(12 days)
The Microlife MT1751Q Digital Pacifier Thermometer is a non-sterile, reusable device intended for the determination of oral body temperature in infants to children five years of age.
The Microlife Digital Pacifier Thermometer, Model MT1751Q, is a batterypowered, liquid crystal display device using a thermistor inside the nipple. The patient contact portion is composed of medical silicone rubber. The body is of ABS plastic. This device is reusable and no components are disposable.
In addition, to speed up the measurement time, we have added the fixed offset into this thermometer, which is fulfilled by the hardware. With these characteristics, this thermometer can provide both a very high clinical accuracy and quick measurement time.
The basic principle of this thermometer is that change of thermistor resistance, caused by changes of temperature, are converted to changes of frequency of R-Coscillator circuit, Therefore, temperature can be given by measuring the frequency of the oscillator.
The provided document does not contain all the requested information for acceptance criteria and study details as it primarily focuses on the 510(k) summary for a digital pacifier thermometer. However, based on the available text, here is a breakdown of what can be extracted:
1. Table of Acceptance Criteria and Reported Device Performance
The document states compliance with ASTM E1112 for clinical electronic thermometers. This standard typically defines accuracy requirements for such devices. While the specific numerical acceptance criteria (e.g., maximum allowable deviation from reference temperature) are not explicitly stated in this summary, the discussion section suggests improved performance.
| Acceptance Criteria (Implied by standard) | Reported Device Performance |
|---|---|
| Accuracy (per ASTM E1112) | "very high clinical accuracy" and "quick measurement time" (achieved by fixed offset and hardware) |
| Response Time | Improved (implicitly compared to predicate device) |
| Clinical Bias (per Microlife Clinical Test Protocol) | Evaluated, but specific results not reported here |
| Clinical Uncertainty (per Microlife Clinical Test Protocol) | Evaluated, but specific results not reported here |
| Clinical Repeatability (per Microlife Clinical Test Protocol) | Evaluated, but specific results not reported here |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not specified. The document only states "Controlled human clinical studies were conducted."
- Data Provenance: Not specified (e.g., country of origin). The studies were "human clinical studies," implying prospective data collection in a clinical setting.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This information is not provided in the document.
4. Adjudication Method for the Test Set
This information is not provided in the document.
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 as the device is a thermometer, not an AI-assisted diagnostic tool for human readers.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is implicitly a standalone device. The "algorithm" in this context is the thermistor and associated circuitry. The measurement is taken directly by the device without human interpretation or intervention in the temperature reading process.
7. The Type of Ground Truth Used
For clinical accuracy, the ground truth would typically be a reference thermometer (e.g., a mercury-in-glass thermometer or a highly accurate electronic thermometer) against which the pacifier thermometer's readings are compared. The document mentions "clinical bias, clinical uncertainty and clinical repeatability," which are standard metrics for validating a thermometer's accuracy against a known reference.
8. The Sample Size for the Training Set
Not applicable. This device does not use machine learning or AI that would require a separate "training set" in the conventional sense.
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.