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Disposable needle for obtaining biopsies from soft tissues such as kidney, lisposable needie 101 obtains, spleen and various soft tissue tumors.

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This document is a 510(k) clearance letter from the FDA for a medical device called "Light Saber™ Core Tissue Biopsy Needle." It states that the device is substantially equivalent to a legally marketed predicate device.

However, this document does NOT contain any information regarding acceptance criteria, study details, device performance, sample sizes, ground truth establishment, or expert involvement as requested in your prompt.

The letter is a regulatory approval document and does not detail the technical performance or validation studies of the device.

Therefore, I cannot fulfill your request for information regarding acceptance criteria and the study that proves the device meets them based solely on the provided text. This information would typically be found in the 510(k) submission itself, not in the clearance letter.

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