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Intended to emit energy in the infrared spectrum to provide topical heating for the purposes of elevating tissue temperature when heat is indicated for the temporary relief of minor muscle and joint pain and stiffness, for the temporary relief of minor joint pain associated with arthritis, to temporarily increase local blood circulation where applied and the relaxation of muscles. This is a prescription only device.

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I am unable to extract information about the acceptance criteria and the study that proves the device meets the acceptance criteria from the provided document. The document appears to be an FDA 510(k) clearance letter for a medical device (Physiolaser Olympic) and an associated Indications for Use form.

This type of document typically confirms that the device is substantially equivalent to a legally marketed predicate device, but it does not usually contain the detailed technical studies, acceptance criteria, or performance data that would be part of the 510(k) submission itself.

Therefore, I cannot provide the requested information, including:

1. A table of acceptance criteria and the reported device performance
2. Sample size used for the test set and the data provenance
3. Number of experts used to establish the ground truth for the test set and their qualifications
4. Adjudication method for the test set
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, and its effect size
6. If a standalone performance study was done
7. The type of ground truth used
8. The sample size for the training set
9. How the ground truth for the training set was established

The document primarily focuses on regulatory clearance, general controls, and labeling requirements, along with the device's intended use for temporary relief of minor pain, stiffness, and to increase local blood circulation through topical heating.

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