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The provided document is a 510(k) "Substantially Equivalent" letter from the FDA regarding a "Whatman Body Fluid Collection Paper" (Whatman BFC 180). This document does not contain the information requested about acceptance criteria and device performance studies (e.g., sample size, expert qualifications, study methodologies, effect sizes for AI assistance).

The letter primarily focuses on:

• Confirming that the device is substantially equivalent to legally marketed predicate devices.
• Outlining the general controls and regulatory requirements (e.g., registration, labeling, medical device reporting, good manufacturing practice) that the manufacturer must comply with.
• Providing contact information for regulatory guidance.

Therefore, I cannot extract the detailed information about acceptance criteria and study particulars from this document.

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