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

The device consists of a preshaped, multi-armed electrode array which is contained within a delivery cannula. The array is attached to a handle mechanism that deploys the array into the targeted tissue. In addition, each device is supplied with an insulated introducer sheath/stylet assembly to allow the physician to locate the target tissue prior to placing and deploying the electrode. The device is connected to a RadioTherapeutics RF generator so that RF energy passes from the array to a patient ground pad and heats the tissue surrounding the array.

This document does not contain the information requested in the prompt. The provided text is a 510(k) summary for a medical device (LeVeen™ Electrode), which primarily focuses on establishing substantial equivalence to a predicate device for marketing purposes.

Specifically, the document lacks details about:

• Acceptance criteria for device performance.
• A study proving the device meets acceptance criteria.
• A table of acceptance criteria and reported device performance.
• Sample sizes for test or training sets.
• Data provenance.
• Number and qualifications of experts for ground truth.
• Adjudication method.
• MRMC comparative effectiveness study or its effect size.
• Standalone algorithm performance.
• Type of ground truth used.
• How ground truth for the training set was established.

The document states the device is "substantially equivalent" to a previously cleared device, implying that its safety and effectiveness are considered comparable based on existing data or device characteristics, rather than requiring a detailed new clinical or performance study with defined acceptance criteria to be presented in this summary.

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