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Infrared Ear Thermometer ET-101A is indicated for the intermittent measurement and monitoring of human body temperature by consumers in a home use environment. It's intended for use on people of all ages.

Infrared Ear Thermometer ET-101A is electronic thermometers using an infrared detector (thermopile detector) to detect body temperature from the auditory canal. Its operation is based on measuring the natural thermal radiation emanating from the tympanic membrane and the adjacent surfaces of the patient.
To measure ear temperature, put a new clean probe cover on the infrared ear thermometer, then insert it into a patient's outer ear canal. A test button is pressed to start the measurement through the radiation exchanges. The electrical signal read out from the detector is fed to the circuit for amplification and calculation. The measured temperature then appears on a LCD display. The total operation takes a few seconds.

The provided text describes a 510(k) summary for the Infrared Ear Thermometer ET-101A, comparing it to a predicate device and outlining non-clinical and clinical tests. However, it does not explicitly state detailed acceptance criteria with numerical targets or specific performance metrics that were compared against those criteria.

Here's an analysis based on the information provided:

1. Table of Acceptance Criteria and Reported Device Performance:

The document states compliance with ASTM E1965-98 for non-clinical standards and implies that clinical studies evaluated clinical bias, clinical uncertainty, and clinical repeatability. However, specific numerical acceptance criteria (e.g., maximum allowable bias, precision limits) for these parameters and the reported performance values are not explicitly detailed in the provided text. The document concludes that the device is "substantially equivalent" to the predicate, implying it meets comparable performance levels.

2. Sample Size Used for the Test Set and Data Provenance:

• Sample Size for Test Set: Not explicitly stated. The document mentions "Controlled human clinical studies were conducted using the Infrared Ear Thermometer ET-101A" but does not give a number for participants.
• Data Provenance: Not explicitly stated. The document indicates "human clinical studies were conducted," but details like country of origin or whether the data was retrospective or prospective are not provided. Given it's a clinical study, it's typically prospective.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications:

This information is not provided in the document. For a thermometer, "ground truth" would typically refer to a reference temperature measurement method, not expert consensus on an image or diagnosis.

4. Adjudication Method for the Test Set:

This information is not provided. As "ground truth" for a thermometer is usually a reference device, a human adjudication method like 2+1 or 3+1 for diagnostic interpretation is not applicable here.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:

No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic imaging devices where human readers interpret results, and an AI provides assistance. For a thermometer, the output is a numerical temperature reading, not an interpretation by a human reader.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:

Yes, the clinical evaluation of the thermometer's performance (clinical bias, uncertainty, repeatability) would inherently be a standalone performance evaluation of the device itself, as it directly measures a physical parameter. There is no "human-in-the-loop" influencing the temperature reading provided by the device.

7. The Type of Ground Truth Used:

The type of ground truth used for clinical studies of a thermometer would typically be comparison to a precisely calibrated reference thermometer or a "gold standard" clinical thermometry method (e.g., rectal thermometer, central venous temperature) under controlled conditions. The document states "Clinical data was presented which evaluated clinical bias, clinical uncertainty and clinical repeatability per the Sejoy Clinical Test Protocol outline," implying such a comparison was performed, but the specific "gold standard" used is not mentioned.

8. The Sample Size for the Training Set:

This information is not applicable/provided. Thermometers like the ET-101A typically do not employ machine learning or AI algorithms that require a "training set" in the conventional sense. Their operation is based on established physical principles (infrared detection) and calibration procedures. If any internal calibration or adjustment uses data, it's not described as a "training set" in this context.

9. How the Ground Truth for the Training Set Was Established:

This information is not applicable/provided for the reasons stated in point 8.

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