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SUPERA VERITAS™ Interwoven Self-Expanding Nitinol Stent Transhepatic Biliary System is indicated for palliative treatment of biliary strictures produced by malignant neoplasms.

The SUPERA VERITAS™ Interwoven Self-Expanding Nitinol Stent Transhepatic Biliary System is a 7Fr, 0.014" or 0.018" guidewire compatible, multi-lumen sheath based delivery system comprised of a Handle and a SUPERA® Biliary Stent. The stent delivery catheter includes a radiopaque Stent Length Marker Band and Distal Sheath Marker Band embedded in the Outer Sheath to aid in proper stent positioning; a Thurnb Slide connected internally for advancing the Stent out of the Outer Sheath while the Outer Sheath moves proximally in a de-coupled fashion; a Sheath Flush Port for flushing the central lumen of the device; a Deployment Lock that when actuated enables the final deployment stroke of the stent; a Guidewire Lumen with a radiopaque Catheter Tip located on the distal end of the Catheter Shaft; a Guidewire Flush Port used for flushing the Guidewire Lumen; a Stent Driver which deploys the stent distally relative to the Outer Sheath; the System Lock which eliminates the possibility of premature deployment. The working length of the delivery catheter is 120cm.

The SUPERA® Stent housed within the SUPERA VERITAS" stent delivery catheter is a closed end interwoven self-expanding Nitinol stent. The SUPERA® stent is composed of 6 interwoven, closed loop Nitinol wires. The wire loops are closed via a proprietary welding process which utilizes small Nitinol tubes that act as a coupler to provide the mechanical means of joining the wire ends.

The provided text describes the 510(k) summary for the SUPERA VERITAS™ Interwoven Self-Expanding Nitinol Stent Transhepatic Biliary System. It details the device, its intended use, comparison to predicate devices, and the performance testing conducted.

Here's the information extracted and organized as requested:

1. Table of Acceptance Criteria and Reported Device Performance

The submission states that "Engineering studies were performed per the FDA's 'Guidance of Premarket notification 510(k) Submissions for Short Term and Long Term Intravascular Catheters'; the Guidance for the Content of Premarket Notifications for Metal Expandable Biliary Stents; ISO 10555 - Sterile, Single-use Intravascular Catheters; and ISO 10993 - International Standard for 'Biological Evaluation of Medical Devices.'"

While specific quantitative acceptance criteria and their corresponding reported device performance values are not explicitly listed in a detailed table within this summary, the overall acceptance criterion was demonstrating substantial equivalence to predicate devices. The reported device performance, in this context, is that the device met this criterion.

2. Sample size used for the test set and the data provenance

• Sample size for the test set: Not explicitly stated. The document mentions "bench and animal performance testing" but does not provide details on the number of units tested or animals used.
• Data provenance: Not explicitly stated, but given it's a 510(k) submission to the FDA, it is expected to be from studies conducted by the manufacturer (IDEV Technologies, Inc.) or contracted labs. The studies appear to be prospective in nature, as they were conducted to support the 510(k) submission. No country of origin for the data is specified, but the submitter is a US-based company.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. This submission relies on engineering and animal testing, not human expert interpretation of data or images to establish ground truth.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set

Not applicable. This study does not involve human interpretation or adjudication of results to establish ground truth.

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

Not applicable. This is a medical device (stent and delivery system) submission, not an AI/software-as-a-medical-device (SaMD) submission. No MRMC study was conducted.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done

Not applicable. This is a physical medical device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

The ground truth for the performance testing was based on engineering measurements and observations from bench testing (e.g., mechanical properties, deployment characteristics, material integrity) and physiological and safety outcomes in animal models (e.g., biocompatibility, deployment success, patency).

8. The sample size for the training set

Not applicable. This is not a machine learning or AI device that requires a training set.

9. How the ground truth for the training set was established

Not applicable.

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