(175 days)
The Self-destruction Safety Syringes for Single Use are intended to be used for medical purposes to inject fluid into or withdraw fluid from body. Its secondary intended use is to retract inside the safety barrel, contain the contaminated needle and aid in the prevention of accidental needle stick injuries.
The Sterile Hypodermic Syringes for Single Use are intended to be used for medical purpose to inject fluid into or withdraw fluid from body.
The Sterile Hypodermic Needles for Single Use are intended to be used with a luer slip syringe and injection devices for general purpose fluid injection/aspiration.
The Sterile Safety Hypodermic Needles for Single Use are intended to be used with a luer slip or luer slip syringe for aspiration and injection of fluids for medical purpose. After withdrawal of the needle from the body, the attached needle safety shield can be manually activated to cover the needle immediately after use to minimize risk of accidental needlestick.
The Self-destruction Safety Syringes for Single Use are intended for single use only. The proposed device is available in 1mL, 3mL, 5mL, 10mL volumes with a 25 gauge, 25mm needle. The safety feature will be manually activated to retract the needle immediately after use to minimize risk of accidental needle sticks.
The Sterile Hypodermic Syringes for Single Use are intended for single use only, which consists of barrel, plunger and piston. The proposed device is available in 1mL, 2mL, 5mL, 10mL, 20mL, 30mL and 50mL volumes. The syringe is available in luer lock connector types which are intended to be connected with a hypodermic needle.
The Sterile Safety Hypodermic Needles for Single Use are intended for single use only, which consists of a hypodermic needle with a safety sheath attached to the needle hub. The proposed device is available in 18-27 gauge and 6-50 mm lengths. The safety sheath will be manually activated to cover the needle immediately after use to minimize risk of accidental needle sticks.
The Sterile Hypodermic Needles for Single Use are intended for single use only. The proposed device is available in 14-30 gauge and 6-60 mm lengths.
The provided text is an FDA 510(k) summary for various medical devices, including "Self-destruction Safety Syringes for Single Use" and "Sterile Safety Hypodermic Needles for Single Use," which incorporate safety features to prevent accidental needle stick injuries. The summary describes the non-clinical tests performed to demonstrate substantial equivalence to predicate devices, focusing on physical, mechanical, chemical properties, sterility, shelf-life, and biocompatibility.
However, the provided document does not describe a study involving an AI-powered device or a multi-reader multi-case (MRMC) comparative effectiveness study. Instead, it focuses on the performance and safety of physical medical devices (syringes and needles). Therefore, I cannot extract the requested information related to acceptance criteria and study proving AI device performance, sample sizes for test and training sets, expert ground truth establishment, adjudication methods, or effects of AI assistance on human readers.
The section "Simulated Clinical Use" on page 8 of 13 does mention "pre-established criteria" and a study on 500 device samples for the safety features of the syringes and needles, but these are related to the physical device's function, not an AI or imaging diagnostic performance.
In summary, the provided document does not contain the information required to answer the prompt's specific questions about an AI device's acceptance criteria and performance study.
§ 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).