(82 days)
Used within health care settings (i.e., medical, dental, veterinarian, or other health care facility) for the collection of used disposable sharps.
Containers are supplied to the health care facilities by BFI representatives.
Containers are used by health care providers at the point of disposal where potentially infectious sharps' waste is generated.
Not Found
The provided text is a 510(k) premarket notification letter from the FDA regarding a medical device called "SharpTrack™ Reusable Sharps Container." It does not contain information about acceptance criteria, device performance, study details, or any of the specific points requested in your prompt (sample size, expert qualifications, adjudication, MRMC, standalone performance, ground truth, training set size).
This document is a regulatory approval letter stating that the device is substantially equivalent to legally marketed predicate devices, allowing it to be marketed. It is not a study report or clinical trial summary.
Therefore, I cannot fulfill your request using the provided input. To answer your prompt, I would need a document describing a scientific study or performance evaluation of the device.
§ 880.5570 Hypodermic single lumen needle.
(a)
Identification. A hypodermic single lumen needle is a device intended to inject fluids into, or withdraw fluids from, parts of the body below the surface of the skin. The device consists of a metal tube that is sharpened at one end and at the other end joined to a female connector (hub) designed to mate with a male connector (nozzle) of a piston syringe or an intravascular administration set.(b)
Classification. Class II (performance standards).