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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

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.

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The Lumiscope Model 2018 Thermometer has the same intended use as the predicate device. It is indicated for use in the measurement of oral and axillary temperature. It is not intended for rectal (rectum) temperature measurement. The device also provides a clock function when not in the temperature mode. The Lumiscope Model 2018 Thermometer is intended for use by adults and may be used by the infant or pediatric patient population for measurements of axillary body temperature or for measurements of oral body temperature if the child is able to hold the thermometer beneath the tongue while his mouth is closed.

The Lumiscope Model 2018 Thermometer is a thermometer of standard electrical transducer design, consisting of a flexible probe, connecting cord and display unit. The probe consists of a transducer and supporting plastic tube which houses the connection between the tube and cord. The display unit houses a 1.5V DC button battery, Liquid Crystal Display (LCD), slide switches for controlling the thermometer/clock mode and °F/°C mode, hour and minute set buttons, and temperature alert beeper.

Here's an analysis of the provided text regarding the Lumiscope Model 2018 Thermometer, focusing on acceptance criteria and study details.

1. A table of acceptance criteria and the reported device performance

Note: The provided 510(k) summary only states that the device meets ASTM E 1112-86. It does not elaborate on the specific quantitative acceptance criteria within that standard or the exact numerical performance results of the Lumiscope Model 2018 against those criteria.

2. Sample size used for the test set and the data provenance

The document states "Bench testing confirmed accuracy, precision and repeatability measurements specified in the labeling." This indicates that the testing was performed in a lab setting, not on human subjects.

• Sample Size for Test Set: Not specified. The document only refers to "bench testing." For a thermometer, "sample size" would typically refer to the number of individual thermometers tested, or the number of measurements taken, or the number of simulated temperature points evaluated. None of these details are provided.
• Data Provenance (country of origin, retrospective/prospective): The data provenance is from "bench testing," meaning laboratory-generated data. The country of origin of the testing is not specified, nor is whether the data was retrospective or prospective (which is less relevant for bench testing than for clinical studies).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This section is not applicable to the described study. The ground truth for a digital thermometer's accuracy, precision, and repeatability in bench testing would typically be established against highly accurate calibration standards or reference thermometers, not by human experts.

4. Adjudication method for the test set

This section is not applicable. Adjudication methods (like 2+1, 3+1) are used when there are multiple human readers providing interpretations that need to be resolved. For bench testing of a thermometer, objective measurements against a standard are performed, not subjective 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 was not done. This type of study is relevant for AI systems assisting human interpretation (e.g., in medical imaging). The Lumiscope Model 2018 is a standalone digital thermometer and does not involve AI or human readers for its operation or interpretation.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Yes, in essence, a standalone performance assessment was done. The "bench testing" described evaluates the device itself (the "algorithm only" in a broader sense of device function, though not an AI algorithm) against established standards (ASTM E 1112-86) without human-in-the-loop interpretation being part of its core function. The device's performance is independent of human interpretation for reading the temperature.

7. The type of ground truth used

The ground truth for the "accuracy, precision, and repeatability" testing was established by the ASTM Standard Specification for Electronic Thermometer for Intermittent Determination of Patient Temperature (ASTM E 1112-86). This standard outlines the methods and reference values/tolerances against which the thermometer's performance is measured. It relies on calibrated reference equipment and defined test procedures.

8. The sample size for the training set

This section is not applicable. The Lumiscope Model 2018 Thermometer is a traditional electronic device, not an AI/machine learning system that requires a "training set." Its functionality is based on predefined electronic circuits and physical principles, not learned from data.

9. How the ground truth for the training set was established

This section is not applicable for the same reason as point 8.

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