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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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The device measures the body temperature of a patient by means of a sensor (transducer) coupled with electronic signal amplification, conditioning and digital LCD (display) unit. The device is reusable and intended for oral, axillary or rectal temperature measurements.

Digital Clinical Thermometer, Models ST8C Series

The provided text is a letter from the FDA regarding a 510(k) premarket notification for a Digital Clinical Thermometer. It does not contain information about acceptance criteria for a device's performance, a study proving it meets those criteria, or any details related to AI algorithms, ground truth, expert reviews, or sample sizes for testing or training sets.

Therefore, I cannot provide the requested information based on the input. The document merely states that the device is substantially equivalent to legally marketed predicate devices.

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The wireless temperature monitor, model ST323C, ST323F are the battery-operated electronic devices with intended use of measuring human body temperature precisely. This device is reusable and intended for armpit temperature measurement of the person of all age.

The ST323C and ST323F are the wireless temperature monitor intended to be worn at left arm to monitor the armpit temperature continuously. ST323C and ST323F is composed of two operational parts, the receiver and transmitter. The receiver is the main operation unit on which, the LCD display control circuit and the main operation keys are included. And the transmitter was constructed with the thermo sensor, measuring circuit, and the signal communication unit and is to be worn at left arm for the continuous armpit temperature monitor. For the monitoring operation, both receiver and transmitter shall be switched on. Sooner after these two parts are switched on, the wireless signal communication will be set up between receiver and transmitter. The temperature monitoring signal measured at armpit will be continuously indicated on the LCD of receiver every 15 sec. This system uses a 3.0V 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 ST323C and ST323F, it was designed and verified according to the US standard ASTM E1112-00.

The provided 510(k) summary describes a wireless temperature monitor (ST323C and ST323F). This device is a thermometer, not an AI/ML device, and therefore the majority of the requested information (related to AI acceptance criteria, training/test sets, expert adjudication, MRMC studies, etc.) is not applicable.

However, I can extract and present the information that is relevant to the device's accuracy and the study conducted.

Here's the relevant information:

1. Table of Acceptance Criteria and Reported Device Performance

The submission refers to compliance with ASTM E1112: 2000 for performance verification. This standard is for electronic thermometers for intermittent determination of patient temperature. Specific acceptance criteria in terms of accuracy (e.g., ±0.1°C) and the device's reported performance against these numerical criteria are not explicitly stated in this 510(k) summary. However, the summary states: "Regarding the performance of ST323C and ST323F, it was designed and verified according to the US standard ASTM E1112-00."

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

A clinical report for measurement accuracy was conducted.

• Sample Size: Not explicitly stated in the document.
• Data Provenance: The measurement was taken from "children less than eight years old." The location of the study (country) is not specified, but the applicant company is based in Taiwan. The study appears to be prospective as it involves taking new measurements for comparison.

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

This is not applicable as the device measures a physical parameter (temperature). The "ground truth" is established by a reference thermometer, not by human expert interpretation.

4. Adjudication Method for the Test Set

Not applicable. The "ground truth" for temperature measurement is established by a reference thermometer.

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

Not applicable. This device is a physical measurement device, not an AI/ML diagnostic or assistive tool.

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

Not applicable. This is not an AI/ML algorithm. The device's performance is inherently "standalone" in that it directly measures and displays temperature.

7. The Type of Ground Truth Used

The "ground truth" for the accuracy study was established by comparison with a "Mesure digital thermometer ST8A3C" which served as a reference. The method followed ASTM-E1965, which specifies standards for clinical thermometers.

8. The Sample Size for the Training Set

Not applicable. This is a non-AI device.

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

Not applicable. This is a non-AI device.

Summary of Relevant Information from the provided text:

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The device measures the body temperature of a patient by means of a sensor (transducer) coupled with an electronic signal amplification, conditioning and digital 1.CD (display) unit. The device is reusable and intended for oral, axillary or rectal temperature measurements.

The 5 Sec Digital Thermometer, models ST8630X/ST8640X, ST8730X/ST8740X, ST8930X/ST8940X, ST8030X/ST8040X, and ST8B30X/ST8B40X, 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 5 Sec Digital Thermometer, models ST8630X/ST8640X, ST8730X/ST8740X, ST8930X/ST8940X, ST8030X/ST8040X and ST8B30X/ST8B40X it was designed and verified according to the US standard ASTM E 1112-00.

