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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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