(95 days)
The Microlife Dual Mode Thermometer IFR1MJ1 is intended for the intermittent measurement and monitoring of human body temperatures. The device is indicated for use by people above 12 years old to geriatric for ear mode and from newborn to geriatric for forehead mode in the home.
The Microlife Dual Mode Thermometer, Model IFR1MJ1 is an electronic thermometer using an infrared sensor (thermopile) to detect body temperatures from the forehead or auditory canal. This Dual Mode Thermometer enables very safe and reliable measurements and with its technology the thermometer offers a very high clinical accuracy and has been designed to provide a maximum of userfriendliness. The Microlife Dual Mode Thermometer consists mainly of six parts: a) Thermopile Sensor b) ASIC c) E2PROM IC d) LCD and Backlight e) 2 Buttons, 1 Buzzer, Automatic switch f) Probe cap
The provided text describes the Microlife Dual Mode Thermometer, Model IFR1MJ1, and its substantial equivalence to predicate devices, but it does not contain specific acceptance criteria, detailed study results, or information about AI performance. The document is a 510(k) summary for a medical device approval.
Therefore, many of the requested sections (e.g., sample size for test set, number of experts, adjudication method, MRMC study, standalone performance, training set sample size, training set ground truth) cannot be extracted from this document as it focuses on regulatory compliance and equivalence to existing devices rather than a detailed performance study as one might see for an AI-powered device.
However, I can provide the available information based on the text:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Voluntary Standards Compliance: ASTM E1965, IEC60601-1, IEC60601-1-2 requirements | The device demonstrated compliance with ASTM E1965, IEC60601-1, and IEC60601-1-2 requirements. (Details on specific performance metrics against these standards are not provided in this summary.) |
| Clinical Accuracy (as per ASTM E1965 guidelines) | Clinical bias, clinical uncertainty, and clinical repeatability were evaluated per clinical validation for the Microlife Dual Mode Thermometer, consistent with ASTM E1965 guidelines. (Specific numerical values for these metrics are not provided in this summary.) |
| Substantial Equivalence to Predicate Devices: Microlife Digital Infrared Ear Thermometer (Model IR1DV1-1, K#091040) and Microlife Digital Infrared Forehead Thermometer (Model FR1DM1, K#033820) | The Microlife Dual Mode Thermometer, Model IFR1MJ1, was found to have the same intended use and technological characteristics as the predicate devices. Bench testing demonstrated no new questions of safety or effectiveness, thus proving substantial equivalence. |
| Intended Use: Intermittent measurement and monitoring of human body temperatures. For ear mode: people above 12 years old to geriatric. For forehead mode: newborn to geriatric. | The device meets this intended use. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size for Test Set: Not explicitly stated in the provided document. The document mentions "Controlled human clinical studies were conducted," but does not provide the number of participants.
- Data Provenance: Not explicitly stated. The studies were "Controlled human clinical studies."
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. The study focused on clinical validation of temperature measurement against a reference standard, not ground truth established by experts in an interpretative task.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- This information is not applicable or provided. The study involved clinical measurements, not expert adjudication of diagnostic interpretations.
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, a multi-reader multi-case (MRMC) comparative effectiveness study involving AI assistance was not mentioned. This device is a standalone thermometer, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Yes, the clinical studies evaluate the standalone performance of the device in measuring temperature. The device itself is a standalone measurement tool.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- The ground truth for temperature measurement would typically be established against a highly accurate reference thermometer (e.g., a rectal thermometer or an instrument used in a calibration lab) according to the ASTM E1965 standard. The summary states "the bland-Altman plot was presented evaluating clinical bias, clinical uncertainty and clinical repeatability per clinical validation," which implies comparison against a reference standard. Specific details of the reference standard are not provided.
8. The sample size for the training set
- Not applicable/Not provided. This device is not an AI algorithm that undergoes "training" in the conventional sense. Its firmware/algorithm for temperature calculation is pre-programmed.
9. How the ground truth for the training set was established
- Not applicable/Not provided. As above, this device does not have a "training set" in the context of machine learning.
§ 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.