(68 days)
The AVITA Sanéo IR Thermometer (Model no. TS2x/TS3x series) is infrared thermometers intended for the intermittent measurement of human body temperature in people of all ages in the home.
The AViTA Scanéo TS2x/TS3x series IR Thermometer is hand-held, non-sterile, reusable, battery operated device that can measure human body temperature.
The AVITA TS2x series IR Ear Thermometer measures human body temperature natural thermal emitted from the ear tympanic.
The AViTA TS3x series IR Ear / Forehead Thermometer can measure human body temperature in 2 ways:
(1) The temporal artery over forehead.
(2) Tympanic temperature via the human ear. Operation is based on the measuring of the natural thermal infrared radiation emitted from the surface of the skin over the temporal artery or from the ear tympanic.
Here's an analysis of the provided text regarding the AViTA Scanéo IR Thermometer's acceptance criteria and study, structured to address your specific points:
1. Table of Acceptance Criteria and Reported Device Performance
The provided text does not explicitly state quantitative acceptance criteria for temperature accuracy or other performance metrics. Instead, it refers to conformance to established standards.
| Acceptance Criteria (Standard Conformance) | Reported Device Performance |
|---|---|
| ASTM E1965-98(2003) | Conforms |
| IEC 60601-1 (Safety) | Conforms |
| IEC 60601-1-2 (EMC) | Conforms |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify a sample size for any clinical or performance test set. It mentions "bench testing" but provides no details on the number of subjects or measurements. There is no information regarding the country of origin of data or whether it was retrospective or prospective.
3. Number of Experts Used to Establish Ground Truth and Qualifications
This information is not provided. The approval is based on conformance to standards and substantial equivalence to a predicate device, rather than a study involving expert-established ground truth.
4. Adjudication Method for the Test Set
No adjudication method is mentioned as there's no described clinical test set with human ground truth establishment.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No MRMC study is mentioned. The device is an infrared thermometer, which typically does not involve human readers interpreting results in the same way an imaging AI would.
6. Standalone Performance Study
A standalone performance study was done in the sense that the device was tested to conform to the specified standards (ASTM E1965-98(2003), IEC 60601-1, and IEC 60601-1-2) through "bench testing." However, the specific results of these tests (e.g., exact accuracy values, repeatability, etc.) are not provided in this summary. The summary only states that the device "conforms to applicable standards."
7. Type of Ground Truth Used
For the non-clinical performance (conformance to ASTM, IEC standards), the ground truth would be the defined specifications and measurement methods within those standards. For example, ASTM E1965-98(2003) sets out specific methods for evaluating the accuracy of infrared thermometers against a traceable reference.
8. Sample Size for the Training Set
This device is not an AI/ML device in the context that would typically require a "training set" for an algorithm. It is a traditional hardware device for temperature measurement. Therefore, no training set sample size is applicable or provided.
9. How the Ground Truth for the Training Set Was Established
As above, no training set is applicable for this type of device.
Summary of Key Gaps in Information for an AI/ML Device Context:
From the perspective of evaluating an AI/ML medical device, the provided 510(k) summary is significantly lacking in the details you've requested. This is primarily because the device (an infrared thermometer) is a traditional medical device, not an AI/ML-driven diagnostic or interpretative system. Therefore, concepts like "training set," "test set" with expert ground truth, "adjudication," and "MRMC studies" are generally not applicable to its regulatory submission. Its performance is demonstrated through conformance to established engineering and performance standards rather than clinical studies with human expert interpretation.
§ 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.