(55 days)
ThermoFlash LX-26 is an infrared thermometer for body surface and forehead temperature measurement for infants and adults without contact to human body. It can be used by consumers in household environment and doctor in clinic as reference.
Infrared Thermometer ThermoFlash LX-26 is a hand held, reusable, battery operated, maximum device that can measure human body surface and forehead temperature measurement for infants and adults without contact to human body. It can be used by consumers in household environment and doctor in clinic as reference. It is manufactured in accordance with the ASTM 1965-98 Standard Specification for Infrared Thermometers for Intermittent Determination of Patient Temperature. The operation principle is based on infrared sensor technology. IR Sensor can putout different signal when mcasuring different object temperature or in different ambient temperature. An ASIC can turn the signal from IR schsor to digital value and display it by LCD.
The provided text, K080759, is a 510(k) summary for the device "Infrared Thermometer ThermoFlash LX-26". Based on the information provided, it's a submission for an infrared thermometer, which is a fairly mature and well-understood technology. The "acceptance criteria" and "device performance" in such submissions generally refer to compliance with recognized standards rather than a clinical study with detailed statistical outcomes like those for novel AI systems.
Here's the breakdown of the requested information based on the provided document:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria / Standard | Reported Device Performance |
|---|---|
| ASTM E 1965-98 (2003) | The device conforms to applicable standards included ASTM E 1965-98 (2003). (Implicitly, the device meets the performance requirements specified in this standard for infrared thermometers for intermittent determination of patient temperature.) |
| IEC 60601-1 | The device conforms to applicable standards included IEC 60601-1 requirements. (This standard covers general requirements for basic safety and essential performance of medical electrical equipment.) |
| IEC 60601-1-2 | The device conforms to applicable standards included IEC 60601-1-2 requirements. (This standard covers electromagnetic compatibility for medical electrical equipment.) |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not provide details about a specific "test set" in the context of a clinical study with a sample size. The conformity to standards implies that the device underwent testing according to those standards, which would involve a test set of the device itself and likely environmental conditions, but not a patient-based "test set" as typically understood in AI/diagnostic device studies. There is no information on data provenance (country of origin, retrospective/prospective).
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 applicable and not provided in the document. The device is an infrared thermometer, and its performance is evaluated against physical measurement standards, not subjective expert interpretation of images or other data.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable and not provided. Performance is evaluated against technical specifications and standards, not through expert adjudication of results.
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 information is not applicable and not provided. The device is a standalone temperature measurement tool, not an AI-assisted diagnostic tool that would be used by "human readers" to interpret data.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
The device itself is a standalone device. Its performance is measured directly (algorithm only) against physical standards. However, the term "algorithm only" refers to the device's internal processing of infrared signals to determine temperature. There's no mention of a traditional "standalone study" as would be performed for a complex AI diagnostic algorithm. The compliance with ASTM E 1965-98 essentially serves as the standalone performance evaluation.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The ground truth for an infrared thermometer is typically established by:
- Traceable reference thermometers: These are highly accurate thermometers calibrated against national or international standards, serving as the "true" temperature.
- Standardized black bodies/calibrators: These devices emit a known, stable infrared radiation corresponding to a specific temperature, used to calibrate and verify the accuracy of the infrared thermometer.
- Controlled environmental conditions: Ensuring accurate measurement requires controlling ambient temperature and other environmental factors influencing infrared readings.
The document states conformity to ASTM E 1965-98, which outlines the methods and ground truth definitions for testing infrared thermometers.
8. The sample size for the training set
This information is not applicable and not provided. Infrared thermometers are not typically "trained" in the machine learning sense. Their operation is based on established physical principles of infrared radiation and an internal algorithm for signal conversion.
9. How the ground truth for the training set was established
This information is not applicable and not provided for the reason stated above.
§ 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.