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The Microlife Non-Contact Infrared Forehead Thermometer, Model FR1MF1-B (NC150 BT) is intended for the intermittent measurement and monitoring of human body temperature. The device is indicated for use by people of all ages in the home. The device can be used in connection with a smart phone running the «Microlife Connected Health +» APP. The memory data can be transferred to the smart phone via Bluetooth.

The Microlife Non-Contact Infrared Forehead Thermometer, Model FR1MF1-B (NC150 BT) is an electronic thermometer using an infrared sensor, which is composed of thermistor and thermopile, to measures infrared energy radiated from the forehead as well as objects. This energy is collected through the lens and converted to a temperature value. The thermistor measures the ambient temperature of the sensor by changing the resistance. The function of thermopile is to measure the voltage difference between the temperature corresponding to the infrared radiation induction and the temperature difference measured by thermistor. Based on the voltage difference, difference temperature can be calculated, and the target temperature can be obtained by adding thermistor's temperature. The Microlife Non-Contact Infrared forehead thermometer, Model FR1MF1-B (NC150 BT), consists of the following parts: a) Thermopile Sensor b) Microcontroller Unit c) LCD and Backlight d) 4 buttons ("START" button, "ON/OFF" button, "M" button, "MODE" button) e) Alkaline batteries; size AAA, 2 x 1.5 V f) Lens g) Bluetooth module

The provided text is a 510(k) summary for the Microlife Non-Contact Infrared Forehead Thermometer, Model FR1MF1-B (NC150 BT). It focuses on demonstrating substantial equivalence to a predicate device (Microlife Non-Contact Infrared Forehead Thermometer, Model FR1DG1 (NC200)) rather than describing an independent study of the device's acceptance criteria and proven performance.

Therefore, much of the requested information regarding acceptance criteria, specific study design details (sample size, data provenance, expert numbers/qualifications, adjudication, MRMC studies, standalone performance), and ground truth establishment for this specific device's test set (FR1MF1-B) is not explicitly present in the provided document.

Instead, the document primarily leverages the equivalence to its predicate device (FR1DG1), whose clinical validation is referenced indirectly. The key argument is that because the core measurement technology and algorithm are the same as the predicate which has already undergone clinical testing, a new clinical test for the identical measurement algorithm in the subject device is not required.

However, I can extract the following information that is available or implied:

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

The document refers to the accuracy specifications shared between the subject device and the predicate device. These can be considered the performance criteria.

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

• Sample Size: Not explicitly stated for the FR1MF1-B (NC150 BT) in a direct clinical test. The document states that a new clinical test is "not necessary" for this device because its measurement algorithm is identical to the predicate (FR1DG1).
• Data Provenance: Not specified for a direct clinical test on FR1MF1-B (NC150 BT). The predicate device's clinical test report (Clinical Test Report of FR1DG1 NC200) is referenced but not detailed. It is implied that any relevant clinical data comes from the predicate's validation.

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

• Not applicable/Not specified for this submission, as a new clinical test for FR1MF1-B (NC150 BT) was deemed unnecessary. This information would be found in the clinical test report for the predicate device (FR1DG1), which is not included here.

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

• Not applicable/Not specified, as a new clinical test for FR1MF1-B (NC150 BT) was deemed unnecessary.

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 device is a thermometer, not an AI-assisted diagnostic imaging tool that would involve "human readers" or "AI assistance" in the context of MRMC studies.

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

• The device itself is a standalone clinical electronic thermometer. Its performance is based on its measurement algorithm and hardware. The document implies that the "measurement algorithm" (which is the core of its standalone performance) for the subject device is "identical" to that of the predicate, which has been validated to standards like ASTM E1965-98 and ISO 80601-2-56. These standards typically involve rigorous standalone testing.

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

• For clinical thermometers, the "ground truth" for temperature measurement is typically established using highly accurate reference thermometers or direct invasive methods (e.g., rectal or oral core temperature) in a controlled clinical setting, as specified by standards like ASTM E1965-98 and ISO 80601-2-56. The document mentions "Body mode/laboratory" accuracy, indicating the use of controlled laboratory conditions.

8. The sample size for the training set:

• Not applicable. This is a non-AI/ML device. There is no concept of a "training set" in the context of this 510(k) submission for a clinical electronic thermometer.

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

• Not applicable (see point 8).

Summary of Device Performance Study (as implied for the predicate device, and by extension the subject device):

The document references that the predicate device (Model FR1DG1 (NC200)) has been validated in accordance with ISO 80601-2-56 and ASTM E1965-98. These are international and US standards for clinical thermometers, which prescribe specific methodologies for clinical accuracy testing.

• ASTM E1965-98 (Standard Specification for Infrared Thermometers for Intermittent Determination of Patient Temperature): This standard outlines clinical accuracy requirements and test methods for infrared thermometers, including specifics on how to conduct a clinical study to assess performance against a reference temperature. It defines statistical requirements for accuracy (e.g., mean difference, standard deviation) when compared to a reference temperature.
• 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): This international standard also details requirements for clinical accuracy validation of thermometers, including clinical study design, patient population, and statistical analysis.

The "Clinical Test Report of FR1DG1 NC200" is cited as evidence for the predicate's validation, and thus, indirectly for the subject device's. While the details of that report are not present, it would contain the specific sample sizes, methods for ground truth establishment (likely using high-precision reference thermometers in a clinical setting), and other study parameters. The core argument for K211776's substantial equivalence is that the critical components (IC, sensor, measuring algorithm) affecting temperature measurement performance are identical to the already-cleared predicate.

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