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TT1001 Digital Thermometer is intended to measure the body temperature orally and to be used by medical professionals in clinical and hospital environments and consumers in a home environment. It is intended for use on people of all ages.

The Digital Thermometer TT1001 enables easy and accurate readings over the body temperature range. It must be used in conjunction with disposable probe cover when taking temperature. From the construction point of view, the digital thermometer comprises of a thermistor for measuring sensor, a reference resistor for comparison of temperature, a buzzer for sounding effect, an ASIC for calculating, and LCD for displaying the measuring temperature digitally for which the thermistor contacts.

The KINGTECH Digital Thermometer, TT1001, is intended for measuring body temperature orally in clinical, hospital, and home environments for people of all ages.

The 510(k) submission for the KINGTECH Digital Thermometer, TT1001, primarily establishes substantial equivalence to a predicate device (TaiDoc Digital Thermometer, TD-1001, K122520) rather than presenting a de novo study with specific acceptance criteria and performance results directly from the TT1001 device. The submission states that the two devices have "entire identical specifications." Therefore, the "reported device performance" for the TT1001 is implicitly tied to the performance attributed to the predicate device and the general standards applied to digital thermometers.

1. Table of Acceptance Criteria and Reported Device Performance

Based on the provided document, the device's performance is demonstrated through adherence to recognized international and national standards for clinical thermometers. Since a direct performance study of the TT1001 with pass/fail criteria and specific results is not presented, the acceptance criteria are drawn from the cited standards, and the reported performance is the claim of compliance with these standards.

2. Sample Size and Data Provenance for Test Set

The provided 510(k) summary does not specify a distinct "test set" for the KINGTECH Digital Thermometer TT1001 for which a sample size or data provenance is detailed. The submission is a "change the application name" type, stating that the TT1001 has "entire identical specifications" to the predicate device (TaiDoc Digital Thermometer, TD-1001, K122520). The test reports and documentation for this submission were prepared by TaiDoc Technology Corporation and BioCare Co., Ltd. (a branch office of TaiDoc Technology Corporation).

Therefore, any performance data for the TT1001 is implicitly derived from the testing activities conducted for the predicate device, within the framework of the cited standards. The sample sizes and data provenance for those underlying studies for the predicate device are not explicitly provided in this document.

3. Number of Experts and Qualifications for Ground Truth of Test Set

This information is not applicable and not provided in the 510(k) summary. For a digital thermometer, "ground truth" typically refers to the accuracy of temperature measurement against a reference standard, not subjective expert assessment of an image or signal. The clinical performance testing would involve comparing the device's readings to a validated reference thermometer, rather than expert interpretation.

4. Adjudication Method for Test Set

This is not applicable and not provided. Performance testing of a digital thermometer involves objective measurement comparisons to standards, not human adjudication of ambiguous cases.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No. An MRMC study is not relevant for a simple digital thermometer. These studies are typically employed for diagnostic imaging devices where human interpretation is a critical component influencing diagnostic accuracy, and AI assistance can potentially improve reader performance.

6. Standalone (Algorithm Only) Performance Study

No. While the thermometer uses an ASIC for calculation, the "device" is the complete physical product with its sensor, processing unit, and display. The performance studies cited (e.g., EN12470, ASTM E1112-00) evaluate the performance of the integrated device in measuring temperature, not a standalone algorithm in isolation from the hardware.

7. Type of Ground Truth Used

For the performance of the digital thermometer (implied by compliance with EN12470, ASTM E1965-98, and ASTM E1112-00), the ground truth for temperature measurement would be established by reference to a highly accurate and calibrated temperature standard (e.g., a laboratory reference thermometer or a temperature-controlled bath). The device's readings are compared against this known "true" temperature under specified conditions.

8. Sample Size for Training Set

This information is not applicable. The KINGTECH Digital Thermometer TT1001 is not an AI/ML-driven device that undergoes a "training" phase in the conventional sense of machine learning. Its operation is based on a fixed algorithm (ASIC) processing sensor input, validated against known physical principles and standards.

9. How Ground Truth for Training Set was Established

This information is not applicable, as there is no "training set" or AI/ML model for this device.

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