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The SUPERATM Interwoven Self-Expanding Nitinol Biliary Stent Delivery Catheter is indicated for use with the 510(k) cleared SureSave™ Self-Expandable Biliary Nitinol Stent (K060557), a.k.a. SUPERA™ biliary nitinol stent, in palliative treatment of biliary strictures produced by malignant neoplasms.

The SUPERATM Interwoven Self-Expanding Nitinol Biliary Stent Delivery Catheter was designed and is manufactured by IDev Technologies, Inc. for use with the FDA 510(k) cleared SureSave™ Self-Expandable Biliary Nitinol Stent (K060557), a.k.a. SUPERA™ biliary nitinol stent, in the palliation of malignant strictures (neoplasms) in the biliary tree. It shares the same indication for use and design features as the Precision™ Stent Delivery Catheter (K060557) with the exception of modifications that do not significantly affect the function and/or safety of the device.

Please refer to Figure 1. The SUPERA™ Interwoven Self-Expanding Nitinol Biliary Stent Delivery Catheter is a 7 Fr, 0.018" guide wire compatible, multi-lumen sheath based delivery system comprised of an Outer Sheath (1) attached proximally to a Handle (2); a radiopaque Marker Band (3) located on the Outer Sheath that can be visualized under fluoroscopy to assist in system placement/SUPERA™ stent deployment; a Thumb Slide (4) connected internally to a means for advancing the SUPERA™ stent out of the Outer Sheath as the Outer Sheath moves proximally in a de-coupled fashion; a Stopcock (5) for flushing the central lumen of the device and for contrast injection; a Retention Cable (6) connected to the proximal end of a stent to assist in resheathing/repositioning the stent; a Resheath Collar (7) that can be actuated to allow for resheathing or deployment of a stent; a Torquer (8) connected to the Retention Cable for external visualization of the deployment process, a dedicated Guidewire Lumen (9) for traversing over an 0.018" guidewire with a radiopaque Flexible Tip (10) and Guidewire Luer Fitting (11), used for flushing the Guidewire Lumen, located on the distal and of the Guidewire Lumen, respectively; a Hemostasis Valve (12) that can be tightened to eliminate relative motion of the Flexible Tip with respect to the Outer Sheath; a Y-Port (13) housing the Retention Cable and serving as a point of reference for deployment; an introducer Valve Defeater (14); a Re-Sheathing Indicator (15); and a Packaging Mandrel (16).

Here's a breakdown of the requested information based on the provided text, focusing on the acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

The provided text does not explicitly list specific acceptance criteria with numerical performance metrics for the device itself (SUPERA™ Interwoven Self-Expanding Nitinol Biliary Stent Delivery Catheter). Instead, it states that the device is "substantially equivalent" to a predicate device based on preclinical testing.

Therefore, a table of specific numerical acceptance criteria and reported device performance from the provided document cannot be generated.

However, based on the narrative, the implicit acceptance criterion is substantial equivalence to the predicate device, the Precision™ Stent Delivery Catheter (K060557).

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

The document mentions "preclinical testing" but does not specify the sample size for any test set or the data provenance (e.g., country of origin, retrospective/prospective). This often implies bench testing, animal studies, or a combination, but the details are not provided.

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

The document does not mention the use of experts to establish ground truth. Preclinical testing for a device like a stent delivery catheter often focuses on engineering specifications, mechanical properties, and functional performance in simulated environments or animal models. Expert adjudication is more common in diagnostic or image-interpretation devices.

4. Adjudication Method for the Test Set

As there's no mention of experts establishing ground truth, there is no adjudication method described.

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

No, an MRMC comparative effectiveness study was not done or is not mentioned in the provided text. The evaluation method focused on preclinical testing for substantial equivalence, not human reader performance.

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

N/A. This device is a medical instrument (stent delivery catheter), not an algorithm or AI system. Therefore, the concept of "standalone performance" in the context of an algorithm does not apply. The device itself performs its function.

7. The Type of Ground Truth Used

The text doesn't explicitly state the "type of ground truth" using terms like "pathology" or "outcomes data." However, given it's a medical device, the ground truth for preclinical testing would likely involve:

• Engineering specifications and measurements: Verifying dimensions, material properties, deployment forces, etc.
• Functional performance in simulated environments: Assessing the catheter's ability to navigate, deliver, and resheath a stent under controlled conditions.
• Animal study observations (if conducted): Direct observation of successful stent delivery and performance in an in-vivo model, potentially with histological evaluation or imaging to confirm proper placement and tissue response.

8. The Sample Size for the Training Set

Not Applicable (N/A). This device is not an AI/ML algorithm. Therefore, there is no "training set."

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

Not Applicable (N/A). As there is no training set for an AI/ML algorithm, this question is not relevant.

Summary of Acceptance Criteria and Study (Based on Substantial Equivalence):

The primary acceptance criterion described is substantial equivalence to the predicate device, the Precision™ Stent Delivery Catheter (K060557). This equivalence was confirmed through preclinical testing. While the details of this testing (specific tests, sample sizes, metrics) are not provided, the implication is that the tests demonstrated that the modified features of the new device "do not significantly affect the function and/or safety of the device" compared to the predicate. The FDA's 510(k) clearance confirms their agreement with this assessment of substantial equivalence.

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