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The HES® Ultrasonic Therapy Appliance generates deep heat within body tissues for the treatment of selected medical conditions such as temporary relief of minor pain, muscle spasms, and joint contractures, but not for the treatment of malignancies.

The HES® Ultrasonic Therapy Appliance generates deep heat within body tissues.

I am sorry, but based on the provided text, there is no information about acceptance criteria or a study proving that the device meets specific criteria. The document is a 510(k) clearance letter from the FDA for the HES® Ultrasonic Therapy Appliance, confirming its substantial equivalence to a legally marketed device for the stated indications for use.

The text does not include:

• A table of acceptance criteria or reported device performance.
• Details about sample sizes, data provenance, or ground truth establishment for any studies.
• Information on expert review, adjudication methods, or MRMC studies.
• Details about standalone algorithm performance or training sets.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study proving the device meets them based on the given input.

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The HES® Ultrasonic Therapy Appliance generates deep heat within body tissues for the treatment of selected medical conditions such as temporary relief of minor pain, muscle spasms, and joint contractures, but not for the treatment of malignancies.

Not Found

I am sorry, but based on the text provided, I cannot answer your request. The document is a 510(k) clearance letter for an ultrasonic therapy appliance and primarily focuses on regulatory approval. It does not contain information about acceptance criteria, device performance studies, sample sizes, expert qualifications, or ground truth establishment.

Ask a specific question about this device