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General purpose single use piston syringe used to withdraw or inject first into the body. The device is sold as a sold as a sold as a sold and in a sold and is monther is sold device is sold device is not of The device is not intended for use with any specific drugs or biologics. It is sold as a prescription device with needle . attached and ready for use.

RAMY Piston Syringe

I'm sorry, but the provided text is a 510(k) clearance letter from the FDA for a medical device (Ramy Syringe). It does not contain information about acceptance criteria for a study, device performance data, sample sizes, expert qualifications, or details about comparative effectiveness studies.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets the acceptance criteria based on the input provided. The document primarily discusses regulatory clearance based on substantial equivalence to an existing device.

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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.

Ask a specific question about this device