(229 days)
Monoject Magellan Insulin Safety Syringes are intended for delivery of U-100 insulin. The needle stick prevention feature of the device, once activated, guards against accidental needle-sticks.
The Monoject™ Magellan™ Insulin Safety Syringe consists of a piston syringe with a permanently attached needle, and safety shield designed to extend, fully cover, and permanently lock over the needle when activated by a fingertip or thumb to reduce the occurrence of accidental needle sticks. The device is provided sterile and is intended for single use only. An orange needle cap indicates for use with insulin. The barrel of the syringe is graduated for measuring a prescribed dose. The syringe is intended for use immediately after filling and is not intended to contain or store insulin for extended periods of time.
The provided text is a 510(k) summary for a medical device (Monoject Magellan Insulin Safety Syringe). It details the device's characteristics, intended use, and comparison to a predicate device to establish substantial equivalence.
However, this document does not contain any information about an AI/ML-driven device or its acceptance criteria and study results. The device described is a physical medical device (syringe), not a software or AI/ML product.
Therefore, I cannot fulfill the request to describe acceptance criteria and associated study results for an AI/ML device based on the provided text. The questions posed (e.g., sample size for test set, number of experts, MRMC study, standalone performance, training set data) are relevant to the evaluation of AI/ML models, but the provided document is not about such a device.
§ 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).