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The Schneider WALLSTENT® Biliary Endoprosthesis is indicated for use in the treatment of biliary strictures produced by malignant neoplasms.

The WALLSTENT® Biliary Endoprosthesis is a self-expanding prosthesis constructed of biomedical superalloy and an elastomeric polymer. The prosthesis is a braided wire structure. The outward radial force along with the ends of the device serve to stabilize the prosthesis after implanted. The stent's purpose is to increase or maintain the inner lumen diameter of the biliary duct.

The stent is placed by means of a delivery system. The delivery system is a coaxial tubing assembly that constrains the prosthesis until it is released in a controlled manner. The release of the stent is accomplished by retracting the outer sheath. The prosthesis is packaged constrained on the delivery system ready for placement. The system is sterile and intended for single use only.

This document is a 510(k) summary for a medical device called the WALLSTENT® Biliary Transhepatic Endoprosthesis with Unistep™ Plus Delivery System. It describes the device, its intended use, and argues for its substantial equivalence to previously marketed devices.

However, the provided text does not contain the information requested in the prompt regarding acceptance criteria and a study proving the device meets those criteria.

Specifically, the following information is missing or not applicable based on the provided text:

• A table of acceptance criteria and the reported device performance: This document only describes the device and its proposed modifications, but does not present specific performance metrics or acceptance criteria for those metrics.
• Sample size used for the test set and the data provenance: No information about a "test set" or its sample size is provided. The document mentions "in vitro and in vivo deployment testing" but gives no details about the size or nature of these tests.
• Number of experts used to establish the ground truth... and qualifications: Not applicable, as there's no mention of a ground truth being established by experts for performance evaluation.
• Adjudication method: Not applicable.
• If a multi reader multi case (MRMC) comparative effectiveness study was done: Not indicated. The document focuses on regulatory approval based on substantial equivalence, not comparative effectiveness.
• If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable, as this is a physical medical device, not an AI algorithm.
• The type of ground truth used: Not applicable, as no performance study with ground truth is detailed.
• The sample size for the training set: Not applicable, as this is not an AI/machine learning device that would require a "training set."
• How the ground truth for the training set was established: Not applicable.

Summary of what is present:

The document describes a modified delivery system for an existing WALLSTENT® Biliary Endoprosthesis. The claim for substantial equivalence is based on:

• In vitro and in vivo deployment testing: These tests were performed to demonstrate that "deployment forces and handling characteristics are comparable to the current delivery systems." No specific results, sample sizes, or acceptance criteria for these tests are provided in this summary.
• Comparison to predicate devices: The modified system is compared to existing WALLSTENT® models (K923993, K961262, K964119) and the WALLSTENT® Tracheobronchial Endoprosthesis (K980163) for material changes.

In conclusion, the provided text serves as a regulatory submission (510(k) Summary) and focuses on demonstrating substantial equivalence to predicate devices, rather than detailing a study against specific acceptance criteria for performance.

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The WALLSTENT® Biliary Endoprosthesis is intended for use in the treatment of biliary strictures produced by malignant neoplasms.

The WALLSTENT® Biliary Endoprosthesis is a self-expanding prosthesis constructed of biomedical superalloy and an elastomeric polymer. The prosthesis is a braided wire structure. The outward radial force along with the ends of the device serve to stabilize the prosthesis after implanted. The stent's purpose is to increase or maintain the inner lumenal diameter of the biliary duct. The stent is placed by means of a delivery system. The delivery system is a coaxial tubing assembly which constrains the prosthesis until it is released in a controlled manner. The release of the stent is accomplished by retracting the outer sheath. The prosthesis is packaged constrained on the delivery system ready for placement. The system is sterile and intended for single use only.

The provided text is a 510(k) summary for a medical device (WALLSTENT® Biliary Endoprosthesis). It focuses on the substantial equivalence of an alternate delivery system for the stent, rather than the performance of the stent itself or an AI-powered device.

Therefore, most of the requested information regarding acceptance criteria, device performance, sample sizes, expert ground truth, MRMC studies, or standalone algorithm performance for an AI device is not applicable and cannot be extracted from this document.

