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The Digital temperature monitor, model GT-202, GT-204, and GT-205 is the battery-operated electronic devices with intended use of measuring human body temperature precisely. This device is reusable and intended for the measurement of oral, armpit and rectal temperature of all ages.

The Digital temperature monitor, model GT-202/GT-204/GT-205, are the electronic thermometers by using a 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 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. Regarding the performance of GT-202/GT-204/GT-205, it was designed and verified according to the US standard ASTM E1112-98.

Here's an analysis of the provided text regarding the acceptance criteria and study for the Digital Temperature Monitor, models GT-202, GT-204, GT-205:

1. Table of Acceptance Criteria and Reported Device Performance

The provided 510(k) summary explicitly states that the device was designed and verified according to the US standard ASTM E1112-98. As the document does not provide specific numerical acceptance criteria from ASTM E1112-98 or detailed performance results, the table below reflects what is stated in the document.

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

The document does not specify the sample size used for the test set or the data provenance (e.g., country of origin, retrospective/prospective). It only states that the device was "designed and verified according to the US standard ASTM E1112-98" and that "verification and validation tests contained in this submission demonstrate that the difference in the submitted demonstrate that the difference in the submitted models could maintain the same safety and effectiveness as that of cleared device."

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

The document does not provide information on the number of experts used or their qualifications for establishing ground truth. The testing mentioned appears to be related to engineering verification against a standard rather than clinical expert evaluation for ground truth.

4. Adjudication Method for the Test Set

The document does not describe any adjudication method for a test set. The validation appears to be against a technical standard (ASTM E1112-98) rather than an expert-adjudicated clinical dataset.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No multi-reader multi-case (MRMC) comparative effectiveness study is mentioned in the provided text. The device is a standalone temperature monitor, and the evaluation focuses on its technical performance against a standard, not on assisting human interpretation.

6. Standalone Performance Study

Yes, a standalone performance evaluation was done. The document states: "Regarding the performance of GT-202/GT-204/GT-205, it was designed and verified according to the US standard ASTM E1112-98." This indicates that the device's accuracy and performance were evaluated according to this standard.

7. Type of Ground Truth Used

The ground truth used for the standalone performance study was based on the standards and specifications outlined in ASTM E1112-98. This standard would define the acceptable accuracy limits and test methodologies for digital clinical thermometers. It's an engineering and performance standard rather than a clinical ground truth like pathology or expert consensus on a medical image.

8. Sample Size for the Training Set

The document does not mention any training set size. This device (a digital thermometer) is a hard-wired control system (ASIC-controlled circuit) rather than a software-based AI system that would typically require a training set. The performance is determined by its hardware design and implementation to meet specific accuracy standards.

9. How Ground Truth for the Training Set Was Established

Since there is no mention of a training set, there is no information on how its ground truth was established. This type of device does not involve machine learning or AI that would typically use a training set with established ground truth.

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The Digital temperature monitor, model KY-01 is the battery-operated electronic devices with intended use of measuring human body temperature precisely. This device is reusable and intended for abdominal temperature measurement of a body less then eight ages old, and the measurement of oral, armpit and rectal temperature for all ages.

The Digital temperature monitor, model KY-01, are the electronic thermometers by using a thermistor 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 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. Regarding the performance of KY-01, it was designed and verified according to the US standard ASTM E1112-98.

Here's an analysis of the provided 510(k) summary, specifically focusing on acceptance criteria and the study details:

1. Table of Acceptance Criteria and Reported Device Performance

The provided document refers to compliance with ASTM E1112-98 as the primary standard for performance verification. This standard is for electronic thermometers. Therefore, the acceptance criteria are derived from this standard. The document doesn't explicitly state all performance metrics or their specific values from the standard, but it asserts compliance.

Study Proving Device Meets Acceptance Criteria:

The document states: "Regarding the performance of KY-01, it was designed and verified according to the US standard ASTM E1112-98." And also, "Discussion of Non-Clinical Tests Performed Determination of Substantial Equivalence are as follows: Compliance to applicable voluntary standards includes ASTM E1112: 1998, as well as EN 60601-1, EN 60601-1-1, and EN 60601-1-2 requirement."

This indicates that the device underwent non-clinical testing to demonstrate compliance with these standards. The specific details of these tests (e.g., number of measurements, specific temperature points tested) are not provided in this summary.

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

The document does not specify the sample size used for the test set or any details about human subjects. The testing described is "non-clinical tests" and compliance with standards, which would typically involve laboratory measurements on the device itself, potentially using simulated body temperatures or calibrated constant temperature baths. Given the nature of a digital thermometer, a "test set" in the context of patient data (prospective or retrospective) is not the primary means of demonstrating compliance with performance standards like ASTM E1112.

The data provenance is not applicable in the human subject data sense, as the performance evaluation referenced appears to be engineering and laboratory-based. The device's manufacturer is Kang Ying Medical Appliances Inc. in Taiwan.

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

This question is not applicable in the traditional sense of clinical imaging or diagnostic device ground truth. The "ground truth" for a thermometer's accuracy would be established by reference to highly accurate, calibrated temperature standards in a laboratory setting, not by human experts. The involved "experts" would be metrology engineers or technicians. The document does not specify their number or qualifications.

4. Adjudication Method for the Test Set

This is not applicable as the evaluation described is laboratory-based compliance testing against a standard, not expert adjudication of a diagnostic finding.

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

This is not applicable. The device is a digital thermometer, not an AI-assisted diagnostic tool.

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

The device itself is a standalone electronic thermometer. Its performance, as measured by compliance with ASTM E1112-98, would be its "standalone" performance. The document doesn't describe separate "algorithm only" performance, as the device's functionality is directly tied to its physical components (thermistor, ASIC).

7. The Type of Ground Truth Used

The ground truth used for assessing the thermometer's performance would be:

• Calibrated Reference Temperatures: Highly accurate and traceable temperature standards (e.g., from a national metrology institute) used in a laboratory setting to verify the accuracy of the thermometer's readings.
• Compliance with ASTM E1112-98: This standard itself defines the acceptable deviations from true temperature for different temperature ranges, acting as the ground truth for performance.

8. The Sample Size for the Training Set

This is not applicable. The device is a digital thermometer that uses a thermistor and an ASIC for calculation. It is not an AI/machine learning device that requires a "training set" of data in the computational sense. Its "training" is in its design and calibration processes.

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

This is not applicable for the same reasons as point 8.

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