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The Contour 24 is intended for use with Siemens 1.5T MR systems to produce diagnostic images of general human anatomy that can be interpreted by a trained physician.

The Contour 24 is a receive-only, 24-channel phased array coil designed for magnetic resonance imaging (MRI) using the Siemens 1.5T MR systems. The Contour 24 is intended to be used for imaging general human anatomy, such as the abdomen and pelvis. The Contour 24 is a reusable, non-invasive device with limited exposure with regard to duration of contact with the body. The coil elements are encapsulated in polycarbonate and aramid felt which are fire-rated and provide impact and tensile strength, then covered with a polyurethane coated nylon fabric which has been evaluated for biocompatibility.

I am sorry, but the provided text does not contain the detailed information needed to fill out your request about acceptance criteria and a study proving device performance in the requested format.

The text mentions that "The SNR and uniformity of the Contour 24 was analyzed per NEMA MS-9 and was found to conform to predetermined acceptance criteria" and that "clinical images from volunteer scanning of general human anatomy were obtained from the Contour 24. These images were used to demonstrate that the Contour 24 produces diagnostic quality images of the intended anatomies." However, it does not provide:

• A specific table of acceptance criteria and reported device performance values.
• Sample sizes for test sets, data provenance, or details on ground truth establishment (number of experts, qualifications, adjudication methods).
• Information on MRMC comparative effectiveness studies or standalone performance.
• Sample size or ground truth establishment for the training set.

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