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The HeTaiDa electronic thermometers HTD8818A, HTD8808C are infrared thermometers which use infrared sensor to detect human body temperature of all ages. It is intended to be used on one's forehead to detect body temperature. The HTD8816C, HTD8816C, HTD8808C are intended for use in home and clinical environment.

Device Description

The HeTaiDa infrared body thermometer, Models HTD8818A,HTD8816C,HTD8808C are hand-held device powered by batteries and designed to measure human body temperature without contacting patient's forehead. The thermometer can switch modes between "Body Mode" and "Surface Mode". The "Surface Mode" is DIRECT MODE and the "Body Mode" is ADJUSTED MODE. Forehead temperature of the ADJUSTED MODE is calculated by converting the measured temperature of the DIRECT MODE to an axillary equivalent temperature without contacting the patients' forehead.

AI/ML Overview

The provided text describes the acceptance criteria and the studies conducted to prove that the "Non-contact Infrared Body Thermometer" (Models HTD8808C, HTD8818A, HTD8816C) meets these criteria.

Here's a breakdown of the requested information based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Acceptance Criteria	Reported Device Performance
Labeling	All applicable items for the devices shall meet the requirements (IEC 60601-1 clause 7.9, IEC60601-1-11 clause 7.4, IEC60601-1-2 for EMC declaration, ISO 80601-2-56:2017 clause 201.7.9).	All the changes have been added on labeling.
Operating Environment Change	Laboratory Accuracy: Device complies with its specifications and all requirements of the standard when operated in normal use within Temperature.
Clinical Accuracy: The bias of the test thermometer is non-inferior to the bias of the predicate thermometer when compared to the reference thermometer. The repeatability for the test article is less than or equal to ± 0.3°C.	Laboratory Accuracy: The accuracy of the laboratory under operating environment was within ±0.3°C.
Clinical Accuracy: The clinical bias is equal to 0.05°C/0.07°C/-0.04°C with uncertainty of ±0.20/±0.19/±0.18 respectively for group I (Infants), group II (children) and group III (adults). The "Repeatability" is: 0.13. It's considered reasonably small and not to pose a problem for diagnostic purposes.
Storage Environment Change	Device allowed to return and stabilize at operation conditions of normal use, and provides basic safety and essential performance.	After storage with lowest condition and highest condition of transportation and storage, basic safety and essential performance met the requirements of devices.
Measurement Range Change	Laboratory Accuracy: Laboratory accuracy for lower limit and upper limit of measurement range under five different environments shall be within ±0.3°C.
Clinical Accuracy: The bias of the test thermometer is non-inferior to the bias of the predicate thermometer when compared to the reference thermometer. The repeatability for the test article is less than or equal to ± 0.3°C.	Laboratory Accuracy: The accuracy of the laboratory under operating environment was within ±0.3°C.
Clinical Accuracy: The clinical bias is equal to 0.05°C/0.07°C/-0.04°C with uncertainty of ±0.20/±0.19/±0.18 respectively for group I (Infants), group II (children) and group III (adults). The "Repeatability" is: 0.13. It's considered reasonably small and not to pose a problem for diagnostic purposes.
Temperature Range for Accuracy Change	Laboratory accuracy for lower limit and upper limit of measurement range under five different environments shall be within ±0.3°C.	The accuracy of the laboratory under operating environment was within ±0.3°C.
Feature: Memory Change	The device shall perform right functions, and don't introduce any bug.	The devices perform right functions, and don't introduce any bug.
Feature: Parameter Setting Change	The device shall perform right functions, and don't introduce any bug.	The devices perform right functions, and don't introduce any bug.
Shelf Life Change	All the functions and performance shall meet the requirements after each cycle in the expected shelf-life.	The test from July 3rd, 2017 to October 20th, 2017, totally 107 days and 22 cycles, Total test time is 2112 hours, the accelerated aging test time is 1056 hours under 75°C, 93%RH condition, the life is 5 years after calculation.

2. Sample size used for the test set and the data provenance

The document refers to a clinical accuracy test (referenced as "Appendix 11" and compliant with ASTM E1965-98) for evaluating operating environment and measurement range changes.

Sample Size: The document indicates that clinical bias was calculated for three groups:
- Group I (Infants)
- Group II (Children)
- Group III (Adults)
  However, the specific number of subjects within each group or the total sample size for the clinical test is not explicitly stated in the provided text.
Data Provenance: The document does not explicitly state the country of origin of the data or whether the study was retrospective or prospective.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

The document provides very limited information regarding the clinical study, particularly concerning the establishment of ground truth. It states that "the bias of the test thermometer is non-inferior to the bias of the predicate thermometer when compared to the reference thermometer." This implies a comparison to a "reference thermometer," which would typically be a highly accurate, calibrated device used to establish true body temperature.

Number of Experts: Not mentioned.
Qualifications of Experts: Not mentioned.

4. Adjudication method for the test set

The document does not describe any adjudication method (like 2+1 or 3+1). The evaluation of clinical accuracy seems to be based on direct comparison to a "reference thermometer" and statistical analysis of bias and repeatability.

5. 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

This device is a non-contact infrared body thermometer, not an AI-assisted diagnostic tool involving "human readers" or "cases" in the typical sense of medical imaging or clinical decision support systems. Therefore, an MRMC comparative effectiveness study involving AI assistance for human readers is not applicable to this device and was not performed.

6. If a standalone (i.e., algorithm only without human-in-the loop performance) was done

The device itself is a standalone thermometer. The "standalone" performance is assessed by various bench tests (IEC 60601-1, IEC 60601-1-11, IEC 60601-1-2, ISO 80601-2-56) and a clinical accuracy test comparing its readings directly to a reference thermometer. These tests evaluate the device's accuracy and functionality without human intervention outside of operating the device for measurement.

7. The type of ground truth used

The ground truth for the clinical accuracy tests appears to be established by comparison to a "reference thermometer." This indicates a highly accurate, calibrated device used to obtain the true body temperature against which the performance of the non-contact infrared thermometer is measured.

8. The sample size for the training set

The document primarily focuses on substantiation of modifications and performance testing, not on the development of the core algorithm. It does not provide information on a "training set" in the context of machine learning, as this is an infrared thermometer and not a learning-based algorithm. The device's "algorithm" likely refers to its internal logic for converting infrared readings to a displayed temperature, which would be developed through engineering and calibration, not a machine learning training set.

9. How the ground truth for the training set was established

As there is no mention of a traditional "training set" for a machine learning algorithm, this question is not directly applicable. The device's calibration and accuracy are established through laboratory and clinical testing against reference standards and methods, as detailed under points 1, 2, and 7.

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