(33 days)
The LifeStent Turbo Biliary Stent System is indicated for use in the palliation of malignant strictures (neoplasms) in the biliary tree.
The LifeStent Turbo consists of a balloon expandable stent that is provided on an over-the-wire catheter that acts as a delivery system. The stent is a permanently implanted device used to maintain patency of a major bile duct obstructed by tissue of an impinging tumor. The flexible, balloon expandable stent is made by laser cutting an open lattice design into a stainless steel tube. The subject device is supplied in a length of 11mm and diameters of 5mm and 6mm.
The provided text describes a 510(k) premarket notification for the LifeStent Turbo Biliary Stent System. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than conducting new clinical studies with defined acceptance criteria for device performance. Therefore, many of the requested elements for a study proving device performance against acceptance criteria are not explicitly present in the document.
Here's an analysis based on the information provided:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly define quantitative acceptance criteria for the new device as would be seen in a clinical trial. Instead, the performance assessment is based on demonstrating "substantial equivalence" to predicate devices through various bench tests.
| Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|
| Materials: Identical to predicate devices | "identical" to predicate devices |
| Performance Properties: Similar to predicate devices | "similar performance properties" to predicate devices; bench testing "performed in a manner substantially equivalent to the predicate devices" |
| Biocompatibility: Similar to predicate devices | "substantially equivalent" to predicate devices |
| Method of Sterilization: Identical to predicate devices | "identical" to predicate devices |
| Packaging: Identical to predicate devices | "identical" to predicate devices |
| Bench Testing (Deployment, Dimensional, Compression Force, Balloon Performance, Stent Deformation, Tensile Strength): Results indicate substantial equivalence to predicate devices. | Results "indicate that the system performed in a manner substantially equivalent to the predicate devices" |
2. Sample Size Used for the Test Set and Data Provenance
The document does not describe a "test set" in the context of human subjects or clinical data. The performance evaluation was based on bench testing of the device itself. Therefore, concepts like country of origin for data and whether it was retrospective or prospective are not applicable. The sample sizes for each type of bench test (e.g., how many stents were tested for deployment) are not specified.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
This information is not applicable. The evaluation was for a medical device through bench testing, not an AI or diagnostic system requiring expert-established ground truth.
4. Adjudication Method for the Test Set
This information is not applicable. There was no "test set" requiring adjudication by experts. The performance was assessed through engineering and physical tests.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size
No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic devices where human readers interpret images or data, and the goal is often to measure the impact of an AI adjunct on reader performance. The LifeStent Turbo is a therapeutic device (stent).
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
No, a standalone performance evaluation in the context of an algorithm or AI without human-in-the-loop performance was not done. This is not an AI device. The "standalone" performance here refers to the device's physical and mechanical properties demonstrated through bench testing.
7. The Type of Ground Truth Used
For a physical medical device like a stent, the "ground truth" for bench testing typically refers to:
- Engineering specifications and design tolerances.
- Material properties (e.g., stainless steel composition).
- Known performance characteristics of the predicate devices.
- Standardized testing methodologies (e.g., ASTM standards) for evaluating properties like tensile strength or fatigue.
The document states that the bench testing covered deployment testing, dimensional testing, compression force testing, balloon performance testing, stent deformation testing, and tensile strength testing. The "ground truth" for evaluating these tests would be the established engineering and materials specifications for the device and a comparison to the known performance of the predicate devices.
8. The Sample Size for the Training Set
This is not applicable. The device is a physical medical implant, not an AI model that requires a training set.
9. How the Ground Truth for the Training Set Was Established
This is not applicable. There was no training set for an AI model.
§ 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.