(419 days)
The Sol-Guard Auto-Disable Syringe is intended for aspiration and injection of fluids into the body. In addition, the Sol-Guard™ Auto-Disable Syringe is designed to prevent syringe and needle reuse.
The SOL-GUARD Auto-Disable syringe is a sterile, single-use, 3-part hypodermic syringe with an auto-disable feature that is intended to deliver a fixed dose of medicine/vaccine immediately after filling. The SOL-GUARD Auto-Disable syringe has a fixed needle and plunger rod with affixed metal clip which is designed for the prevention of the syringe and needle re-use by automatically activating the clip and locking the plunger after injection. The syringe is individually blister packaged, and EtO sterilized with SAL of 106. This syringe is intended for aspiration and injection of fluids.
This document is an FDA 510(k) summary for a medical device (Sol-Guard Auto-Disable Syringe). It does not describe an AI medical device or a study involving AI, nor does it use terms like "acceptance criteria," "test set," "ground truth," "MRMC," or "standalone performance" in the context of AI algorithm validation.
Therefore, I cannot extract the requested information regarding acceptance criteria and study proving device meets acceptance criteria for an AI device from this document. The document describes the non-clinical (bench) testing performed for a mechanical syringe to demonstrate its substantial equivalence to a predicate device, with a focus on the new auto-disable feature.
If you are looking for information about the validation of an AI medical device, you would need a different type of document, typically a clinical study report or a 510(k) summary for an AI/ML-enabled 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).