(352 days)
Ageless Health Medical Digital Thermometers are intended for the measurement and monitoring of human body temperature by doctor or consumers in the hospital or home. lt can be used for axillary measurement, oral measurement and rectal measurement.
Ageless Health Medical Digital Thermometers 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. The design principle of thermometer is based on thermos sensor and ASIC technology. A thermistor is used as thermos sensor. 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 provided document is a 510(k) summary for the "Ageless Health Medical Digital Thermometer." It details the device's characteristics and compares it to predicate devices to establish substantial equivalence.
Here's an analysis of the acceptance criteria and study information based on the document:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for the device are largely based on adherence to recognized standards and specific performance metrics, particularly measurement accuracy and range.
| Acceptance Criteria / Performance Metric | Reported Device Performance (Subject Device) |
|---|---|
| Safety and Essential Performance Standards: | Complies with IEC 60601-1, IEC 80601-2-56, IEC 60601-1-2, IEC 60601-1-11, ASTM E1112, ISO 10993-5, ISO 10993-10. |
| Thermometer Type: | Digital Thermometer |
| Intended Use / Indication for Use: | Measurement and monitoring of human body temperature by doctor or consumers in the hospital or home; for axillary, oral, and rectal measurement. |
| Sensor Type: | Thermistor |
| Signal Processing & Display: | Uses resistance change of thermal resistor to detect body temperature, displayed through LCD. |
| Power Requirement: | 1.5V button battery |
| Measurement Temperature Range: | 32.0°C ~ 42.9°C |
| Measurement Accuracy: | 35.0 ~ 39.0°C: +/- 0.1°C |
| The rest of the range: +/- 0.2°C | |
| Ambient Temperature for Operation: | 10 ~ 35°C |
| Response Time: | 60s |
2. Sample size used for the test set and the data provenance
The document states that the device's safety and performance were evaluated by "lab bench testing" according to a list of standards. However, it does not provide details on the sample size used for these tests. There's also no explicit information on data provenance in terms of country of origin or whether the tests were retrospective or prospective, beyond being "lab bench testing." It is implied that these tests were conducted as part of the device development and verification process.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
The document does not mention the use of experts to establish ground truth for a test set. The validation appears to be based on engineering and performance testing against established standards for temperature measurement devices.
4. Adjudication method for the test set
Since there is no mention of experts or a subjective assessment test set, there is no adjudication method described. The evaluation is against objective engineering and performance standards.
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 type of study is not applicable to a digital thermometer. The device is a direct measurement tool, not an AI-assisted diagnostic device requiring human interpretation of complex data. Therefore, an MRMC comparative effectiveness study was not performed, nor is there any mention of AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
The device is inherently a standalone measurement tool. Its performance is evaluated purely on its ability to accurately measure temperature according to the specified standards, without human intervention in the measurement process itself. So, in a sense, a "standalone" performance evaluation was done on the device's core function.
7. The type of ground truth used
The ground truth used for this type of device is established by:
- Reference standards and calibrated equipment: The "lab bench testing" implicitly relies on highly accurate and traceable reference thermometers and controlled environmental conditions as the ground truth for temperature measurement.
- Biological evaluation standards: ISO 10993-5 (in vitro cytotoxicity) and ISO 10993-10 (irritation and skin sensitization) involve standardized biological assays where the "ground truth" is determined by the absence or presence of adverse biological reactions as defined by the standards.
8. The sample size for the training set
The concept of a "training set" is not applicable here as this is a traditional medical device (digital thermometer) and not an AI/machine learning device. The device's operation is based on fixed physical principles and programmed logic, not learned from data.
9. How the ground truth for the training set was established
As there is no training set for this device, this question is not applicable. The device's functionality is designed and verified against established engineering and medical standards, not by training on a dataset.
§ 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.