(59 days)
Not Found
Not Found
This document is a 510(k) premarket notification letter from the FDA regarding a medical device, the TMD™ Safety Syringe. It does not contain information about acceptance criteria, device performance, study designs, sample sizes, expert qualifications, or ground truth establishment. Therefore, I cannot extract the requested information from the provided text.
The letter explicitly states: "We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent... to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976...". This indicates that the device's approval is based on substantial equivalence to a predicate device, not on meeting specific acceptance criteria proven by a new clinical study.
Therefore, I cannot populate the table or answer the specific questions about a study, as that information is not present in this document.
§ 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).