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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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The Microlife Non-Contact Infrared Forehead Thermometer, Model FR1DG1 (NC200) 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 Microlife Non-Contact Infrared Forehead Thermometer, Model FR1DG1 (NC200) is an electronic thermometer using an infrared sensor to measure infrared energy radiated from the forehead. This energy is collected through the lens and converted to a temperature value. The device uses CapSense Technology to detect distance this technology is used to assist measurement. The concept of proximity sensor detects human electrical proximity level to transform to distance. The distance control feature is added to the user interface to identify the measurement distances are in the correct parameter. In other words, the device will enter into measurement mode after the correct measurement distance is detected. This device can take a measurement automatically when the device detects the distance is appropriate within 5 cm.

The provided text describes the Microlife Non-Contact Infrared Forehead Thermometer, Model FR1DG1 (NC200), and its comparison to a predicate device (Microlife Non-Contact Infrared Forehead Thermometer FR1DZ1, K100953) for substantial equivalence in an FDA 510(k) submission.

Here's an analysis of the acceptance criteria and study information:

1. Table of Acceptance Criteria and Reported Device Performance

The document states that the Microlife Non-Contact Infrared Forehead Thermometer, Model FR1DG1 (NC200) intends to meet the accuracy requirements of the ISO 80601-2-56: 2017 standard (implicitly, as it's listed as a standard the device was tested against and clinical testing was done according to ASTM E1965-98, which typically defines accuracy limits for clinical thermometers).

The device's reported laboratory accuracy is as follows:

The document also mentions that "the test report demonstrated that the clinical data, represented by clinical bias met the acceptance criteria of the clinical study protocol." However, the specific numerical acceptance criteria for clinical bias are not explicitly stated in the provided text.

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size for Test Set: 116 subjects.
  • 38 infants (newborn to one year)
  • 41 children (greater than one to five years)
  • 37 adults (greater than five years old)
• Data Provenance: The document does not explicitly state the country of origin. It describes a "clinical study" which implies prospective data collection, but does not explicitly state "prospective."

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications

This information is not provided in the document. The study is described as a "randomization, simple blind homologous control, pairing design of clinical investigation," and it states that "clinical bias met the acceptance criteria," suggesting a comparison against a reference thermometer measurement taken by an expert, but the number and qualifications of such experts are not detailed.

4. Adjudication Method for the Test Set

The adjudication method is not explicitly stated. The study design mentions "simple blind homologous control" and "pairing design," but doesn't specify how ground truth discrepancies (if any) were resolved or if multiple readers were involved in establishing the ground truth measurements.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

This information is not provided. The text describes a clinical study to assess the accuracy of the device itself, not a comparative effectiveness study involving human readers with and without AI assistance. The device is a thermometer, not an AI diagnostic tool.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

Yes, a standalone study was performed. The clinical testing described is primarily focused on the device's ability to measure temperature directly, without human interpretation of complex images or data where "human-in-the-loop" would typically apply. The "clinical bias met the acceptance criteria" refers to the instrument's performance.

7. Type of Ground Truth Used

The ground truth used was clinical data obtained from a "randomization, simple blind homologous control, pairing design of clinical investigation." In thermometer studies, this typically involves comparing the device's readings against a highly accurate reference thermometer (e.g., a rectal or oral mercury/electronic thermometer, or another gold standard for body temperature measurement) by an expert under controlled conditions. The term "clinical bias" supports this interpretation.

8. Sample Size for the Training Set

This information is not provided. The document makes no mention of a "training set," as the device is a medical measurement instrument. While it has algorithms (e.g., PH15.0 Algorithm for temperature calculation), these are typically developed through engineering and calibration, not through machine learning training sets in the same way an AI diagnostic algorithm would be.

9. How the Ground Truth for the Training Set Was Established

This information is not provided, as the concept of a "training set" with established ground truth in the context of machine learning does not directly apply to the development and validation of this type of electronic thermometer. The algorithms for temperature calculation would be based on physical principles, calibration, and engineering, rather than a data-driven training process with labeled ground truth data.

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The Microlife Non-Contact Infrared Forehead Thermometer, Model FR1DZ1 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 Microlife Non-contact Infrared Forehead Thermometer, Model FR1DZ1 is an electronic thermometer using an infrared sensor (thermopile) to detect body temperature from the forehead. Microlife FR1DZ1 specially enables you to take measurements and judge the readings according to vour local habits. It can measure for three types of readings comparable to readings measured at such three conventional measuring sites as rectal, oral, and axillary with an ordinary pen-type thermometer.

This Infrared Forehead Thermometer enables very safe and reliable measurements and with its technology the thermometer offers a very high clinical accuracy and has been designed to provide a maximum of userfriendliness.

The Microlife Non-Contact Infrared Forehead Thermometer consists mainly of seven parts:

• a) Thermopile Sensor
• b) ASIC
• c) E2PROM IC
• d) Lens
• e) LCD and Backlight
• f) 3 Keys (Offset 2 keys: optional), 1 Buzzer
• g) 2 batteries AAA (LR03)

This document describes the Microlife Non-Contact Infrared Forehead Thermometer, Model FR1DZ1, and studies supporting its regulatory submission.

1. Table of Acceptance Criteria and Reported Device Performance

The submission references compliance with ASTM E1965, which sets standards for infrared thermometers. While the precise acceptance criteria and detailed device performance metrics from the study are not explicitly itemized in the provided text, the standard implies the following (common for clinical thermometers):

Note: The document states that "Clinical data was presented evaluating clinical bias, clinical uncertainty and clinical repeatability per clinical validation for Microlife FR1DZ1," but it does not provide the specific numerical values or acceptance thresholds used within ASTM E1965 for the 510(k) summary.

2. Sample Size Used for the Test Set and Data Provenance

The text states that "Controlled human clinical studies were conducted in accordance with ASTM E1965." However, the sample size used for the test set is not specified. The data provenance is also not specified (e.g., country of origin, retrospective or prospective), beyond being "controlled human clinical studies."

3. Number of Experts Used to Establish Ground Truth and Qualifications

This information is not provided in the given text.

4. Adjudication Method for the Test Set

This information is not provided in the given text.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

A multi-reader multi-case (MRMC) comparative effectiveness study was not mentioned or implied in the provided text, as the device is a standalone thermometer, not an AI-assisted diagnostic tool for human readers.

6. Standalone Performance

A standalone performance study was done. The clinical studies evaluating "clinical bias, clinical uncertainty and clinical repeatability" directly assess the algorithm's (thermometer's) performance without human interpretation as part of the measurement process. The device's primary function is to provide a direct temperature reading.

7. Type of Ground Truth Used

The ground truth for the clinical studies would have been established by a reference method for temperature measurement (e.g., a highly accurate rectal thermometer or other standardized clinical thermometer). This is implied by the adherence to ASTM E1965, which outlines methods for clinical accuracy evaluation against a reference standard. The specific reference method is not explicitly stated in the provided text, but it would be a form of clinical measurement data.

8. Sample Size for the Training Set

This information is not applicable for this device as it is a physical thermometer with embedded algorithms for temperature conversion, not a machine learning model that undergoes a training phase with a distinct training set. The algorithms are based on established thermometry principles.

9. How Ground Truth for the Training Set Was Established

This information is not applicable for this device, as explained in point 8.

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