(100 days)
BREG's e-PAIN CARETM is intended to provide infusion of a 'local anesthetic into an intra-operative site for the post-operative management of pain.
Not Found
I am sorry, but the provided text is a 510(k) clearance letter from the FDA to Breg, Inc. for their "E-Pain Care" device. This document does not contain the information requested in your prompt regarding acceptance criteria, study details, sample sizes, ground truth establishment, or expert qualifications.
The letter primarily focuses on the FDA's determination of substantial equivalence to a predicate device, allowing the company to market the E-Pain Care device. It lists the device name, regulation number, regulatory class, and product code, and clarifies the "Indications for Use."
Therefore, I cannot extract the information asked for in your request from this document.
§ 880.5725 Infusion pump.
(a)
Identification. An infusion pump is a device used in a health care facility to pump fluids into a patient in a controlled manner. The device may use a piston pump, a roller pump, or a peristaltic pump and may be powered electrically or mechanically. The device may also operate using a constant force to propel the fluid through a narrow tube which determines the flow rate. The device may include means to detect a fault condition, such as air in, or blockage of, the infusion line and to activate an alarm.(b)
Classification. Class II (performance standards).