(112 days)
Insulin syringes are intended for the injection of insulin.
Not Found
The provided text is a 510(k) clearance letter from the FDA for an "Allison Medical Insulin Syringe (AMIS)". This document is not a study report or a device performance evaluation. It is a regulatory letter indicating that the FDA has found the device to be "substantially equivalent" to predicate devices already on the market, thus allowing it to be marketed.
Therefore, the document does not contain the information requested in the prompt regarding acceptance criteria, study details, sample sizes, ground truth establishment, or expert qualifications.
To answer your prompt, I would need a different type of document, such as a clinical study report, a scientific publication detailing performance evaluation, or a submission document that includes the technical specifications and testing results for the device.
§ 880.5860 Piston syringe.
(a)
Identification. A piston syringe is a device intended for medical purposes that consists of a calibrated hollow barrel and a movable plunger. At one end of the barrel there is a male connector (nozzle) for fitting the female connector (hub) of a hypodermic single lumen needle. The device is used to inject fluids into, or withdraw fluids from, the body.(b)
Classification. Class II (performance standards).