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The Non-contact Infrared Thermometer (Models WL-301, WL-501, WL-601, WL-701) is an electronic thermometer using an infrared sensor to detect human body temperature from forehead on people of one month old and above. The device is reusable for home and clinical use.

The Infrared thermometers are hand-held, battery powered devices designed to measure human body temperature from the central forehead. Its operation is based on measuring the natural thermal radiation from central forehead.

The thermometers use a thermopile sensor with integrated thermistor for the target reading, a thermistor mounted in the head of the thermometer for ambient temperature readings, a parabolic mirror to help focus the infrared energy emitted from the forehead, and an infrared distance sensor for detection of no-contact use and compensation of the temperature reading.

The device mainly consists of infrared sensor, microprocessor, embedded software (Identified Software version is No: V1), memory, electro-acoustic components, LED display and the device is powered by 2AAA alkaline batteries.

The non-contact infrared thermometer included WL-301, WL-501, WL-601, WL-701. They can be selected calibration mode, body temperature mode and surface mode.

Here's a breakdown of the acceptance criteria and study information for the Non-contact Infrared Thermometer (Models WL-301, WL-501, WL-601, WL-701), based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

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The Non-Contact Infrared Thermometer, Models JXB-315, JXB-320, JXB-311, is a non-sterile, reusable, handheld device. It can be used by consumers in household environment and doctor in clinic as reference. It is intended for non-contact measuring of human body temperature of people of all ages (neonate, infant, pediatric, adult) by detecting infrared heat from the center of the forehead.

The Non-contact Infrared Thermometer (include models JXB-315, JXB-320, JXB-311) is a hand-held forehead thermometer, and it is intended for the non-contact intermittent measurement and monitoring of forehead temperature of human body which measures the body temperature based on the infrared energy emitted from the forehead. It is indicated for use by people of all ages. The thermometer is also intended to measure the object temperature. After measurement, the temperature is directly displayed on the LED screen. These thermometers have the following features: 1) Body temperature mode 2) Fahrenheit and Celsius temperature unit setting LED display screen with automatic range selection, resolution is 0.1 degree Celsius (0.1 degree Fahrenheit) 3) 4) Memorize the latest 32 measurement data LED display screen 5) 6) Low battery indication 7) Measurement distance indication 8) Over range prompt (HI/LO) 9) Auto shutdown when the device is idle for 30 seconds 10) High temperature indication

The provided document describes the acceptance criteria and a clinical study conducted for the Non-contact Infrared Thermometer, Models JXB-315, JXB-319, JXB-320, JXB-311.

Here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

The document references compliance with specific standards for measurement accuracy rather than explicitly stating numerical acceptance criteria. However, it does compare the subject device's declared accuracy with the predicate device and relevant standards.

2. Sample size used for the test set and the data provenance

• Sample Size: 150 subjects for the clinical accuracy validation.
• Data Provenance: Not explicitly stated (e.g., country of origin). The study is described as a "clinical investigation," which implies prospective data collection for the purpose of the validation.

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

The document does not specify the number of experts or their qualifications for establishing ground truth in the clinical study.

4. Adjudication method for the test set

The document does not specify an adjudication method for the test set.

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 was not done. The device is a standalone thermometer, and the study focused on its accuracy in measuring body temperature, not on assisting human readers with interpreting medical images or data.

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

Yes, a standalone performance study was done for the device itself to measure its accuracy against established standards. The section "Clinical Accuracy Validation" specifically details how the device's readings were validated against clinical ground truth.

7. The type of ground truth used

The ground truth for the clinical accuracy validation was based on clinical measurements performed on subjects, implicitly alongside a reference method (though the reference method is not explicitly named, it's standard practice in such studies to compare against a highly accurate clinical thermometer). The study assessed "clinical bias and clinical repeatability" against this ground truth.

8. The sample size for the training set

The document does not mention a training set because this is a hardware medical device (a thermometer), not an AI/machine learning algorithm that typically requires a distinct training phase.

