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The device is an electronic clinical thermometer using an infrared sensor to detect body temperature. The device is intended for use on the pediatric and adult population used in the home setting.

The Radiant Innovation Inc., Infrared Ear Thermometer, Models TH00XY series are electronic clinical thermometers using an infrared detector (thermopile detector) to detect electromagnetic radiation. The operation is based on measuring the body temperature from the auditory canal from the tympanic membrane and the adjacent surfaces of the patient. To measure ear temperature, the ear thermometer is inserted into a patient's outer ear canal. A Start button is pressed to start the measurement through the radiation exchanges. The measured temperature then appears on a LCD display. The total operation takes a few seconds.

The provided text describes a Special 510(k) Summary for a Radiant Innovation Inc. Infrared Ear Thermometer TH00XY series. This is a submission to the FDA for a modification to an existing, previously cleared device. Therefore, the "study" referred to is primarily focused on demonstrating substantial equivalence to the predicate device and compliance with established standards, rather than a de novo clinical trial with new acceptance criteria.

The document does not contain a detailed study report with specific acceptance criteria beyond compliance with standard performance metrics for thermometers, nor does it explicitly state performance metrics in a summarized table format with reported values. It primarily references compliance with existing standards.

Here's an analysis based on the provided text, addressing your points where information is available:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly provide a table with specific acceptance criteria and reported device performance. Instead, it states compliance with recognized standards.

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

• Sample Size: The document does not specify a "test set" sample size in terms of patient data. The tests conducted appear to be bench testing as stated: "More are bench testing contained in this submission supplicd demonstrate that the modification of TH00XY do not raise any new [questions]."
• Data Provenance: The document does not refer to clinical data or patient data with provenance information (country of origin, retrospective/prospective). The tests mentioned are laboratory/bench tests.

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

This information is not applicable as the document describes bench testing and compliance with standards, not a clinical study involving expert-established ground truth for patient data.

4. Adjudication Method for the Test Set

This information is not applicable as the document describes bench testing and compliance with standards, not a clinical study requiring adjudication of patient cases.

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

• Was it done? No, an MRMC comparative effectiveness study was not done. The submission is for an infrared ear thermometer, which is a standalone measurement device, not an AI-assisted diagnostic tool that would typically involve human readers.
• Effect Size of Human Readers Improve with AI vs without AI assistance: Not applicable, as no MRMC study or AI assistance is described.

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

• Was it done? Yes, in essence, the bench testing and compliance with ASTM E1965-98 can be considered a standalone performance assessment of the device (algorithm/hardware combination) without human intervention in the measurement process beyond operation. The thermometer itself provides a direct reading.

7. Type of Ground Truth Used

The ground truth for the performance claims is based on standardized measurement references and methodologies mandated by the cited standards (e.g., ASTM E1965-98). This involves calibrated heat sources and precision measurement techniques to assess accuracy, repeatability, and other performance characteristics. It is not expert consensus, pathology, or outcomes data.

8. Sample Size for the Training Set

This information is not applicable. Infrared ear thermometers rely on physical principles and calibration, not machine learning algorithms that require a "training set" in the conventional sense.

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

This information is not applicable for the reasons stated in point 8.

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