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The Vascular Architects aSpire® Covered Stent and 718™ Delivery System are indicated for use in the treatment of tracheobronhial strictures produced by malignant neoplasms.

The Vascular Architects aSpire® Covered Stent is a spiral stent made from Nickel Titanium covered with a thin layer of Silicone. Stainless Steel rings are located at the proximal and distal ends completely encapsulating the Nickel Titanium. The 718TM Delivery Catheter is designed to allow the user to expand the stent within the stricture and confirm positioning prior to release.

The provided text describes the regulatory clearance of a medical device, the Vascular Architects aSpire® Covered Stent and 718™ Delivery System, through a 510(k) premarket notification. It does not contain information about acceptance criteria, a specific study proving the device meets those criteria, or the detailed aspects of a clinical study that would typically involve human subjects or complex performance metrics.

Instead, the document focuses on demonstrating substantial equivalence to existing predicate devices. This means that the FDA determined the new device is as safe and effective as a legally marketed device that does not require premarket approval (PMA).

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

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not explicitly state acceptance criteria in a quantitative or qualitative manner for specific performance metrics in relation to clinical outcomes. The "performance" assessment is based on demonstrating mechanical integrity and device performance through bench testing, which is considered "substantially equivalent" to the predicate device.

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

• Test Set Sample Size: Not applicable. The document describes "bench testing," not a clinical test set with human subjects. The sample size for the bench tests (e.g., number of stents tested for mechanical integrity) is not specified.
• Data Provenance: The testing appears to be internal "bench testing" conducted by the manufacturer, Wallace Enterprises, Inc. DBA Vascular Architects. No information about country of origin of data or retrospective/prospective nature is provided, as it's not a clinical study.

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

Not applicable. For bench testing, ground truth is typically established by engineering specifications and industry standards, not expert clinical consensus.

4. Adjudication Method for the Test Set:

Not applicable. This concept applies to clinical studies where interpretation of results (e.g., imaging, clinical outcomes) requires expert review and potential tie-breaking, which is not described for bench testing.

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. An MRMC study is relevant for AI-powered diagnostic devices involving human interpretation. This document is about a covered stent and delivery system, a physical medical device, not an AI product.

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

Not applicable, as this is not an AI algorithm.

7. The Type of Ground Truth Used:

For the bench testing, the "ground truth" would be established by:

• Engineering Specifications: Designed parameters and expected performance characteristics of the device.
• Predicate Device Performance: The established mechanical and functional performance of the legally marketed predicate devices serves as the benchmark against which the new device's performance is compared for substantial equivalence.
• Standardized Test Methods: Adherence to recognized testing standards for medical devices (though specific standards aren't listed, they are implied).

8. The Sample Size for the Training Set:

Not applicable. No training set is mentioned as this is not an AI/machine learning device.

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

Not applicable.

Summary of the Study that Proves the Device Meets Acceptance Criteria:

The "study" described is bench testing (simulated use and performance testing). The document states:
"Simulated use and performance testing was conducted on the Vascular Architects aSpire® Covered Stent and 718™ Delivery System. Results of the bench testing performed demonstrate the mechanical integrity and device performance of the subject device is substantially equivalent to that of the predicate device."

This bench testing aimed to demonstrate that the new device's mechanical integrity and overall performance were comparable to those of the predicate devices. The "acceptance criterion" was effectively substantial equivalence to the predicate device in terms of these performance aspects. The specific details of these bench tests (e.g., what parameters were measured, specific numerical results, the exact quantity of devices tested) are not provided in this 510(k) summary.

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The Vascular Architects aSpire® Covered Stent and Controlled Expansion® Delivery System are indicated for use in the treatment of tracheobronhial strictures produced by malignant neoplasms.

The Vascular Architects aSpire® Covered Stent is a spiral stent made from Nickel Titanium and fully covered with ePTFE sleeve. The ePTFE is sealed at the proximal and distal ends completely encapsulating the Nickel Titanium. The Controlled Expansion® Delivery Catheter is designed to allow the user to expand the stent within the stricture and confirm positioning prior to release.

This document is a 510(k) summary for a medical device (a stent) and does not describe an AI/ML powered device or a study involving such a device. Therefore, it is not possible to extract the requested information about acceptance criteria and a study proving device conformance using AI/ML specific metrics.

The document focuses on demonstrating substantial equivalence of a new stent length to a previously cleared predicate device, based on materials, mode of action, and intended use. The "Testing Summary" section mentions simulated use and performance testing to demonstrate mechanical integrity and device performance, but this is traditional bench testing, not an AI/ML study.

Therefore, I cannot provide the requested information.

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The Vascular Architects aSpire® Covered Stent and Controlled Expansion® Delivery System are indicated for use in the treatment of tracheobronhial strictures produced by malignant neoplasms.

The Vascular Architects aSpire® Covered Stent and Controlled Expansion® Delivery I he vasound firemted the luminal diameter within tracheobronhial strictures produced by malignant neoplasms.

The provided document {0}-{4} is a 510(k) premarket notification for a medical device called the "Vascular Architects aSpire® Covered Stent and Controlled Expansion® Delivery System." This document primarily focuses on establishing substantial equivalence to a predicate device and does not contain information about clinical study results, acceptance criteria for device performance, or details about ground truth establishment.

Therefore, I cannot provide the requested information. The document only states:

• Testing Summary: "Simulated use and performance testing was conducted on the Vascular Architects aSpire® Covered Stent and Controlled Expansion® Delivery System. Results of the bench testing performed demonstrate the mechanical integrity and device performance of the subject device are substantially equivalent to that of the predicate device."

This statement confirms that testing was done to show equivalence, but it does not specify the acceptance criteria used for that testing, the actual performance metrics, or any details about a study involving human subjects or AI.

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Ask a specific question about this device

Ask a specific question about this device