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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 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 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 which deploys 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 120cm.

The SUPERA® stent housed within the 120cm 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.

Here's a breakdown of the acceptance criteria and the study information for the SUPERA VERITAS® Interwoven Self-Expanding Nitinol Stent Transhepatic Biliary System, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document mentions "Verification Bench-top Testing" and that this testing ensured the device met product specifications. However, specific sample sizes for each test are not provided in the document. The data provenance is from bench-top testing, not clinical data, and is therefore neither retrospective nor prospective in the typical clinical sense.

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

This information is not provided in the document. The testing described is physical, bench-top testing of the device's mechanical properties, not an evaluation requiring expert interpretation of diagnostic output.

4. Adjudication Method for the Test Set

This information is not applicable or not provided as the testing is bench-top performance verification, not an evaluation that typically involves adjudication of results by multiple human observers.

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 MRMC study was performed or is mentioned. This device is a medical stent, not an AI diagnostic tool. Therefore, the concept of human readers improving with or without AI assistance is not relevant to this submission.

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

No standalone algorithm performance study was done. This device is a physical medical device (stent delivery system), not a software algorithm.

7. The Type of Ground Truth Used

The ground truth for the performance testing ("Verification Bench-top Testing") was product specifications and requirements. Each test (e.g., Bond Tensile Strength, Dimensional Characterization) would have had a predefined acceptable range or threshold set by the manufacturer against which the device's performance was measured.

8. The Sample Size for the Training Set

Not applicable. This device is a physical stent and delivery system, not an AI model requiring a training set.

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

Not applicable. As the device is not an AI model, there is no training set or ground truth in that context.

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The S.M.A.R.T. ® Nitinol Stent Transhepatic Biliary System is intended for use in the palliation of malignant neoplasms in the biliary tree.
The S.M.A.R.T. " Nitinol Stent Transhepatic Biliary System is intended for palliation of malignant strictures in the biliary tree.

6 French stent delivery system profile; . Stent material - Nickel Titanium alloy and tantalum . micromarkers; Expanded stent diameters: 6, 7 and 8 mm; . Stent lengths: 120 and 150 mm; . Stent delivery system usable length: 120 cm; and . Guidewire lumen 0.035" ● The S.M.A.R.T. ® Nitinol Stent Transhepatic Biliary System is provided sterile (via Ethylene Oxide sterilization) and is intended for single use only.

The provided text describes a 510(k) premarket notification for a medical device, the S.M.A.R.T. Nitinol Stent Transhepatic Biliary System. This documentation is for demonstrating substantial equivalence to predicate devices, not for proving specific performance criteria through a study with acceptance criteria in the manner one might find for a novel device or software. Therefore, the information typically requested in your prompt (e.g., acceptance criteria table, sample sizes for test/training sets, ground truth establishment, expert qualifications, MRMC studies) is not present in the provided text, as it doesn't describe such a study.

The primary "proof" in this context is the demonstration of substantial equivalence to existing legally marketed predicate devices, supported by non-clinical in-vitro bench testing and animal testing.

Here's an analysis based on the information available in the provided text:

1. A table of acceptance criteria and the reported device performance:

This information is not provided in the given text. The 510(k) summary focuses on demonstrating substantial equivalence to predicate devices rather than establishing novel performance acceptance criteria for a new device type.

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

• Sample Size for Test Set: Not applicable/Not provided. The text does not describe a clinical "test set" for performance evaluation in the way a diagnostic AI device would. It mentions "non-clinical in-vitro bench testing and animal testing (stent placement in a biliary duct)" but does not specify sample sizes for these tests.
• Data Provenance: The testing mentioned (in-vitro bench testing and animal testing) would typically be conducted by the manufacturer (Cordis Corporation). The text does not specify country of origin for the data or whether it was retrospective or prospective.

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

Not applicable/Not provided. Since there's no mention of a clinical test set requiring ground truth established by human experts, this information is absent. Animal testing (stent placement in a biliary duct) would likely be evaluated by veterinary or medical professionals, but their number and specific qualifications are not detailed.

4. Adjudication method for the test set:

Not applicable/Not provided. No clinical test set requiring adjudication is described.

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/Not provided. This is a medical device (stent), not an AI/software device designed to assist human readers. Therefore, an MRMC study related to AI assistance is irrelevant and not mentioned.

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

Not applicable/Not provided. This is a physical medical device (stent), not an algorithm or software. "Standalone performance" in this context refers to the device's functional integrity as a physical implant, which is assessed through bench and animal testing.

7. The type of ground truth used:

• For the non-clinical in-vitro bench testing, the "ground truth" would be engineering specifications and measurements (e.g., stent diameter, length, expansion force, material properties) compared against design requirements.
• For the animal testing (stent placement in a biliary duct), the "ground truth" would likely involve direct observation, imaging, and potentially histopathological analysis of the animal tissue to assess stent patency, migration, and tissue reaction.
• No explicit mention of "expert consensus," "pathology," or "outcomes data" in the typical AI/diagnostic study sense.

8. The sample size for the training set:

Not applicable/Not provided. The device is a physical stent, not a machine learning algorithm. There is no concept of a "training set" in this submission.

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

Not applicable/Not provided. As there is no training set, this information is not relevant.

Summary of Device and Approval Process based on Provided Text:

• Device Name: S.M.A.R.T.® Nitinol Stent Transhepatic Biliary System
• Intended Use: Palliation of malignant neoplasms (strictures) in the biliary tree.
• Regulatory Pathway: 510(k) Premarket Notification.
• Mechanism of Proof: Substantial Equivalence to predicate devices (Cordis S.M.A.R.T.® CONTROL™ Nitinol Stent Transhepatic Biliary System, Cordis S.M.A.R.T.® Nitinol Stent Transhepatic Biliary System, Cordis PRECISE™ Nitinol Stent Transhepatic Biliary System, ev3 Protégé EverFlex Self-Expanding Nitinol Stent).
• Supporting Data for Substantial Equivalence: Non-clinical in-vitro bench testing and animal testing (stent placement in a biliary duct).
• FDA Conditions: The FDA required specific labeling limitations: "The safety and effectiveness of this device for use in the vascular system have not been established" and the biliary use indication must be prominently displayed.

The provided document is a regulatory approval document for a physical medical device (stent) via the 510(k) pathway, which focuses on demonstrating substantial equivalence, not on studies proving acceptance criteria for a diagnostic/AI device. Therefore, most of your requested information is not relevant or present in this context.

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