The provided text describes the 510(k) summary for the Mesure 5 Sec Digital Thermometer. It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a detailed study proving the device meets specific acceptance criteria with a novel AI algorithm. Therefore, many of the requested details related to AI-specific studies (e.g., multi-reader multi-case studies, standalone algorithm performance, AI training/test set details) are not applicable or findable in this document.

Here's an analysis based on the available information:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of acceptance criteria with corresponding performance data in the typical sense of a clinical trial for an AI-powered device. Instead, it states that the device was designed and verified according to the US standard ASTM E 1112-00. This standard defines performance requirements for electronic thermometers.

Acceptance Criteria (from ASTM E 1112-00, as implied by compliance):

Study Proving Acceptance Criteria:

The study proving the device meets the acceptance criteria is referred to as "verification and validation tests" conducted according to the US standard ASTM E 1112-00 and other relevant safety standards (EN 60601-1 series). These are typically non-clinical laboratory tests to ensure accuracy, precision, and safety parameters.

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

• Sample Size for Test Set: Not specified. For a digital thermometer conforming to ASTM E 1112-00, the "test set" would typically refer to the number of individual thermometer units tested, the number of temperature measurements taken under controlled conditions (e.g., water bath), and potentially a small number of human subjects for limited clinical validation (though in-depth clinical trials are not usually required for substantial equivalence of such devices). The document does not provide these numbers.
• Data Provenance: Not specified. However, the company is based in Taiwan (Mesure Technology Co., Ltd., Taipei Hsien, Taiwan, R.O.C.), suggesting testing likely occurred in Taiwan or through certified labs. The submission is to the FDA for the US market. The term "retrospective or prospective" is not applicable as this concerns a medical device's physical performance, not an AI model's data.

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

This query is typically relevant for AI/imaging devices where ground truth is established by expert consensus (e.g., radiologists). For a digital thermometer, the "ground truth" for temperature measurement is established by reference standards (e.g., highly accurate temperature baths traceable to national standards or calibration standards). Experts involved would be metrology engineers, technicians, and quality control personnel within the manufacturing and testing facilities, ensuring compliance with standards like ASTM E 1112-00. The document does not specify the number or qualifications of such experts.

4. Adjudication Method for the Test Set

Not applicable in the context of a digital thermometer's performance testing. Adjudication methods (e.g., 2+1, 3+1) are for resolving discrepancies among human readers interpreting medical images or data. For a thermometer, performance is objectively measured against a reference standard.

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

No. An MRMC study is relevant for AI systems assisting human readers in interpreting medical data (e.g., radiology). This is a simple digital thermometer, not an AI-powered diagnostic device.

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

Yes, in essence. The "device" (thermometer) itself is a standalone measurement tool. Its performance is evaluated intrinsically through laboratory testing against metrological standards, not in conjunction with human interpretation in the way an AI algorithm might be. However, this is not an "algorithm" in the sense of a complex AI model. The "algorithm" here is simply the ASIC (Application Specific IC) controlling the circuit to calculate and display the temperature. Its standalone performance is what's verified against ASTM E 1112-00.

7. The Type of Ground Truth Used

The ground truth for a digital thermometer's accuracy and precision testing is established using calibrated reference standards, such as highly stable and accurate temperature-controlled water baths, whose temperatures are known with high certainty and are traceable to national/international measurement standards.

8. The Sample Size for the Training Set

Not applicable. This device is not an AI algorithm that undergoes a "training phase." Its function is determined by its hardware design (thermistor, ASIC circuit) which translates a physical measurement into a digital reading based on fundamental physics and electronics, not machine learning from a training set.

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

Not applicable, as explained in point 8.

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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 ST61, ST62, ST63, ST64, and ST64, 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 ST61, ST62, ST63,ST64 and ST65, they were designed and verified according to the US standard ASTM E 1965-00.

This 510(k) submission describes the Mesure Technology Co., Ltd. Ear Thermometer, Models ST61, ST62, ST63, ST64, and ST65.

Here's an analysis based on the provided text:

1. Acceptance Criteria and Reported Device Performance

The device was designed and verified according to the US standard ASTM E 1965-00. While the specific acceptance criteria values of ASTM E 1965-00 are not explicitly stated in the provided text, compliance with this standard implies that performance metrics such as accuracy, precision, and response time were evaluated and met the established thresholds within that standard for infrared thermometers.

The document states that the devices (ST61-ST65) were developed from a cleared predicate device (ST613C & ST613F) with "only the small change in dimension, device housing, and some non-performance and safety related features." The conclusion is that these engineering differences do not affect intended use or alter the fundamental scientific technology, thereby maintaining the same safety and effectiveness as the predicate.

