| Packaging | Similar to predicate devices |
| Sterilization Methods | Similar to predicate devices |
| Intended Use | Same as predicate devices (Palliation of malignant neoplasms in biliary tree) |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
This document describes in-vitro performance tests on the device itself, not a clinical study on patient data. Therefore, there is no information about patient sample sizes or data provenance in the context of clinical data. The "test set" would refer to the number of devices tested for each in-vitro parameter, which is not specified.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This is irrelevant for an in-vitro device performance study. "Ground truth" in this context would be objective physical measurements of the stent's properties. No experts are mentioned for establishing ground truth on physical properties.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Not applicable for in-vitro device performance testing.
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 device is a physical medical implant (stent), not an AI-based diagnostic or prognostic tool. Therefore, an MRMC study and AI performance metrics are not applicable and not mentioned.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable as this is not an AI algorithm.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc):
For the in-vitro performance tests, the 'ground truth' would be the objective measurements of the physical and mechanical properties of the stent, compared against established engineering and material standards, or directly against the predicate device's measured properties. No expert consensus, pathology, or outcomes data is mentioned for establishing this.
8. The sample size for the training set:
Not applicable, as this is not an AI model.
9. How the ground truth for the training set was established:
Not applicable, as this is not an AI model.
Summary of what is available from the document:
The 510(k) summary focuses on demonstrating substantial equivalence of the LifeStent Biliary Endoprosthesis to previously marketed predicate devices. This demonstration is primarily based on:
- Identical Intended Use: Palliation of malignant neoplasms in the biliary tree.
- Identical Material Properties: Made from 316L stainless steel.
- Similar Performance Properties: Assessed through in-vitro tests (deployment, expansion force, compression force, dimensions, expansion damage, corrosion testing) the summary claims the device performs in a manner substantially equivalent to predicates.
- Similar Packaging and Sterilization Methods.
The FDA's review confirms this substantial equivalence, allowing the device to be marketed, with specific labeling limitations regarding its use in the vascular system. The document pertains to a physical device approval, not an AI or software device, hence many of the requested criteria are not relevant or discussed.
§ 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.