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D. Heart Medical intravascular administration set, safety access device and accessories are devices used to administer fluids from a container to a patient's vascular system through a needle or catheter inserted into a vein.

Each device is comprised of components commonly found in intravascular administration sets and extension sets. Incorporation of safety access device aid in the prevention of accidental needle sticks to healthcare workers and patients.

I am sorry, but the provided text does not contain the detailed information necessary to answer your request about acceptance criteria and a study proving a device meets them.

The document is an FDA 510(k) clearance letter for the "D. Heart Medical Intravascular Administration Set, Safety Access Device, and Accessories." While it confirms that the device has been found substantially equivalent to a predicate device, it does not include:

• A table of acceptance criteria or reported device performance.
• Information about specific studies conducted to establish performance (like sample sizes, data provenance, ground truth establishment, expert qualifications, or adjudication methods).
• Details regarding stand-alone performance or multi-reader multi-case (MRMC) comparative effectiveness studies, as these types of studies are typically associated with performance claims for AI/image analysis devices, which this particular device does not appear to be.

The letter focuses on regulatory clearance based on substantial equivalence to existing devices, and therefore does not delve into the granular study details you've requested.

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