(140 days)
The Unitract Tuberculin Syringe, as supplied, is a device with a small barrel, plunger, and fixed needle, calibrated in milliliters (0.01 increments) to be used to administer (infuse) medication subcutaneous, intramuscular, or intradermal. It incorporates features that include reuse prevention (auto-disable) and sharps injury prevention (automatic needle retraction).
The 1mL Unitract® Tuberculin Syringe is a sterile, fixed needle, single use, syringe, consisting of a barrel and plunger assembly. The syringe is supplied as 27G x 1/2". The devices function in a manner similar to standard syringes, but also incorporates a sharps injury prevention (automatic needle retraction) and reuse prevention (auto disable) feature. The sharps injury prevention feature allows for automatic and full retraction of the needle into the syringe barrel immediately after the full dose has been expelled; where the rate of retraction may be controlled by the user. The reuse prevention feature also engages immediately after retraction, which prevents further movement of the plunger in either direction.
The provided text describes a medical device, the 1mL Unitract® Tuberculin Syringe, and its regulatory submission (K100998). It does not contain information about the acceptance criteria or a study proving the device meets those criteria in the context of an AI/ML model for medical image analysis.
The document is a 510(k) summary for a physical medical device (syringe) and details its design, intended use, and substantial equivalence to predicate devices, primarily based on mechanical, chemical, biocompatibility, and sterilization performance tests. There is no mention of "acceptance criteria," "device performance" in terms of AI metrics, "sample sizes" for test or training sets, "data provenance," "experts," "adjudication methods," "MRMC studies," "standalone algorithms," or "ground truth" as these terms relate to AI/ML device evaluations.
Therefore, I cannot extract the requested information from the provided text as it is not relevant to the type of device or study described.
§ 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).