(63 days)
The AViTA Radar Thermo IR Thermometer (Model no. NT 152) is an infrared thermometer intended for the intermittent measurement of human body temperature in people of all ages.
The AVITA Radar Thermo NT152 IR Thermometer is hand-held and battery-operated, taking skin temperature mainly in the middle of the forehead. The AVITA Radar Thermo NT152 IR Thermometer uses the principle of surveying the natural emission of infrared thermal radiation from all objects, including the human body. The AViTA Radar Thermo IR Thermometer (Model no. NT 152) takes the temperature at distance, without any contact with the patient.
The provided text for K.092955 does not contain detailed information regarding specific acceptance criteria for performance, the design of a study to demonstrate compliance with such criteria, or the results of such a study.
The summary primarily states:
- Conformance to standards: "In terms of operating specification, Safety & EMC performance requirements, the device conforms to applicable standards included ASTM E1965-98(2003) , IEC 60601-1 and IEC 60601-1-2 requirements."
- Bench testing: "Moreover, bench testing contained in this submission demonstrate that any differences in their technological characteristics do not raise any new questions of safety or effectiveness."
- Substantial equivalence to predicate device: The conclusion is that the device is substantially equivalent to the predicate device (K081160) because it has the same intended use and similar technological characteristics, and bench testing shows no new safety or effectiveness concerns.
Without further details, I cannot complete the table or answer most of the specific questions about the study design, sample sizes, ground truth establishment, or multi-reader studies.
Here's what can be inferred or explicitly stated from the provided text, and what cannot:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Inferred from ASTM E1965-98(2003)) | Reported Device Performance |
|---|---|
| Accuracy specifications (e.g., maximum error) | Conforms to ASTM E1965-98(2003) |
| Operating specifications | Conforms to applicable standards |
| Safety & EMC performance requirements | Conforms to applicable standards: IEC 60601-1 and IEC 60601-1-2 |
Note: The specific numerical acceptance criteria (e.g., accuracy bounds) from ASTM E1965-98(2003) are not provided in this summary. The summary only states conformance to the standard.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not specified. The summary mentions "bench testing" but does not detail the test set size, data provenance, or study type (retrospective/prospective clinical data vs. purely lab-based testing).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not applicable, as a clinical study with human ground truth establishment is not described. The testing appears to be based on engineering and performance standards (bench testing).
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable, as a clinical study with human expert adjudication is not described.
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 standalone infrared thermometer, not an AI-assisted diagnostic tool involving human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Yes, the performance evaluation appears to be of the standalone device, as it is a medical device (thermometer) that performs its function without a human interpretation loop in the way AI algorithms are typically evaluated. The "bench testing" assesses the device's inherent performance.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For bench testing against ASTM E1965-98(2003), the ground truth would typically be a reference temperature measured by a highly accurate, calibrated reference thermometer according to the specified test methodology within the standard. It's not based on expert clinical consensus, pathology, or outcomes data in the traditional sense.
8. The sample size for the training set
Not applicable. This device is an infrared thermometer, not an AI/machine learning model that undergoes a training phase with a dataset.
9. How the ground truth for the training set was established
Not applicable, as there is no training set for this type of 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.