(546 days)
The infrared thermometer, models KFT-22M, KFT-22, KFT-24, KFT-25, KFT-26, KFT-27, KFT-28 is designed to measuring human body temperature through ear or forehead in the healthcare environments or home use and is non-sterile. The thermometer is a reusable device intended for people of all ages except neonates/newborns.
The KFT series infrared thermometer measures the body temperature through receiving the infrared energy radiation from the surface of human body. It is capacified with forehead mode and ear temperature mode, directly shown on the LCD screen.
- The device is widely used for home healthcare and medical environment.
- . The product is mainly comprised of infrared temperature sensors, signal receiving processor, buttons, buzzer, LCD display, battery, etc.
- . It focuses the infrared from the human's forehead or ear by the Fresnel lens.
The provided document is a 510(k) summary for an infrared thermometer, focusing on its substantial equivalence to a predicate device. It contains information about performance data, including clinical and non-clinical testing. However, it does not describe an AI/ML-enabled device or a study involving human readers or expert consensus for ground truth establishment. Therefore, I cannot provide details on acceptance criteria and a study proving device performance in the context of an AI/ML device per your request.
The document discusses the following:
- Device: Kangfu Medical Equipment Factory Infrared thermometer, models KFT-22, KFT-23, KFT-24, KFT-25, KFT-26, KFT-27, KFT-28.
- Predicate Device: Shenzhen Brav Electronic Technologies Co., Ltd Infrared Thermometer, Model EFT-165 (K171214).
- Indication for Use: Measuring human body temperature through ear or forehead in healthcare environments or home use, intended for people of all ages except neonates/newborns.
- Performance Data: Non-clinical (biocompatibility, electrical safety/EMC, bench testing, software V&V) and clinical data.
Regarding the clinical study for this specific device (an infrared thermometer):
The clinical study mentioned is for the accuracy validation of the thermometer itself, not for an AI/ML component or human reader performance.
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Acceptance Criteria for Infrared Thermometer Accuracy (Implied from "Accuracy for body temperature measurement" table):
- 32.0°C~34.9°C: ±0.3°C /0.5°F
- 35.0°C~42.0°C: ±0.2°C /0.4°F
- 42.1°C~42.9°C: ±0.3°C / 0.5°F
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Reported Device Performance (Implicit from "Comparison to predicate device" and "Performance Data" sections): The document states that the "system complies with the ... ISO 80601-2-56: 2009 ... standards for performance effectiveness," and the "subject devices were found to have a performance that is similar to the predicate device," which shares the same accuracy specifications. This implies the subject device meets the listed accuracy criteria.
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Sample Size for the test set (Clinical Data): 116 patients. The data seems to be prospective as it's a "clinical accuracy validation." Country of origin is not explicitly stated but implied to be China (Kangfu Medical Equipment Factory is in China).
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Number of experts used to establish the ground truth for the test set and qualifications: Not applicable/not specified. For thermometer accuracy, ground truth is typically established using a highly accurate reference thermometer, not expert human readers.
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Adjudication method for the test set: Not applicable/not specified, as it's not an image reading study.
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Multi-reader multi-case (MRMC) comparative effectiveness study: Not applicable. This study focuses on the inherent accuracy of a temperature measurement device, not on AI assistance to human readers.
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Standalone (algorithm only) performance: Performance data is for the device itself, which includes its internal algorithm for temperature measurement. This can be considered the standalone performance of the thermometer.
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Type of ground truth used: For clinical accuracy validation of a thermometer, the ground truth is typically established by simultaneous measurement using a highly accurate, calibrated reference thermometer (e.g., rectal thermometer for core body temperature, or a blackbody calibrator for infrared devices), sometimes referred to as a "master thermometer" or "reference method." This is an objective measurement, not expert consensus, pathology, or outcomes data in this context.
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Sample size for the training set: Not applicable/not specified. Infrared thermometers use established physical principles and calibration, not machine learning models that require training data in the AI sense.
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How the ground truth for the training set was established: Not applicable, as it's not an AI/ML device requiring a training set with established ground truth labels in the typical sense.
In summary, the provided text describes a traditional medical device (infrared thermometer), not an AI/ML-enabled device. Therefore, many of the requested details pertaining to AI/ML device studies (like MRMC studies, expert ground truth, training sets) are not found in this document.
§ 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.