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

Not applicable, as there is no mention of a training set for this hardware device.

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The Non-Contact Infrared Thermometer, model HL710H is intend for the measurement of human body temperature from the forehead. The device is indicated for use by people of all ages in the home.

The Non-Contact Infrared Forehead Thermometer, Model HL710H is an electronic thermometer using an infrared sensor which can put out different signal when measuring different object temperature or in different ambient temperature to measure infrared energy radiated from the forehead. This energy is collected through the Infrared sensor and converted to a temperature value, then display it by LCD. The subject device HL710H features a Bluetooth transmission function, which enables the device transmit measured results to paired Bluetooth-enabled device after measurement. Additional, HL710H has a built-in "High Temperature Notice" feature.

The provided text is a 510(k) summary for a non-contact infrared thermometer (model HL710H). It focuses on demonstrating substantial equivalence to a predicate device rather than providing a detailed study report for meeting specific acceptance criteria for an AI/ML diagnostic device.

Therefore, I cannot extract the information required to fill out the table and answer the study-related questions as they pertain to the evaluation of an AI-based diagnostic algorithm. The document discusses regulatory standards for medical devices and thermometers (e.g., ISO, ASTM, IEC), but it does not describe a clinical study of an AI/ML algorithm that would have acceptance criteria for performance metrics like sensitivity, specificity, or AUC, nor does it mention a ground truth established by experts, an MRMC study, or training/test set details for an AI model.

The document is about a hardware medical device (a thermometer) and its compliance with standards for temperature measurement, electrical safety, biocompatibility, and software development, not about an AI diagnostic algorithm's performance.

To provide the requested information, the input would need to be a clinical study report or an FDA submission that evaluates the performance of an AI/ML-based medical device against specific clinical endpoints using a defined ground truth, separate test/training sets, and expert evaluations.

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Advocate Non-Contact Infrared Thermometer is a non-sterile, reusable, handheld device. It can be used by consumers in homecare environment and doctors in clinic as reference. It is intended for measuring human body temperature of all ranges of people by detecting infrared heat from the forehead.

The Advocate Non-Contact Infrared Thermometer, model EF001S, measures temperatures of people by detecting the infrared energy radiated directly from the forehead without physical contact. The device is composed of a Probe of metals with infrared sensor inside to detect the infrared energy, an LCD Display, a SCAN button to start measuring temperatures, a Power switch button to switch on or off the device, a Body/Ambient button to switch between two measuring modes, and an Enclosure of ABS. The device has the following features: one-second measuring time, measuring Body or Ambient temperature, 12-memory recalls, "F/"C unit switchable, over range message (Hi/Lo), low battery indication, auto display for the last reading when power is on, auto shut-off when the device is idle for 60 seconds and voice function.

Here's a breakdown of the acceptance criteria and study information for the Advocate Non-Contact Infrared Thermometer, Model EF001S, based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are derived from the referenced standards, and the reported device performance is indicated by the "Pass" verdict for all tests. Specific numerical criteria are provided for measuring accuracy.

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

• Sample Size for Test Set (Clinical Accuracy): 120 subjects
  • 40 subjects in each age group: infants (0-1 year), children (1-5 years), and adults (>5 years).
• Data Provenance: The document does not explicitly state the country of origin or whether the study was retrospective or prospective. It only mentions "EF001 Clinical Test" and that it "had been clinically assessed."

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. The study description focuses on meeting the criteria of the referenced standards rather than on a ground truth established by experts in a typical diagnostic AI setting. For a thermometer, the "ground truth" for temperature measurement is typically a highly accurate reference thermometer measurement, not an expert's interpretation.

4. Adjudication Method for the Test Set

This information is not provided in the document. Adjudication methods like 2+1 or 3+1 are typically used for subjective diagnostic tasks involving human readers, which is not directly applicable to a thermometer's performance evaluation against a reference standard.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and the effect size of how much human readers improve with AI vs without AI assistance

• No, an MRMC comparative effectiveness study was not done. This type of study is relevant for AI-assisted diagnostic tools where human interpretation is involved. The Advocate Non-Contact Infrared Thermometer is a direct measurement device; its performance is assessed against a technical standard for accuracy, not against human readers.

