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The Pro Check™ Digital Pacifier Thermometer, is a non-sterile, re-usable clinical thermometer intended for the determination of oral body temperature in infants to children five years of age.

The Pro Check™ Digital Pacifier Thermometer, is a battery-powered, liquid crystal display device using a thermometer embedded in the nipple. The patient contact portion is composed of medical silicone rubber. The body is of ABS plastic. This device is reusable and no components are disposable. This device is not intended for use with other sheaths or devices.

The Pro Check™ Digital Pacifier Thermometer relies on previously performed clinical testing for predicate devices (Pasi-Temp Pacifier Digital Thermometer and Basis® Temp Pacifier Digital Thermometer) to demonstrate substantial equivalence. Therefore, the information provided focuses on the predicate devices' performance.

Acceptance Criteria and Reported Device Performance

Study Details (Inferred from Predicate Device Information)

Since the Pro Check™ Digital Pacifier Thermometer directly references clinical testing from its predicate devices, the specifics below apply to those predicate devices and are attributed to the Pro Check™ by reference.

• Sample size used for the test set and the data provenance: Not explicitly stated in the provided document. The document only mentions "Clinical testing previously performed."
• Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not explicitly stated.
• Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not explicitly stated.
• If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This device is a digital thermometer, not an AI-assisted diagnostic tool.
• If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: The device is a standalone thermometer, meaning its performance is measured directly, not as an algorithm assisting human interpretation. The clinical testing likely evaluated its accuracy in measuring temperature.
• The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not explicitly stated, but for a thermometer, the ground truth would typically be a highly accurate reference thermometer (e.g., a calibrated laboratory thermometer) against which the device's temperature readings are compared.
• The sample size for the training set: Not applicable, as this is a traditional medical device not employing machine learning that requires a training set.
• How the ground truth for the training set was established: Not applicable.

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