(257 days)
The Infrared thermometer is intended to measure human body temperature of people over three months old from the eardrum or forehead. It is indicated to be used in homecare and healthcare environments.
The AOJ-20 series Infrared thermometer is a handheld device, which can measure human body's temperature either via the eardrum or the forehead, for clinical or home use. The results can be displayed on LCD. The device operates in adjusted mode, and the reference body site of output temperature is oral. The measurement distance for forehead mode is 0 cm ~ 3 cm. The thermometers are powered by AAA 1.5V×2 alkaline batteries. A thermopile sensor is employed to detect or monitor the infrared thermal energy emitted from the eardrum or the surface of the skin of forehead, which is converted to the equivalent oral temperature with the unit of °C or ºF. All the models share the similar design and the same critical components. The major differences include: - Mechanical changes and the corresponding hardware adjustment happened to AOJ-20A, AOJ-20B, AOJ-20C, AOJ-20D, AOJ-20E, AOJ-20F, AOJ-20H, AOJ-20M, AOJ-20T, AOJ-20R and AOJ-20Y - In the measurement function, two measurement modes are distinguished between children and adults for AOJ-20B and AOJ-20E.
The provided text describes the regulatory clearance of an Infrared Thermometer (AOJ-20 series) and includes detailed performance testing against acceptance criteria. Here's a breakdown of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance
The device is an Infrared Thermometer, and its primary performance criterion is accuracy. The relevant standard for accuracy is ISO 80601-2-56.
| Acceptance Criteria (from ISO 80601-2-56) | Reported Device Performance |
|---|---|
| Accuracy: ±0.2°C (±0.4°F) | ±0.2°C (±0.4°F) |
| Biocompatibility: No cytotoxicity | No potential cytotoxicity |
| Biocompatibility: No sensitization | No sensitization observed |
| Biocompatibility: No irritation | Negligible irritation |
| Electrical Safety & EMC: Compliance with specific IEC standards (60601-1, 60601-1-11, 60601-1-2) | Device complies with specified IEC standards |
| Software Verification & Validation: Software functions meet requirements | Test results demonstrated software functions met requirements |
| Minimum Subject Numbers for Clinical Accuracy Validation (ISO 80601-2-56 Section 201.102) | All models met minimum subject number requirements for each age group (refer to table in source for specific counts) |
The text explicitly states: "The system complies with the 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 for performance effectiveness." and "Clinical accuracy validation was carried out on people over three month indicated in the instructions for use. The number of subjects in each age group met the minimum number requirements."
2. Sample Size Used for the Test Set and Data Provenance
The "test set" in this context refers to the clinical study subjects for accuracy validation.
- Sample Size: The sample sizes vary per model, but generally around 135-138 subjects per model. The specific breakdown is provided in the table:
- AOJ-20A: 138 subjects
- AOJ-20B: 136 subjects
- AOJ-20C: 137 subjects
- AOJ-20D: 138 subjects
- AOJ-20E: 137 subjects
- AOJ-20F: 137 subjects
- AOJ-20H: 135 subjects
- AOJ-20M: 137 subjects
- AOJ-20T: 137 subjects
- AOJ-20R: 137 subjects
- AOJ-20Y: 137 subjects
- Data Provenance: The document does not specify the country of origin for the clinical data. It also does not explicitly state whether the study was retrospective or prospective, but clinical accuracy validation per ISO standards is typically done in a prospective manner.
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 given document. For clinical thermometers, ground truth for body temperature is typically established using a highly accurate reference thermometer (e.g., rectal or oral thermometer depending on the standard's requirements for reference body site), not necessarily by human experts.
4. Adjudication Method for the Test Set
This information is not provided in the given document. Adjudication methods like 2+1 or 3+1 are more common in studies involving subjective assessments (e.g., image interpretation by radiologists), which is not directly applicable to a thermometer's clinical accuracy validation where objective measurements against a reference are typically performed.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not explicitly mentioned or performed. This type of study is more relevant for diagnostic aids where human interpretation is involved. The document describes clinical accuracy validation of the device itself.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
The device is an Infrared Thermometer, which is a standalone measurement device. Its performance is inherently standalone. There is no "algorithm only" component separate from human interaction, as a human user operates the device to take a temperature reading. The clinical and bench testing described assess this standalone performance.
7. The Type of Ground Truth Used
The ground truth used for clinical accuracy validation of a thermometer is typically based on a reference body temperature measurement obtained by a highly accurate, calibrated reference thermometer (e.g., a specific type of oral or rectal thermometer). The document states the device "operates in adjusted mode, and the reference body site of output temperature is oral," implying oral temperature is the reference for adjusted readings. The study was conducted "per Section 201.102 of ISO 80601-2-56," which would define the exact method for establishing ground truth.
8. The Sample Size for the Training Set
This information is not applicable and therefore not provided. Infrared thermometers are hardware devices with embedded algorithms, but they are not typically "trained" on large datasets of temperature readings in the way AI/ML models are. The device relies on physical principles of infrared detection and calibrated conversion algorithms, not a training set in the AI sense.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable as there is no mention of a "training set" in the context of this infrared thermometer. The device's internal algorithms and calibrations are developed and verified through engineering principles and bench testing, not machine learning training on a ground truth dataset.
§ 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.