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The Digital Thermometer, models MT-XX8 and MT-XX9 are the battery-operated electronic devices with intended use of measuring human body temperature precisely. It can be measurement of oral, axially and rectal temperature.

The Digital Thermometers, models MT-XX8 and MT-XX9, are the electronic themometers by using a thermistor as the temperature sensor. The signal of sensor is calculated and displayed by an ASIC (Application Specific IC) control instead of programmable control. Basically MT-XX8 and MT-XX9 have the same control and only the different measuring range caused by some small different design in IC circuit. From the construction point of view, the digital thermometer comprises of a thermistor for measuring sensor, a reference resistor for comparison of temperature, a buzzer for sounding effect, an ASIC for calculating, and LCD for displaying the measuring temperature digitally for which the thermistor contacts. This system uses a 1.5V 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.

The provided text describes the submission for a 510(k) premarket notification for the VEGA TECHNOLOGIES, INC. Digital Thermometers, models MT-XX8 and MT-XX9. It focuses on demonstrating substantial equivalence to a predicate device and compliance with relevant standards, rather than providing detailed acceptance criteria and a comprehensive study report with the specific information requested.

Therefore, many of the requested details cannot be extracted from the given document.

Here's an attempt to answer what can be inferred:

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

The document states that the performance of MT-XX8 and MT-XX9 was "designed and verified according to the US standard ASTM E1112-98". This standard sets the acceptance criteria for electronic thermometers. However, the specific values for the acceptance criteria from ASTM E1112-98 (e.g., accuracy ranges) and the reported device performance directly measured against these criteria are not present in the provided text. The text only says it was "designed and verified according to" the standard.

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

This information is not provided in the document. The document mentions "verification and validation tests contained in this submission," but does not detail the sample size, type of test set (e.g., human subjects, calibration blocks), or data provenance.

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. For a digital thermometer, "ground truth" would typically be established by a highly accurate reference thermometer in a controlled environment, not by human experts in the way it would be for image analysis.

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

This information is not provided.

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

A Multi-Reader Multi-Case (MRMC) comparative effectiveness study is not applicable to this device. This type of study is typically used for AI-powered diagnostic tools where human readers (e.g., radiologists) interpret cases with and without AI assistance. The described device is a standalone electronic thermometer, not an AI-assisted diagnostic tool.

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

Yes, a standalone performance assessment was conducted in the sense that the device's accuracy was "designed and verified according to the US standard ASTM E1112-98." This standard dictates performance testing of the device itself, independent of human interpretation or involvement beyond operating the device. However, specific performance metrics are not listed.

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

For a digital thermometer, the ground truth would typically be established using calibrated reference thermometers and controlled temperature environments, in accordance with standards like ASTM E1112-98. The document does not explicitly state this, but it is implied by the reference to the standard.

8. The sample size for the training set

This information is not provided. The device is an electronic thermometer controlled by an ASIC (Application Specific Integrated Circuit) with hard-wired control, not a machine learning or AI algorithm that requires a "training set" in the conventional sense.

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

As explained in point 8, the concept of a "training set" and "ground truth for training" as typically used for AI algorithms is not applicable to this device. Its function is based on thermistor physics and established electronics, not a learnable model. The design and verification would rely on fundamental engineering principles and calibration against known temperature standards.

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