(267 days)
The digital thermometer 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.
The digital thermometer is an electronic thermometer using a thermistor to measure human body temperature for people of all ages. The digital thermometer are designed to be non-sterile, reusable clinical thermometers intended for the determination of human body temperature by contact the sensing probe with patient's axillary and oral. The measurement duration is less than 1 minute. The device has a storage function in which the last measured value is automatically stored after measurement is successfully completed. This device is designed for people of all ages to use at home. There is BF applied part. No special protection against the use in the environment of ignitable gases.
The provided text is a 510(k) summary for a digital thermometer (Models T103, T104). It describes the device, its intended use, comparison to a predicate device, and the testing performed to demonstrate substantial equivalence.
Here's an analysis to extract the requested information, specifically focusing on the acceptance criteria and the study that proves the device meets them:
1. A table of acceptance criteria and the reported device performance
The document references compliance with several international and industry standards, including specific performance requirements related to temperature measurement accuracy. The acceptance criteria are implicit in these standards, and the reported performance is that the device "Pass[es]" the tests and "complies with the applicable requirements."
| Acceptance Criteria (Standard Reference & Description) | Reported Device Performance |
|---|---|
| ISO 80601-2-56: 2017 & ASTM E1112-00 (2008) - Performance Testing (Laboratory & Clinical Accuracy) |
- Displayed temperature range
- Laboratory accuracy
- Ambient conditions for operation and storage
- Identification, marking, and documents
- Clinical accuracy and repeatability for axillary and oral measurements | Pass
"The T103 and T104 digital thermometer complies applicable requirements of ISO 80601-2-56 and ASTM E1112 including displayed temperature range, laboratory accuracy, ambient conditions for operation and storage, identification, marking and documents."
"The subject complies with the applicable requirements set forth in the referenced performance standards."
"The methods and criteria of clinical accuracy and repeatability testing had been clinically assessed to meet the requirements of clinical accuracy per the referenced standards." |
| IEC 60601-1: 2005/A1: 2012 - Electrical Safety Testing - General requirements, protection against electrical hazards, mechanical hazards, excessive temperatures, hazardous situations, fault conditions, and constructions. | Pass
"The subject complies with the applicable requirements set forth in the referenced electric safety standard."
"The digital thermometer complies with to applicable IEC 60601-1 requirements..." |
| IEC 60601-1-2: 2014 - EMC Testing - Radiated emission test, electrostatic discharge immunity test, radiated RF electromagnetic field immunity test, power frequency magnetic field immunity test. | Pass
"The subject complies with the applicable requirements set forth in the referenced EMC standard."
"The digital thermometer complicable IEC 60601-1-2 requirements..." |
| IEC 60601-1-11: 2015 - Electrical Safety for Medical Devices in Home Healthcare Environment | Pass
"The subject complies with the applicable requirements set forth in the referenced IEC 60601-1-11:2015."
"For lay person, the IEC 60601-1-11 was performed and the thermometer is accordance with applicable requirements." |
| IEC 60601-1-6 Edition 3.1 2013-10 - Usability | Pass
"The subject complies with the applicable requirements set forth in the referenced IEC 60601-1-6:2010+A1:2013."
"Usability testing was completed in accordance with IEC 60601-1-6 and the digital thermometer is complied with the applicable requirements of standard." |
| ISO 10993-1:2018, ISO 10993-5:2009, ISO 10993-10:2010 - Biocompatibility Testing - Cytotoxicity, Sensitization, and Irritation for patient-contacting materials (cap and outer shell). | Pass
"The subject complies with the applicable requirements set forth in the referenced biological evaluation standards."
"Biocompatibility of patient-contacting materials (cap and outer shell) was performed according to ISO 10993-1/5/10..." |
| Software Verification and Validation (according to "Guidance for the content for premarket submissions for software contained in medical devices") | "Software verification and validation report in accordance with 'Guidance for the content for premarket submissions for software contained in medical devices'." (Implicitly "Pass" as part of the overall acceptance for substantial equivalence.) |
2. Sample size used for the test set and the data provenance
- Test Set Sample Size: For clinical accuracy and repeatability testing, the study involved 150 subjects, divided into three age groups of 50 subjects each: infants (0-1 year), children (1-5 years), and adults (>5 years).
- Data Provenance: The document does not explicitly state the country of origin for the clinical data or whether it was retrospective or prospective. However, given the manufacturer is based in China and the nature of a 510(k) submission, it is likely that the testing (including clinical) was conducted in a controlled, prospective manner to meet regulatory requirements, potentially in China or a region where the standards are applicable.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
The document does not specify the number or qualifications of experts used to establish the ground truth for the clinical accuracy and repeatability testing. It simply states that "The methods and criteria of clinical accuracy and repeatability testing had been clinically assessed to meet the requirements of clinical accuracy per the referenced standards." For a digital thermometer, the ground truth for temperature measurement is typically established by highly accurate reference thermometers or alternative validated methods under controlled clinical conditions, rather than expert consensus in the way image-based diagnoses might be.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
The document does not mention any adjudication method for the test set. Given the nature of a digital thermometer measuring a physiological parameter (body temperature), adjudication by multiple readers is not typically applicable in the same way it would be for interpreting medical images. The "ground truth" for temperature measurement would be derived from a highly accurate reference method.
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
No, an MRMC comparative effectiveness study was not done. This study is for a digital thermometer, which is a direct measurement device, not an AI-powered diagnostic tool that assists human readers. Therefore, the concept of human readers improving with or without AI assistance is not relevant to this device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Yes, the primary performance evaluation for this digital thermometer is its standalone performance in measuring body temperature. This means its accuracy and repeatability are assessed directly against established standards (ISO 80601-2-56 and ASTM E1112) without human interpretation affecting the device's reading. The user simply reads the displayed temperature.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The ground truth for the clinical accuracy and repeatability testing for the digital thermometer would be highly accurate reference temperature measurements obtained through methods specified by the referenced standards (ISO 80601-2-56 and ASTM E1112). These standards outline precise methods for temperature measurement validation, often using known stable temperature baths or highly calibrated reference thermometers. It's not based on expert consensus, pathology, or outcomes data in the way a diagnostic imaging AI would be.
8. The sample size for the training set
This document does not specify a training set sample size. Digital thermometers are hardware devices that perform a direct physical measurement using a thermistor and convert it to a digital display. They are not typically "trained" in the same way a machine learning algorithm would be. Their performance is inherent in their design, calibration, and manufacturing consistently across units.
9. How the ground truth for the training set was established
Not applicable, as there is no "training set" in the context of an AI/machine learning algorithm for this device. The device's performance is driven by its engineering and adherence to established physical principles and manufacturing tolerances, validated against standards using the test set described.
§ 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.