Search Results

Plasma IQ is used in the removal and destruction of skin lesions and coagulation of tissue.

PLASMA IQ utilizes a treatment method called plasma sublimation, which causes controlled skin damage through the generation of an electrical arc. The arc between the electrode tip and the skin is created by a radio frequency generator housed in an electrosurgical unit (handpiece) that ionizes the gas particles in the air. A straight active electrode made of 316L stainless steel is available with the system. The handheld device is cordless and is charged in a docking/charging station prior to use.

I am sorry, but based on the provided text, I cannot provide a table of acceptance criteria and reported device performance related to an AI/ML device, as the document describes a 510(k) submission for a non-AI medical device called "Plasma IQ" for electrosurgical cutting and coagulation.

The document discusses performance testing for electrical safety, tissue testing (thermal spread comparison), and packaging, but not for an AI/ML component. Therefore, there is no information in the provided text to address the following points:

• Acceptance criteria and reported device performance for an AI/ML device.
• Sample size for the test set and data provenance.
• Number of experts used to establish ground truth and their qualifications.
• Adjudication method for the test set.
• Multi-reader multi-case (MRMC) comparative effectiveness study or its effect size.
• Standalone (algorithm only) performance.
• Type of ground truth used.
• Sample size for the training set.
• How ground truth for the training set was established.

Ask a specific question about this device