(166 days)
The RII Multi-function Infrared Thermometer, Model TH52Z is intermittent measurement of human body temperatures. The device is intended for the use at home by people of all ages including neonates and it can be selected Ear mode or Forehead mode.
The RII Multi-function Infrared Thermometer, Model TH52Z is an electronic thermometer using an infrared sensor (thermopile) to detect body temperature from the auditory canal or central forehead. Its operation is based on measuring the natural thermal radiation from the tympanic membrane or central forehead.
The end of ear canal is the tympanic membrane, which is thin and flooded with blood at the core temperature. The central forehead skin is thin & flat, and the temperature is uniform to cover the Whole FOV (Field of View) of the sensor.
The thermometer consists mainly of two parts - an IR sensor with a built-in ambient temperature sensor and the associated circuit. To measure body temperature, the probe of the thermometer is inserted into a patient's outer ear canal or put onto the skin of a patient's central forehead. Pressing the activation button (for ear or forehead) to start the measurement of target's infrared radiation. The electrical signal read out from the detector is fed to the circuit for amplification and calculation. The final measured temperature will be appeared on a LCD display. The total operation takes a few seconds.
Here's a summary of the acceptance criteria and the study that proves the device meets them, based on the provided text:
Device: RII Multi-function Infrared Thermometer, Model TH52Z
Intended Use: Intermittent measurement of human body temperatures for home use by people of all ages, including neonates, with selectable Ear mode or Forehead mode.
1. Table of Acceptance Criteria and Reported Device Performance
| Characteristic | Acceptance Criteria (from predicate & ASTM E1965-98) | Reported Device Performance (TH52Z) |
|---|---|---|
| Accuracy for Body Temperature Measurement | ±0.4°F (0.2°C) within 95 | Meets Criteria: The clinical investigation reported that temperature readings difference between a digital thermometer and the TH52Z were "within acceptable range" which implies adherence to these accuracy standards. |
| Measuring Range | Ear / Forehead mode: 93.2 | Ear / Forehead mode: 93.2 |
| Performance Standard | Meet ASTM E1965-98 and EN ISO 80601-2-56 | Meets Criteria: Performance test demonstrates TH52Z meets ASTM E1965-98 standard. |
| Safety (Electrical) | Compliance with EN 60601-1 (IEC 60601-1) | Meets Criteria: Successful completion of testing to EN 60601-1 standard. |
| Safety (EMC) | Compliance with EN 60601-1-2 (IEC 60601-1-2) | Meets Criteria: Successful completion of testing to EN 60601-1-2 standard. |
| Biocompatibility | Compliance with ISO 10993-5 and ISO 10993-10 for patient contacting components | Meets Criteria: Biocompatibility evaluation for patient contacting components complied with ISO 10993-5 and ISO 10993-10. |
2. Sample Size for the Test Set and Data Provenance
The document states, "The clinical investigation report and data analysis is followed the requirements the ASTM E 1965-98." ASTM E 1965-98, "Standard Specification for Infrared Thermometers for Intermittent Determination of Patient Temperature," typically specifies minimum sample sizes for clinical accuracy studies, usually involving a certain number of subjects across different age groups. While the exact number of subjects is not explicitly stated in this document, the reliance on ASTM E 1965-98 implies that an appropriate sample size was used to meet that standard.
Data Provenance: The document does not explicitly state the country of origin or whether the data was retrospective or prospective. However, clinical investigations for medical devices are generally prospective.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This information is not explicitly stated in the provided text. For a clinical thermometer study, the "ground truth" (reference temperature) is typically established using a highly accurate, calibrated reference thermometer (e.g., a rectal or oral electronic thermometer as per ASTM standards), rather than expert consensus.
4. Adjudication Method for the Test Set
The document does not describe an adjudication method. For clinical accuracy studies of thermometers, an adjudication method in the typical sense (e.g., 2+1 for reviewing discordant readings) is not applicable. The comparison is against a physically measured reference temperature.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No. A MRMC comparative effectiveness study is not relevant for the evaluation of a clinical thermometer, as it is not an imaging device requiring human interpretation of cases. The device directly provides a numerical measurement.
6. Standalone Performance Study
Yes. A standalone performance study was conducted. The clinical investigation directly assessed the accuracy of the RII Multi-function Infrared Thermometer, Model TH52Z, by comparing its readings against a digital thermometer (acting as the reference/ground truth). The report states, "The clinical investigation report and data analysis is followed the requirements the ASTM E 1965-98. The test report shows the three group's temperature readings difference between digital thermometer and the subject device, TH52Z are within acceptable range."
7. Type of Ground Truth Used
Reference Standard Measurement. The ground truth for the clinical accuracy study was established using a "digital thermometer." This implies a comparison against a calibrated, highly accurate reference thermometer, as prescribed by standards like ASTM E1965-98 for clinical accuracy evaluation.
8. Sample Size for the Training Set
Not applicable. This device is a traditional infrared thermometer, not an AI / machine learning-based algorithm that requires a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable. As stated above, this device does not use an AI/ML algorithm requiring a training set.
§ 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.