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

• Yes, a standalone performance assessment was done. The device's accuracy was tested against the standards ASTM E1965-98(2016) and ISO 80601-2-56:2017 directly, without a human in the loop for the temperature measurement itself. The "Clinical Accuracy" testing evaluates the device's ability to accurately measure body temperature.

7. The Type of Ground Truth Used

• The ground truth for the clinical accuracy testing is implicitly the reference measurements of body temperature taken concurrently with the device being tested, as required by the ASTM E1965-98(2016) standard. This standard outlines procedures for evaluating the accuracy of infrared thermometers for intermittent determination of patient temperature, which involves comparing the device's readings to established, highly accurate temperature measurements.

8. The Sample Size for the Training Set

• This information is not provided as this is not an AI/machine learning device that typically involves a distinct training set. The "software validation report" mentioned relates to the device's embedded software functionality, not a learning algorithm trained on data.

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

• This information is not applicable as there is no mention of a training set for a learning algorithm. The software validation ensures the embedded software functions as intended and meets regulatory guidelines.

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Advocate Non-Contact Infrared Thermometer is a non-sterile, reusable, handheld device. It can be used by consumers in homecare environment and doctors in clinic as reference. It is intended for measuring human body temperature of all ranges of people by detecting infrared heat from the forehead.

The Advocate Non-Contact Infrared Thermometer model EF001A measures temperatures of people by detecting the infrared energy radiated directly from the forehead without physical contact. The device is composed of a Probe of metals with infrared sensor inside to detect the infrared energy, an LCD Display, a SCAN button to start measuring temperatures, a Power switch button to switch on or off the device, a Body/Ambient button to switch between two measuring modes, and an Enclosure of ABS.

The device has the following features: one-second measuring time, measuring Body or Ambient temperature, 12-memory recalls, 9F/℃ unit switchable, over range message (Hi/Lo), low battery indication, auto display for the last reading when power is on, and auto shut-off when the device is idle for 60 seconds.

The device under consideration is the Advocate Non-Contact Infrared Thermometer, Model EF001A. The provided information details its acceptance criteria and the studies conducted to prove it meets these criteria.

1. Table of Acceptance Criteria and Reported Device Performance

The core acceptance criterion for infrared thermometers is accuracy, as defined by standards such as ASTM E1965-98.

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

The primary study mentioned is a "Clinical test."

• Sample Size: 120 subjects, categorized into:
  • 40 infants (0-1 year)
  • 40 children (1-5 years)
  • 40 adults (>5 years)
• Data Provenance: Not explicitly stated from which country or location the subjects were sourced. The study is described as a "Clinical test" which typically implies prospective data collection, but it is not definitively stated whether it was prospective or retrospective.

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

This information is not provided in the document. The document refers to "Clinical Test" and compliance with standards like ASTM E1965-98, which outlines methods for determining clinical accuracy. However, it does not specify the number or qualifications of experts involved in establishing the ground truth measurements against which the device was compared.

4. Adjudication Method for the Test Set

This information is not provided in the document. The clinical test section describes the assessment criteria for clinical accuracy but does not detail any adjudication methods.

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

No, an MRMC comparative effectiveness study was not done. The device is a thermometer, and its performance is evaluated against established temperature measurement standards, not through comparison with human readers or AI assistance in interpretation.

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

The device itself is a standalone thermometer. The performance tests ("Performance testing" and "Clinical test") demonstrate the device's accuracy in measuring temperature without human intervention other than the act of taking the measurement. Therefore, the reported performance is inherently standalone performance.

