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The Digital Clinical thermometers, Models ACT 2030 and ACT 2038's intended use are medical devices, supplied by internal power and intended to precisely measure temperature. It can be used in the measurement of oral, axillary and rectal temperature. This is the same intended use as previously cleared for the Actherm Digital Clinical Thermometers, K010238.

Digital Clinical Thermometers, Models ACT 2030, ACT 2038

The provided text is a 510(k) clearance letter from the FDA for Digital Clinical Thermometers. It does not contain any information regarding acceptance criteria, device performance, study details, sample sizes, ground truth establishment, or expert qualifications. The letter primarily states that the device is substantially equivalent to legally marketed predicate devices and outlines regulatory responsibilities.

Therefore, I cannot provide the requested information based on the input text. The request asks for details of a study that proves the device meets acceptance criteria, but no such study details are present in the provided document.

To answer your questions, I would need a different document, such as a summary of safety and effectiveness, a clinical study report, or a comprehensive 510(k) submission document that includes performance data.

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