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Found 3 results
510(k) Data Aggregation
(233 days)
WALLSTENT RP ENDOPROSTHESIS TRACHEOBRONCHIAL, WALLSTENT ENDOPROSTHESIS TRACHEOBRONCHIAL
The WALLSTENT™ RP Endoprosthesis and WALLSTENT™ Endoprosthesis Tracheobronchial are indicated for use in the treatment of tracheobronchial strictures produced by malignant neoplasms.
The WALLSTENT RP Endoprosthesis Tracheobronchial and WALLSTENT Endoprosthesis Tracheobronchial are comprised of two components: The implantable metallic stent and the UNISTEP Plus delivery system. The stent is composed of biomedical superalloy wire, braided in a tubular mesh configuration. This design configuration results in a stent that is flexible, compliant, and self-expanding. The delivery system consists in part of coaxial tubes. The exterior tube serves to constrain the stent until retracted during delivery. Radiopaque marker bands situated on the interior and exterior tubes aid in imaging during deployment. Small stent sizes (5mm-12mm) may have a radiopaque core to improve radiopacity. The interior tube of the coaxial system contains a central lumen that accommodates a 0.035 in (0.89mm) guidewire.
This document describes the regulatory clearance for the WALLSTENT™ RP Endoprosthesis Tracheobronchial and WALLSTENT™ Endoprosthesis Tracheobronchial. This is a medical device, specifically a self-expanding stent used to treat tracheobronchial strictures caused by malignant neoplasms.
The submission is a 510(k) premarket notification, which means the manufacturer is demonstrating that the device is substantially equivalent to a legally marketed predicate device. Therefore, the "study" described is primarily focused on demonstrating this substantial equivalence, particularly regarding MRI compatibility, rather than a clinical study evaluating the device's efficacy against clinical acceptance criteria in a human population.
Given the nature of the document (a 510(k) summary), many of the requested details about acceptance criteria for device performance, ground truth establishment, expert adjudication, multi-reader multi-case studies, and training set information are not directly applicable or available. The study in question is a non-clinical bench test study for MR compatibility.
Here's a breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not present specific quantitative acceptance criteria for clinical performance (e.g., success rates, complication rates) or an AI model's performance. Instead, it focuses on demonstrating substantial equivalence to a predicate device and safety, particularly regarding MR compatibility.
| Acceptance Criteria (General Principle for 510(k)) | Reported Device Performance (Summary of Non-Clinical Test) |
|---|---|
| Substantial Equivalence to Predicate Device (WALLSTENT™ Tracheobronchial Endoprosthesis K992510) | "The proposed WALLSTENT RP Endoprosthesis Tracheobronchial and WALLSTENT Endoprosthesis Tracheobronchial is substantially equivalent to the existing Wallstent Endoprosthesis Tracheobronchial cleared by FDA under premarket notification K992510 (November 18, 1999). WALLSTENT RP Endoprosthesis Tracheobronchial and WALLSTENT Endoprosthesis Tracheobronchial has the same intended use, scientific technology, design, sterilization method, and packaging as the applicable predicate device. The only difference is to the MR Safety labeling information within the Directions for Use." |
| Safety and Compatibility in the Magnetic Resonance (MR) Environment | "Bench testing in accordance with FDA guidance document Establishing Safety and Compatibility of Passive Implants in the Magnetic Resonance (MR) Environment, dated December 11, 2014) to support labeling as MR Conditional. The results of these tests provide reasonable assurance that the proposed device has been designed and tested to assure conformance to the requirements for its intended use. No new safety or performance issues were raised during the device testing." |
2. Sample Size Used for the Test Set and Data Provenance
The document describes non-clinical bench testing. Therefore, the concept of a "test set" in the context of patient data or clinical images does not apply. The "sample size" would refer to the number of physical devices or components tested in the lab. This specific number is not explicitly stated in the provided text, but the testing was for MR compatibility. The data provenance is from bench testing conducted by Boston Scientific Corporation.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
Not applicable. The study is non-clinical bench testing for MR compatibility, not a study involving medical images needing expert interpretation.
