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THE DEVICE IS INTENDED TO READ THE TEMPERATURE OF ANY PEOPLE , WHEN NEEDED.

1. IT ADOPTS EITHER FAHRENHEIT OR CENTIGRADE DEPENDS ON NEED.
2. IT CAN BE ORAL, RECTAL OR AXILLLARY USE.

SUPER SOOTHER CLINICAL ELECTRONIC THERMOMETER

The provided document is a 510(k) premarket notification letter from the FDA regarding the "SUPER SOOTHER CLINICAL ELECTRONIC THERMOMETER." This is a regulatory clearance letter, not a study report or a detailed performance evaluation. Therefore, it does not contain the specific information requested in your prompt regarding acceptance criteria, study details, sample sizes, expert qualifications, or ground truth methodologies.

The letter explicitly states: "We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976..."

This means the device's clearance is based on its substantial equivalence to a pre-existing device, not on a new, comprehensive clinical study validating specific performance metrics against pre-defined acceptance criteria as would be found in a performance study report.

Therefore, I cannot provide the requested information from the given document.

If you have a different document (e.g., a clinical study report or a detailed device specification document), I would be happy to analyze it for the criteria you've outlined.

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