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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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TF1265, TF1267 Forehead Thermometer is an electronic thermometer using an infrared sensor to detect human body temperature fro the surface of human skin without contact. It is for use by people of all ages in the homecare environment.

The Forehead Thermometer TF1265, TF1267 is characterized by measuring human body temperature from the surface of human skin. It utilizes infrared technology to measure infrared energy emitted from the skin surface when making a temperature measurement.

This document describes the regulatory submission for the KINGTECH Forehead Thermometer, Models TF1265 and TF1267. It is a 510(k) summary, indicating that the device is seeking clearance based on substantial equivalence to a legally marketed predicate device.

Here's the breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

The provided document does not explicitly state specific numerical acceptance criteria for clinical performance (e.g., accuracy against a gold standard) for the subject device. Instead, it relies on a claim of "entire identical specifications" and a direct comparison to a predicate device, K122221, "Nexus IR30 Thermometer, Model: TD-1265."

The performance tests mentioned are safety and electromagnetic compatibility (EMC) standards:

Note: The document states, "This 510k submission only need change the application name of the predicate K122221 from 'Nexus IR30 Thermometer, TD-1265' to 'KINGTECH Forehead Thermometer, TF1265' there is the entire identical specifications and only need to separate into different 510k." This implies that the KINGTECH device's clinical performance is assumed to be identical to the predicate device's performance, as they share the same specifications. However, the performance metrics of the predicate device are not included in this summary.

2. Sample Size Used for the Test Set and Data Provenance

The document does not provide information on a specific clinical test set for the KINGTECH device, nor does it specify sample size or data provenance. It explicitly states under "Clinical Tests:" followed by a blank entry, suggesting no new clinical testing was conducted for this 510(k) submission. Instead, the submission relies on the "entire identical specifications" to the predicate device.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This information is not applicable or provided as no specific clinical test set for the KINGTECH device is described. The device's substantial equivalence is based on its identical specifications to the predicate device, not on new clinical data with an independent ground truth.

4. Adjudication Method for the Test Set

This information is not applicable or provided as no specific clinical test set requiring adjudication for the KINGTECH device is described.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size of Human Readers Improvement with AI vs. Without AI Assistance

This information is not applicable or provided. The device is an infrared thermometer, not an AI-assisted diagnostic tool requiring MRMC studies for human reader performance.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

This information is not applicable or provided. The device is a thermometer, not an algorithm. Its performance is measured directly, though the document defers to the predicate device's performance characteristics.

7. The Type of Ground Truth Used

This information is not applicable or provided for the subject device. For a thermometer, the "ground truth" for reported temperature accuracy would typically be a highly accurate reference thermometer measurement. However, since no new clinical testing is presented, the ground truth methodology for the predicate device is not detailed here.

8. The Sample Size for the Training Set

This information is not applicable or provided. The device is a hardware product (thermometer) and not a machine learning algorithm that requires a training set in the typical sense.

9. How the Ground Truth for the Training Set Was Established

This information is not applicable or provided. Refer to point 8.

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The KINGTECH Infrared Ear Thermometer, models: TM810B, TM810B, TM817, TM818, TM818A, TM819, and TM820 are battery-operated electronic devices with intended use of measuring body temperature from the auditory canal of a patient by means of an infrared sensor coupled with electronic signal amplification, conditioning and a digital LCD (display) unit. The devices are reusable and intended for home use on people at all ages.

The Infrared Ear Thermometer, models TM810B, TM810B, TM817, TM818, TM818A, TM819 and TM820 is a handheld electronic thermometer that measures the temperature through the opening of the auditory canal by using a thermopile as the temperature sensor. The signal of sensor is calculated and displayed by an ASIC (Application Specific IC)- controlled circuit, which is considered the hard-wire control instead of programmable control. From the construction point of view, the ear thermometer comprised of a thermopile for the measuring sensor, a reference thermometer for comparison of temperature, a buzzer for sounding effect, an ASIC for calculating, and LCD for displaying the measuring temperature digitally for which the thermopile sensor detect the ear canal temperature through the infrared. This system uses a 3.0V DC battery (2*AAA batteries) for operation of complete system whenever the battery is low, the ASIC circuit will detect the low battery condition automatically, and displays 'Low battery' in LCD display.

The provided text describes the acceptance criteria and the study for the Kingtech Infrared Ear Thermometer, Models TM810A, TM810B, TM817, TM818, TM818A, TM819, and TM820.

Here's the breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

The primary standard referenced for performance assessment is ASTM E 1965-2003. This standard outlines the requirements for infrared thermometers for intermittent determination of patient temperature. While the extract doesn't provide a specific table with numerical acceptance criteria and direct reported performance values in a side-by-side format, it states that the devices "were designed and verified according to the US standard ASTM E 1965-2003" and that "The results of the clinical Test Report could positively support the claim of Substantial Equivalence."

Therefore, based on the document, the acceptance criteria are implicitly those defined by ASTM E 1965-2003 for infrared ear thermometers.

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size for Test Set: The document does not explicitly state the sample size used for the clinical test set. It mentions "A Clinical Test Report conducted according to ASTM E1965:2003." ASTM E1965-2003 itself specifies requirements for subject numbers, typically recommending a minimum of 25 subjects for clinical accuracy testing. Without the report, the exact number isn't known, but it would have to meet the ASTM standard.
• Data Provenance: The study was "performed by the manufacturer." The manufacturer, Kingtech Enterprises Limited, is based in China. The study is prospective in nature, as it was a "Clinical Test Report carried out in such a way that compared the accuracy performance between models TM810A, TM810B, TM817, TM818, TM818A, TM819 and TM820, as well as TM818A and the predicate device."

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This information is not provided in the document. For a thermometer, ground truth is typically established by simultaneous or near-simultaneous measurements with a highly accurate reference thermometer (e.g., rectal or oral electronic thermometer, or a well-calibrated thermocouple) in a controlled clinical setting, rather than through expert consensus.

4. Adjudication Method for the Test Set

Adjudication methods (like 2+1, 3+1, none) are typically used for subjective assessments where multiple readers provide interpretations (e.g., radiology studies). For a device like an ear thermometer that provides a numerical output, a human adjudication method is not applicable or mentioned. The "ground truth" for thermometer accuracy is usually based on direct comparison to a validated reference measurement.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is relevant for diagnostic imaging devices where human readers interpret images. Mechanical performance (accuracy) of a thermometer is assessed by comparing its readings to a reference standard, not through multiple human interpretations. The study involved comparing the new devices to a predicate device.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done

The device is an infrared ear thermometer, a physical measurement device. Its performance is its standalone performance in measuring temperature. There isn't an "algorithm only without human-in-the-loop" concept in the same way it applies to AI software. The device itself performs the measurement. The "human-in-the-loop" aspect is limited to correctly placing the thermometer and reading the displayed temperature. The clinical test evaluated the device's performance directly, which is equivalent to a standalone performance evaluation for this type of product.

7. The Type of Ground Truth Used

The ground truth for the clinical study would have been established using reference temperature measurements from a highly accurate and validated method. While not explicitly stated, ASTM E1965-2003 dictates using a clinical reference thermometer (e.g., rectal, oral) or a traceable calibration standard to establish the "true" body temperature against which the ear thermometer's readings are compared.

8. The Sample Size for the Training Set

Not applicable. This device is a hardware-based infrared thermometer using an ASIC for calculation, not an AI/machine learning device that requires a "training set." The ASIC-controlled circuit is described as "hard-wire control instead of programmable control."

9. How the Ground Truth for the Training Set Was Established

Not applicable. As stated above, this device does not utilize a training set in the conventional sense of machine learning.

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