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MIRARI® Cold Plasma System provides heating for the purpose of elevating tissue temperature for selected medical conditions such as temporary relief of pain, muscle spasms and increase in local circulation.

The Mirari Cold Plasma System is a portable, hand-held device that emits RF energy at 80kHz. The system is comprised of a battery-operated RF generator, a rechargeable power supply powered by a pair of lithium batteries and a plasma array which is placed in fleece pouch. The plasma array is then placed in a fleece pouch which is then placed on the RF energy is emitted through the array..

The provided text does not contain information about acceptance criteria and a study proving a device meets them in the context of AI/ML performance. Instead, it is an FDA 510(k) summary for a medical device called the "MIRARI® Cold Plasma System," which is an electrosurgical cutting and coagulation device.

The document focuses on demonstrating substantial equivalence to a predicate device (TempSure FlexSure Applicator) for the purpose of market clearance, not on evaluating the performance of an AI/ML algorithm against specific acceptance criteria.

Therefore, I cannot extract the requested information (such as acceptance criteria table, sample sizes, expert qualifications, adjudication methods, MRMC study details, standalone performance, ground truth types, or training set details) from the provided text because it describes a different type of medical device submission that does not involve AI/ML performance evaluation.

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