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The FAVP: Femoral Artery Vascular Pad is used to provide pressure hemostasis following femoral catheterization procedures.

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The provided document is a 510(k) premarket notification letter from the FDA for a medical device called the "Femoral Artery Vascular Pad". This type of document is a regulatory approval for a physical medical device, not a software AI/ML device.

Therefore, the requested information about acceptance criteria, study details, ground truth, and AI/ML specific details (like multi-reader multi-case studies, standalone performance, training sets, etc.) is not applicable to this document.

The document primarily states that the device is substantially equivalent to legally marketed predicate devices for providing pressure hemostasis after femoral catheterization procedures. It does not contain any performance data, clinical study details, or acceptance criteria in the format typically used for AI/ML device evaluations.

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The FAVC-HH: Femoral Artery Vascular Clamp-Hand Held is used to provide pressure hemostasis after the removal of arterial catheters following femoral catherterization procedures. The FAVC-HH: Femoral Artery Vascular Clamp-Hand Held is positioned prior to removal of femoral catheters and applies controlled pressure to the puncture site until hemostasis is complete.

FAVC-HH: Femoral Artery Vascular Clamp-Hand Held

The provided document is a 510(k) clearance letter from the FDA for a medical device called the "Femoral Artery Vascular Clamp-Hand Held (FAVC-HH)". This document focuses on regulatory approval and does not contain information about acceptance criteria, device performance studies, or clinical trial data as requested in your prompt.

Therefore, I cannot provide the requested information based on the given input. The document confirms that the device is substantially equivalent to previously marketed devices and outlines regulatory requirements, but it does not detail the scientific studies or performance metrics for the FAVC-HH.

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Femoral Artery Vascular Clamp-Mobile is used to provide pressure hemostasis after the removal of arterial catheters following femoral catheterization procedures. The FAVC-M: Femoral Artery Vascular Clamp-Mobile is positioned prior to removal of femoral catheters and apply controlled pressure to the puncture site until hemostasis is complete.

FAVC-M: Femoral Artery Vascular Clamp-Mobile

This document is a 510(k) clearance letter from the FDA for a medical device called "FAVC-M: Femoral Artery Vascular Clamp-Mobile". It is a regulatory approval document and does not contain information about the acceptance criteria or a study proving the device meets those criteria.

Therefore, I cannot provide the requested information.

Ask a specific question about this device

Ask a specific question about this device