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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.

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The provided text is a clearance letter from the FDA for a device called "OBC-127 Breast Array Coil." It is a premarket notification (510(k)) clearance, which means the device was found to be substantially equivalent to a legally marketed predicate device.

The document does not contain information about acceptance criteria, device performance, particular studies conducted to prove performance, sample sizes, expert qualifications, adjudication methods, multi-reader multi-case studies, standalone performance, or ground truth establishment.

Instead, the document primarily focuses on:

• The FDA's decision to clear the device for marketing.
• The regulatory classification of the device (Class II, Product Code: 90 MOS).
• General responsibilities under the Act (registration, listing, GMP, labeling).
• Contact information for various FDA offices.
• The specific "Indications for Use" for the OBC-127 Breast Array Coil.

Therefore, I cannot provide the requested information based on the given input. The content is an FDA clearance letter, not a study report or clinical trial summary.

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