(295 days)
The Infrared Thermometer (Model: IR8807) is intended for the intermittent measurement of human body temperature from the forehead. It is a non-contact clinical thermometer and intended for use on people of all ages except for neonates/newborns.
The Infrared Thermometer (Model: IR8807) is an electronic thermometer using an infrared sensor to measure infrared energy radiated from the forehead. This energy is collected through the lens and converted to a temperature value. The Infrared Thermometer (Model: IR8807) has a forehead measurement mode and an object measurement mode.
The Infrared Thermometer (Model: IR8807), consists of the following parts:
a) Thermopile Sensor
b) Application-Specific Integrated Circuitry
c) Erasable Programmable Read-Only Memory Integrated Circuit
d) Capacitance-touch Integrated Circuit
e) LCD display
f) 2 buttons (Scan button, Setting button,)
q) 2×1.5V AAA dry batteries
The operation principle is based on infrared sensor technology. The sensor in the thermometer detects the infrared energy, and the device processes the data to body temperature result with its internal microcontroller unit. It operates in an adjusted mode.
The main functions of Infrared Thermometer (Model: IR8807) are as followings:
Forehead temperature measure functions
Wide range of temperature readings: from 32.0ºCto 42.9ºC (89.6ºF ~ 109.2ºF)
The measurement results can be displayed in either °Cor °F units
The LCD display showing clear measurement result.
Memory data reading/removal function: The device can store a total of 32 groups of memorable values. All memory values can be removed after the battery is removed
Low battery indicator
Buzzer reminder function
Users can set temperature alarm value
Environment or object temperature measurement function
The reference body site of the output temperature is Oral.
The provided document describes the Infrared Thermometer, Model: IR8807, and its compliance with relevant standards and performance criteria. Here's a breakdown of the requested information based on the text:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (from ASTM E 1965-98) | Reported Device Performance (Model: IR8807) |
|---|---|
| Measurement Range | 32°C ~ 42.9°C (89.6°F ~ 109.2°F) |
| Accuracy (Forehead mode) | ±0.2°C for 35.0°C ~ 42.0°C |
| ±0.3°C outside this temperature range | |
| Measurement Time | ≤3 seconds |
| Measurement Distance | 2-5 cm |
Note: The document states that the device's accuracy requirements meet ASTM E1965-98. The specific ASTM E1965-98 requirements for measurement range, accuracy, measurement time, and measurement distance are not explicitly detailed in the provided text beyond what's shown for the device's performance. The table above uses the device's reported performance as the "reported device performance" and implies these meet the ASTM E 1965-98 criteria because the document explicitly states compliance.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample size for clinical test set: 169 subjects.
- Data Provenance: The document does not specify the country of origin. The test was a "clinical test" which implies a prospective study.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This information is not provided in the document. The document only mentions "clinical tests were conducted" and that the "clinical performance of the subject device complied with the requirement of ASTM E1965-98 (2016)." It does not describe the method or personnel used to establish the ground truth (reference temperature).
4. Adjudication method (e.g. 2+1, 3+1, none) 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 an Infrared Thermometer. The document describes clinical tests for device accuracy, not a comparative effectiveness study involving human readers or AI assistance. Therefore, no MRMC comparative effectiveness study was done in the context of human readers improving with or without AI.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Yes, a standalone performance study was done for the device. The "clinical tests" described in section 8 were conducted on the Infrared Thermometer (Model: IR8807) itself, evaluating its direct measurement performance against a ground truth (implied by compliance with ASTM E1965-98 for clinical accuracy). This assesses the algorithm/device's performance without human interpretation or intervention in the measurement process beyond standard use.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The document does not explicitly state the type of ground truth used. However, given that it's a clinical thermometer study and states compliance with ASTM E1965-98, the ground truth would most likely be a reference clinical thermometer (e.g., a highly accurate rectal, oral, or tympanic thermometer, depending on the standard's protocol for correlating to forehead temperature) used simultaneously or sequentially with the test device.
8. The sample size for the training set
This device is a physical thermometer, not an AI/ML model that typically requires a "training set." The concept of a training set is not applicable to this device.
9. How the ground truth for the training set was established
As the concept of a training set is not applicable to this device, this question is not relevant.
§ 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.