4. Adjudication Method for the Test Set
Not applicable. This was a non-clinical bench test, not a study involving human interpretation or adjudication of medical data.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
No. This document describes a 510(k) submission for a physical medical device, not an AI or imaging software. The study performed was non-clinical bench testing for MR compatibility.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This is not an AI or algorithm-based device.
7. The Type of Ground Truth Used
For the MR compatibility testing, the "ground truth" would be established by physical measurements and adherence to the FDA guidance document "Establishing Safety and Compatibility of Passive Implants in the Magnetic Resonance (MR) Environment." This involves objective physical testing for parameters such as magnetically induced displacement force, torque, and heating, and assessment of image artifact.
8. The Sample Size for the Training Set
Not applicable. This is not an AI or algorithm-based device, so there is no "training set."
9. How the Ground Truth for the Training Set was Established
Not applicable. There is no training set for this type of device submission.
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(52 days)
WALLSTENT RP Endoprosthesis Transhepatic Biliary, WALLSTENT Endoprosthesis Transhepatic Biliary
The WALLSTENT RP Endoprosthesis Transhepatic Biliary and WALLSTENT Endoprosthesis Transhepatic Biliary are indicated for use in the treatment of biliary strictures produced by malignant neoplasms.
The WALLSTENTTM RP Endoprosthesis Transhepatic Biliary and WALLSTENTTM Endoprosthesis Transhepatic Biliary are comprised of two components: The implantable metallic stent and the Unistep Plus delivery system. The stent is composed of biomedical superalloy wire, braided in a tubular mesh configuration. This design configuration results in a stent that is flexible, compliant, and self-expanding. The delivery system consists in part of coaxial tubes. The exterior tube serves to constrain the stent until retracted during delivery. Radiopaque marker bands situated on the interior and exterior tubes aid in imaging during deployment. Small stent sizes (8 & 10mm) may have a radiopaque core to improve radiopacity. The interior tube of the coaxial system contains a central lumen that accommodates a 0.035in (0.89mm) guidewire.
This document does not contain information about an AI/ML medical device, but rather a medical device called the WALLSTENT RP Endoprosthesis Transhepatic Biliary and WALLSTENT Endoprosthesis Transhepatic Biliary, which is a self-expanding metallic stent used to treat biliary strictures produced by malignant neoplasms.
Therefore, I cannot answer the questions regarding acceptance criteria and the study that proves an AI/ML device meets the acceptance criteria, as the provided text does not describe such a device or study.
The document indicates that the device undergoes bench testing to support MR Conditional labeling, and this testing provides assurance of conformance to requirements for its intended use. However, these are not the types of studies typically conducted for AI/ML devices proving clinical performance with metrics like sensitivity, specificity, or reader improvement.
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(29 days)
WALLSTENT ENDOPROSTHESIS
The WALLSTENT® Tracheobronchial Endoprosthesis is indicated for use in the treatment of tracheobronchial strictures produced by malignant neoplasms.
The WALLSTENT® Tracheobronchial Endoprosthesis is a self-expanding prosthesis constructed of braided wire of biomedical superalloy, in some cases partially covered by a polymeric covering. Some models include a radiopaque core. The stent's purpose is to maintain or increase the luminal diameter of the passage in which it is implanted. The stent is placed by means of a delivery system, which is a coaxial tubing assembly that constrains the prosthesis until it is released in a controlled manner by retraction of the outer tube.
This document is a 510(k) premarket notification correction letter for multiple Boston Scientific WALLSTENT® Endoprosthesis devices. It does not contain information about acceptance criteria or a study demonstrating the device meets such criteria because it's focused on establishing substantial equivalence to previously cleared devices and adding an MRI safety claim.
Therefore, the requested information cannot be extracted from the provided text. The document's purpose is regulatory clearance based on substantial equivalence, not performance evaluation against specific acceptance criteria.
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