(51 days)
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.
| Metric | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| System Accuracy Performance (Ear Thermometer) | Not explicitly stated as a numerical value, but implied to be equivalent to the predicate device. | "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." |
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.
§ 880.2910 Clinical electronic thermometer.
(a)
Identification. A clinical electronic thermometer is a device used to measure the body temperature of a patient by means of a transducer coupled with an electronic signal amplification, conditioning, and display unit. The transducer may be in a detachable probe with or without a disposable cover.(b)
Classification. Class II (performance standards). The device is exempt from the premarket notification procedures in part 807, subpart E of this chapter, subject to the limitations in § 880.9 and the following conditions for exemption:(1) Device is not a clinical thermometer with telethermographic functions;
(2) Device is not a clinical thermometer with continuous temperature measurement functions; and
(3) Appropriate analysis and testing (such as that outlined in the currently FDA-recognized editions, as appropriate, of 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,” or ASTM E1965, “Standard Specification for Infrared Thermometers for Intermittent Determination of Patient Temperature,” or ASTM E1112, “Standard Specification for Electronic Thermometer for Intermittent Determination of Patient Temperature,” or ASTM E1104, “Standard Specification for Clinical Thermometer Probe Covers and Sheaths”) must validate specifications and performance of the device.