(194 days)
Microlife MT19S1R Instant Digital Electronic Thermometer is used for the intermittent measurement and monitoring of oral human body temperature. The intended use of this thermometer is for ages 18 months and above.
This Instant Digital Electronic Thermometer enables very fast and reliable measurements and with its predicative technology the thermometer offers a very high clinical accuracy and has been designed to provide a maximum of user-friendliness.
The basic principle of this thermometer's that change of thermistor resistance, caused by changes of temperature, are converted to changes of frequency of RC oscillator circuit, Therefore, temperature can be given by measuring the frequency of oscillator.
The provided document describes the Microlife Instant Digital Electronic Thermometer, Model MT19S1R, and its substantial equivalence to a predicate device. However, it does not contain the detailed clinical study results and acceptance criteria in the format requested. The document focuses on regulatory submission and comparisons to a predicate device, rather than a detailed performance study with specific metrics.
Therefore, much of the requested information cannot be extracted directly from this document.
Here's a breakdown of what can be inferred or directly stated from the provided text, and what is missing:
1. A table of acceptance criteria and the reported device performance
This information is not explicitly provided in the document. The document states compliance with ASTM E1112, which is the standard for electronic thermometers and would define accuracy requirements. However, the specific acceptance criteria used for this submission and the numerical results are not listed.
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: Not explicitly stated. The document mentions "Controlled human clinical studies were conducted," but the number of subjects is not provided.
- Data Provenance: Not explicitly stated. It mentions "clinical data was presented," which implies prospective collection for the study. Country of origin is not specified.
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 as the device measures temperature, and ground truth would likely be established against a reference thermometer, not by expert interpretation.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
This information is not applicable/provided as the device measures temperature, which typically involves direct comparison to a reference standard, not expert adjudication of subjective findings.
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 information is not applicable/provided. The device is a thermometer, not an AI-assisted diagnostic tool requiring human reader studies.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
The entire device operates as a standalone algorithm for temperature measurement. The document states, "Clinical data was presented which evaluated clinical bias, clinical uncertainty and clinical repeatability per the Microlife Clinical Test Protocol outline." This implies a standalone evaluation of the device's accuracy.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The ground truth for temperature measurement would typically be established using a highly accurate reference thermometer (e.g., a calibrated mercury thermometer or a laboratory-grade electronic thermometer). The document implies this by stating "clinical bias, clinical uncertainty and clinical repeatability" were evaluated, which requires a reference standard. However, the specific type of reference used is not explicitly detailed.
8. The sample size for the training set
The device is a traditional electronic thermometer, not an AI/ML model that requires a "training set" in the conventional sense. The "training set" concept is not applicable.
9. How the ground truth for the training set was established
As above, the concept of a "training set" and its ground truth is not applicable to 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.