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Mjolnir Pro. With single-electrode plasma tip is used in the removal and destruction of skin lesions and coagulation of tissue.

Mjolnir Pro. With Multi-electrode plasma tip is intended for use in dermatologic and general surgical procedures for coagulation and hemostasis.

Mjolnir Pro. With single-electrode plasma tip is used in the removal and destruction of skin lesions and coagulation of tissue. With Multi-electrode plasma tip is intended for use in dermatologic and general surgical procedures for coagulation and hemostasis. Under the controllable way, the device 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 316 stainless steel is available with the system.

The provided document describes the Mjolnir Pro. (Multi-electrode plasma) device and its substantial equivalence to predicate devices, but it does not contain information about acceptance criteria and a study proving the device meets those criteria in the context of clinical performance or diagnostic accuracy.

The document focuses on demonstrating substantial equivalence based on:

• Intended Use and Technological Characteristics Comparison: Highlighting similarities in indications for use, product code, classification regulation, mode of operation, and maximum output power with predicate devices (pages 6-7).
• Non-Clinical Testing: Including compliance with electrical safety (ANSI/AAMI ES60601-1, IEC 60601-2-2), EMC (IEC 60601-1-2), and biocompatibility (ISO 10993-5, ISO 10993-10, ISO 10993-23) standards.
• Performance Testing for Tissue Thermal Effect: "The tests were conducted on freshly ex vivo pig tissue. Histological evaluation with Hematoxylin-Eosin (H&E) demonstrated the tissue damages by the subject device are less than 0.25mm, which is considered superficial and substantially equivalent to the tissue damages." (page 9)
• Software Verification and Validation Testing: Conducted per FDA guidance, with a moderate level of concern (page 9).

Therefore, I cannot provide a table of acceptance criteria and reported device performance, nor details on sample sizes for test sets (as no clinical test set for diagnostic accuracy or clinical effectiveness is mentioned), number/qualifications of experts, adjudication methods, MRMC studies, standalone performance, or ground truth types related to a clinical study demonstrating performance against specific clinical acceptance criteria.

The document's scope is primarily a non-clinical evaluation to support substantial equivalence for a 510(k) submission for an electrosurgical device, not a clinical trial with performance metrics like sensitivity, specificity, accuracy, or reader agreement.

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