(50 days)
The Cardicare Model MT-301C and Model MT-301F digital thermometers are intended for use in the measurement of oral, axillary and rectal body temperature.
The Cardicare Model MT-301F & MT-301C Thermometers are thermometers of standard electrical transducer design, consisting of a sensor tip, connecting probe and display unit. The probe consists of a transducer and supporting plastic case, which houses the connection between the sensor and the circuitry. The display unit houses a 1.55V DC button battery, LCD and push button switch for controlling temperature and alert beeper.
The provided document is a 510(k) summary for a digital electronic thermometer, not a study of an AI-powered medical device. Therefore, many of the requested categories (such as sample sizes for test/training sets, expert qualifications, adjudication methods, MRMC studies, and ground truth types) are not applicable or cannot be extracted from this type of regulatory submission. This document pertains to a traditional medical device (thermometer) and its performance data relate to basic accuracy, precision, and repeatability, which are typically assessed through laboratory testing, not clinical studies with "ground truth" as described for AI or diagnostic imaging.
However, I can provide the available information based on the document:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Accuracy | Confirmed |
| Precision | Confirmed |
| Repeatability | Confirmed |
Note: The document states that the performance data "confirmed accuracy, precision and repeatability measurements specified in labeling." However, the specific quantitative acceptance criteria and the measured values are not detailed in this summary.
2. Sample Size Used for the Test Set and Data Provenance
Not applicable. The "test set" and "data provenance" as understood in a study for an AI or diagnostic device are not relevant to a standard thermometer's performance testing described here. The performance data refers to "testing" performed in a lab, not a clinical study with patients or data.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts
Not applicable. Ground truth as typically established by experts for diagnostic or AI studies is not relevant for the performance testing of a digital thermometer.
4. Adjudication Method for the Test Set
Not applicable. Adjudication methods are relevant for interpretation discrepancies in diagnostic studies, not for the direct measurement results of a thermometer.
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
Not applicable. This is not an AI-powered device, and no MRMC study was performed.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. This is a standalone device (thermometer); the concept of an "algorithm only" performance without human interaction, as understood for AI, does not apply here. Its performance is its standalone performance.
7. The Type of Ground Truth Used
Not applicable in the context of diagnostic/AI studies. For a thermometer, the "ground truth" for accuracy would typically be established against a highly calibrated reference thermometer or a standardized temperature source in a laboratory setting. The document only states "accuracy, precision and repeatability measurements specified in labeling" were confirmed.
8. The Sample Size for the Training Set
Not applicable. No training set is involved for this type of device and its performance testing.
9. How the Ground Truth for the Training Set was Established
Not applicable. No training set is involved.
§ 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.