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The SiteSeal SV is a compression device to assist hemostasis of the radial artery after a transradial procedure or the brachial artery after a transbrachial procedure.

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I am sorry, but the provided text from the FDA letter is a notification of substantial equivalence for a physical medical device (SiteSeal SV, a vascular clamp), not an AI/ML software device.

Therefore, the document does not contain any information about:

• Acceptance criteria for software performance
• Any study proving a device meets acceptance criteria via AI/ML methods
• Sample sizes for test or training sets
• Data provenance
• Number or qualifications of experts for ground truth
• Adjudication methods
• MRMC studies or human reader improvement with AI
• Standalone algorithm performance
• Types of ground truth used for AI models
• How ground truth was established for training data

Thus, I cannot fulfill your request as the necessary information regarding AI/ML device performance and testing is not present in the provided text.

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The SiteSeal SV is a compression device to assist hemostasis of the radial artery after a transradial procedure.

The SiteSeal SV is a compression device to assist hemostasis of the radial artery after a transradial procedure.

The provided document is a 510(k) clearance letter from the FDA for a device called "Site Seal SV," which is a compression device to assist hemostasis of the radial artery after a transradial procedure.

This document does not contain information about acceptance criteria, device performance, study details (sample size, data provenance, ground truth, experts, adjudication, MRMC, standalone performance), or training set information. It is purely an FDA clearance letter confirming substantial equivalence to a predicate device and outlining regulatory guidelines.

Therefore, I cannot fulfill the request as the necessary information is not present in the provided text.

Ask a specific question about this device