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The intended use of the Ceragem Automatic Thermal Massager, Model CGM MB-2301 & CGM MB-2302 is to provide muscle relaxation therapy by delivering heat and soothing massage.

Additionally, the product provides topical radiant infrared heat for:

• Temporary relief of minor muscle and joint pain stiffness
• Temporary relief of minor joint pain associated with arthritis
• Temporary increase in local circulation where applied
• Relaxation of muscles

The Air Cell Massager is indicated for the temporary relief of minor muscle aches and for temporary increase in blood circulation to the treated areas. The Air Cell Massager stimulates kneading and stroking of tissues by using an inflatable garment.

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I am sorry, but the provided text is a 510(k) clearance letter from the FDA for a medical device (Ceragem Automatic Thermal Massager). This type of document does not contain any information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert qualifications.

The letter is primarily concerned with:

• Confirming that the device is substantially equivalent to legally marketed predicate devices.
• Outlining the regulatory requirements the manufacturer must adhere to (e.g., registration, labeling, quality system regulations).
• Providing contact information for regulatory inquiries.
• Stating the intended use of the device.

Therefore, I cannot extract the information you requested regarding acceptance criteria and study details from the provided text.

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