(118 days)
The Continuous Stimulating Catheter News Block Set permits placement of catherers next to nerves and nerve plexus for continuous stimulating and analgesia techniques. It is indicated for use up to 72 hours.
ContiStim Continuous Stimulating Catheter Nerve Block Set
The provided document is a 510(k) clearance letter from the FDA for a device called "ContiStim Continuous Stimulating Catheter Nerve Block Set." It indicates that the device has been found substantially equivalent to legally marketed predicate devices.
However, this document does not contain information about acceptance criteria or a study proving the device meets acceptance criteria. It is a regulatory approval document confirming substantial equivalence, not a summary of performance testing or clinical trial results.
Therefore, I cannot provide the requested information from this document. The sections you asked for, such as "Table of acceptance criteria and reported device performance," "Sample size used for the test set," "Number of experts used," "Adjudication method," "MRMC comparative effectiveness study," "Standalone performance," "Type of ground truth," "Sample size for the training set," and "How ground truth for training set was established," are not present in this regulatory clearance letter.
§ 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).