(281 days)
The Macosta Medical B-Smart Nerve Block Injection Pressure Manometer is a device for measuring injection pressure during administration of peripheral nerve blocks.
Not Found
This document is a 510(k) clearance letter from the FDA for a medical device called the "B-Smart Nerve Block Injection Pressure Manometer." It confirms that the device is substantially equivalent to legally marketed predicate devices.
However, the provided document does not contain the information requested about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert involvement. These details are typically found in the 510(k) summary or other supporting documentation submitted to the FDA, not in the clearance letter itself.
Therefore, I cannot provide the requested information based on the text provided.
§ 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).