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The intended use of the Worldwide Medical Technologies Bone Marrow Aspiration/Core Needle is to obtain samples of aspirates and bone marrow for cytologic and histologic examination in the diagnosis and treatment of various diseases. The samples are typically taken by percutanious puncture of the posterior iliac crest of the pelvic bone.

Worldwide Medical Technologies AspirCore

The provided text is a 510(k) premarket notification letter from the FDA regarding the Worldwide Medical Technologies AspirCore, a bone marrow aspiration/core needle. This document does not contain information about acceptance criteria, device performance, sample sizes for testing or training, expert qualifications, ground truth establishment, or any details of a study that proves the device meets specific acceptance criteria.

The letter simply states that the FDA has reviewed the 510(k) and determined the device is substantially equivalent to legally marketed predicate devices, allowing it to be marketed. It refers to the "indications for use" but does not detail any performance metrics or studies to support those indications beyond substantial equivalence to existing devices.

Therefore, I cannot fulfill your request for the specific information regarding acceptance criteria and study details based on the provided text.

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