(392 days)
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.
| Metric / Characteristic | Acceptance Criteria (Implied by Standards / Predicate) | Reported Device Performance (HeTaiDa-thermometers) |
|---|---|---|
| Accuracy (Body Mode) | ||
| 34.0~34.9°C (93.2-94.8°F) | ±0.3°C (±0.5°F) | ±0.3°C (±0.5°F) |
| 35.0~42.0°C (95.0-107.6°F) | ±0.2°C (±0.4°F) | ±0.2°C (±0.4°F) |
| 42.1~42.9°C (107.8-109.2°F) | ±0.3°C (±0.5°F) | ±0.3°C (±0.5°F) |
| Accuracy (Surface Mode) | N/A (Predicate varies, but this device states) | ±2°C (±3.6°F) |
| Clinical Bias | Within clinically acceptable range (ISO 80601-2-56) | -0.027 |
| Clinical Accuracy | Within clinically acceptable range (ISO 80601-2-56) | ±0.14 |
| Clinical Repeatability | Within clinically acceptable range (ISO 80601-2-56) | 0.07 |
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.
§ 880.2910 Clinical electronic thermometer.
(a)
Identification. A clinical electronic thermometer is a device used to measure the body temperature of a patient by means of a transducer coupled with an electronic signal amplification, conditioning, and display unit. The transducer may be in a detachable probe with or without a disposable cover.(b)
Classification. Class II (performance standards). The device is exempt from the premarket notification procedures in part 807, subpart E of this chapter, subject to the limitations in § 880.9 and the following conditions for exemption:(1) Device is not a clinical thermometer with telethermographic functions;
(2) Device is not a clinical thermometer with continuous temperature measurement functions; and
(3) Appropriate analysis and testing (such as that outlined in the currently FDA-recognized editions, as appropriate, of ISO 80601-2-56, “Medical electrical equipment—Part 2-56: Particular requirements for basic safety and essential performance of clinical thermometers for body temperature measurement,” or ASTM E1965, “Standard Specification for Infrared Thermometers for Intermittent Determination of Patient Temperature,” or ASTM E1112, “Standard Specification for Electronic Thermometer for Intermittent Determination of Patient Temperature,” or ASTM E1104, “Standard Specification for Clinical Thermometer Probe Covers and Sheaths”) must validate specifications and performance of the device.