(434 days)
The Non-contact Forehead Thermometer is an infrared thermometer intended for the intermittent measurement of human body temperature in people of all ages.
The Non-contact Forehead Thermometers are hand-held, battery powered devices designed to measure human body temperature. The subject devices are Infrared thermometers that convert a user's forehead temperature using the infrared energy emitted in the area around the user's forehead to an oral equivalent temperature when placed in the distance from subject's forehead up to 5-8cm(HW-2,HW-2S,HW-3,HW-302 and HW-303) or 1-2cm(HW-4 and HW-4S).
The thermometers use a thermopile sensor with integrated thermistor for the target reading, a thermistor mounted in the head of the thermometer for ambient temperature readings, a parabolic mirror to help focus the infrared energy emitted from the forehead, and an infrared distance sensor for detection with the distance from forehead up to 5~8cm(HW-2,HW-2S,HW-3,HW-302 and HW-303) or 1-2cm(HW-4 and HW-4S) and compensation of the temperature reading.
Here's an analysis of the acceptance criteria and study details for the Non-contact Forehead Thermometer, Model: HW-2/HW-2S/HW-3/HW-4/HW-4S/HW-302/HW-303, based on the provided FDA 510(k) summary:
Acceptance Criteria and Reported Device Performance
The primary standard referenced for performance is ASTM E1965-98. The key performance metric is accuracy.
| Acceptance Criteria (from ASTM E1965-98) | Reported Device Performance (from K173048 Summary) |
|---|---|
| Forehead mode: ±0.2°C (0.4°F) within 36-39°C (96.8-102°F) | Forehead mode: ±0.2°C (0.4°F) within 35.5°C~42.9°C (95.9°F ~109.2°F) |
| Forehead mode: ±0.3°C (0.5°F) other ranges | Forehead mode: ±0.3°C (0.5°F) other ranges |
Note: The subject device's reported accuracy range (35.5°C~42.9°C) is broader than the predicate's 36-39°C range for the higher accuracy specification, which still meets the overall requirements of ASTME1965-98.
Study Details
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Sample Size Used for the Test Set and Data Provenance:
- Test Set Size: 96 subjects.
- Age Groups: Divided into three groups:
- Infant (newborn to 1 year): 32 patients
- Children (greater than 1 to 5 years old): 32 patients
- Adult (greater than 5 years old): 32 patients
- Temperature Distribution: 30% of the subjects in each group had a temperature equaling or exceeding 38.0°C.
- Data Provenance: Not explicitly stated regarding country of origin or whether it was retrospective/prospective. However, "clinical tests were conducted" implies a prospective study.
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Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of those Experts:
- This information is not provided in the summary. The summary only mentions "Clinical data" and that "Clinical tests were conducted." It does not specify how the ground truth (e.g., core body temperature for comparison) was established or who assessed it.
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Adjudication Method for the Test Set:
- This information is not provided in the summary.
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Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- No, an MRMC comparative effectiveness study was not done. This device is a medical thermometer, and the standard evaluation involves comparing its readings against a reference thermometer or standard, not assessing human reader improvement with AI assistance.
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Standalone Performance Study:
- Yes, a standalone performance study was conducted. The "Clinical data" section describes the evaluation of the device "complied with the requirement of ASTM E1965-98 (2016)." This refers to the accuracy performance of the device itself.
- Additionally, the "Non-Clinical Data" section lists a "Performance test in home healthcare environment" and "Laboratory accuracy test" as part of the ASTM E1965-98 testing, indicating comprehensive standalone performance evaluation.
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Type of Ground Truth Used:
- The primary ground truth for clinical thermometers is typically a reference body temperature measurement obtained through a highly accurate and validated method (e.g., rectal temperature for infants, oral or tympanic for adults, or even invasive core temperature in some research settings) against which the device's forehead temperature readings are compared. The summary does not explicitly state the method used for the reference temperature, but ASTM E1965-98 specifies requirements for this.
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Sample Size for the Training Set:
- This device is an infrared thermometer, not an AI/machine learning algorithm that requires a separate "training set." Therefore, this question is not applicable in the context of this device.
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How the Ground Truth for the Training Set Was Established:
- As stated above, this device does not use a training set in the typical AI/ML sense. This question is not applicable.
§ 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.