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The 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 0.014" or 0.018" guidewire compatible, multi-lumen sheath based delivery system and a SUPERA® Biliary Stent. The stent delivery catheter includes a radiopaque Stent Length Marker and Distal Sheath Marker embedded in the Outer Sheath to aid in proper stent positioning; a Thumb 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 (ratchet) which moves the stent distally relative to the Outer Sheath; and the System Lock which eliminates the possibility of premature deployment. The working length of the delivery catheter is 80cm and 120cm. The SUPERA® Stent is housed within the SUPERA VERITAS® stent delivery catheter and 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.

Here's an analysis of the acceptance criteria and the study proving the device meets them, based on the provided text:

Important Note: The provided document is a 510(k) summary for a medical device (SUPERA VERITAS® Interwoven Self-Expanding Nitinol Stent Transhepatic Biliary System). This type of submission focuses on demonstrating substantial equivalence to a predicate device, primarily through bench testing, and usually does not involve clinical studies with human patients or "AI" in the context of diagnostic algorithms. Therefore, many of the questions related to AI performance metrics (e.g., human reader improvement with AI assistance, MRMC studies, training set details, ground truth for training) are not applicable to this specific type of device and submission.

Acceptance Criteria and Device Performance Study (SUPERA VERITAS® Interwoven Self-Expanding Nitinol Stent Transhepatic Biliary System)

1. Table of Acceptance Criteria and Reported Device Performance

The submission does not explicitly list quantitative "acceptance criteria" in the typical sense of performance metrics (e.g., sensitivity, specificity for a diagnostic device). Instead, the acceptance is based on demonstrating substantial equivalence to a predicate device through a series of engineering and material characterization tests. The primary acceptance criterion is that the new device performs comparably to the predicate and does not introduce new safety concerns.

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

• Sample Size: Not applicable in the context of a clinical "test set" for performance evaluation like diagnostic devices. The "test set" here would refer to the number of stents/delivery systems tested in various engineering studies. The document does not specify the exact number of units tested for each engineering study, but such tests typically involve a statistically relevant number of units to ensure reliability.
• Data Provenance: The studies were bench performance testing and engineering studies, not studies on human patients. The data is thus internally generated by the manufacturer (IDEV Technologies, Inc.) through laboratory experiments. No country of origin for patient data is relevant. The studies are by nature prospective in their design (i.e., experiments were designed and executed to test specific parameters).

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

Not applicable. "Ground truth" in this context would refer to the characteristics being measured (e.g., material composition, mechanical properties). These are established by standardized physical/chemical testing methods, not by expert interpretation.

4. Adjudication Method for the Test Set

Not applicable. There's no interpretive "ground truth" requiring adjudication by experts. The results are quantitative measurements from engineering tests.

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

No. This device is a physical medical implant (stent) and its delivery system, not a diagnostic imaging device, AI software, or a device that assists human readers. Therefore, MRMC studies and AI assistance metrics are not relevant or performed.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done

No. This is a physical medical device, not an algorithm.

7. The Type of Ground Truth Used

The "ground truth" in this context is based on engineering and material standards and specifications. This includes:

• Chemical analysis standards (e.g., ASTM A967-05)
• Mechanical property test standards (e.g., ASTM F2516-07e2, ASTM E739-91, ASTM F2129-08, ASTM F2063-05, ASTM E1447-09, ASTM E1409-08)
• Nickel ion release testing standards.
• The established design and performance characteristics of the legally marketed predicate device (SUPERA VERITAS® Interwoven Self-Expanding Nitinol Stent Transhepatic Biliary System, K122546).

8. The Sample Size for the Training Set

Not applicable. There is no training set as this is not an AI/machine learning device.

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

Not applicable.

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