(260 days)
Digital Thermometer (models TM-2011, TM-3002, TM-3102) intended for the measurement and monitoring of human body temperature by users for home use. It can be used for axillary measurement and oral measurement.
Digital Thermometers comprises a thermistor for getting temperature signal, a reference resistor for comparing the resistance of the thermistor, an ASIC for processing the target temperature digitally, and a LCD for displaying the temperature. The design principle of thermometer 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. There is buzzing noise occurs when the device turns on and when the measurement is completed (for model TM-3002 and TM-3102 only.
The provided document describes the 510(k) premarket notification for a Digital Thermometer. It includes a summary of tests performed to demonstrate safety and performance.
Here's the breakdown of the acceptance criteria and study information:
1. Table of Acceptance Criteria and Reported Device Performance
The document refers to adherence to specific standards rather than explicitly listing acceptance criteria with numerical targets in a table against which the device performance is reported. However, the "Remark" column in the comparison table indirectly indicates that the device meets the criteria by stating "SE" (Substantially Equivalent) or by providing explanations if there are differences.
| Acceptance Criteria (Standard Reference) | Reported Device Performance (Compliance) |
|---|---|
| Electrical safety (IEC 60601-1) | Complied |
| Electromagnetic compatibility (IEC 60601-1-2) | Complied |
| Biocompatibility (ISO 10993-1, -5, -10) | Complied |
| Usability (IEC 62366) | Complied |
| Particular Requirements for Basic Safety and Essential Performance of Clinical Thermometers for Body Temperature Measurement (ASTM E1112-00) | Complied |
| Basic Safety and Essential Performance of Clinical Thermometers for Body Temperature Measurement (ISO 80601-2-56) | Complied |
| Software verification and validation (FDA Guidance for Content of Premarket Submissions for Software Contained in Medical Devices) | Complied |
| Measurement Accuracy | ±0.1°C, 37.0°C ~ 39.0°C |
| ±0.2°C, 35.0°C ~ 36.9°C, 39.1°C ~ 42.0°C | |
| ±0.3°C, 32.0°C ~ 34.9°C, 42.1°C ~ 43.0°C (At 25°C) | |
| Measurement Speed | 45s |
Note 1: The document states that "Although there is a little difference between the 'measurement accuracy' and 'Measurement Speed', the subject device accuracy is compliance with ISO 80601-2-56 and ASTM E 1112 requirements. So, the difference of accuracy will not raise any safety of effectiveness issue." This implies that the specific performance values meet the acceptance criteria defined by these standards.
2. Sample size used for the test set and the data provenance
- Sample Size for Clinical Tests: 240 subjects were evaluated for the clinical tests performed on Model TM-3102.
- Data Provenance: The document does not explicitly state the country of origin or whether the data was retrospective or prospective. It only mentions that the clinical performance test protocol and data analysis were conducted "in accordance with the requirement of ISO 80601-2-56."
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. This device is a digital thermometer, and the ground truth for temperature measurement is typically obtained directly from the device's reading or a reference standard, not through expert interpretation of images or other subjective data. No experts were used to establish ground truth in the context of diagnostic interpretation.
4. Adjudication method for the test set
Not applicable, as this is a digital thermometer and not an AI/imaging device requiring expert adjudication for ground truth. The performance is assessed against physical standards and clinical measurements.
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 standalone medical device (digital thermometer), not an AI-assisted diagnostic tool that would involve human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Yes, a standalone performance evaluation was done. The "Test Summary" and "Discussion of Clinical Tests Performed" sections describe various lab bench tests and clinical tests to evaluate the safety and performance of the device itself (Models TM-2011, TM-3002, TM-3102) against established standards (e.g., IEC 60601-1, ISO 80601-2-56, ASTM E1112-00). This indicates the algorithm (or the device's internal processing) only performance was assessed.
7. The type of ground truth used
The ground truth for the clinical performance tests (temperature measurements) would primarily be the actual body temperature measurements obtained through a reference standard or the device's readings compared against such standards, as required by ISO 80601-2-56 and ASTM E1112-00 for clinical electronic thermometers.
8. The sample size for the training set
Not applicable. This is not an AI/machine learning device that requires a training set. Its functionality is based on established thermistor and ASIC technology.
9. How the ground truth for the training set was established
Not applicable, as there is no training set for this type of 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.