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The RII Smart IR Thermometer, Model TMS-01A is a non-contact infrared forehead thermometer and can only be used with an APP since the display only on a device with the APP. It is intermittent measurement of human body temperatures and is to be used at home for people of all ages.

The RII Smart IR Thermometer, Model TMS-01A is an electronic thermometer using an infrared sensor (thermopile) to detect body temperature from center of forehead. The principle of operation is based on measuring the natural thermal radiation from the center of forehead. The thermometer consists mainly of two parts - an IR sensor with a built-in ambient temperature sensor and an associated circuit. TMS-01A can only be used with an APP called "Radiant Forehead" which is available on APP store for iOS devices with version 7.0 or above. The APP is designed for use with TMS-01A to take forehead temperature by plugging the TMS-01A in the phone jack of the iOS devices. To measure body temperature, simply aim the device within 1 cm from the center of forehead. Press the "MEASURE" button on the smart phone touch screen, the temperature sensor detects the infrared thermal energy emitted from the targeted area. The electrical signal is sent to the circuit for amplification and calculation. The final measured temperature can be display on smart phone. The time consuming for measurement might be 1 second.

Here's a breakdown of the acceptance criteria and the study that proves the device meets them, based on the provided text:

Acceptance Criteria and Device Performance

The core acceptance criterion for the RII Smart IR Thermometer, Model TMS-01A, is its accuracy for body temperature measurement, aligned with established standards.

Table of Acceptance Criteria and Reported Device Performance:

Note: The FDA's 510(k) clearance process focuses on "substantial equivalence" to a predicate device. Therefore, the acceptance criteria are largely defined by the performance characteristics of the predicate device and relevant industry standards.

Clinical Study Details

The provided document describes a clinical performance test.

1. Sample Size Used for the Test Set and Data Provenance:

• Sample Size: 198 subjects.
• Data Provenance: Not explicitly stated regarding country of origin. The study was conducted as a "clinical performance test" which suggests prospective data collection for the purpose of this submission.
• Subject Groups: The 198 subjects were divided into three groups:
  • Infants: Newborn to one year
  • Children: Greater than one to five years
  • Adults: Greater than five years old

2. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications:

• This information is not provided in the document. For a thermometer, ground truth is typically established by highly accurate reference thermometers, not human experts in the same way it would be for an AI diagnostic algorithm.

3. Adjudication Method for the Test Set:

• This information is not applicable as the ground truth for thermometer accuracy is established by a reference standard, not through expert consensus requiring adjudication.

4. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:

• No, an MRMC study was not done. This type of study is more relevant for diagnostic imaging AI where human readers interpret medical images with and without AI assistance. The RII Smart IR Thermometer is a direct measurement device.

5. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done:

• The clinical test evaluates the device's performance (i.e., algorithm/device only) against a reference standard. While the device requires connection to an APP and a smartphone for display, its core measurement capability is standalone. The study directly assesses this standalone performance.

6. The Type of Ground Truth Used:

• The ground truth for the clinical performance test was established based on the requirements of ASTM E1965-98. This standard specifies how the accuracy of infrared thermometers for intermittent determination of patient temperature should be evaluated, generally relying on highly accurate reference temperature measurements.

7. The Sample Size for the Training Set:

• This information is not applicable to this device. The RII Smart IR Thermometer is not an AI/ML algorithm that requires a "training set" in the conventional sense. It's a sensor-based device with embedded algorithms calibrated during manufacturing. The clinical test is for validation/performance assessment, not for training.

8. How the Ground Truth for the Training Set Was Established:

• As noted above, there is no "training set" in the context of this device. The device's internal calibration and algorithmic performance would be established during its development and manufacturing process, likely using traceable temperature standards.

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