(172 days)
Infrared Thermometer DET series are intended for the intermittent measurement of human body temperature by people of all ages. The devices are reusable for home use only.
The Infrared thermometers are hand-held, battery powered devices designed to measure human body temperature from the auditory canal or forehead. Its operation is based on measuring the natural thermal radiation from the tympanic membrane or forehead. 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 thermopile collect, the infrared energy emitted from the forehead. The Infrared thermometer included DET-205,DET-305,DET-305,DET-306 and DET-215. DET-205 and DET-206 units are contact Infrared forehead thermometer,DET-305 and DET-306 units are non-contact Infrared forehead thermometer(measurement distance is 2~3cm), DET-215 unit is multifunction infrared thermometer and it can be selected Ear mode or Forehead mode. In addition,all models have voice function that used to broadcast the measurement temperature results after complete the measurement. It's working principle is that Microcontroller Unit sends voice commands to the voice integrated circuit and then broadcast the measurement temperature results that display on the LCD.The voice function is use English language and actives after each measurement completed.
The provided document is a 510(k) premarket notification for a medical device (Infrared Thermometers). It details the substantial equivalence of the subject device to legally marketed predicate devices, focusing on technical specifications and conformance to standards. However, it does not include the specific details typically found in a study proving a device meets acceptance criteria related to AI/ML performance, especially those involving human expert review, MRMC studies, or clear ground truth establishment for a test set. This document describes the validation of a traditional hardware thermometer, not an AI-powered device.
Therefore, many of the requested items (e.g., sample size for test set provenance, number of experts for ground truth, adjudication method, MRMC study, standalone performance for AI, training set details) are not applicable to this document as it concerns a non-AI/ML device.
Here's an attempt to extract the relevant information based on the document, noting where the requested information is absent or not applicable:
Device Type: Infrared Forehead Thermometer, Infrared Ear/Forehead Thermometer
Models: DET-205, DET-206, DET-305, DET-306, DET-215
1. Acceptance Criteria and Reported Device Performance
The acceptance criteria for these thermometers are based on conformance to recognized standards, primarily ASTM E1965-98 for performance and ISO 80601-2-56 for general safety and essential performance of clinical thermometers. The key performance metric is accuracy of temperature measurement.
| Acceptance Criteria (from ASTM E1965-98 / ISO 80601-2-56 compliance) | Reported Device Performance (Accuracy) |
|---|---|
| Forehead mode: ±0.2℃ (0.4℉) during 35.5℃~42.0℃ (95.9℉~107.6℉) at 15℃~35℃ (59.0℉~95.0℉) operating temperature range | Meets the criteria: ±0.2℃ (0.4℉) during 35.5℃~42.0℃ (95.9℉~107.6℉) at 15℃~35℃ (59.0℉~95.0℉) operating temperature range |
| Forehead mode: ±0.3℃ (0.5℉) for other measuring and operating temperature range | Meets the criteria: ±0.3℃ (0.5℉) for other measuring and operating temperature range |
| Ear / Forehead mode (for DET-215): ±0.2°C (0.4°F) during 35.5°C | Meets the criteria: ±0.2°C (0.4°F) during 35.5°C |
| Ear / Forehead mode (for DET-215): ±0.3℃ (0.5°F) for other measuring and operating temperature range | Meets the criteria: ±0.3℃ (0.5°F) for other measuring and operating temperature range |
Additional Conformance Standards:
- IEC 60601-1:2012 (Safety)
- IEC 60601-1-2:2014 (EMC)
- ISO 10993-5:2009 (Biocompatibility - In Vitro cytotoxicity)
- ISO 10993-10:2010 (Biocompatibility - irritation and skin sensitization)
- IEC 60601-1-11:2015 (Home healthcare environment)
The document states that a clinical performance test protocol and data analysis were conducted as required by ASTM E1965-98 (2016), and "The test report showed the clinical performance of the subject device complied with the requirement of ASTM E1965-98 (2016)."
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Clinical Tests: 165 subjects.
- Data Provenance: Not explicitly stated regarding country of origin, but the submitting company is based in China. The study is described as "clinical tests were conducted," implying a prospective study for the device's performance evaluation.
- Subject Groups: Infants (newborn to one year), Children (greater than one to five years), and Adults (greater than five years old).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
Not Applicable. For a traditional thermometer, "ground truth" for temperature measurement is typically established using highly accurate reference thermometers or through controlled calibration procedures traceable to national standards, not through human expert review or consensus as would be the case for AI image interpretation. The clinical study evaluates the device's reading against an established reference method.
4. Adjudication Method for the Test Set
Not Applicable. As "ground truth" is not established by human experts in this context, an adjudication method is not relevant.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and its effect size
No. This is a hardware thermometer, not an AI/ML device. Therefore, no MRMC comparative effectiveness study was conducted to evaluate human reader improvement with AI assistance.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done
Not Applicable. This is a hardware device; there is no AI algorithm to evaluate in a standalone manner. The device's performance is intrinsically its "standalone" performance.
7. The Type of Ground Truth Used
The ground truth for temperature measurement would typically be established by:
- Comparison with a traceable reference thermometer (e.g., in a laboratory setting for accuracy testing against a known temperature).
- In the context of the "clinical performance test," it refers to the device's ability to accurately measure human body temperature as determined by standardized clinical protocols (e.g., comparison to rectal temperature as a gold standard in some contexts, or high-accuracy reference thermometers within a controlled clinical environment). The document explicitly states the test "complied with the requirement of ASTM E1965-98 (2016)," which outlines the methodology for clinical accuracy testing of infrared thermometers against a reference thermometer.
8. The Sample Size for the Training Set
Not Applicable. This is a hardware device, not an AI/ML model that requires a training set.
9. How the Ground Truth for the Training Set was Established
Not Applicable. No training set was used.
§ 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.