(77 days)
This Device is a Safety Hypodermic Syringe for injection of medicine to patients. This device aids in the prevention of needlestick injuries.
Not Found
The provided document is a 510(k) clearance letter from the FDA for a safety syringe, not a study report for an AI/ML medical device. Therefore, it does not contain the information required to answer the questions about acceptance criteria, device performance, study design, or ground truth establishment.
Specifically, the document:
- Does not describe acceptance criteria for an AI/ML device.
- Does not report device performance against any such criteria.
- Does not detail any study involving AI/ML.
- Does not mention sample sizes, data provenance, expert qualifications, or adjudication methods.
- Does not refer to MRMC comparative effectiveness studies or standalone algorithm performance.
- Does not discuss ground truth types or how ground truth was established.
- Does not specify training set sizes.
The document is a regulatory approval for a physical medical device (a safety syringe) based on substantial equivalence to a predicate device, as opposed to performance against specific efficacy or accuracy metrics typically associated with AI/ML device studies.
§ 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).