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The Medtronic Cardioblate System is intended to ablate soft tissue during general surgery using radiofrequency energy.

Cardioblate® Bipolar Radiofrequency Surgical Ablation System

I am sorry, but based on the provided document, I cannot describe the acceptance criteria and the study that proves the device meets the acceptance criteria. The document is an FDA 510(k) clearance letter for the Cardioblate® Bipolar Radiofrequency Surgical Ablation System, which confirms its substantial equivalence to a predicate device.

This type of document typically does not contain detailed information about the specific acceptance criteria, study design, sample sizes, ground truth establishment, or expert qualifications that would be found in a clinical study report or a more technical regulatory submission. The letter confirms clearance based on a review of provided information, but it does not detail the specifics of that information related to performance studies.

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