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To obtain percutaneous core biopsy samples from soft tissue 10 obtain perculations core bropsy surves, kidney, prostate, and culturs of sach organs as awnen used for breast blopsy, the product is for diagnosis only.

Automated Core Biopsy Device

The provided text is an FDA 510(k) clearance letter for the "Automated Core Biopsy Device" and does not contain any information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert qualifications.

The letter primarily states that the device has been found substantially equivalent to legally marketed predicate devices and can therefore be marketed. It discusses regulatory matters such as general controls, manufacturing practices, and labeling, but does not include technical details about the device's validation or performance.

Therefore, I cannot fulfill your request for a table of acceptance criteria and device performance based on the provided input.

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