(333 days)
Digital Thermometers are intended for the measurement and monitoring of human body temperature by doctor or consumers in the hospital or home.
It can be used for axillary measurement, oral measurement and rectal measurement.
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 application describes a Digital Thermometer (Models: BT-301, BT-302, BT-303, BT-305, BT-306, BT-308, BT-311, BT-318) intended for measuring and monitoring human body temperature.
Here's an analysis of the acceptance criteria and study information provided:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are implied by the "Measurement Accuracy" and "Response Time" listed and are identical to the predicate device. The performance is reported as meeting these criteria, asserting substantial equivalence.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Measurement Accuracy: | |
| 35.0 ~ 39.0°C | +/- 0.1°C |
| The rest (outside 35.0-39.0°C) | +/- 0.2°C |
| Response Time: | 60s |
2. Sample size used for the test set and the data provenance:
The document states, "The whole product and manufacturing used for the Digital thermometer are identical to those of the predicate device... All hardware and software of the subject device are based on that of the predicate device (K172508), since no new testing is presented in the submission."
This indicates that no new test set or data provenance information is provided for the subject device (K193621). The substantial equivalence argument relies on the predicate device's prior testing and the assertion of identical components and manufacturing.
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 as no new testing data for the subject device is presented.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
This information is not provided in the document as no new testing data for the subject device is presented.
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 is not applicable as the device is a digital thermometer, not an AI-assisted diagnostic tool requiring human interpretation.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
The device itself is a standalone thermometer. The performance criteria (accuracy and response time) inherently describe its standalone performance. However, there's no dedicated study for the subject device's standalone performance described as separate from the predicate's established performance.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
For a digital thermometer, the ground truth for performance testing is typically established using calibrated reference thermometers or environmental conditions to provide a known, accurate temperature for comparison. This document relies on the testing performed for the predicate device, which would have used such ground truth. Specific details on the ground truth for the predicate are not provided in this summary, but the listed standards (IEC 80601-2-56, ASTM E1112-00) dictate how such ground truth is established for clinical thermometers.
8. The sample size for the training set:
This information is not applicable/not provided as the device is not an AI/ML device that requires a training set.
9. How the ground truth for the training set was established:
This information is not applicable/not provided as the device is not an AI/ML device that requires a training set.
§ 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.