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The PainShield"M MD diathermy device is intended to apply ultrasounic energy to generate deep heat within body tissues for the treatment of selected medical conditions such as relief of pain, muscle spasms, and joint contractures.

The PainShield™ MD is an ultrasonic diathermy device used to apply deep heat to tissues in the body with a transducer/applicator that is incorporated into a patch that adheres to the skin, as does a bandage.The PainShield™ MD is used to generate continuous wave ultrasound at 90 kHz, through a reusable applicator/transducer that covers an area of about 6 cm². The small applicator allows treatment of less accessible body parts such as, for example, the heel, the achilles tendon and the wrist. The device includes the above-mentioned transducer, a small, rechargeable, battery-powered driver unit and a cable that connects the driver to the transducer.

The provided text is a summary of safety and effectiveness for a medical device called PainShield™ MD, a 510(k) clearance letter from the FDA, and the indications for use. It primarily focuses on demonstrating substantial equivalence to a predicate device and regulatory compliance.

Crucially, the document DOES NOT contain information regarding acceptance criteria, performance studies with specific statistical outcomes, sample sizes for test or training sets, ground truth establishment, expert qualifications, or details about any comparative effectiveness studies (MRMC) or standalone performance studies.

The "Summary of Safety and Effectiveness" section describes the device, its intended use, and lists several advantages it has over existing devices. It concludes by stating, "The Painshield™ MD complies with the FDA standard for ultrasonic therapy products." This is a general statement of compliance, not a detailed report of performance against specific acceptance criteria.

Therefore, I cannot fulfill the request to provide a table of acceptance criteria and reported device performance or information about the studies mentioned in your prompt because this information is not present in the provided text.

The text is a regulatory submission about the device, not a scientific study of the device's performance against specific metrics. It focuses on regulatory equivalence and safety assurances.

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