(77 days)
Fudakang Digital Thermometers are intended for the measurement and monitoring of human body temperature by doctor or consumers in the hospital or home. BT-A11CN, BT-A21CN, BT-A41CN can be used for axillary measurement, oral measurement and rectal measurement.
Fudakang digital thermometers are hand-held, reusable, battery operated. The models include BT-A11CN, BT-A21CN, and BT-A41CN. All the models have the same indication for use. The difference points are their shapes, colors, voice function, and measurement speed. The operation principle is based on thermosensor and ASIC technology. A thermistor is used as thermosensor. The ASIC gets the sensor's signal from human body, then processes the signal and calculates the result, after that displays the temperature result by a LCD. The digital thermometer comprises a thermistor for getting temperature signal, a reference resistor for comparing the resistance of the thermistor, a buzzer for sounding effect, an ASIC for processing the target temperature digitally, and a LCD for displaying the temperature result.
Acceptance Criteria and Device Performance for Fudakang Digital Thermometers
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Standard: ASTM E1112-2006) | Reported Device Performance (Fudakang Digital Thermometers) | Meets Criteria? |
|---|---|---|
| +/- 0.1°C (0.2°F) for specific range (e.g., 35.0 - 39.0°C) | 35.0 - 39.0°C (95.0 - 102.0°F): +/- 0.1°C (0.2°F) | Yes |
| +/- 0.2°C (0.3°F) for the rest of the range | The rest: +/- 0.2°C | Yes |
| (Implicit by compliance with ASTM E1112) | Accuracy, precision, and repeatability compliant with ASTM E1112-2006 requirements. | Yes |
| (Implicit by compliance with ASTM E1112) | Response time compliant with ASTM E 1112 requirements (Subject device 60s, Predicate device 30s). | Yes |
| Biocompatibility with patient contact materials | Patient contact materials (stainless steel, ABS plastic, thermoplastic rubber) comply with ISO10993-1, ISO10993-5, and ISO10993-10. | Yes |
| Compliance with general medical electrical equipment safety standards | IEC 60601-1 and IEC 60601-1-2 requirements met. | Yes |
| Environmental conditions | Compliance with IEC 60601-1 and ASTM E1112 requirements. | Yes |
2. Sample size used for the test set and the data provenance:
The document does not explicitly state the sample size used for the test set or the data provenance (e.g., country of origin, retrospective/prospective). It generally mentions "bench test confirmed" the accuracy, precision, and repeatability.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This information is not provided in the document. The "bench test" likely refers to standardized laboratory testing rather than expert-derived ground truth.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Not applicable. The evaluation was based on conformance to a recognized standard (ASTM E1112-2006) through bench testing, not through expert adjudication of output.
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:
Not applicable. This is a digital thermometer, not an AI-powered diagnostic imaging device. No human-in-the-loop performance or MRMC study was conducted.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Yes, the performance evaluation described ("bench test confirmed that the accuracy, precision and repeatability of device are compliance with ASTM E1112-2006 requirements") is a standalone assessment of the device's inherent performance characteristics against a standard. The device operates autonomously without human intervention to interpret its output in the context of its accuracy claim.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
The ground truth for the performance evaluation was established by a recognized standard for electronic thermometers, ASTM E1112-2006. This standard defines the acceptable range of deviation from a true or reference temperature measurement. Therefore, the ground truth is a standardized reference measurement.
8. The sample size for the training set:
Not applicable. This device is a digital thermometer based on traditional sensor and ASIC technology, not a machine learning or AI-based device that requires a training set.
9. How the ground truth for the training set was established:
Not applicable, as there is no training set for this 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.