(268 days)
Monoject Syringes with Luer tip are intended for single use by health care professionals for general purpose fluid aspiration and and/or injection.
Not Found
The provided FDA 510(k) clearance letter pertains to Monoject™ Syringes, which are physical medical devices (piston syringes) and not an AI/ML software device. Therefore, the concepts of acceptance criteria for algorithm performance, study methodology for AI models, sample sizes for training/test sets, ground truth establishment, expert adjudication, or MRMC studies are not applicable to this document.
The letter indicates that the device has received substantial equivalence to legally marketed predicate devices, meaning it meets the safety and effectiveness requirements for its intended use, which is general purpose fluid aspiration and/or injection by healthcare professionals.
To answer your request, if this were an AI/ML device, the information would typically be found in the 510(k) submission summary or a separate clinical study report, neither of which is present in the provided FDA clearance letter. The letter itself is a notice of clearance, not a detailed technical report of the studies performed.
Therefore, I cannot extract the requested information from the provided document as it does not contain details about an AI/ML study or its performance criteria.
§ 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).