7. The Type of Ground Truth Used

The ground truth for the clinical accuracy test was established by assessing the device's measurements against the requirements of specific standards. For temperature measurement, the ground truth is typically a highly accurate reference thermometer or a standardized method as outlined in the referenced clinical accuracy standards. In this case, the "Clinical test" methods and criteria were assessed to meet the requirements of clinical accuracy per the referenced standard ASTM E1965-98 (Reapproved 2016) Standard Specification for Infrared Thermometer for Intermittent Determination of Patient temperature. This standard itself would describe the method for establishing ground truth, likely involving comparative measurements with an accepted standard.

8. The Sample Size for the Training Set

This information is not applicable and therefore not provided. As a non-AI/ML device (a digital infrared thermometer), there is no "training set" in the context of algorithms that learn from data.

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

This information is not applicable and therefore not provided, as there is no training set for this type of device.

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Non-contact Infrared Thermometer is a non-sterile, reusable, handheld device. It can be used by consumers in homecare environment and doctors in clinic as reference. It is intended for measuring human body temperature of two months and above of people by detecting infrared heat from the center of the forehead.

The thermometer measures the temperatures of people by detecting the energy. The external probe plays an important role in the measuring process. As soon as the thermometer is placed at the center of the forehead or the object with a distance of 15mm-50mm and the radiation sensor is activated, the measurement will be taken instantly by detection of the infrared heat.

The thermometer AET-R161 can be connected with FOND APP through Bluetooth. The FOND APP applies to mobile phones which systems are Android 4.3 and above, or IOS 8.0 and above, and can be downloaded from Google store (for Android 4.3 and above) or iPhone APP Store (for IOS 8.0 and above). The data measured with AET-R161 can be transmitted to the FOND APP, where data can be recorded, saved and shared.

The device principle of operation is described as below:

All object, solid, liquid or gas, emit energy by radiation. The intensity of this energy depends on the temperature of the object. The Infrared Thermometer is therefore able to measure the temperature of a person by the energy the person emits. This measurement can be taken by an external temperature probe on the device for analysis and register the ambient temperature. Therefore, as soon as the operator holds the thermometer near forehead and activates the radiation sensor, the measurement is taken instantly by detection of the infrared heat generated by the arterial blood flow. Body heat can therefore be measured without any interference from the heat of the surrounding environment.

The thermometer includes four models: AET-R161, AET-R171, AET-R1D2, AET-R1B1. They all have the following basic functions:

• Sound alarm if the temperature exceeds 37.8℃.
• LCD back-lighted digital screen.
• Data displayed in Celsius or Fahrenheit.
• Automatic stop (energy saver).

This document describes the regulatory submission for a Non-contact Infrared Thermometer (Models: AET-R161, AET-R171, AET-R1D2, AET-R1B1) seeking substantial equivalence to a predicate device. The information provided is primarily focused on non-clinical and clinical performance testing to demonstrate that the device meets established standards for accuracy and safety.

Here's an analysis of the provided information, framed as acceptance criteria and proof, as well as limitations based on the document's content:

Acceptance Criteria and Reported Device Performance

The document doesn't explicitly present a "table of acceptance criteria" in the format of pass/fail thresholds for each metric alongside the reported performance. However, it implicitly defines acceptance by stating compliance with various international standards, particularly for performance and safety. The key performance criterion for a thermometer is its accuracy.

Implicit Acceptance Criteria (based on standards) and Reported Performance:

Study Details Proving Device Meets Acceptance Criteria

The primary study cited for clinical performance is the clinical accuracy validation conducted according to ASTM E1965-98 (2009).

2. Sample Size and Data Provenance

• Test Set Sample Size:
  • Infants (two months to 1 year old): 38 subjects
  • Children (1 up to 5 years old): 36 subjects
  • Adults (older than 5 years): 42 subjects
  • Total Sample Size: 38 + 36 + 42 = 116 subjects
• Data Provenance: The document does not explicitly state the country of origin. It is presented as a general clinical study. It is a prospective clinical accuracy test as it involves testing a device on live subjects to determine its performance characteristics.

