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Ultrasound for use in applying deep heat can be used for treatment of selected medical conditions such as the relief of pain, muscle spasms and joint contractures. These conditions may be associated with adhesive capsulitis, bursitis with slight calcification, myositis and soft tissue injuries. The CPS Ultrasound, while using any of the applicators available for this device, can provide therapeutic deep heating between 40° and 45°C in all of its operating modes.

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The provided document is a 510(k) clearance letter from the FDA for several devices manufactured by Chattanooga Group, Inc., specifically the Forte CPS 400 Stim, Forte CPS 200 Stim, Forte CPS Ultrasound, Forte CPS 400 Combo, and Forte CPS 200 Combo. These are physical therapy devices, and the letter confirms that they are substantially equivalent to devices marketed prior to May 28, 1976.

The document does not contain any information regarding acceptance criteria, device performance studies, sample sizes, expert qualifications, or ground truth establishment. The letter is a regulatory approval document, not a scientific study report. It states that the FDA has reviewed the submission and found the devices substantially equivalent based on the indications for use provided.

Therefore, I cannot fulfill your request for information on acceptance criteria and a study proving device performance from the provided text.

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