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The Safe Plus Disposable Safety Syringe is an ETO sterile, non-toxic, non-pyrogenic, latex free, single-use, non-reusable, disposable manual retractable safety syringe in which medication can be injected into or fluid withdrawn from the human body. This device aids in prevention of needle stick injuries and reuse of the needle.

The Safe Plus Disposable Syringe is a single use hypodermic syringe similar to a traditional syringe in application and function except for its safety mechanism which when activated:

1. completely retracts and encloses the needle in the barrel thereby preventing finger access
2. renders the needle unusable again as it is crushed within the puncture resistant barrel.

I am sorry, but based on the provided text, there is no information about a study that assesses acceptance criteria for the "Safe Plus Disposable Safety Syringe".

The document is a 510(k) summary for the device, which focuses on demonstrating substantial equivalence to a predicate device. It lists specifications and attributes of the device and compares them to the predicate, but it does not detail specific acceptance criteria values or a study proving those criteria are met.

Therefore, I cannot provide a table of acceptance criteria and reported device performance, nor details about sample sizes, data provenance, expert involvement, adjudication methods, MRMC studies, standalone performance, ground truth types, or training set information.

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