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To be used in conjunction with a Magnetic Resonance Scanner to produce diagnostic images of the female breast, chest wall, and axillary tissues that can be interpreted by a trained physician.

Model BBC-63-GE Breast Array Coil

The provided text is an FDA 510(k) clearance letter for the "Model BBC-63-GE Breast Array Coil." This document does not contain any information about acceptance criteria, device performance metrics, or details of a study used to prove the device meets acceptance criteria.

The letter primarily:

• Confirms the device (a breast array coil for MRI) has been found substantially equivalent to a legally marketed predicate device.
• States the device's indications for use (to produce diagnostic images of the female breast, chest wall, and axillary tissues).
• Outlines post-market regulatory requirements for the manufacturer.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them based solely on the provided text. The requested information would typically be found in the 510(k) submission itself (specifically in sections detailing performance data and clinical/non-clinical studies), not in the clearance letter.

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