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This document is a 510(k) clearance letter from the FDA for a medical device called the "Prolong Continuous Nerve Block Set." It indicates that the device has been determined to be substantially equivalent to legally marketed predicate devices.
However, this document does not contain any information about acceptance criteria, device performance, study designs, sample sizes, expert qualifications, ground truth establishment, or any other details related to a scientific study proving the device meets acceptance criteria.
The letter is a regulatory document confirming clearance, not a scientific publication detailing a study. Therefore, I cannot extract the requested information from the provided text.
§ 868.5140 Anesthesia conduction kit.
(a)
Identification. An anesthesia conduction kit is a device used to administer to a patient conduction, regional, or local anesthesia. The device may contain syringes, needles, and drugs.(b)
Classification. Class II (performance standards).