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This product is intended to be used in an MR environment for the Administration of Contrast and Flush for Magnetic Resonance Imaging (MRI) or Magnetic Resonance Angiography (MRA).

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The provided text is a 510(k) premarket notification approval letter for the "Smart Set" intravascular administration set. This document does not describe or contain information about acceptance criteria, a study that proves a device meets acceptance criteria, or any of the detailed study parameters requested (sample size, expert qualifications, ground truth, MRMC study, standalone performance, etc.).

The letter is a regulatory document confirming that the FDA has reviewed the device and determined it is substantially equivalent to a legally marketed predicate device. It specifies the device name, models, regulation number, regulatory class, and indications for use. It also outlines general compliance requirements.

Therefore, I cannot provide the requested information based on the given input text. The information needed to answer the prompt (acceptance criteria, study details, performance data) is not present in this regulatory approval letter.

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This device is intended for use in MR imaging of peripheral blood yessels in the lower extremity for patients with suspected peripheral vascular disease for diagnostic purposes and pre-operative information.

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The provided text is a 510(k) clearance letter from the FDA for a medical device. It does not contain any information about acceptance criteria or a study proving that the device meets acceptance criteria.

The letter states that the device, an "MRI Compatible Thigh Tourniquet," has been determined to be substantially equivalent to legally marketed predicate devices. This determination is based on the indications for use provided by the applicant.

Therefore, I cannot extract the requested information as it is not present in the provided document.

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This product is intended to be used to assist in : the administration of fluids into a patient's vascular system during a Magnetic Resonance Imaging (MRI) or Magnetic Resonance Angiography (MRA) examination.

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I am sorry, but the provided text from the FDA 510(k) summary for the "Smart Set" device does not contain information about acceptance criteria, device performance metrics, or details of a study that proves the device meets specific criteria. The document is primarily a letter of substantial equivalence from the FDA, indicating that the device can be marketed.

Therefore, I cannot fulfill your request for the detailed information regarding acceptance criteria, study design, sample sizes, expert qualifications, or ground truth establishment based on the provided input.

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