(44 days)
Famidoc Digital Clinical Thermometers are intended for the measurement and monitoring of human body temperature, by doctor or consumers in the hospital or home. It is used alone for human beings at all ages.
Famidoc Digital Clinical Thermometer (model FDTH-V0-1, FDTH-V0-2, FDTH-V0-3, FDTH-V0-4) are hand-held, reusable, battery operated, maximum device that can measures human body temperature. Models FDTH-V0-1, FDTH-V0-2, FDTH-V0-3, FDTH-V0-4 have the same indication for use. the difference points are their shapes、waterproof function and measurement speed. The operation principle is based on thermistor and ASIC technology, a thermistor using as temperature sensor, the sensor's signal is then calculated and displayed by an ASIC. The digital thermometer comprises a thermistor for temperature sensing, a reference resistor for comparing the resistance of the thermistor, a buzzer for sounding effect, an ASIC and a LCD for calculating and displaying the target temperature digitally which the thermistor is immersed.
The document provided describes the Famidoc Digital Clinical Thermometer and its FDA 510(k) summary. Here's a breakdown of the requested information based on the provided text:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Standards Met: | |
| ASTM Standard Specification for Electronic Thermometer for intermittent Determination of Patient Temperature (ASTM Ell12-00) | Bench testing confirmed accuracy, precision, and repeatability measurements specified in the labeling. |
| IEC 60601-1 | Met |
| IEC 60601-1-2 | Met |
| EN 12470-3:2000 (repeatability and standard deviation) | Clinical tests proved repeatability and standard deviation are in accord with the demand of EN 12470-3:2000 when applied to humans. |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document mentions "clinical tests" for repeatability and standard deviation based on EN 12470-3:2000. However, it does not specify the sample size used for these tests. The country of origin and whether the data was retrospective or prospective are not mentioned.
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 provided in the document. The nature of the device (a thermometer) suggests that ground truth would likely be established by a reference temperature standard rather than expert consensus on interpretation.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not provided in the document. Given the type of device, an adjudication method as typically described for image analysis or diagnostic interpretation by experts would not be applicable.
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
A multi-reader multi-case (MRMC) comparative effectiveness study is not mentioned in the document. This type of study is typically relevant for AI-powered diagnostic tools that assist human readers, which is not the function of a digital clinical thermometer.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
The device itself is a standalone electronic thermometer. The "bench testing" mentioned for accuracy, precision, and repeatability, as well as the "clinical tests" for repeatability and standard deviation, effectively constitute standalone performance assessments. The performance reported in the table (meeting ASTM and IEC standards) is the standalone performance of the device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the bench testing and clinical tests, the ground truth would inherently be a highly accurate reference temperature (e.g., from a calibrated standard thermometer or controlled thermal environment). The document doesn't explicitly state "reference temperature" as the ground truth but refers to meeting standards like ASTM Ell12-00, which govern the accuracy of thermometers against such reference standards.
8. The sample size for the training set
The device described is a digital clinical thermometer, which is a physical measurement device based on thermistor and ASIC technology. It does not involve a "training set" in the context of machine learning or AI algorithms. Therefore, this question is not applicable to the described device.
9. How the ground truth for the training set was established
As there is no "training set" for this type of device, this question is not applicable.
§ 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.