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The device measures the body temperature from the auditory canal of of a patient by means of an infrared sensor coupled with an electronic signal amplification, conditioning and digital LCD (display) unit. The device is reusable and intended for home use on people of all ages.

The Mesure ear thermometer, models ST66, and ST67, are the handheld electronic thermometers that measures the temperature through the opening of the auditory canal by using a thermopile as the temperature sensor. The signal of sensor is calculated and displayed by an ASIC (Application Specific IC) - controlled circuit, which is considered the hard-wire control instead of programmable control. From the construction point of view, the ear thermometer comprises of a thermopile for the measuring sensor, a reference thermistor for comparison of temperature, a buzzer for sounding effect, an ASIC for calculating, and LCD for displaying the measuring temperature digitally for which the thermopile sensor detect the ear canal temperature through the infrared. This system uses a 3.0 V DC battery for operation of complete system whenever the battery is low, the ASIC circuit will detect the low battery condition automatically, and displays 'Low battery' in LCD display. Regarding the performance of ST66 and ST67, they were designed and verified according to the US standard ASTM E 1965-00.

Here’s a breakdown of the acceptance criteria and study information based on the provided document:

Acceptance Criteria and Device Performance

The document indicates that the device (Ear Thermometers Models ST66 and ST67) was designed and verified according to the US standard ASTM E 1965-00. It also states compliance with EN 60601-1 and EN 60601-1-2. However, the document does not explicitly list specific numerical acceptance criteria or reported device performance metrics from these standards. Instead, it makes a general statement of compliance and states that the devices maintain the "same safety and effectiveness" as the predicate device.

Table of Acceptance Criteria and Reported Device Performance:

Study Information

1. Sample size used for the test set and the data provenance:

   • The document does not specify the sample size used for the test set.
   • The document does not specify the data provenance (e.g., country of origin, retrospective or prospective).

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

   • This information is not provided in the document. The study described is an engineering verification and validation against standards, not a clinical study involving human readers or expert-established ground truth in the traditional sense of AI/medical imaging applications.

3. Adjudication method for the test set:

   • This information is not applicable as the document does not describe a clinical study requiring expert adjudication.

4. 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, an MRMC comparative effectiveness study was not done. The device is a standalone ear thermometer, not an AI-assisted diagnostic tool that would typically involve human readers.

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

   • Yes, the evaluation described is essentially a standalone performance assessment against engineering standards (ASTM E1965-00, EN 60601-1, EN 60601-1-2). The device itself operates as a standalone measurement tool.

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

   • The ground truth would be established by calibrated reference standards and controlled environmental conditions as specified by the engineering standards (e.g., blackbody radiators for temperature, controlled ambient temperatures, etc.). It's not clinical diagnosis-based ground truth.

7. The sample size for the training set:

   • This information is not applicable. The device is an electronic thermometer with an ASIC (Application Specific IC) - controlled circuit, not a machine learning or AI-based device that requires a "training set" in the conventional sense. The ASIC is described as "hard-wire control instead of programmable control."

8. How the ground truth for the training set was established:

   • This information is not applicable as there is no training set for this device.

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