(157 days)
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.
§ 878.4400 Electrosurgical cutting and coagulation device and accessories.
(a)
Identification. An electrosurgical cutting and coagulation device and accessories is a device intended to remove tissue and control bleeding by use of high-frequency electrical current.(b)
Classification. Class II.