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The LeMaitre Over The Wire Embolectomy Catheter is indicated for use in the removed of emboli and Thrombi during embolectomy and/or thrombectomy. It can also be used for catheter placement over a guidewire, vessel occlusion, fluid infusion and/or aspiration.

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The provided text is an FDA 510(k) clearance letter for the LeMaitre Vascular Inc. Over The Wire Embolectomy Catheter. It states that the device is substantially equivalent to legally marketed predicate devices. However, this document does not contain any information regarding acceptance criteria, device performance results from a study, sample sizes, expert qualifications, ground truth establishment, or any details about a study to prove the device meets acceptance criteria.

The letter is a regulatory approval, not a scientific study report. It indicates that the device has been cleared to market based on its substantial equivalence to pre-existing devices, but it does not describe the specific tests or data used to demonstrate that equivalence beyond a general statement.

Therefore, I cannot fulfill your request for the specific information regarding acceptance criteria and a study proving their fulfillment, as these details are not present in the provided text.

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