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The KINGTECH Infrared Ear Thermometer, models: TM810B, TM810B, TM817, TM818, TM818A, TM819, and TM820 are battery-operated electronic devices with intended use of measuring body temperature from the auditory canal of a patient by means of an infrared sensor coupled with electronic signal amplification, conditioning and a digital LCD (display) unit. The devices are reusable and intended for home use on people at all ages.

The Infrared Ear Thermometer, models TM810B, TM810B, TM817, TM818, TM818A, TM819 and TM820 is a handheld electronic thermometer 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 comprised of a thermopile for the measuring sensor, a reference thermometer 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 3.0V DC battery (2*AAA batteries) 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.

The provided text describes the acceptance criteria and the study for the Kingtech Infrared Ear Thermometer, Models TM810A, TM810B, TM817, TM818, TM818A, TM819, and TM820.

Here's the breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

The primary standard referenced for performance assessment is ASTM E 1965-2003. This standard outlines the requirements for infrared thermometers for intermittent determination of patient temperature. While the extract doesn't provide a specific table with numerical acceptance criteria and direct reported performance values in a side-by-side format, it states that the devices "were designed and verified according to the US standard ASTM E 1965-2003" and that "The results of the clinical Test Report could positively support the claim of Substantial Equivalence."

Therefore, based on the document, the acceptance criteria are implicitly those defined by ASTM E 1965-2003 for infrared ear thermometers.

A Clinical Test Report conducted according to ASTM E1965:2003, comparing the accuracy performance between the new models and the predicate device, demonstrated results that "could positively support the claim of Substantial Equivalence." This implies the devices met the accuracy requirements of the standard.|
| Other Performance Aspects: Compliance with electromagnetic compatibility (EMC), electrical safety, and biocompatibility. | Electrical Compliance Test according to IEC 60601-1 by accredited laboratory.
EMC Compliance Test according to IEC 60601-1-2 by accredited laboratory.
Biocompatibility Compliance Test according to ISO 10993-5 & ISO 10993-10 by accredited laboratory.
These tests indicate adherence to relevant safety and performance standards. |

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

• Sample Size for Test Set: The document does not explicitly state the sample size used for the clinical test set. It mentions "A Clinical Test Report conducted according to ASTM E1965:2003." ASTM E1965-2003 itself specifies requirements for subject numbers, typically recommending a minimum of 25 subjects for clinical accuracy testing. Without the report, the exact number isn't known, but it would have to meet the ASTM standard.
• Data Provenance: The study was "performed by the manufacturer." The manufacturer, Kingtech Enterprises Limited, is based in China. The study is prospective in nature, as it was a "Clinical Test Report carried out in such a way that compared the accuracy performance between models TM810A, TM810B, TM817, TM818, TM818A, TM819 and TM820, as well as TM818A and the predicate device."

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

This information is not provided in the document. For a thermometer, ground truth is typically established by simultaneous or near-simultaneous measurements with a highly accurate reference thermometer (e.g., rectal or oral electronic thermometer, or a well-calibrated thermocouple) in a controlled clinical setting, rather than through expert consensus.

4. Adjudication Method for the Test Set

Adjudication methods (like 2+1, 3+1, none) are typically used for subjective assessments where multiple readers provide interpretations (e.g., radiology studies). For a device like an ear thermometer that provides a numerical output, a human adjudication method is not applicable or mentioned. The "ground truth" for thermometer accuracy is usually based on direct comparison to a validated reference measurement.

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

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is relevant for diagnostic imaging devices where human readers interpret images. Mechanical performance (accuracy) of a thermometer is assessed by comparing its readings to a reference standard, not through multiple human interpretations. The study involved comparing the new devices to a predicate device.

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

The device is an infrared ear thermometer, a physical measurement device. Its performance is its standalone performance in measuring temperature. There isn't an "algorithm only without human-in-the-loop" concept in the same way it applies to AI software. The device itself performs the measurement. The "human-in-the-loop" aspect is limited to correctly placing the thermometer and reading the displayed temperature. The clinical test evaluated the device's performance directly, which is equivalent to a standalone performance evaluation for this type of product.

7. The Type of Ground Truth Used

The ground truth for the clinical study would have been established using reference temperature measurements from a highly accurate and validated method. While not explicitly stated, ASTM E1965-2003 dictates using a clinical reference thermometer (e.g., rectal, oral) or a traceable calibration standard to establish the "true" body temperature against which the ear thermometer's readings are compared.

8. The Sample Size for the Training Set

Not applicable. This device is a hardware-based infrared thermometer using an ASIC for calculation, not an AI/machine learning device that requires a "training set." The ASIC-controlled circuit is described as "hard-wire control instead of programmable control."

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

Not applicable. As stated above, this device does not utilize a training set in the conventional sense of machine learning.

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