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

The document does not specify the exact sample size used for the test set. It mentions "verification and validation tests," but the number of subjects or measurements is not provided.

The data provenance is not explicitly stated. Given that the company is based in Taiwan (Mesure Technology Co., Ltd., Taipei Hsien, Taiwan, R.O.C.), it's plausible the testing was conducted there, but this is not confirmed. There is no information on whether the study was retrospective or prospective.

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 submission. For a medical device like a thermometer, the "ground truth" for temperature measurement would typically be established by highly accurate reference thermometers and controlled environments, rather than human experts, though clinicians might be involved in evaluating performance in clinical settings. The document focuses on compliance with a technical standard, ASTM E 1965-00.

4. Adjudication Method for the Test Set

This information is not provided. Given the nature of a thermometer performance test, an adjudication method in the sense of expert consensus on ambiguous cases is not typically applicable. Performance is usually assessed against a known reference.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size

No, an MRMC comparative effectiveness study was not conducted. This type of study is relevant for image interpretation or diagnostic tasks where human readers' performance is influenced by AI assistance. For a standalone thermometer, this is not applicable.

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

Yes, a standalone performance evaluation was conducted. The assessment focused on the device itself against established standards (ASTM E 1965-00, EN 60601-1, EN 60601-1-1, EN 60601-1-2). The device is a "hard-wire control" system, not programmable, implying that its performance is inherent to its design and hardware, without a human-in-the-loop for its basic function of temperature measurement.

7. The Type of Ground Truth Used

The ground truth for temperature measurement would be established by reference standards (e.g., highly accurate standard thermometers, temperature-controlled environments) as specified within ASTM E 1965-00. The document indicates compliance with this standard, which dictates how temperature accuracy and other metrics are determined.

8. The Sample Size for the Training Set

Not applicable. The device described uses an ASIC (Application Specific IC) - controlled circuit, which is characterized as "hard-wire control instead of programmable control." This implies it's not an AI/ML device that requires a "training set" in the conventional sense. The device's logic is fixed in hardware.

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

Not applicable. As stated above, this device does not use a training set for an AI/ML algorithm.

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The device measures the body temperature of a patient by means of a sensor (transducer) coupled with an electronic signal amplification, conditioning and digital LCD (display) unit. The device is reusable and intended for oral, axillary or rectal temperature measurements.

The digital clinical thermometer, models ST-8A3C, and ST-8A3F, 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.

The Mesure Technology Co., Ltd. Digital Clinical Thermometer, models ST-8A3C and ST-8A3F, demonstrated compliance with ASTM E 1112-98 and other international standards to meet its acceptance criteria.

1. Table of Acceptance Criteria and Reported Device Performance:

   Acceptance Criterion (Standard)	Reported Device Performance
   ASTM E 1112-98 Compliance	Compliant
   EN 60601-1 Compliance	Compliant
   EN 60601-1-1 Compliance	Compliant
   EN 60601-1-2 Compliance	Compliant
   Low Battery Detection	Displays 'Low battery'

2. Sample Size Used for the Test Set and Data Provenance:
   The provided summary does not explicitly state the sample size used for the test set or the data provenance. It indicates that the device was "designed and verified according to the US standard ASTM E 1112-98," which implies testing was conducted. However, specific details about the number of measurements, patients, or the origin of the test data (e.g., country of origin, retrospective or prospective) are not provided.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
   This information is not applicable and is not provided in the 510(k) summary. The device's performance is assessed against recognized standard specifications (e.g., ASTM E 1112-98), rather than requiring expert adjudication of results.

4. Adjudication Method for the Test Set:
   This information is not applicable and is not provided in the 510(k) summary. Adjudication methods like 2+1 or 3+1 are typically used in studies involving human interpretation or subjective assessment, which is not the case for a digital clinical thermometer.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance:
   This is not applicable as the device is a standalone clinical thermometer measuring body temperature, not an AI-assisted diagnostic tool that would involve human readers.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:
   Yes, the performance evaluation described would be considered standalone. The "device performance" refers to the thermometer's ability to accurately measure and display temperature according to the specified standards without human interaction influencing the measurement itself. The device uses an ASIC for calculation, which functions as an algorithm.

7. The Type of Ground Truth Used:
   The ground truth for the performance evaluation of the thermometer would be established by the reference standards and methodologies outlined in ASTM E 1112-98 and other applicable standards. This typically involves comparison against known, precisely controlled temperatures (e.g., from a calibrated temperature bath) or highly accurate reference thermometers, rather than expert consensus, pathology, or outcomes data.

