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The Medical Infrared Thermometer is a non-sterile. reusable clinical thermometer intended for the intermittent determination of human body temperature in no touch mode on the center of the forehead as the measurement site on people of one month and above.

The Medical Infrared Thermometer is a non-contact, hand-held, battery powered device designed to measure human body temperature, which has the feature of simple and easy use, rapid measurement and accurate temperature feedback. The Medical Infrared Thermometer is an infrared thermometer to measure human body temperature using the infrared energy emitted in the area around the subject's forehead. The reference body site of the temperature measurement is axillary. The temperature measurement distance is 1-5 cm. The product is composed of enclosure, control panel, LCD screen, infrared sensor, PCB board, battery pack and USB charging inlet. The thermometer has three functions of digital LCD display, buzzer indication for measurement results and three color back light indication for temperature (32.0℃ to 37.3℃ with green back light; 37.4℃ to 38.0℃ with yellow back light; 38.1℃ to 43.0℃ with red back light). The device is powered by Li-ion Battery (3.7VDC; 30mAh), which can be recharged through a computer with USB port or by switching power supply (100-240V, 50/60Hz) connected with a USB charging cable. The switching power supply is not provided with the subject device and the USB charging cable will be provided with the subject device as an accessory. There are two models RST-TC59-1001 and RST-TC60-1001 included in this document. Both models share the same construction except differences on product structure including appearance of enclosure, PCB design, sensor, MCU and working condition (ambient temperature). There are three buttons on control panel of both models, the first button is for power on/off and temperature measurement function, the second button is for temperature unit shift (°C and °F) function, the third button is for memory function.

Here's a breakdown of the acceptance criteria and the study proving the device meets them, based on the provided FDA 510(k) summary:

Acceptance Criteria and Device Performance

Device Name: Medical Infrared Thermometer (Model: RST-TC59-1001, RST-TC60-1001)

Study Details for Clinical Accuracy Validation Test:

The provided document describes a clinical accuracy validation test for the device.

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

   • Sample Size: A total of 165 subjects were selected for temperature measurement.
   • Data Provenance: The study was conducted in a clinical setting, but no specific country of origin is mentioned. It is described as a "clinical trial." The nature of the study (retrospective or prospective) is not explicitly stated, but the description "clinical accuracy validation is designed and performed" and "total of 165 subjects are selected to temperature measurement" strongly suggests a prospective study.

2. 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):

   • The document does not specify the number of experts or their qualifications for establishing ground truth.
   • Instead, the ground truth was established by a reference clinical thermometer (RCT), specifically a "mercury axillary thermometer (Geratherm Medical AG)." The accuracy of this reference thermometer itself is assumed to be the "ground truth."

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

   • The document does not mention an adjudication method. The ground truth was established by a reference device, not by multiple human readers needing adjudication.

4. 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, an MRMC study was not done. This device is an infrared thermometer, which provides a direct temperature reading, not an AI-assisted diagnostic tool that would typically involve human readers interpreting outputs.

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

   • Yes, the clinical accuracy validation test described is effectively a standalone performance test of the thermometer. It compares the device's readings directly against a reference clinical thermometer. The device itself is an "algorithm only" in the sense that it processes infrared data to produce a temperature reading, without a human intermediary interpreting its output for diagnosis purposes.

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

   • The ground truth was established by comparison to a reference clinical thermometer (mercury axillary thermometer), which is a widely accepted standard for body temperature measurement.

7. The sample size for the training set:

   • The document does not provide information about a training set. This is a medical device that measures a physical parameter (temperature) using established principles of infrared thermometry, rather than an AI/Machine Learning model that typically requires a large training dataset. The "algorithm" mentioned refers to the internal calculations for converting infrared energy to a temperature reading, which is based on physics, not statistical learning from a training set in the modern AI sense.

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

   • As no training set is described in the context of typical AI/ML, this question is not applicable.

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