(72 days)
U-RIGHT TD-1240 Thermometer is an electronic thermometer using an infrared sensor to detect human body temperature on people of all ages and for use in the home. It is also available to detect object's surface temperature including human skin.
U-RIGHT TD-1240 Thermometer is characterized by measuring human body temperature from the surface of human skin. It utilizes infrared technology to measure infrared energy emitted from the skin surface when making a temperature measurement.
The provided text is a 510(k) summary for the U-RIGHT TD-1240 Thermometer. It describes the device and claims substantial equivalence to a predicate device. However, it does not contain a detailed study report with acceptance criteria or performance data for the U-RIGHT TD-1240 Thermometer itself. Instead, it relies on the assertion of "substantial equivalence" to a predicate device, the FORA ComfortScan Ear Thermometer (model TD-1261, K081445).
Therefore, I cannot directly extract the specific information requested in your prompt regarding the acceptance criteria and a study proving the device meets those criteria for the U-RIGHT TD-1240. The document states: "U-RIGHT TD-1240 Thermometer has the same performance characteristics as the predicate device. A comparison of system accuracy performance demonstrated that U-RIGHT TD-1240 Thermometer and Fora ComfortScan Ear Thermometer (cleared under K081445) are substantially equivalent."
This means that the performance characteristics are assumed to be met because they are the same as the predicate device, which would have undergone its own studies.
If you are looking for the original performance data, you would need to access the K081445 submission for the FORA ComfortScan Ear Thermometer.
Based on the provided text, here's what can be answered, and what cannot:
1. A table of acceptance criteria and the reported device performance
- Cannot provide. The document does not specify unique acceptance criteria or detailed performance data for the U-RIGHT TD-1240. It claims "same performance characteristics" as the predicate device.
2. Sample size used for the test set and the data provenance
- Cannot provide. No specific test set sample size or data provenance is mentioned for the U-RIGHT TD-1240.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Cannot provide. No information on ground truth establishment or experts is given for the U-RIGHT TD-1240.
4. Adjudication method for the test set
- Cannot provide. No information on adjudication is given.
5. 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
- Not applicable. This device is a thermometer, not an AI-assisted diagnostic tool involving human readers or cases.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Partially applicable, but no data provided. The device is a "standalone" thermometer in that its measurement is direct. However, the document doesn't provide specific performance metrics for this standalone operation beyond stating it has "same performance characteristics" as the predicate.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Cannot provide. No information on ground truth type is available in this document for the U-RIGHT TD-1240. For a thermometer, ground truth typically involves comparison to a highly accurate reference thermometer measurement.
8. The sample size for the training set
- Not applicable. This is not an AI/machine learning device that uses a "training set" in the conventional sense.
9. How the ground truth for the training set was established
- Not applicable. See point 8.
Summary of what the document does state about performance equivalence (not direct performance):
The document asserts that the U-RIGHT TD-1240 Thermometer is substantially equivalent to the predicate device, FORA ComfortScan Ear Thermometer (model TD-1261, K081445).
- "U-RIGHT TD-1240 Thermometer has the same performance characteristics as the predicate device."
- "A comparison of system accuracy performance demonstrated that U-RIGHT TD-1240 Thermometer and Fora ComfortScan Ear Thermometer (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-1240 Thermometer are equivalent to the predicate device."
To understand the actual acceptance criteria and performance data, one would need to refer to the 510(k) submission for the predicate device, K081445.
§ 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.