(131 days)
The DuraMax™ .035 Biliary Stent System is indicated for palliation of malignant neoplasms in the biliary tree.
The DuraMax™ .035 Biliary Stent Delivery System is a balloon- expandable 316L stainless steel stent pre-mounted on a delivery catheter. The delivery catheter is an Over-the-Wire (OTW) design with a distal balloon and two radiopaque markers to aid in the placement of the stent. The proximal end of the catheter has a Y-connector that allows for the use of a guidewire ≤ 0.035" and the attachment of a balloon inflation device via a standard luer connector. Stents sizes include diameters of 7, 8, 9 & 10 mm in lengths of 18, 28 and 28 mm. The catheter is available in two working lengths, 80 cm and 135 cm. Shaft markers at 93 and 103 cm are provided on the 135 cm catheter. The catheter system is provided sterile and is intended for one use only.
The provided text describes the 510(k) premarket notification for the DuraMax™ .035 Biliary Stent System. It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study to prove predetermined acceptance criteria through specific performance metrics.
Therefore, many of the requested sections about explicit acceptance criteria and a detailed study proving performance against them cannot be extracted directly from this document. The submission is based on comparison and non-clinical testing.
Here's an analysis of the provided text in relation to your request:
1. A table of acceptance criteria and the reported device performance
This information is not explicitly stated in the provided document in the form of a table with specific performance metrics and acceptance criteria. The document states:
- "Performance Standards Have not been established for this device."
- "The safety and effectiveness of the DuraMax™ .035 Biliary Stent Delivery System have been demonstrated with data collected form non-clinical design verification tests and analyses."
The conclusion of the safety and effectiveness is presented as:
| Acceptance Criteria Category | Reported Device Performance (as implied by Substantial Equivalence) |
|---|---|
| Material Composition | Constructed of similar materials to the predicate device. |
| Dimensions | Available in similar diameters and lengths to the predicate device. |
| Design | Has a similar design to the predicate device. |
| Indications for Use | Has the same indications as the predicate device. |
| Biocompatibility | Passed all Biocompatibility testing. |
| Overall Safety & Effectiveness | Demonstrated through non-clinical design verification tests and analyses, leading to a conclusion of substantial equivalence to the predicate device and other currently marketed Biliary Stent Systems. |
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 document. The document mentions "non-clinical design verification tests and analyses," which typically refer to bench testing, not clinical studies with human subjects or a defined test set of patients/data. Therefore, there's no "sample size" in the context of clinical data.
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 applicable/not provided. The document describes non-clinical testing for design verification and analyses, not a clinical study requiring expert ground truth establishment for a test set of cases.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
This information is not applicable/not provided. There is no mention of a test set with adjudicated ground truth, as the study was non-clinical.
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 information is not applicable/not provided. The device is a physical medical device (a stent system), not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable/not provided. The device is a physical medical device, not an algorithm.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
This information is not applicable/not provided. Ground truth in the clinical sense is not relevant for the described non-clinical design verification tests. These tests would typically compare device performance against engineering specifications or established standards for components.
8. The sample size for the training set
This information is not applicable/not provided. The document describes a traditional medical device, not a machine learning model that requires a "training set."
9. How the ground truth for the training set was established
This information is not applicable/not provided, as there is no training set mentioned in the context of this device's evaluation.
§ 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.