(23 days)
The intended use of the Prolong is for local anesthesia and analgesia via blockade of peripheral nerves.
Not Found
The provided document is a 510(k) clearance letter from the FDA for a medical device. It does not contain information about acceptance criteria, device performance, a study proving the device meets acceptance criteria, sample sizes, data provenance, ground truth establishment, or any details related to the evaluation of an AI/ML powered device.
This document is a standard regulatory communication confirming that the device, "ProLong Continuous Nerve Block Set", is substantially equivalent to a legally marketed predicate device and can therefore be marketed. It does not delve into the specific technical performance or clinical study results in the manner requested by your prompt.
Therefore, I cannot extract the requested information from this text.
§ 868.5830 Autotransfusion apparatus.
(a)
Identification. An autotransfusion apparatus is a device used to collect and reinfuse the blood lost by a patient due to surgery or trauma.(b)
Classification. Class II (performance standards).