(88 days)
The RX and OTW MEGALINK™ SDS Biliary Stent Systems are indicated for the palliation of malignant strictures in the biliary tree.
The RX and OTW MEGALINK™ SDS Biliary Stent Systems are comprised of a bailoon-expandable stent pre-mounted onto either a rapid exchange (RX) or an over-thewire (OTW) delivery catheter designed to be placed percutaneously into the common bile duct and intended to treat malignant strictures in the biliary tree. The stent is fabricated from a single piece of 316L medical grade stainless steel tubing. The stent is premounted onto either an RX or an OTW delivery catheter with an integrated shaft system and an XCELON™ (nylon blend) balloon bonded at the distal end. The RX shaft has a combination of a single lumen design at the proximal end and a coaxial lumen at the distal end. The proximal lumen provides for inflation of the balloon with contrast medium. The distal lumen permits use of a guide wire to facilitate advancement of the catheter to and through the stricture to be dilated. The OTW shaft has a coaxial dual lumen extending the entire length of the catheter. The outer lumen provides for inflation of the balloon with contrast medium. The central lumen permits use of a guide wire to facilitate advancement of the catheter to and through the stricture to be dilated. The balloon, which is identical on both RX or OTW configurations, has 2 radiopaque markers to aid in positioning the balloon in the biliary duct, and is designed to provide an expandable segment of known diameter and length at specific pressures. The proximal end of the RX catheter has a single arm adapter that provides access to the inflation lumen. The proximal end of the OTW catheter has a dual arm adapter, one for the guide wire lumen and the other for access to the inflation lumen. The adapter arm used to access the inflation lumen is designed with a luer-lock fitting for connection with an inflation device. The RX and OTW MEGALINK™ SDS Biliary Stent Systems consists of an 28 mm length stent pre-mounted onto 75 cm length delivery catheters with balloon diameters of 6.0, 7.0, 8.0, 9.0, and 10.0 mm. The RX and OTW MEGALINK™SDS Biliary Stent Systems are intended to be delivered and deployed in the biliary tree.
The provided document is a 510(k) premarket notification summary for the RX and OTW MEGALINK™ SDS Biliary Stent Systems. It details the device's description, intended use, and substantial equivalence to predicate devices. However, it does not contain information on acceptance criteria for device performance, nor does it describe a study specifically designed to prove the device meets such criteria.
The document states:
"The safety and effectiveness of the RX and OTW MEGALINK™ SDS Biliary Stent Systems have been demonstrated through data collected from in vitro bench tests and analyses."
This indicates that the safety and effectiveness were established through laboratory testing rather than clinical trials with human subjects. The details of these bench tests, including specific acceptance criteria and the results, are not provided in this summary.
Therefore, I cannot populate the table or answer most of the questions you've posed based on the provided text.
Here's a breakdown of what can be extracted and what is missing:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not provided in the document. | Not provided in the document. |
2. Sample size used for the test set and the data provenance:
- Sample size: Not provided for in vitro bench tests.
- Data provenance: "in vitro bench tests and analyses." This implies laboratory data, not human patient data, so country of origin and retrospective/prospective status are not applicable in the human study sense.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable and not provided. Since it was in vitro bench testing, ground truth would likely be established by engineering specifications and measurements, not expert clinical consensus from images.
4. Adjudication method for the test set:
- Not applicable and not provided. Adjudication methods like 2+1 or 3+1 are used for expert consensus on clinical data.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and the effect size of how much human readers improve with AI vs without AI assistance:
- No. This is a medical device for treating malignant strictures, not an AI diagnostic tool. MRMC studies are not relevant here.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This isn't an algorithm. It's a physical stent and delivery system.
7. The type of ground truth used:
- Not explicitly stated, but implicitly based on engineering specifications and physical properties. For in vitro bench tests, ground truth would be determined by precise measurements and adherence to design parameters (e.g., stent expansion diameter at specific pressures, material integrity, delivery system functionality).
8. The sample size for the training set:
- Not applicable and not provided. This refers to in vitro bench testing, not a machine learning model.
9. How the ground truth for the training set was established:
- Not applicable and not provided.
In summary, the provided 510(k) summary focuses on establishing substantial equivalence based on design, materials, and intended use compared to predicate devices, and refers to "in vitro bench tests and analyses" for demonstrating safety and effectiveness. It does not include the detailed performance data, acceptance criteria, or specifics of the studies that would be required to answer your questions in the context of, for example, a diagnostic AI device.
§ 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.