(62 days)
The device is an infrared thermometer intended for the intermittent measurement of human body temperature in people of all ages.
AViTA Radar Thermo NT1 Series IR Thermometer is hand-held and battery-operated, taking skin temperature mainly in the middle of the forehead. The AViTA Radar Thermo NT1 Series IR Thermometer uses the principle of surveying the natural emission of infrared thermal radiation from all objects, including the human body. Making use of an IR Emitter/Deector Operation Distance Detecting System, the AViTA Radar Thermo NT1 Series IR Thermometer takes the temperature at distance. without any contact with the patient.
The provided text describes a 510(k) summary for the AViTA Radar Thermo IR Thermometer, Model no.: NT1 Series. However, it does not contain specific details about acceptance criteria, device performance metrics, or a detailed study description with sample sizes, expert qualifications, or ground truth establishment.
The document primarily states general conformity to international standards and substantial equivalence to a predicate device based on intended use and technological characteristics.
Here's an attempt to answer your request based only on the provided text, highlighting what is missing:
Acceptance Criteria and Device Performance
The submission states that the device conforms to applicable standards. For an infrared thermometer, the key performance acceptance criteria typically relate to accuracy. While the specific numerical acceptance criteria (e.g., maximum allowable error) are not provided in this summary, the relevant standards would define these.
| Acceptance Criteria (Inferred from Standard) | Reported Device Performance |
|---|---|
| Conformance with ASTM E1965-98(2003) | Device conforms |
| Conformance with IEC 60601-1 | Device conforms |
| Conformance with IEC 60601-1-2 | Device conforms |
| Substantial equivalence to predicate device (Thermofocus 01500 Series Thermometer) | Device is substantially equivalent based on intended use and similar technological characteristics. Bench testing demonstrated that technological differences do not raise new questions of safety or effectiveness. |
| Specific Accuracy Metrics (e.g., bias, limits of agreement) | Not reported in this summary. |
| Clinical Performance Metrics | Not reported in this summary. |
Study Details
The document refers to "bench testing" but does not provide specific details about any clinical or performance study that would typically establish the quantitative performance metrics against acceptance criteria.
- Sample size used for the test set and the data provenance: Not specified. The document only mentions "bench testing contained in this submission." This implies laboratory testing rather than data from human subjects.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable/Not specified. For a thermometer, "ground truth" might refer to a reference thermometer reading, not an expert assessment.
- Adjudication method for the test set: Not applicable/Not specified. This is typically relevant for studies involving qualitative assessments by multiple experts.
- 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 common for diagnostic imaging AI algorithms where human interpretation is involved.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: The device itself is a standalone thermometer; its performance would inherently be "standalone." However, specific performance data (e.g., accuracy compared to a reference standard) is not provided in this summary.
- The type of ground truth used: Not explicitly stated, but for a thermometer, the ground truth would typically be temperature readings obtained from a highly accurate reference thermometer (e.g., a laboratory-grade blackbody calibration source or a rectal thermometer for clinical settings, although the document only mentions "bench testing").
- The sample size for the training set: Not applicable/Not specified. The device appears to be a hardware-based infrared thermometer, not a machine learning algorithm that requires a "training set."
- How the ground truth for the training set was established: Not applicable.
Conclusion based on the provided text:
The provided 510(k) summary focuses on demonstrating substantial equivalence to a predicate device and conformity to general safety and performance standards (ASTM E1965-98(2003), IEC 60601-1, and IEC 60601-1-2). It mentions "bench testing" but does not provide detailed results, specific acceptance criteria beyond standard conformity, or the methodology of the study, including sample sizes, expert involvement, or ground truth establishment in a way that would allow for a comprehensive answer to your questions. The information typically found in a detailed study report (e.g., a clinical study or a detailed bench performance report) is not present in this FDA summary.
§ 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.