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The LeVeen Needle Electrode is intended to be used in conjunction with a RadioTherapeutics Corporation radiofrequency (RF) generator for the thermal coagulation necrosis of soft tissues, including partial or complete ablation of nonresectable liver lesions.

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This document is a 510(k) clearance letter from the FDA for the LeVeen Needle Electrode. It does not contain information about acceptance criteria or a study proving device performance against such criteria. The letter emphasizes that the effectiveness of this device for use in the treatment of liver cancer or liver disease (i.e., improved clinical outcomes) has not been established.

Therefore, I cannot provide the requested information. The document explicitly states that clinical outcomes or effectiveness for specific diseases have not been established, meaning the studies proving device performance against acceptance criteria for clinical effectiveness either don't exist or were not presented or deemed sufficient by the FDA for this clearance.

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The MR Compatible LeVeen Needle Electrode is intended to be used in conjunction with separately approved RF Generators such as the RadioTherapeutics RF-2000, for the thermal coagulation necrosis of soft tissues.

MR Compatible LeVeen Needle Electrode

This document is a 510(k) clearance letter from the FDA for a medical device (MR Compatible LeVeen Needle Electrode). It does not contain information about acceptance criteria or a study proving the device meets those criteria. The letter confirms substantial equivalence to a predicate device and allows the manufacturer to market the device.

Therefore, I cannot provide the requested information. This document does not describe:

• A table of acceptance criteria and reported device performance.
• Sample sizes or data provenance for a test set.
• Number or qualifications of experts for ground truth establishment.
• Adjudication method.
• Multi-reader multi-case comparative effectiveness study results.
• Standalone algorithm performance.
• Type of ground truth used.
• Sample size for the training set.
• How ground truth for the training set was established.

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