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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.

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.

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

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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The Infrared Body Thermometer, Model: HTD8823US, is an electronic clinical thermometer using an infrared sensor to detect body temperature from the forehead in people of all ages for home setting use.

Infrared (IR) Body Thermometer, model: HTD8823US, is a hand-held, battery powered, infrared thermometer that measures human body temperature from forehead. The reference body site is oral. The device can measure temperature with two modes, forehead mode and forehead scan mode, and both modes measure forehead temperature. The forehead mode measures temperature from center of the forehead. Forehead scan mode measures temperature by gently positioning the probe flush (flat) on the center of the forehead, midway between the eyebrow and the hairline, press and hold the On/Scan button. Lightly slide the thermometer across the forehead keeping the sensor flat and in contact with the skin until reaching the right hairline, release the On/Scan button and remove the thermometer from the forehead, then the temperature will display on the screen, the whole process takes 3~10 seconds.

The provided document is a 510(k) Summary for the HeTaiDa Technology Co., Ltd. Infrared Body Thermometer, Model: HTD8823US. It outlines the device's characteristics and its substantial equivalence to predicate devices, supported by non-clinical and clinical testing.

Here's an analysis of the acceptance criteria and the study that proves the device meets them:

1. A table of acceptance criteria and the reported device performance

The document references two primary performance standards for the Infrared Body Thermometer: ASTM E1965-98 (2016) and ISO 80601-2-56: 2017. While it states that the device "Meets" these standards, specific quantitative acceptance criteria from these standards and the device's reported performance against each of those specific numerical criteria (e.g., maximum permissible error at different temperature ranges) are not explicitly itemized in a table within the provided text.

However, the "Summary of technological characteristics of device compared to the predicate devices" (Pages 5-7) includes some key performance characteristics that imply acceptance criteria and performance, mostly by stating "Same" or "Similar" to predicates which are presumed to meet equivalent criteria.

Here's a curated table based on the available information, inferring acceptance criteria from the predicates and performance against those:

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

• Sample size for the test set: 140 subjects.
• Data provenance: The document does not explicitly state the country of origin of the data. It also does not explicitly state if the study was retrospective or prospective, but clinical accuracy studies for new devices are typically prospective. The text mentions "Each model was evaluated in 0 up to 3 months, 3 months up to one year, older than 1 year and younger than 5 years, and older than 5 years age groups," indicating a structured, likely prospective clinical trial.

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

This information is not provided in the document. For a clinical thermometer, the "ground truth" for temperature measurement is typically established by using a highly accurate reference thermometer (e.g., laboratory-grade thermometer or a rectal/oral thermometer considered the gold standard in a clinical setting by trained medical professionals). The document only states "The clinical accuracy test report and data analysis followed the requirements of the ASTM E 1965-98 (2016)," which is a standard for infrared thermometers. It doesn't detail the personnel involved in supervised measurements.

4. Adjudication method for the test set

This information is not provided in the document. Adjudication methods like 2+1 or 3+1 are typical for subjective interpretations (e.g., radiology reads). For quantitative measurements like temperature, the ground truth is usually established by direct measurement with a reference standard, not typically through expert adjudication of images or subjective findings.

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

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done, nor would it be relevant for this type of device. This device is an infrared thermometer, not an AI-assisted diagnostic tool that involves human "readers" or interpretation of complex cases. Therefore, there's no mention of AI assistance or its effect size on human performance.

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

The device itself is a standalone algorithm, in the sense that it automatically measures and displays temperature without requiring human interpretation of an output from an underlying AI (beyond reading the numerical display). The "clinical accuracy testing" evaluates the device's performance in this standalone capacity.

7. The type of ground truth used

The ground truth for the clinical accuracy testing was established by comparing the device's measurements against a reference standard of body temperature measurement, as specified by ASTM E1965-98 (2016). While not explicitly stated, this usually involves a core body temperature measurement method (e.g., rectal, oral, or an equivalent highly accurate reference thermometry system) performed by trained personnel.

8. The sample size for the training set

This information is not applicable and therefore not provided. Infrared thermometers like the HTD8823US are hardware-based measurement devices that employ fixed algorithms and calibrations, not machine learning or AI models that require "training sets" in the conventional sense. Any "training" would refer to internal calibration and validation data used during the device design and manufacturing process, which is distinct from a machine learning training set.

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

As inferred above, this information is not applicable as the device does not utilize a machine learning model that requires an external "training set" with established ground truth. The device is calibrated and validated against physical temperature standards and clinical performance requirements.

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The HeTaiDa non-contact infrared body thermometers HTD8818A,HTD8816C, HTD8808C are non-sterile, reusable thermometers intended for the intermittent determination of human body temperature measured at the patients' forehead without contact. The devices are intended for use on people of all ages. The HTD8818A, HTD8816C, HTD8808C are intended for use in clinical and home use environment.

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' 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.

The thermometers HTD8818A, HTD8816C and HTD8808C infer temperature from the blackbody radiation emitted from the patient. Temperature is calculated from the knowledge of the amount of infrared energy emitted from the human body. The thermometer design consists lens to focus the infrared thermal radiation on to a detector, which converts the radiant power to an electrical signal that can be displayed in units of temperature. This permits temperature measurement from a distance without contact with the object to be measured.

The provided document describes the acceptance criteria and the study that demonstrates the performance of the HeTaiDa non-contact infrared body thermometers (Models HTD8818A, HTD8816C, HTD8808C).

Here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are generally implied by adherence to standards like ISO 80601-2-56:2009 and ASTM 1965-68 (Reapproved 2009) for clinical bias, clinical accuracy, and clinical repeatability. The document provides specific accuracy ranges for body and surface modes.

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

• Sample Size for Test Set: The document states "The four groups of subjects being tested were: (1) 0-3 months, (2) 3 months-1 year old, (3) 1-5 years old, and (4) >5 years older." However, the specific number of subjects within each group or total number of subjects is not provided.
• Data Provenance: The document does not explicitly state the country of origin or whether the data was retrospective or prospective. It describes a "clinical investigation was performed," which typically implies prospective data collection, but this is not explicitly confirmed.

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

• Number of Experts: This information is not provided.
• Qualifications of Experts: This information is not provided. The ground truth was established by a "reference contact clinical electronic thermometer BT-21H," implying a standardized measurement rather than expert interpretation.

4. Adjudication Method for the Test Set

• Adjudication Method: This information is not applicable/provided. The ground truth was based on measurements from a reference contact clinical electronic thermometer (axillary temperature) rather than subjective assessments requiring adjudication.

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

• MRMC Study: This information is not applicable. The device is a thermometer, not an AI-assisted diagnostic tool that would involve human readers interpreting images or results. No MRMC study was conducted or is relevant for this type of device.

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

• Standalone Performance: Yes, the clinical investigation evaluates the device's standalone performance directly by comparing its readings to a reference thermometer. The "clinical bias, clinical accuracy and clinical repeatability" are measures of the device's inherent performance.

7. The Type of Ground Truth Used

• Type of Ground Truth: The ground truth for the clinical study was established using measurements from a reference contact clinical electronic thermometer BT-21H, which measured axillary temperatures. This serves as a point of comparison for the non-contact infrared thermometer.

8. The Sample Size for the Training Set

• Sample Size for Training Set: This information is not provided and is generally not applicable in the context of a non-AI based medical device like a thermometer. Thermometers are typically designed and calibrated based on physical principles and standards, not through machine learning training data.

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

• Ground Truth for Training Set: This information is not provided and is generally not applicable for a non-AI device. Calibration and design validation would follow established metrological practices and standards rather than a "training set" with ground truth in the machine learning sense.

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