3. Number of Experts and Qualifications for Ground Truth

The document does not provide details on the number of experts or their specific qualifications for establishing ground truth. However, the ground truth for human body temperature in a clinical accuracy study (like ASTM E1965-98) would typically be established by highly accurate, often invasive, reference thermometers (e.g., rectal thermometers) operated by trained medical professionals (e.g., nurses, doctors). The "RCT (model: WDJ-001)" mentioned for the clinical study likely refers to a Reference Clinical Thermometer.

4. Adjudication Method for the Test Set

The document does not mention any adjudication method. For a direct clinical accuracy study comparing a device's reading to a reference standard, "adjudication" in the sense of expert consensus on ambiguous cases is generally not applicable, as the "ground truth" is a direct measurement from a validated reference instrument.

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

No. An MRMC study was not performed. This device is a non-contact infrared thermometer, which directly measures temperature. Its performance is evaluated against a reference thermometer, not by human readers interpreting images or data. Therefore, the concept of human readers improving with or without AI assistance is not relevant to this type of device.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance)

Yes. The primary clinical accuracy study described assesses the standalone performance of the thermometer (the algorithm/device itself) in measuring temperature against a reference standard. While a human operates the device, the performance being evaluated is the device's accuracy in autonomously generating a temperature reading.

7. Type of Ground Truth Used

The ground truth used is based on direct measurements from a reference clinical thermometer (model: WDJ-001) in live human subjects across different age groups. This is a direct measurement ground truth, considered highly reliable for temperature measurement studies.

8. Sample Size for the Training Set

The document does not provide any information about a specific training set. Medical devices undergoing 510(k) clearance, especially non-AI based devices like a thermometer, typically rely on fixed algorithms and calibration rather than machine learning models that require training data. If any internal calibration or development was done, the data used for that is not disclosed here.

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

As no training set is described in the context of machine learning, this question is not applicable based on the provided document. The device's calibration and performance are validated against physical standards and clinical studies, rather than "training" an AI model.

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Non-conact Infrared Themometer, model JPD-FR 100, can measure for infants and adults without contact to human body. It can be used by consumers in household environment and doctor in clinic as reference.

The Non-contact Infrared Thermometer, Model JPD-FR100, uses infrared sensor (thermopile) to detect the radiated infrared energy emitted by the object, solid, liquid or gas. The intensity of the emitted energy depends on the temperature of the object and the infrared sensor can recognize it to transfer to the proper electronic signal. The electronic signal can be processed in the subject device to convert to the temperature reading. Therefore, the subject device is able to measure the temperature of a person by the energy the person emits. The predicated device KI-8280, use the same detection principle to measure the patient's temperature.

The subject device also use the focusing design to collect the infrared emitted from nearby area of patient's forehead. This mechanism make the subject device have the ability to detect the forehead temperature in the distance of 1-6cm. The subject device intended to detect the temperature of patients. The temperature is converted to the oral temperature. The temperature reading shown in the device display after measuring is the patient's oral temperature.

The compact, small and light-weight design, the Shenzhen Jumper Medical Equipment Co., Ltd. Non-contact Infrared Thermometer, model JPD-FR100, enables to provide safe and reliable result and offers a very good clinical accuracy for human body temperature measurements.

The medical device in question is a Non-contact Infrared Thermometer, Model JPD-FR100.

Here's an analysis of the provided text for acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

The primary acceptance criterion mentioned is compliance with the ASTM E1965-98 (2009) standard for infrared thermometers.

Further details about the specific accuracy requirements within ASTM E1965 for different temperature ranges, as well as repeatability and other performance metrics, are not explicitly detailed in the provided summary. However, the study "complied with the requirements of ASTM E1965."

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

• Sample Size: The document does not explicitly state the sample size used for the clinical test set. It mentions "the clinical performance test protocol and data analysis followed the requirements of ASTM E 1965."
• Data Provenance: Not specified (e.g., country of origin, retrospective or prospective). ASTM E1965 specifies clinical testing, implying prospective data collection on human subjects, but the location is not provided.

