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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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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.

Not Found

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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The RadioTherapeutics Corp. RF Generator is a medium power electrosurgical generator intended for use with separately approved electrodes for the thermal coagulation of soft tissues.

RadioTherapeutics RF-2000 Radiofrequency Generator

I am sorry, but based on the provided text, there is no information available about acceptance criteria, device performance, or any studies conducted (such as standalone, MRMC, or those related to sample size, ground truth, or expert qualifications).

The document is an FDA 510(k) clearance letter for the RadioTherapeutics RF-2000 Radiofrequency Generator, indicating that the device is substantially equivalent to a predicate device for the thermal coagulation of soft tissues. This type of letter confirms regulatory approval to market the device based on substantial equivalence, but it does not typically include detailed performance study results or acceptance criteria.

Therefore, I cannot provide the requested table or answer the specific questions regarding studies, sample sizes, ground truth establishment, or expert involvement.

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The RadioTherapeutics Corp. RF Generator is a medium power electrosurgical generator intended for use with separately approved electrodes for the thermal coagulation of soft tissues.

Not Found

I am sorry, but based on the provided text, I cannot provide the detailed information you requested about acceptance criteria and the study that proves the device meets them.

The document is a 510(k) clearance letter from the FDA for the RadioTherapeutics RF Generator Model #RF-2000. It states that the device has been reviewed and determined to be "substantially equivalent" to predicate devices marketed prior to May 28, 1976. This letter primarily focuses on the regulatory clearance and indications for use, rather than detailed performance study results or acceptance criteria.

The text does not contain:

• A table of acceptance criteria and reported device performance.
• Information about sample sizes for test or training sets.
• Data provenance, number of experts, qualifications, or adjudication methods.
• Details about MRMC comparative effectiveness studies or standalone algorithm performance.
• The type of ground truth used or how it was established.

This document is a regulatory approval, not a scientific study report describing the device's performance in detail against specific criteria.

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Ask a specific question about this device

Ask a specific question about this device