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The LUDWIG Electrosurgical System is intended for use in dermatologic and general surgical procedures for electrocoagulation and hemostasis.

The LUDWIG Electrosurgical System is comprised of the following components:

• . The system's main body, which consists of:
  • Touch-screen control/display panel O
  • High radio frequency (RF)-generating output component at 0.5, 1 or 2 MHz o
  • RF Handpiece for transfer of energy to human tissue O
  • Ultrasound Handpiece for visualization of dermis and epidermis O
  • Disposable bipolar micro-needle cartridge (electrode) that is inserted into RF o Handpiece and used for coagulation of human tissue
  • O Power cord

The LUDWIG Electrosurgical System generates radiofrequency (RF) energy by means of high RF at .5 MHz, 1MHz. The RF energy is delivered through the skin into the target tissue via a handpiece equipped with an electrode tip. As the RF energy passes through the tissue, it generates an electrothermal reaction which is capable of coagulating the tissue.

The provided text is a 510(k) summary for the LUDWIG Electrosurgical System. It outlines the device's intended use, description, and comparison to predicate devices, referencing various performance data and testing standards. However, it does not contain information about acceptance criteria or a study proving the device meets those criteria in the context of an AI/ML medical device.

The document discusses non-clinical testing (electrical, biocompatibility, sterility, shelf life, packaging, ultrasound, software verification/validation, and thermal testing) that was completed with the statement "All acceptance criteria were met." However, it does not detail what those specific acceptance criteria were for each test, nor does it provide the results of those tests. More importantly, it is not an AI/ML device but an electrosurgical system, and therefore, the concepts of "test set," "training set," "ground truth," "expert readers," "MRMC study," and "stand-alone performance" as they relate to AI/ML device performance evaluation are not applicable to this document.

Therefore, I cannot fulfill the request as the essential information related to an AI/ML device's acceptance criteria and a study proving it meets them (including sample sizes, ground truth establishment, expert qualifications, etc.) is not present in the provided text. The device is a physical electrosurgical system, not a software algorithm that would require such evaluation methodologies.

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