(264 days)
Non Contact Infrared Forehead Thermometer is a non-sterile, reusable, handheld device. It can be used by consumers in homecare environment and doctors in clinic as reference. It is intended for measuring human body temperature of all ranges of people by detecting infrared heat from the forehead.
The thermometer measures the temperatures of people by detecting the energy. The external probe plays an important role in the measuring process. As soon as the thermometer is placed near the body and the radiation sensor is activated, the measurement will be taken instantly by detection of the infrared heat. The thermometer includes two models: TVT-200, TVT-200 PLUS. The TVT-200 model includes four colors: pink, grey, orange and purple. While TVT-200 PLUS has only orange color. The Non Contact Infrared Forehead Thermometer is composed by an IR sensor, a Human temperature measurement button, an object temperature button, Battery compartment, Buzzer, °C /°F button, a LCD and an enclosure. The functions of TVT-200 and TVT-200 PLUS are the same, except the Back Light.
The provided text describes the acceptance criteria and the study conducted for the Non Contact Infrared Forehead Thermometer (Models: TVT-200, TVT-200 PLUS).
Here's the breakdown of the information requested:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are primarily derived from the standards the device claims to meet, specifically ASTM E1965-98 (2009) and ISO 80601-2-56: 2009. The reported device performance indicates that the device passed all tests against these standards.
| Acceptance Criteria / Specification | Reported Device Performance (Compliance) |
|---|---|
| Measuring Accuracy | ±0.2°C (0.4°F) |
| Measuring Range (Forehead mode) | 32° to 43°C (89.6°F to 109.4°F). Meets minimum rated output range of clinical thermometer requirement from 35°C to 42°C (ISO 80601-2-56). |
| Display Resolution | 0.1°C / 0.1°F |
| Biocompatibility | Complies with ISO 10993-5:2009, ISO 10993-10:2010. Patient contact materials (ABS with colorants, Glass and Metal) passed ISO 10993-1:2009, ISO 10993-5:2009, ISO 10993-10:2010 Biocompatibility Test. |
| Electrical Safety | Passed IEC 60601-1:2005+A1:2012, IEC 60601-1-11:2010, IEC 60601-1 (for battery) |
| EMC | Passed IEC 60601-1-2:2014 |
| Bench Performance | Passed ISO 80601-2-56 First Edition 2009-10-01, ASTM E1965-98 (Reapproved 2009) |
| Clinical Accuracy | Passed ASTM E1965-98 (Reapproved 2009) |
| Cleaning/Disinfection | Cleaning has been validated according to ASTM E2314-03(2014). |
2. Sample Size Used for the Test Set and Data Provenance
The document states:
- Sample Size: Not explicitly mentioned in terms of number of subjects or measurements. It only states that the "[c]linical performance test protocol and data analysis is conducted as the requirement of ASTM E1965-98 (2009)." This standard typically specifies requirements for clinical accuracy testing, which involves a certain number of subjects and repeated measurements.
- Data Provenance: Not explicitly stated (e.g., country of origin, retrospective or prospective). However, clinical accuracy tests for medical devices are generally prospective.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not provided in the document. For a thermometer, "ground truth" for temperature is typically established by reference thermometers (e.g., rectal or oral thermometers) measured by trained personnel, not necessarily by "experts" in the sense of radiologists.
4. Adjudication Method for the Test Set
This information is not provided in the document.
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
This is not applicable to this device. The device is a non-contact infrared thermometer, which is a standalone measurement device, not an AI-assisted diagnostic tool that aids human readers.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
Yes, a standalone performance assessment was done. The entire testing listed under "Nonclinical tests" and "Clinical accuracy" (bench performance, clinical accuracy) evaluates the device's performance without human interpretation or intervention in the temperature measurement itself. The device is intended for direct measurement.
7. The Type of Ground Truth Used
For the clinical accuracy testing, based on the reference to ASTM E1965-98 (2009), the ground truth would be measurements from a clinically accepted reference thermometer (e.g., a rectal or oral thermometer whose accuracy is established) taken concurrently with the non-contact forehead thermometer.
8. The Sample Size for the Training Set
This information is not applicable. The device is an infrared thermometer, not a machine learning or AI algorithm that requires a "training set" in the conventional sense. Its performance is based on its physical design and calibration, which are verified through the outlined tests.
9. How the Ground Truth for the Training Set was Established
This information is not applicable for the same reason as in point 8.
§ 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.