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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 Intelect Legend 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 text is a 510(k) premarket notification letter from the FDA to Chattanooga Group, Inc. regarding their Intelect Legend Ultrasound device from 1997. This document primarily focuses on the regulatory clearance of the device based on substantial equivalence to pre-amendment devices. It does not contain information about acceptance criteria, detailed study designs, performance metrics, ground truth establishment, or sample sizes typically found in modern AI/ML device submissions.

Therefore, I cannot extract the requested information as the document does not describe any specific acceptance criteria or a study that proves the device meets those criteria.

The letter states that the device can provide therapeutic deep heating between 40° and 45°C, but this is a characteristic of the device's function, not a performance metric from a study against specific acceptance criteria in the context of an effectiveness study.

To answer your request based on the provided text, I must state that the information is not available in these documents.

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