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The intended use of the Ceragem Automatic Thermal Massager, Model CGM-MB-1902 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

Not Found

I am sorry, but the provided text from the FDA 510(k) clearance letter for the "Ceragem Automatic Thermal Massager (CGM-MB-1902)" does not contain any information about acceptance criteria or a study proving the device meets those criteria, especially in the context of AI/ML performance.

The letter is a standard FDA clearance document that states the device has been determined to be substantially equivalent to legally marketed predicate devices. It discusses:

• The device name and regulation details.
• General controls provisions (registration, listing, GMP, labeling, etc.).
• Applicable regulations (QS regulation, UDI Rule).
• Contact information for FDA.
• The "Indications for Use" for the device, which are limited to providing muscle relaxation therapy, temporary relief of minor muscle and joint pain/stiffness, temporary relief of minor joint pain associated with arthritis, temporary increase in local circulation, and relaxation of muscles.

There is no mention of:

• Any AI/ML component in the device.
• Specific performance metrics or acceptance criteria for such a component.
• Any study data (sample sizes, expert qualifications, ground truth, MRMC studies, standalone performance) related to an AI/ML algorithm.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them, as the provided document does not contain this information. The device, as described, is a physical therapy device and not an AI/ML-driven diagnostic or therapeutic tool for which such detailed performance studies would be typically required for clearance.

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