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

Not applicable. For a thermometer, the "ground truth" for temperature measurement is typically established using a reference thermometer or a controlled environment, not through expert human interpretation. The ASTM E1965 standard defines the methodology for this.

4. Adjudication Method for the Test Set

Not applicable. Temperature measurement through a device like a thermometer does not involve human adjudication in the way medical image analysis or diagnostic studies do. The ground truth is a direct measurement.

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

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is typically used for diagnostic devices where human readers interpret results, and the AI's impact on their performance is evaluated. For a thermometer, the device provides a direct measurement, and human interpretation is not the primary factor of interest in its performance.

6. Standalone Performance Study

Yes, a standalone performance study was done. The document states: "The test report showed the clinical performance of subject device complied with the requirements of ASTM E1965. It is acceptable to measure patient's temperature." This indicates that the device's accuracy was assessed independently against the ASTM standard.

7. Type of Ground Truth Used

The ground truth used for the clinical performance test would be simultaneous measurements from a calibrated reference thermometer as per the methodology defined in ASTM E1965. The standard dictates how to compare the device's readings to highly accurate ground truth measurements.

8. Sample Size for the Training Set

Not applicable. The device is a non-contact infrared thermometer, which is a sensor-based measurement device. It does not employ machine learning or AI models that would require a "training set" in the conventional sense. Its function is based on physical principles of infrared radiation detection.

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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JXB182 Non-contact Infrared Thermometer is an infrared thermometer intended to measure forehead temperature of infants and adults without contacting human body. It can be used by consumers in household environment and doctor in clinic as reference.

All objects, solid, liquid or gas, emit energy by radiation. The intensity of this energy depends on the temperature of the object. The JXB-182 infrared thermometer is therefore able to measure the temperature of a person by the energy the person emits. This measurement can be taken thanks to an external temperature probe on the device which permanently analyses and registers the ambient temperature. Therefore, as soon as the operator holds the thermometer near the forehead and activates the radiation sensor, the measurement is taken instantly by detection of the infrared heat generated by the arterial blood flow. Body heat can therefore be measured without any interference from the heat of the surrounding environment. The JXB-182 thermometer without contact has been developed using latest infrared technology . This technology allows temporal artery (TA) temperature to be taken at a distance of about 5cm away from the forehead. Then the result will be displayed on LCD. Besides, it owns Led backlight which can show three different colors in different temperature ranges and three-language prompt function.

The provided text describes the JXB-182 Non-contact Infrared Thermometer and its substantial equivalence to a predicate device.

Here's the breakdown of the acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size for the Test Set and Data Provenance

The document states: "Subject device JXB 182 is compliant to the ASTM E 1965-98(Reapproved 2009), Standard Specification for Infrared Thermometers for Intermittent Determination of Patient Temperature. All the relevant activities were performed by designate individual(s) and the results demonstrated that the predetermined acceptance criteria were fully met."

However, it does not specify the sample size used for the clinical tests nor the data provenance (e.g., country of origin, retrospective or prospective nature of the study).

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

The document does not provide information on the number of experts used or their qualifications for establishing ground truth in the clinical tests. It only mentions that activities were performed by "designate individual(s)."

4. Adjudication Method for the Test Set

The document does not specify an adjudication method (e.g., 2+1, 3+1, none) for the test set.

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

There is no mention of a multi-reader multi-case (MRMC) comparative effectiveness study. This device is a standalone infrared thermometer, not an AI-assisted diagnostic tool that would involve human readers. Therefore, there's no information on humans improving with AI assistance.

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

Yes, a standalone performance evaluation was conducted. The clinical tests were performed to ensure the device itself met the performance criteria outlined in ASTM E 1965-98. The device's performance characteristics (accuracy, precision, range) are reported for the device operating independently.

