(245 days)
Infrared Forehead Thermometers (model2: JA-11S; model3: JA-11C) are non-sterile, reusable, noncontact and handheld devices. They can be used by consumers in homecare environment and doctors in clinic as reference. They are intended for measuring human body temperature of people over one month old by detecting infrared heat from the forehead.
Infrared Forehead Thermometers (model1: JA-11A; model2: JA-11S; model3: JA-11C) are hand-held, battery powered, Infrared Forehead Thermometers that covert a user's forehead temperature, using the infrared energy emitted in the area around the user's forehead to an equivalent temperature when measuring from 1-3 cm of the subject's forehead with no contact.
It is composed of a probe, a display, two buttons (start button and power button), an enclosure and a battery cover.
It is used to measure human body temperature based on the relationship between temperature and measurable infrared radiation. Simply aim the unit's probe toward the surface to be measured to obtain a quick and accurate temperature.
When measuring body temperature, users need to measure in body mode from 1-3 cm from their forehead. Press the measuring key and then release it. The instrument will start measuring the target temperature. After about 1 second, the buzzer emits the corresponding alert sound, the measurement result is displayed on the LCD, and the backlight of the corresponding color is turned on. After about 3 seconds, the backlight is turned off, the unit symbol flashes, and the buzzer beeps shortly. Wait until the key is pressed to measure the temperature again. Start the thermometer without any operation, or no operation after temperature measurement, the thermometer will shut off and LCD go out with one short beep in 60 s ± 20 s.
It can store 32 sets of measurements. Press the 【M】button to cycle through them.
User contact components are the enclosure and keys. The materials of the components are ABS plastic.
The thermometer is for intermittent use.
The provided text describes information about an Infrared Forehead Thermometer (models: JA-11A, JA-11S, JA-11C) and its substantial equivalence submission to the FDA. The information focuses on the device's technical specifications, comparison to a predicate device, and the standards it conforms to for safety and effectiveness.
However, the document does not provide details about a study that proves the device meets specific acceptance criteria in the context of AI/machine learning performance, which is implied by several of your questions (e.g., "effect size of how much human readers improve with AI vs without AI assistance," "standalone (i.e. algorithm only without human-in-the-loop performance)"). This is a medical device clearance, not an AI/ML software clearance.
The "Clinical Accuracy Validation" section mentions that the device was tested per ASTM 1965-98, which is a standard for infrared thermometers. This standard typically defines the accuracy requirements for temperature measurement.
Therefore, I will extract the relevant performance criteria and reported performance for this non-AI medical device from the provided text. Many of your specific questions related to AI/ML studies cannot be answered from this document.
Acceptance Criteria and Device Performance for Infrared Forehead Thermometer
Based on the provided FDA 510(k) summary, the device's performance is demonstrated through adherence to relevant medical device standards, particularly related to temperature measurement accuracy and safety. The "acceptance criteria" here are the specifications outlined in the standards, and the "reported device performance" is the claim that the device conforms to these standards and their specified accuracy limits.
1. Table of Acceptance Criteria and Reported Device Performance
| Criterion/Parameter | Acceptance Criteria (from predicate/standards) | Reported Device Performance (Claimed by manufacturer) |
|---|---|---|
| Temperature Measurement Accuracy | Predicate (K193253): | Subject Device (JA-11A, JA-11S, JA-11C): |
| (Per ASTM 1965-98 & ISO 80601-2-56) | 32 °C-34.9 °C: ± 0.3 °C (89.6 °F - 94.8 °F: ±0.5 °F) | 34.0 °C - 35.4 °C (93.2 °F - 95.7 °F): ±0.3 °C/±0.5 °F |
| 35 °C-42 °C: ±0.2 °C/95.0°F-107.6 °F: ±0.4 °F | 35.5 °C - 42.0 °C (95.0 °F - 107.6 °F): ±0.2 °C/±0.4 °F | |
| 42.1 °C-42.5 °C: ±0.3 °C/107.8 °F-108.5 °F: ±0.5 °F | 42.1 °C - 43.0 °C (107.8 °F - 109.4 °F): ±0.3 °C/±0.5 °F | |
| Operating Environment | 10 °C - 40 °C, 15 % - 90% RH (Predicate) | 10 °C - 40 °C, 15 % - 90% RH (Claimed conformance) |
| Storage Environment | -25°C - 55°C (-13°F - 131°F) with a relative humidity of up to 85% (non-condensing) (Predicate) | -25 °C - 55 °C (-13 °F - 131 °F) with a relative humidity of up to 85% (non-condensing) (Claimed conformance) |
| Measurement Range | 32 °C - 42.5 °C (Predicate) | 34 °C - 43 °C (Claimed range, deemed "Similar" and "sufficient to measure the human body temperature") |
| Measurement Distance | 3-5 cm (Predicate) | 1-3 cm (Claimed distance, deemed "Different" but "does not affect performance") |
| Biocompatibility | Conformance to ISO 10993-1, -5, -10 (Predicate) | Conformance to ISO 10993-1, -5, -10 (Reported compliance through testing) |
| Electrical Safety | Conformance to IEC 60601-1, IEC 60601-1-2, IEC 60601-1-11 (Predicate) | Conformance to IEC 60601-1, IEC 60601-1-2, IEC 60601-1-11 (Reported compliance through testing) |
2. Sample Size Used for the Test Set and Data Provenance
The document states: "ASTM 1965-98: Sample size, Patient population age, compared to reference thermometer, reference thermometer, designed per ASTM 1965-98: Standard Specification for Infrared Thermometers for Intermittent Determination of Patient Temperature."
- Sample Size: The exact sample size for the clinical accuracy validation is not explicitly stated in this summary, other than referring to compliance with ASTM 1965-98 criteria for sample size.
- Data Provenance: The document does not specify the country of origin of the data or whether the study was retrospective or prospective. It implies a clinical study was conducted as part of the ASTM 1965-98 validation.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This type of information (experts, qualifications) is not applicable to the performance testing described for this device. The ground truth for temperature measurement, as per ASTM 1965-98, typically involves comparison to a highly accurate reference thermometer (e.g., a blackbody radiator or a calibrated clinical standard thermometer) and direct patient measurements. It does not involve expert consensus in the way AI/ML diagnostic studies do.
4. Adjudication Method for the Test Set
This is not applicable as the test involves direct measurement against a reference standard, not subjective interpretation requiring adjudication.
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
No, an MRMC comparative effectiveness study was not conducted and is not applicable to this device. This is a non-AI device for direct temperature measurement, not an AI-assisted diagnostic tool.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
This refers to AI algorithm performance. Not applicable as this is a non-AI device. The device's "standalone" performance is its direct measurement accuracy.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc)
For temperature measurement validation according to ASTM 1965-98, the ground truth is typically established by:
- Highly accurate reference thermometers: Used in controlled laboratory settings (e.g., blackbody radiator) to test the device's accuracy at different temperature points.
- Simultaneous measurements with a clinically accepted reference thermometer: On human subjects to compare the device's reading to a trusted standard.
The specific details are not provided in this summary but are inherent in the referenced standard.
8. The Sample Size for the Training Set
This question relates to AI/machine learning model training. Not applicable, as this is a non-AI device.
9. How the Ground Truth for the Training Set was Established
This question relates to AI/machine learning model training. Not applicable, as this is a non-AI device.
§ 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.