Search Results

The DYNALINK™ .018 Biliary Self-Expanding Stent System is indicated for palliation of malignant strictures in the biliary tree.

The DYNALINK™ .018 Biliary Self-Expanding Stent System is a catheter designed to deploy a self-expanding nickel titanium (Nitinol) stent into the biliary tree. The catheter body is constructed from two coaxial members. The inner member (IM) is compatible with a 0.018" guide wire in an over-the-wire configuration. The outer member (OM) is composed of a distal sheath that constrains the unexpanded stent, an outer shaft over most of the catheter length, and a proximal handle used to retract the assembly. The distal end of the delivery system includes the DYNALINK™ Biliary Self-Expanding Stent held in its constrained state by the stent-restraining sheath, a soft, low profile tip, and two radioopaque markers to indicate the proximal and distal ends of the stent. At the proximal end of the delivery system, the user interface is composed of a pull-back handle attached to the OM, a shaped housing that allows the handle to slide axially, and a luer fitting that is rigidly fixed to the shaped housing. The DYNALINK™ Biliary Self-Expanding Stent is fabricated from superelastic nickel-titanium (nitinol). The DYNALINK™ Biliary Self-Expanding Stent is comprised of a series of serpentine rings that are aligned along a common longitudinal axis. The stent is laser cut from a tube of superelastic nitinol. All of the stent diameters are cut with similar stent patterns, and the stent is expanded and heat-treated to be stable at the desired final diameter. The stents are electropolished to obtain a smooth finish with a thin layer of titanium oxide on the surface.

The provided text describes a 510(k) premarket notification for a medical device, the DYNALINK™ .018 Biliary Self-Expanding Stent System. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving safety and effectiveness through extensive clinical trials with detailed acceptance criteria and standalone performance studies.

Therefore, much of the requested information regarding acceptance criteria, specific study design (test/training sets, expert consensus, MRMC studies, effect sizes), and detailed performance metrics is not explicitly present in the provided document. The submission relies on "in vitro bench tests and analyses" and comparison to a predicate device.

Here's an attempt to extract and infer information based on the provided text, while also explicitly stating what is not available.

1. Table of Acceptance Criteria and Reported Device Performance

As per the given document, detailed acceptance criteria with specific numerical targets and corresponding performance reports are not provided. The submission focuses on demonstrating substantial equivalence to a predicate device rather than meeting specific performance criteria against a predefined standard. The document only generally states:

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size for Test Set: Not specified. The document mentions "in vitro bench tests and analyses" but does not provide any sample sizes for these tests.
• Data Provenance: The data is from "in vitro bench tests and analyses." There is no mention of human subject data, retrospective or prospective studies, or country of origin.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications

Not applicable/Not specified.
Since the document describes "in vitro bench tests and analyses," there is no mention of human experts providing ground truth for a test set in the context of diagnostic or clinical accuracy.

4. Adjudication Method for the Test Set

Not applicable/Not specified.
As there's no mention of expert labeling or human performance evaluation in a test set, an adjudication method is not described.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size

No.
The document does not mention an MRMC comparative effectiveness study. This type of study is typically used for diagnostic imaging devices to assess the impact of AI on human reader performance, which is not relevant for a self-expanding stent system.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

Not applicable/Not specified in detail.
This device is a physical stent system, not an algorithm. The "performance data" refers to the physical and functional performance of the device (e.g., expansion, material properties) as assessed by "in vitro bench tests and analyses." There is no "algorithm only" performance reported.

7. The Type of Ground Truth Used

Not explicitly defined as "ground truth" in the diagnostic sense.
For "in vitro bench tests and analyses," the "ground truth" would likely be established engineering specifications, material standards, and performance metrics for mechanical properties (e.g., expansion force, radial strength, durability, patency in a simulated environment) that the device is tested against. The document does not elaborate on these specific metrics or how they were established.

8. The Sample Size for the Training Set

Not applicable/Not specified.
This device is a physical stent system, not an AI model that requires a "training set" of data.

9. How the Ground Truth for the Training Set Was Established

Not applicable/Not specified.
As there is no "training set" for an AI model, this question is not relevant to the provided text.

Summary of Study Type:

The study described is a premarket notification (510(k)) that relies on in vitro bench tests and analyses to demonstrate substantial equivalence to an existing predicate device (DYNALINK™ Biliary Self-Expanding Stent System, K002143). The focus is on comparing the technological characteristics of the new device to the predicate, with the main difference being the length of the stent. Specific performance metrics and human-centric studies are not detailed as part of this submission process.

Ask a specific question about this device