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The SW-Therm, Model ST 1001, is intended to deliver energy in the radio band of 27.12 MHz to provide deep heating therapeatic effects to body tissues. When shortwave diathermy is delivered to the body at intensities capable of generating a deep tissue temperature increase, it can be used to treat selected medical conditions such as:

I ) Relieving pain;

2. Reducing muscle spasm;

3. Increasing range of motion of contracted joints using heat and stretch techniques; and

4. Increasing blood flow to tissues in the treatment area.

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This document is an FDA 510(k) clearance letter for a medical device (SW-Therm, Model ST1001), not a study report. It does not contain information about the acceptance criteria or a study proving the device meets those criteria.

Therefore, I cannot extract the requested information as it is not present in the provided text. The document primarily focuses on the regulatory clearance process and confirms that the device is substantially equivalent to legally marketed predicate devices, subject to general controls. It does not detail specific performance studies, acceptance criteria, or methodological aspects like sample sizes, ground truth establishment, or expert qualifications.

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