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e-Celsius Medical System is indicated for the measurement of core body temperature in patients for whom accurate continuous core body temperatures are clinically necessary for periods exceeding six (6) hours and with whom rectal catheters are not appropriate. e-Celsius Medical System can only be used on the order of a physician who has clinically evaluated the contraindications and warnings associated with the use of and ingestible thermometer and determined that the risk is clinically justified versus an oral thermometer or- rectal catheter.

e-Celsius Medical System is indicated for patients 18 years or older as long as their body weight is above 80 pounds.

e-Celsius Medical System is not indicated for patients with special needs, esophageal or swallowing disorders, who are psychologically unsound, or have disabilities which may make the patient unable to swallow the device for any reason, these patients should be deemed ineligible for this device.

e-Celsius Medical System is a prescription use device primarily (e.g., initial setup, final data assessment, reprocessing, etc.) indicated for use in clinical environments (e.g., hospitals, hospice, clinics, medical offices.)

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I am sorry, but the provided text only contains an FDA clearance letter for the 'e-Celsius Medical System' and its indications for use. It does not include acceptance criteria, study details, performance data, or information about sample sizes, ground truth establishment, or expert qualifications. Therefore, I cannot fulfill your request based on the given information.

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