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The intended use for the Worldwide Medical Technologies Intracervical Block Needle is to inject anesthetic in the cervical area.

Worldwide Medical Technologies Intracervical Block Needle

The provided text is a 510(k) clearance letter from the FDA for the "Worldwide Medical Technologies Intracervical Block Needle." This document primarily addresses regulatory approval based on substantial equivalence to a predicate device, rather than presenting a detailed study proving performance against specific acceptance criteria.

As such, none of the requested information (acceptance criteria, device performance, study details, sample sizes, expert qualifications, ground truth methods, MRMC studies, or standalone algorithm performance) is present in the provided document.

The document indicates that the device's substantial equivalence was determined based on its intended use "to inject anesthetic in the cervical area" and comparison to devices marketed before May 28, 1976. This regulatory pathway does not typically require the submission of clinical performance data in the same way that a novel device might.

Therefore, I cannot populate the requested table or answer the questions based on the given text.

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