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The U-RIGHT TD-1115 ear thermometer and U-RIGHT TD-1118 ear thermometer are intended for the intermittent measurement and monitoring of human body temperature from ear canal. The device is indicated for use by people of all ages in the home.

The U-RIGHT TD-1115 ear thermometer and U-RIGHT TD-1118 ear thermometer are characterized by measuring human body temperature in the ear canal. It utilizes infrared technology to measure either infrared energy emitted from the eardrum and surrounding tissues when making a temperature measurement.

Here's a breakdown of the acceptance criteria and study information for the U-RIGHT TD-1115 and TD-1118 ear thermometers, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The provided document does not explicitly state numerical acceptance criteria in a table format for the device's accuracy. Instead, it refers to "system accuracy performance" and concludes substantial equivalence based on this.

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

The document does not provide details on the sample size used for the test set or the data provenance (e.g., country of origin, retrospective/prospective). It only mentions a "comparison of system accuracy performance."

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

This information is not available in the provided text. The study described focuses on comparison to a predicate device, not on establishing ground truth via expert consensus.

4. Adjudication Method for the Test Set

The document does not mention any adjudication method for a test set.

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

No multi-reader multi-case (MRMC) comparative effectiveness study is mentioned. The study performed aims to demonstrate substantial equivalence to a predicate device.

6. Standalone Performance Study

A standalone performance study was done, but the details are minimal. The document states:

• "A comparison of system accuracy performance demonstrated that the U-RIGHT TD-1115 ear thermometer and U-RIGHT TD-1118 ear thermometer and the currently marketed Fora ComfortScan Ear Thermometer, TD-1261B (cleared under K081445) are substantially equivalent."
• "Software verification and validation, performance and safety tests confirmed that the performance, safety and effectiveness of the U-RIGHT TD-1115 ear thermometer and U-RIGHT TD-1118 ear thermometer are equivalent to the predicate device."

This indicates that internal performance and safety tests were conducted on the device itself, likely comparing its output against a reference or the predicate.

7. Type of Ground Truth Used

The document does not explicitly state the type of ground truth used. However, given the nature of a thermometer and the comparison to a predicate device (Fora ComfortScan Ear Thermometer, model TD-1261B), the "ground truth" for the performance comparison would likely be the temperature readings from the predicate device or a clinical standard reference thermometer during the testing. This is inferred, not explicitly stated.

8. Sample Size for the Training Set

The document does not mention a training set, as the device is a medical measurement instrument (thermometer), not an AI/machine learning model that typically requires a training set.

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

Not applicable, as there is no mention of a training set for this device.

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