However, I can provide information relevant to the substantial equivalence claim for the alternate delivery system based on the provided text.

Here's a breakdown of the applicable information:

1. A table of acceptance criteria and the reported device performance (for the alternate delivery system):

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

• Sample Size: Not explicitly stated. The text mentions "in vitro and in vivo deployment testing," but does not provide the number of tests, devices, or subjects used.
• Data Provenance: The studies were internal testing ("in vitro and in vivo deployment testing") conducted by Schneider (USA) Inc. The location and specific nature of "in vivo" testing (e.g., animal studies) are not detailed. It is a retrospective analysis of this testing data for the 510(k) submission.

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

• Not applicable. This evaluation is based on engineering and performance testing of a physical device and its delivery system, not on medical image interpretation or diagnostics requiring expert consensus on ground truth.

4. Adjudication method for the test set:

• Not applicable. As above, this is not a study requiring human adjudication for ground truth. The evaluation likely involved objective measurements and observations by engineers/testers.

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 not an AI device or an MRMC study.

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

• Not applicable. This is not an AI device.

7. The type of ground truth used:

• The "ground truth" in this context refers to the measured performance characteristics (deployment forces, handling, ability to reconstrain) of the existing, predicate delivery system, which the alternate system aims to match.

8. The sample size for the training set:

• Not applicable. There is no AI model being trained discussed in this document.

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

• Not applicable. No AI model training or associated ground truth establishment is mentioned.

In summary, the document addresses the substantial equivalence of a medical device's delivery system through in vitro and in vivo testing, focusing on comparable performance characteristics rather than clinical outcomes or AI diagnostic accuracy.

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for treatment of biliary strictures produced by malignant neoplasms.

The WALLSTENT® Biliary Endoprosthesis is a self-expanding prosthesis constructed of biomedical superalloy with a radiopaque core. The prosthesis is a braided wire structure allows for self expansion. Thi; premarket notification deals with the modification of the 12 mm diameter prosthesis to increase the radial force.

The delivery system is a coaxial tubing assembly which constrains the prosthesis until it is released in a controlled manner. The release of the prosthesis is accomplished by pulling the outer tube back, thus exposing the stent and allowing gradual release and expansion of the prosthesis. The prosthesis : packaged constrained on the delivery system ready for placement. The system is steri e and intended for single use only. The fully expanded stents are offered in sizes from 1 to 12 mm.

This appears to be a 510(k) summary for a medical device (WALLSTENT® Biliary Endoprosthesis), specifically a modification to an existing device. The provided text does not contain the kind of information requested in your prompt regarding acceptance criteria, study details, ground truth, or sample sizes related to AI/algorithm performance.

The document describes:

• Device: A self-expanding biliary stent.
• Modification: Increased radial force for the 12mm diameter prosthesis by increasing wire diameter and number of wires.
• Intended Use: Treatment of biliary strictures produced by malignant neoplasms.
• Basis for Substantial Equivalence: Comparison to a predicate device based on design, materials, fabrication methods, indications for use, and mechanical testing (axial fatigue and relative radial force testing).

The prompt's questions are geared towards the validation of an AI/algorithm (e.g., acceptance criteria for diagnostic accuracy, sample sizes for test sets, ground truth establishment, MRMC studies, standalone performance). This 510(k) summary is for a physical medical device and its mechanical performance, not an AI or algorithmic diagnosis/detection system.

Therefore, I cannot provide the requested information from the given text. The text does not discuss:

1. Acceptance criteria and reported device performance (for AI): No AI performance metrics.
2. Sample size for test set and data provenance: No test set data.
3. Number of experts for ground truth and qualifications: No expert review for ground truth.
4. Adjudication method: Not applicable.
5. Multi-reader multi-case (MRMC) comparative effectiveness study: Not mentioned.
6. Standalone (algorithm only) performance: No algorithm discussed.
7. Type of ground truth used: Not applicable in the context of AI.
8. Sample size for training set: No training set mentioned.
9. How ground truth for training set was established: No training set or ground truth mentioned.

The "study" mentioned in the document refers to engineering tests like "axial fatigue and relative radial force testing" on the physical stent, not a clinical or AI performance study.

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