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Single use piston syringe used to inject fluids into the body. The device has an integrated attached needle and can be sold for prescription or non-prescription use. The tuberculin syringe is for prescription use and the insulin syringe can be sold for non-prescription use. The syringes are sold sterile and are also non-pyrogenic and non-toxic.

RAMY PISTON SYRINGE

The provided FDA 510(k) K972452 document is a clearance letter for a medical device called the "Ramy Piston Syringe." This document confirms that the device is substantially equivalent to legally marketed predicate devices and can be marketed.

However, this document does not contain any information regarding acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert involvement as it is an FDA clearance letter and not a detailed clinical study report or technical specification document.

Therefore, I cannot fulfill your request for a table of acceptance criteria, study details, or ground truth information based solely on the provided text. This type of information is typically found in the 510(k) submission itself (which includes engineering specifications, test reports, and clinical data if applicable), but not in the clearance letter issued by the FDA.

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