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This device is intended for use by health care professionals for fluid injection, where it is important to ensure that the quantity of the injected fluid bolus is known exactly.

This device will be used to inject into IV ports (not directly into the patient or into arterial lines).

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The provided text is a 510(k) premarket notification letter from the FDA regarding the Daxor Max100 Syringe. It confirms substantial equivalence but does not contain any information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert involvement. Therefore, I cannot fulfill the request to describe these details.

The document only states the device's indications for use: "This device is intended for use by health care professionals for fluid injection, where it is important to ensure that the quantity of the injected fluid bolus is known exactly. This device will be used to inject into IV ports (not directly into the patient or into arterial lines)."

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