(130 days)
The Procedur-10 device is used to inject fluids into, or withdraw fluids from, the body.
The Procedur-10 device is a piston syringe
I am sorry, but the provided text only contains a 510(k) summary and FDA clearance letter for a piston syringe called "Procedur-10." This document does not contain any information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert involvement that would be required to answer your request.
The K042486 submission is for a Class II medical device (Piston Syringe) and focuses on demonstrating substantial equivalence to a predicate device (Becton Dickinson Single-Use Hypodermic Syringes K980987). Substantial equivalence typically relies on comparing technological characteristics and intended use, rather than extensive clinical performance studies with acceptance criteria as you've requested for AI/software devices.
Therefore, I cannot extract the information required to fill out the table and answer your questions regarding acceptance criteria, study details, and AI-related aspects.
§ 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).