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

The type of ground truth used for the clinical tests is implied to be reference temperature measurements, as per the industry standard ASTM E 1965-98, which sets specifications for infrared thermometers. This standard typically involves comparing the device's measurements to a highly accurate reference thermometer.

8. The sample size for the training set

The document does not provide information on a training set size. As this is a medical device, and not explicitly an AI/ML product developed with distinct training and test sets in the typical AI sense, the concept of a "training set" for the device's core functionality (temperature measurement) is not outlined. Performance is validated against established standards.

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

Since no specific "training set" is mentioned in the context of AI/ML development, how its ground truth would be established is not applicable or described in this document. The device's design and engineering would have been developed against known thermodynamic principles and calibrated using established standards.

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Non-Contact Infrared Thermometer, Model KI-8280, can measure body temperature for infants and adults without contact to human body. It can be used by consumers in household environment and doctor in clinic as reference.

The Non-Contact Infrared Thermometer, Model KI-8280, uses infrared sensor (thermopile) to detect the radiated infrared energy emitted by the objects, solid, liquid or gas. The intensity of the emitted energy depends on the temperature of the object and the infrared sensor can recognize it to transfer to the proper electronic signal. The electronic signal can be processed in the subject device to convert to the temperature reading. Therefore, the subject device is able to measure the temperature of a person by the energy the person emits. The predicate device, JXB Thermoflash, use the same detection principle to measure the patient's temperature. The subject device also use the focusing design to collect the infrared emitted from nearby area of object surface. This mechanism make the subject device have the ability to detect the object surface temperature in the distance of 3-8cm. The subject device intended to detect the temperature of patients. The temperature is converted to the oral temperature. The temperature reading shown in the device display after measuring is the patient's oral temperature. The compact, small and light-weight design, the K-jump Health Co, Ltd. Non-Contact Infrared Thermometer, Model KI-8280, enables to provide safe and reliable results and offers a very good clinical accuracy for human body temperature measurement.

Here's a breakdown of the acceptance criteria and the study details for the Non-Contact Infrared Thermometer, Model KI-8280, based on the provided text:

Acceptance Criteria and Device Performance

Study Details

1. Sample Size Used for the Test Set and Data Provenance:

   • The document states that the clinical performance test protocol and data analysis followed the requirements of ASTM E 1965. However, it does not explicitly state the specific sample size used for the test set of patients.
   • Data Provenance: Not explicitly stated, but clinical testing was conducted. It's common for such tests to be prospective, but this is not explicitly confirmed. The company is based in Taiwan, so it's possible testing occurred there or in another location appropriate for clinical studies.

2. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications:

   • This information is not provided in the summary. The study refers to comparing the device's readings with a "digital thermometer," implying this was the reference standard, but details on how the ground truth was established for the digital thermometer readings (e.g., expert interpretation) are absent.

3. Adjudication Method for the Test Set:

   • This information is not provided. The study focused on the difference between the device's readings and a digital thermometer, rather than using an adjudication process for subjective assessments.

4. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

   • No, an MRMC comparative effectiveness study was not explicitly mentioned or performed. This type of study is more common for diagnostic imaging devices where human interpretation is a key component. This device is a direct measurement tool.

5. Standalone (Algorithm Only Without Human-in-the-Loop) Performance:

   • Yes, the performance reported is for the standalone device. The device measures and displays temperature directly without requiring human interpretation of an output, making its performance inherently standalone. The clinical test evaluated the accuracy of the device's temperature readings.

6. Type of Ground Truth Used:

   • The ground truth was established by readings from a digital thermometer, which is considered a standard clinical reference for temperature measurement.

7. Sample Size for the Training Set:

   • This information is not provided. The summary does not discuss a "training set" in the context of machine learning (which this device pre-dates and doesn't rely on in the typical sense). The performance testing described relates to the final device against a known standard.

8. How the Ground Truth for the Training Set Was Established:

   • As no training set is discussed in the context of machine learning, this information is not applicable. For the clinical validation, the ground truth was established by comparing the device's readings to those of a digital thermometer.

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