(87 days)
The Sterican hypodermic needles, when attached to a male connector, are intended to be used to inject fluid into, or withdraw fluids from, parts of the body below the surface of the skin.
The hypodermic needles are comprised of a metal tube that is sharpened at one end, and at the other end is bonded to a female connector (hub), which is designed to attach to a male connector, such as a syringe. The needles will be available in gauge sizes of 18 G through 27 G, and in lengths ranging from 1/2 inch to 4 3/4 inches.
I am sorry, but based on the provided text, there is no information about acceptance criteria or a study that proves the device meets specific acceptance criteria.
The document is a 510(k) summary for Sterican Needles, which is a premarket notification to demonstrate substantial equivalence to a legally marketed predicate device, not a report on a study proving specific acceptance criteria for performance.
The document mentions:
- "Biocompatibility and functional testing have been performed to verify the safety and effectiveness of the Sterican needles."
- This testing was done to demonstrate "substantial equivalence" to the predicate device, not to meet specific performance criteria beyond that.
Therefore, I cannot provide the requested table or answer the specific questions regarding acceptance criteria, sample sizes, expert involvement, adjudication, MRMC studies, standalone performance, ground truth, or training set details. This information is typically found in design validation or verification reports, which are not included in this 510(k) summary.
§ 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).