(38 days)
The Aaron 950 High Frequency Electrosurgical Generator models are intended to be used for all electrosurgical cut, blend, coagulation, fulguration, and bipolar procedures.
The Aaron 950 High Frequency Electrosurgical Generator is a non-sterile, reusable electrosurgical generator, which is designed to generate high frequencies (RF) of high voltage and low amperage current.
The provided text is a 510(k) Safety and Effectiveness Summary for an electrosurgical generator. It declares substantial equivalence to predicate devices and does not describe a study involving algorithms, AI, or performance metrics in a way that would require the specific acceptance criteria and study details requested in the prompt. The summary focuses on regulatory compliance through substantial equivalence, rather than a detailed performance study with specific quantitative acceptance criteria or a human-in-the-loop evaluation for an AI device.
Therefore, I cannot extract the requested information because the document does not contain it. The information requested (acceptance criteria, sample sizes, ground truth establishment, MRMC studies, standalone performance for AI, etc.) is typically found in the context of performance studies for AI/ML-driven devices, not in a 510(k) summary for a traditional electrosurgical generator establishing substantial equivalence.
§ 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.