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The Microlife Digital Infrared Ear Thermometer IR1DV1-1 is an electronic clinical thermometer using an infrared sensor to detect body temperature from the auditory canal in the neonatal, pediatric and adult population used in the home setting.

The Microlife Digital Infrared Ear Thermometer. Model 1R1DV1-1 is an electronic thermometer using an infrared sensor (thermopile) to detect body temperature from the auditory canal. Its operation is based on measuring the natural thermal radiation emanating from the tympanic membrane and the adjacent surfaces: The Microlife Digital Infrared Ear Thermometer consists mainly of five parts: a) IR Thermopile Sensor b) ASIC c) E2PROM IC d) LCD and Backlight e) 2 Keys, 1 Buzzer This device is used probe cover free.

The provided text is a 510(k) summary for the Microlife Digital Infrared Ear Thermometer, Model IR1DV1-1. It describes the device, its intended use, and its substantial equivalence to a predicate device. However, it does not contain specific acceptance criteria or the detailed results of a study that proves the device meets those criteria.

Here's a breakdown of what is and is not in the provided text in relation to your request:

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

• Not provided. The document states compliance with ASTM E1965 and IEC60601-1/-2, but does not list specific numeric acceptance criteria for temperature accuracy or other performance metrics, nor does it present the device's measured performance against such criteria.

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):

• Partially provided. The submission mentions "Controlled human clinical studies were conducted for the Microlife Digital Infrared Ear Thermometer Model IR1DV1-1 to validate the effectiveness of use without a probe cover."
• Sample size: Not specified.
• Data provenance: "human clinical studies" is mentioned, implying prospective, but no country of origin is stated.
• Retrospective/Prospective: Implied prospective due to "conducted."

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):

• Not provided. This information is generally more relevant for diagnostic AI devices where expert interpretation is the gold standard. For a thermometer, "ground truth" would typically refer to a highly accurate reference thermometer measurement.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

• Not provided. This is not typically relevant for a thermometer's performance validation.

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 provided. This is a question specifically for AI-assisted diagnostic devices and does not apply to a standalone medical device like a thermometer.

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

• Implied, but not explicitly detailed as "standalone performance study." The device is a thermometer, which inherently operates in a "standalone" manner to measure temperature. The clinical studies mentioned aimed to validate its "effectiveness of use without a probe cover," which implies testing its accuracy in that usage mode. No human "in-the-loop" interaction with an algorithm is described beyond reading the temperature.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

• Not explicitly stated in the document. For a thermometer, the "ground truth" for temperature would typically be established by a highly accurate, calibrated reference thermometer measuring core body temperature (e.g., rectal or arterial measurement).

8. The sample size for the training set:

• Not applicable/Not provided. This device is a traditional electronic thermometer, not an AI/machine learning device that requires a "training set" in the sense of supervised learning. Its "algorithm" refers to the signal processing for temperature measurement, not a learned model.

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

• Not applicable/Not provided. (See point 8).

Summary of what is present:

The document states that the device complies with ASTM E1965, IEC60601-1, and IEC60601-1-2 requirements. ASTM E1965, "Standard Specification for Infrared Thermometers for Intermittent Determination of Patient Temperature," would contain the specific acceptance criteria for accuracy.

It also mentions that:

• "Controlled human clinical studies were conducted for the Microlife Digital Infrared Ear Thermometer Model IR1DV1-1 to validate the effectiveness of use without a probe cover."

To fully answer your request, one would need to refer to the actual ASTM E1965 standard to find the acceptance criteria and then examine the full submission or a detailed clinical report that would show the results of the "controlled human clinical studies" against these criteria. The 510(k) summary only provides a high-level overview.

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