(10 days)
The K-Pack II needle being a Hypodermic Single Lumen Needle is a sterile medical device for single use, intended to inject fluids into, or withdraw fluids from parts of the body below the surface of the skin.
The 29 Gauge or 30 Gauge K-Pack II Needle is a sterile hypodermic single lumen needle, for single use consisting of a stainless steel tube that is sharpened at one end and at the other end joined to a female luer connector (hub) made of polypropylene designed to be connected with a male connector (nozzle) of a piston syringe.
The provided text is a 510(k) summary for a medical device (29 Gauge and 30 Gauge K-Pack II Needle) and does not contain information about acceptance criteria or a study proving that the device meets those criteria in the context of an AI/ML system.
The document describes a submission to extend an existing product line of hypodermic needles. It focuses on demonstrating substantial equivalence to previously cleared devices based on intended use, design, technology, materials, and performance, along with safety information regarding sterility, biological evaluation, and expiration dating.
Therefore, I cannot fulfill your request for the specific details outlined (such as a table of acceptance criteria, sample sizes for test/training sets, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth types) because this information is not present in the provided text. The document is for a physical medical device, not an AI/ML diagnostic or predictive system.
§ 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).