(346 days)
The Digital Thermometers DMT series(Except DMT-455) are intended to measure the human body temperature in regular mode orally, rectally or under the arm. And the devices are reusable for clinical or home use on people of all ages, including children under 8 with adult supervision.
The device model DMT-455 is intended to measure temperature orally, and the device is reusable for clinical or home use for children less than 4 years old with adult supervision.
The Digital Thermometers DMT series(Except DMT-455) are used to measure the human body temperature in regular mode orally, rectally, or under the arm.The device model DMT-455 is intended to measure temperature orally.
The Digital Thermometers DMT series consists of a temperature sensor, low power consumption integrated circuit (IC), LCD display, and buzzer. The resistance of sensor changes with temperature and the IC converts the resistance to frequency and calculates the temperature according to the relation of resistance and frequency. The calculated temperature is displayed on the LCD.Only model DMT-4726 and DMT-4735 are predictive optional thermometers.The patient contacting materials are Stainless Steel,TPE and Acrylonitrile Butadiene Styrene (ABS).
1. A table of acceptance criteria and the reported device performance
| Criteria | Acceptance Criteria (from ISO 80601-2-56 and ASTM E1112) | Device Performance |
|---|---|---|
| Accuracy (Standard Models excluding predictive and 0.01°C resolution models) | ±0.1°C between 35.5°C to 42.0°C (±0.2°F, 95.9°F-107.6°F) | Reported to comply with ISO 80601-2-56 and ASTM E1112 |
| ±0.2°C under 35.5°C or over 42.0°C (±0.4°F under 95.9°F or over 107.6°F) | Reported to comply with ISO 80601-2-56 and ASTM E1112 | |
| Accuracy (0.01°C resolution models: DMT-301, DMT-3032, DMT-3033, DMT-3018) | ±0.10°C between 35.5°C to 42°C | Reported to comply with ISO 80601-2-56 and ASTM E1112 |
| Electrical Safety | Complied with IEC 60601-1 | Complied with IEC 60601-1 |
| EMC | Complied with IEC 60601-1-2 | Complied with IEC 60601-1-2 |
| Biocompatibility | Complied with ISO 10993-5 and ISO 10993-10 | Complied with ISO 10993-5 and ISO 10993-10 |
| Home-use medical equipment requirements and environmental test | IEC 60601-1-11:2015 | Complied with IEC 60601-1-11:2015 |
| Software/firmware validation | In accordance with "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices," dated May 11, 2005. | Performed and reported as compliant. |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The clinical tests for the predictive optional thermometers (DMT-4726 and DMT-4735) were conducted on 450 subjects. The data provenance is not explicitly stated regarding country of origin or whether it was retrospective or prospective, but the context of a 510(k) submission for a new device typically implies prospective data collection for safety and effectiveness.
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 document states that the "clinical performance test protocol and data analysis were conducted in accordance with the requirement of ISO 80601-2-56," which is a standard for clinical thermometers, but it does not detail the specific methodology for establishing ground truth or the qualifications of any experts involved in that process.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not provided in the document. The document mentions compliance with ISO 80601-2-56 for clinical performance, but does not specify any adjudication method related to ground truth establishment.
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. The device is a digital thermometer, which directly measures temperature and does not involve "human readers" or "AI assistance" in the context of interpretation of medical images or other diagnostic data where MRMC studies are typically conducted.
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 data presented refers to the direct measurement capabilities of the thermometer. The "clinical tests" described for models DMT-4726 and DMT-4735 assessed the device's ability to measure body temperature in living subjects against clinical standards, which inherently evaluates its standalone performance.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For clinical thermometers, the "ground truth" for temperature measurement is typically established by highly accurate reference thermometers or other established methods considered the gold standard, consistent with the requirements of standards like ISO 80601-2-56 and ASTM E1112. The document states the clinical tests were conducted in accordance with ISO 80601-2-56, which would imply the use of such a reference.
8. The sample size for the training set
This is not applicable. The device is a digital thermometer, which operates based on physical principles of thermistor resistance. It is not an AI/ML-based device that would require a "training set" in the conventional sense of machine learning. The performance data relates to validation and verification against established standards and clinical performance for the manufactured product.
9. How the ground truth for the training set was established
This is not applicable as the device is not an AI/ML-based device requiring a training set. The "ground truth" in the context of thermometer calibration and performance testing would be derived from laboratory standards and validated reference measurements.
§ 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.