8. The Sample Size for the Training Set:
   The provided 510(k) summary does not mention a "training set" in the context of machine learning or AI. As a medical device that measures temperature using a thermistor and ASIC, its development and verification rely on engineering principles and adherence to standards rather than a machine learning training paradigm.

9. How the Ground Truth for the Training Set Was Established:
   Not applicable, as a "training set" in the machine learning sense is not mentioned or relevant to the development and testing of this type of digital clinical thermometer. The "ground truth" for its accuracy and performance is established through calibration against physical standards as defined by test methodologies in ASTM E 1112-98.

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The wireless temperature monitor, model ST313C/F, ST314C/F are the battery-operated electronic devices with intended use of measuring human body temperature precisely. This device is reusable and intended for wrist and abdomen temperature measurement of the baby less than eight years old, and the baby of eight years old.

The Wireless temperature monitor, model ST-314C/F, 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 3.0V 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. Reqarding the performance of ST-314C/F, it was designed and verified according to the US standard ASTM E1112-98.

The provided text describes the 510(k) summary for a Wireless temperature monitor, models ST-313C/F and ST-314C/F. The information related to acceptance criteria and the study proving device performance is extracted below.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Test Set Sample Size: Not explicitly stated as a number of subjects. The text mentions "clinical report for measurement accuracy" and "The measurement was taken by both ST313C and RT-9101 at wrist and abdomen location for the children less than eight years old."
• Data Provenance: The study was a "clinical report," suggesting prospective data collection. The location is not specified, but the submitter is based in Taiwan, R.O.C.

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 given text. For a temperature monitor, the "ground truth" would likely be established by a reference thermometer or highly accurate direct measurement, rather than human experts.

4. Adjudication Method for the Test Set

This information is not provided in the given text. It is unlikely to be relevant for a device measuring a physical parameter directly.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and effect size.

• MRMC Study: No, this was not an MRMC study. It was a comparison of device performance against a predicate device and standards, not a study evaluating human readers' effectiveness with or without AI assistance.
• Effect Size: Not applicable.

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

Yes, the primary evaluation appears to be a standalone performance assessment of the device. The "clinical report for measurement accuracy" compared the new device (ST313C) directly against a predicate device (Funai RT-9101). The device itself is an electronic thermometer, and its accuracy is assessed independently of human interpretation.

7. The Type of Ground Truth Used

The ground truth for accuracy was established by:

• Compliance with ASTM E1112:1998 standard for electronic thermometers.
• Comparison of measurements against a predicate device (Funai model RT-9101). The predicate device's measurements would serve as the "ground truth" for comparative accuracy.

8. The Sample Size for the Training Set

The provided text does not mention a training set as this device is a hardware electronic thermometer and not an AI/machine learning algorithm that requires training data.

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

Not applicable, as there is no training set for this type of device.

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

The 10-second digital thermometer, ST87, ST89, ST80, and ST8B, 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 ST87, ST89, ST80, and ST8B, it was designed and verified according to the US standard ASTM E 1112-98.

This is a 510(k) summary for a digital thermometer, which is a medical device. The information provided heavily references standards for medical devices and does not describe AI/ML software. Therefore, most of the requested information regarding AI/ML clinical studies is not available in the provided text.

Here's an analysis based on the provided text:

Acceptance Criteria and Device Performance (for a digital thermometer)

Note: The provided document is for a digital thermometer, not an AI/ML device. Therefore, the acceptance criteria are based on medical device standards for thermometers, focusing on accuracy, safety, and electromagnetic compatibility.

The following information is not available in the provided text as it pertains to AI/ML device studies, which this device is not.

• Sample size used for the test set and the data provenance: Not applicable. The device is a digital thermometer, not an AI/ML algorithm. Testing would typically involve physical measurements against reference standards, not data sets.
• Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for a thermometer is established through calibration against known temperature standards.
• Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable.
• 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: Not applicable. This is not an AI-assisted device.
• If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable. This is a standalone physical device, not an algorithm.
• The type of ground truth used (expert consensus, pathology, outcomes data, etc.): For a digital thermometer, the ground truth would be established by calibrated reference thermometers or temperature sources traceable to national or international standards. This is not mentioned in detail, but implied by adherence to ASTM E1112.
• The sample size for the training set: Not applicable. There is no AI/ML model to train.
• How the ground truth for the training set was established: Not applicable. There is no AI/ML model to train.

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