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The device is intended for the intermittent measurement and monitoring of human body temperature. The device is indicated for use by people of all ages in the home.

AVITA TS8/TS9 IR Ear/ Forehead Thermometer is a hand-held, non-sterile, reusable, battery operated device that can measures 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 the natural thermal infrared radiation emitted from the surface of the skin over the temporal artery or from the ear Tympanic .

The provided text describes the AVITA TS8/TS9 Series IR Ear/Forehead Thermometer, its intended use, and its substantial equivalence to predicate devices. However, the document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than providing a detailed study proving the device meets specific acceptance criteria with quantitative performance metrics from a dedicated clinical trial.

Therefore, many of the requested details about acceptance criteria, specific study designs, sample sizes, and expert adjudication are not present in this document. The document primarily focuses on conforming to general standards and demonstrating similar technological characteristics to predicate devices.

Here's a breakdown of what can be extracted and what is missing:

1. A table of acceptance criteria and the reported device performance

This information is not explicitly provided in the document. The filing states:

• "In terms of operating specification, Safety & EMC requirements, the device conforms to applicable standards included ASTM E1965-98, IEC 60601-1 and IEC 60601-1-2 requirements."

This indicates that compliance with these general standards serves as a form of acceptance criteria for various aspects (safety, electromagnetic compatibility, general performance), but it does not specify quantitative performance metrics for temperature accuracy. For example, ASTM E1965-98 (Standard Specification for Infrared Thermometers for Intermittent Determination of Patient Temperature) would contain accuracy requirements, but the specific measured performance of the AVITA device against those requirements is not detailed in this summary.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• The document mentions "clinical testing supplied" but does not specify the sample size used for the test set.
• The data provenance (country of origin, retrospective/prospective) is not mentioned.

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)

This information is not provided. The document makes no reference to experts or their qualifications for establishing ground truth.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not provided. The document does not describe any adjudication process.

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

• No, a multi-reader, multi-case comparative effectiveness study was not mentioned or implied. This device is a medical thermometer, not an AI-assisted diagnostic tool for human readers.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

• This question is not applicable in the context of a thermometer. The device itself is standalone in its measurement function, and its performance would be evaluated as such. There is no "algorithm only" performance separate from the device's operation, nor is there a "human-in-the-loop" component in terms of interpretive diagnostic assistance that would typically be evaluated for AI. Clinical testing would assess the device's accuracy in measuring temperature.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

• The document does not explicitly state the "type of ground truth" used for the clinical testing. For a thermometer, the ground truth would typically be a highly accurate reference thermometer measurement (e.g., rectal or oral core temperature by an established medical-grade thermometer) against which the test device's readings are compared.

8. The sample size for the training set

• This information is not applicable/provided. Thermometers typically do not have a "training set" in the machine learning sense. Their performance is based on their physical sensing and processing mechanisms, calibrated during manufacturing and verified through testing.

9. How the ground truth for the training set was established

• This information is not applicable/provided for the reasons stated above for item 8.

Summary of available information regarding performance and studies:

• Device Performance Claims: The device "conforms to applicable standards included ASTM E1965-98, IEC 60601-1 and IEC 60601-1-2 requirements." This implies that it meets the accuracy and safety specifications within these standards, but specific numerical performance values are not given in this summary.
• Study Type: The document states that "bench testing contained in this submission and clinical testing supplied demonstrate that any differences in their technological characteristics do not raise and new questions of safety or effectiveness." This indicates that both laboratory (bench) and human (clinical) testing were performed to support substantial equivalence.
• Purpose of Studies: The studies were conducted to demonstrate that the AVITA TS8/TS9 IR Ear/Forehead Thermometer is substantially equivalent to its predicate devices, AVITA TS2/TS4 Infrared Ear Thermometer (K010462) and Exergen TemporalScanner Thermometer (K011291). The goal was to prove that its technological characteristics do not introduce new questions of safety or effectiveness compared to these legally marketed devices.

In conclusion, this 510(k) summary provides a high-level overview of regulatory compliance and substantial equivalence, but it lacks the granular details of a detailed clinical study report, particularly concerning quantitative performance, specifics of the test population, expert ground truth establishment, and detailed statistical analysis often found in studies for AI/CAD devices.

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