(332 days)
The Infrared Ear Thermometer, Model: HTD8208C, is an electronic clinical thermometer using an infrared sensor to detect body temperature from the auditory canal in people of all ages for home setting use.
Infrared Ear Thermometer, model: HTD8208C, is an electronic thermometer using an infrared sensor (thermopile) to detect body temperature from the auditory canal. The principle of operation is based on measuring the natural thermal radiation emanating from the tympanic membrane when the thermometer is inserted in the ear canal.
The Infrared Ear Thermometer measures temperature by reading infrared radiation emitting from the eardrum tissue when the thermometer is inserted into the ear canal. Pressing the measuring button 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 display on the device's LCD. The total operation takes less than 5 seconds.
Here's a breakdown of the acceptance criteria and study information for the Infrared Ear Thermometer, Model HTD8208C, based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
The document refers to adherence to international standards for performance, rather than explicit acceptance criteria with numerical targets in a direct comparison table. However, it indicates compliance with these standards.
| Acceptance Criteria (Standard Reference) | Reported Device Performance (Compliance Statement) |
|---|---|
| Accuracy (ASTM E1965-98 & ISO 80601-2-56) | The clinical performance test protocol and data analysis was conducted as the requirement of ASTM E1965-98 (2009). The test report demonstrated the clinical performance of the subject device complied with the requirement of ASTM E1965-98 (2009). The proposed device meets ASTM E1965-98, ISO 80601-2-56. |
| Measuring Accuracy | ±0.2°C (0.4°F) within 35 |
| Biocompatibility (ISO 10993-5, ISO 10993-10) | Comply with ISO 10993-5, ISO 10993-10 |
| Electrical Safety (IEC 60601-1) | Complies with IEC 60601-1: 2005+A1:2012 |
| Electromagnetic Compatibility (IEC 60601-1-2) | Complies with IEC 60601-1-2: 2014, The proposed device was demonstrated electromagnetic compatibility...by the testing. |
| Software Life Cycle Processes (IEC 62304) | The software contained in the subject device complies with the applicable requirements set forth in the referenced guidance document, "Guidance for the Content of Premarket Submissions for Software Contained, issued on May 11, 2005. |
| Cleaning and Disinfection Validation | The validation testing result for cleaning and disinfection of the subject device is adequate. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: 140 subjects.
- Data Provenance: Not explicitly stated whether retrospective or prospective, nor the country of origin. However, the study "evaluated 140 of subjects" which suggests a prospective clinical investigation.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
- The document does not mention the use of experts to establish ground truth for the test set. For a clinical thermometer, the ground truth would typically be established by highly accurate reference thermometers (e.g., rectally inserted electronic thermometers or mercury-in-glass thermometers, following a standardized protocol) rather than expert consensus on interpretation. The document indicates the clinical investigation followed the requirements of ASTM E1965-98 and ISO 80601-2-56, which specify methods for establishing reference temperatures.
4. Adjudication Method for the Test Set
- Not applicable as this is not a diagnostic device requiring expert adjudication of outputs. The performance is assessed against a reference temperature.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was Done
- No, a MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic imaging devices where human readers interpret medical images.
- This device is a clinical thermometer, and its performance is evaluated against established temperature measurement standards, not against human reader interpretation of data.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was Done
- Yes, the performance study effectively evaluates the device in a standalone manner. The device measures temperature, and that measurement is compared directly to a "ground truth" reference temperature, without human interpretation influencing the device's output.
7. The Type of Ground Truth Used
- The ground truth used for performance comparison would be reference body temperatures established according to the methods outlined in ASTM E1965-98 and ISO 80601-2-56. These standards specify how to obtain accurate, traceable reference temperature measurements against which the infrared ear thermometer's readings are compared. It's not expert consensus, pathology, or outcomes data in this context.
8. The Sample Size for the Training Set
- Not applicable. This device is a hardware-based thermometer with embedded firmware, not a machine learning algorithm that requires a separate "training set" in the conventional sense. Its "training" is in its design, calibration, and manufacturing processes, which ensure it adheres to physical measurement principles.
9. How the Ground Truth for the Training Set Was Established
- Not applicable, as there is no "training set" for this type of device in the machine learning context. The accuracy of the device is established during its design, calibration, and manufacturing, ensuring its measurements align with established physical standards for temperature measurement.
§ 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.