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The PREMIO 10 moxa is a non-invasive infrared lamp intended to provide topical heating. The PREMIO 10 moxa is indicated for temporary relief of minor muscle and joint pain, arthritis and muscle spasm, relieving stiffness, promoting relaxation of muscle tissue, and to temporarily increase local blood circulation where heat is indicated.

The PREMIO 10 moxa is a non-invasive infrared lamp intended to provide topical heating.

I am sorry, but the provided text does not contain the information required to answer your request. The document is an FDA 510(k) clearance letter for a medical device called "PREMIO 10 moxa," which is an infrared lamp. This type of document typically confirms that a device has been cleared for market based on substantial equivalence to a predicate device, but it does not include detailed information about the acceptance criteria, study design, or performance metrics that would be found in a clinical study report or a detailed premarket submission.

Specifically, the document does not provide any information on:

1. Acceptance criteria or reported device performance
2. Sample size, data provenance, number of experts, adjudication method, MRMC studies, standalone performance, or type of ground truth used for a test set.
3. Sample size or ground truth establishment for a training set.

The letter focuses on regulatory compliance and substantial equivalence, not on the results of a performance study with detailed acceptance criteria and study methodologies.

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