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Intented to use to emit energy in the infrared spectrum to provide topical heating for the purpose of temporarily elevating local tissue temperature.

Intended to use for the temporary relief of minor muscle and joint stiffness, temporary relief of minor muscle strain spasm, temporary increase in local circulation where applied, and the relaxation of muscle.

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The document provided is a 510(k) clearance letter from the FDA for a device called "OK-Wide Band Spectrum Therapeutic Apparatus." This type of document declares that a new medical device is substantially equivalent to a predicate device already on the market.

Unfortunately, this document does not contain any information regarding acceptance criteria, study details, sample sizes, expert qualifications, or ground truth establishment. The letter is a regulatory approval document and focuses on the substantial equivalence determination and regulatory requirements for marketing the device.

To address the request, I need information that would typically be found in a 510(k) summary, clinical study reports, or detailed technical documentation submitted by the manufacturer. Since these are not present in the provided text, I cannot generate the requested table or answer the specific questions about the device's performance study.

Therefore, based solely on the provided text, I cannot describe the acceptance criteria or the study that proves the device meets them.

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