(595 days)
THIS DEVICE IS A SAFETY HYPODERMIC SYRINGE FOR INJECTION OF MEDICATION TO PATIENTS. =THIS DEVICE AIDS IN PREVENTION OF NEEDLE STICK INJURIES=
EXEL SECURE TOUCH SAFETY SYRINGE
This document is a 510(k) clearance letter from the FDA for a medical device called the "EXEL Secure Touch Safety Syringe." It does not contain information on acceptance criteria, a study proving the device meets acceptance criteria, or any of the other specific details requested in your prompt regarding artificial intelligence (AI) and its performance.
The letter explicitly states that the device is "substantially equivalent" to legally marketed predicate devices, meaning it doesn't require a new premarket approval application (PMA). This implies that its safety and effectiveness are established through its similarity to existing, approved devices, rather than through a standalone study with performance metrics in the way your prompt describes for an AI-powered device.
Therefore, I cannot provide the requested information from this document. The information you are looking for (acceptance criteria, study details, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, training set details) is typically found in a detailed clinical study report or a 510(k) summary, which is not provided in this regulatory letter.
§ 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).