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The Smithwick Carotid Shunt intended use is for a carotid endanterectomy procedure. The Doppler crystal built into the shunt provides for Audible verification of blood flow during carotid endarterestomy.

Smithwick Doppler and Non-Doppler Carotid Shunt

This document is a letter from the FDA regarding the 510(k) premarket notification for the "Smithwick Carotid Shunt," and it does not contain information about acceptance criteria or a study proving device performance.

Therefore, I cannot provide the requested information. The document focuses on regulatory approval and substantial equivalence to existing predicate devices, rather than detailed performance study results.

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This device is used during carotid endarterectomies as a temporary conduit, to allow for blood flow between the common and internal carotid arteries.

A tapered shunt used to divert blood flow from the common carotid artery to the internal carotid during carotid endarterectomy.

This document describes a 510(k) premarket notification for a medical device called the "Implantable Devices Shunt" (also referred to as "Smithwick Carotid Shunt") which is a carotid shunt used during carotid endarterectomy. The information provided is primarily a regulatory submission and does not contain details of a clinical study with acceptance criteria and device performance results in the format requested.

Therefore, I cannot directly provide the requested table or answer the specific questions about sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth establishment based on the provided text.

The document states:

• Conclusion: "The Implantable Devices Shunt is safe and effective for carotid endarterectomy."
• Substantial Equivalence: The device is deemed substantially equivalent to legally marketed predicate devices such as Sundt Shunt, Pruitt-Inhara Shunt, Smithwick Shunt, Javid Shunt, Vascuflo Shunt and Modified Carotid Shunt by Uresil Corp.

This indicates that the safety and effectiveness of the device were established by demonstrating equivalence to existing devices rather than a de novo clinical study with explicit acceptance criteria for a novel performance metric.

To answer your questions accurately, a different type of document, such as a clinical study report or a more detailed technical report, would be necessary.

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The Carotid Shunt is intended to be used in carotid endarterectomy as a temporary conduit to allow for blood flow between the common and internal carotid arteries.

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This document is a 510(k) clearance letter from the FDA for the Smithwick Carotid Shunt. It primarily focuses on the regulatory approval process and states that the device is substantially equivalent to legally marketed predicate devices.

Crucially, this document does not contain information about acceptance criteria, device performance studies, sample sizes, expert qualifications, or ground truth establishment.

Therefore, I cannot extract the requested information from the provided text. The letter only confirms that the device can be legally marketed following FDA review, but it does not detail the specific data or studies that led to that determination.

Ask a specific question about this device