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The Mona Lisa Aspiration Needle is intended for ultrasoundguided, transvaginal recovery and collection of oocytes from ovarian follicles.

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The provided document is a 510(k) clearance letter from the FDA for the Mona Lisa Aspiration Needle. It primarily concerns the regulatory approval of the device and does not contain information about acceptance criteria or a study proving the device meets those criteria. The letter confirms that the device is substantially equivalent to legally marketed predicate devices and outlines general regulatory requirements.

Therefore, I cannot provide the requested information based on the given document. The document does not describe a study or specific acceptance criteria for the Mona Lisa Aspiration Needle.

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