(256 days)
The Non-contact Thermometer is intended to measure the human body temperature for children and adults without contact to human body. It can be used by consumers in household environment and doctor in clinics as reference.
The Non-contact Thermometer is a compact, small and light-weight device, which is powered by a battery and can be connected to a smartphone through headphone jack, for detecting body temperature without contact to human body. The measured temperature will be displayed on the screen of a smartphone.
The provided document describes a 510(k) premarket notification for a Non-contact Thermometer (K120711). The primary method for proving the device meets acceptance criteria is through demonstrating substantial equivalence to a predicate device (K102947) and compliance with recognized standards.
Here's an analysis of the acceptance criteria and the study (or lack thereof) that proves the device meets them, based on the provided text:
Acceptance Criteria and Reported Device Performance
The acceptance criteria are primarily derived from the predicate device's performance specifications and industry standards.
| Acceptance Criteria | Reported Device Performance | Notes |
|---|---|---|
| Measurement Method | Infrared radiation detection | Identical to predicate device. This is a characteristic, not a performance metric that directly needs to be met with a numerical value. |
| Measuring Range | Forehead Mode: 32.2℃ | Identical to predicate device. |
| C/F Switchable | Yes | Identical to predicate device. |
| Display Resolution | 0.1℃ (0.1°F) | Identical to predicate device. |
| Measuring Accuracy | Forehead Mode: ±0.2°C (0.4°F) | Identical to predicate device. This is a critical performance acceptance criterion. The document states compliance with ASTM E1965-98, which sets a "maximum permissible laboratory error" (this likely corresponds to the ±0.2°C). |
| Low Battery Detection | Yes | Identical to predicate device. |
| Operating Condition | Temperature: 10℃ | Identical to predicate device. |
| Storage Condition | Temperature: -20℃ | Identical to predicate device. |
| General Safety (Electrical, Mechanical, Temperature, Faults) | Complies with ANSI/AAMI ES60601-1:2005 | The device has been "verified and validated to comply" with this standard, indicating it meets the safety requirements outlined in the standard. This is an acceptance criterion for safety. |
| Electromagnetic Compatibility (EMC) | Complies with ANSI/AAMI/IEC 60601-1-2:2007 | The device has been "verified and validated to comply" with this standard, including radiated emission, ESD, radiated RF immunity, and magnetic field immunity. This is an acceptance criterion for EMC. |
| Infrared Thermometer Standard Compliance | Complies with ASTM E1965-98 | The device has been "verified and validated to comply" with this standard, which covers aspects like displayed temperature range, maximum permissible laboratory error, ambient conditions, low power supply operation, display, human interface, and construction. This standard directly addresses key performance attributes of infrared thermometers. |
Detailed Study Information (Based on provided text)
The document primarily relies on design validation and compliance with established standards rather than a specific clinical study with human subjects for novel performance claims.
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Sample size used for the test set and data provenance:
This information is not provided in the document. The filing states the device "complies" and is "verified and validated," but it does not detail the specific test set size (e.g., number of temperature measurements, number of subjects) or the provenance (e.g., country of origin, retrospective/prospective) of any data collected to demonstrate compliance with ASTM E1965-98, which would typically involve testing on physical samples. -
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This information is not provided. The document does not describe a clinical study relying on expert-established ground truth. Compliance with ASTM E1965-98 would typically involve metrology experts and calibrated reference devices, but specific details are absent. -
Adjudication method for the test set:
This information is not provided. As there's no mention of a clinical study with multiple observers, adjudication methods like 2+1 or 3+1 are not applicable here. -
If a multi reader multi case (MRMC) comparative effectiveness study was done, and the effect size of how much human readers improve with AI vs without AI assistance:
No, an MRMC comparative effectiveness study was not done. This device is a standalone thermometer, not an AI-assisted diagnostic tool for human readers. -
If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
The entire premise of this submission is for a standalone device (a thermometer). The "performance" described is the standalone performance of the device itself (its accuracy, operating range, etc.) in meeting established standards. There's no separate "algorithm only" component vs. "human-in-the-loop," as the human interacts directly with the device to take a measurement. The "study" (or validation) conducted would have been to verify the device's accuracy against a known reference temperature source during testing, as per ASTM E1965-98. -
The type of ground truth used:
The ground truth for performance (specifically temperature accuracy) would have been established through calibrated reference standards and laboratory testing in accordance with ASTM E1965-98. For safety and EMC, the ground truth is adherence to the technical specifications and test methodologies defined in the respective IEC/ANSI/AAMI standards. -
The sample size for the training set:
This information is not applicable/not provided. This device is a hardware product with embedded firmware/sensors for a direct physical measurement. It is not an AI/machine learning device that requires a "training set" in the conventional sense. -
How the ground truth for the training set was established:
This information is not applicable/not provided, as there is no "training set" for this type of 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.