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The Infrared Ear Thermometer, Model: HTD8208C, is an electronic clinical thermometer using an infrared sensor to detect body temperature from the auditory canal in people of all ages for home setting use.

Infrared Ear Thermometer, model: HTD8208C, is an electronic thermometer using an infrared sensor (thermopile) to detect body temperature from the auditory canal. The principle of operation is based on measuring the natural thermal radiation emanating from the tympanic membrane when the thermometer is inserted in the ear canal.

The Infrared Ear Thermometer measures temperature by reading infrared radiation emitting from the eardrum tissue when the thermometer is inserted into the ear canal. Pressing the measuring button to start the measurement of target's infrared radiation. The electrical signal read out from the detector is fed to the circuit for amplification and calculation. The final measured temperature will display on the device's LCD. The total operation takes less than 5 seconds.

Here's a breakdown of the acceptance criteria and study information for the Infrared Ear Thermometer, Model HTD8208C, based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The document refers to adherence to international standards for performance, rather than explicit acceptance criteria with numerical targets in a direct comparison table. However, it indicates compliance with these standards.

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

• Sample Size: 140 subjects.
• Data Provenance: Not explicitly stated whether retrospective or prospective, nor the country of origin. However, the study "evaluated 140 of subjects" which suggests a prospective clinical investigation.

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

• The document does not mention the use of experts to establish ground truth for the test set. For a clinical thermometer, the ground truth would typically be established by highly accurate reference thermometers (e.g., rectally inserted electronic thermometers or mercury-in-glass thermometers, following a standardized protocol) rather than expert consensus on interpretation. The document indicates the clinical investigation followed the requirements of ASTM E1965-98 and ISO 80601-2-56, which specify methods for establishing reference temperatures.

4. Adjudication Method for the Test Set

• Not applicable as this is not a diagnostic device requiring expert adjudication of outputs. The performance is assessed against a reference temperature.

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

• No, a MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic imaging devices where human readers interpret medical images.
• This device is a clinical thermometer, and its performance is evaluated against established temperature measurement standards, not against human reader interpretation of data.

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

• Yes, the performance study effectively evaluates the device in a standalone manner. The device measures temperature, and that measurement is compared directly to a "ground truth" reference temperature, without human interpretation influencing the device's output.

7. The Type of Ground Truth Used

• The ground truth used for performance comparison would be reference body temperatures established according to the methods outlined in ASTM E1965-98 and ISO 80601-2-56. These standards specify how to obtain accurate, traceable reference temperature measurements against which the infrared ear thermometer's readings are compared. It's not expert consensus, pathology, or outcomes data in this context.

8. The Sample Size for the Training Set

• Not applicable. This device is a hardware-based thermometer with embedded firmware, not a machine learning algorithm that requires a separate "training set" in the conventional sense. Its "training" is in its design, calibration, and manufacturing processes, which ensure it adheres to physical measurement principles.

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

• Not applicable, as there is no "training set" for this type of device in the machine learning context. The accuracy of the device is established during its design, calibration, and manufacturing, ensuring its measurements align with established physical standards for temperature measurement.

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Infrared Ear Thermometers are intended for the intermittent measurement of human body temperature by people of all ages. The devices are reusable for home use only.

The Infrared Ear Thermometers are electronic thermometers using an infrared detector (thermopile detector) to detect body temperature from the auditory canal. It's operation is based on measuring the natural thermal radiation emanating from the tympanic membrane.DET-103 and DET-105 include probe cover that is optional.

The Infrared Ear Thermometers include probe which used to measure ear canal temperature,plastic enclosed the display window,buttons and the battery cover.

The provided text describes the 510(k) premarket notification for an Infrared Ear Thermometer. This type of submission focuses on demonstrating "substantial equivalence" to a legally marketed predicate device, rather than providing detailed acceptance criteria and studies in the same way one might for a novel AI/ML device or a device requiring a PMA.

Therefore, many of the requested details about acceptance criteria, study design (sample size, data provenance, expert ground truth, adjudication, MRMC, standalone performance), and training set information are not available in this document. The document primarily focuses on explaining how the new device is similar to an existing one (the predicate device).

However, I can extract the safety and performance standards the device is stated to conform to, which serve as the "acceptance criteria" for this type of device based on regulatory standards.

Here's a breakdown of what can and cannot be answered based on the provided text:

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

For a traditional medical device like a thermometer, "acceptance criteria" refer to the performance specifications defined by recognized standards.

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

The document mentions that "The clinical performance test protocol and data analysis is conducted as the requirement of ASTM E1965-98 (2016)." However, it does not state the specific sample size used in this test, nor the country of origin of the data or whether it was retrospective or prospective. For a 510(k) for a thermometer, the clinical test usually involves human subjects to demonstrate accuracy against a reference method (e.g., oral/rectal mercury thermometer or a highly accurate electronic thermometer).

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)

Not applicable. For a thermometer, "ground truth" for temperature is typically established by comparing the device's reading to a laboratory-calibrated reference thermometer or medical device known for its accuracy in measuring body temperature (e.g., a rectal thermometer in a clinical setting). It does not involve expert readers like radiologists.

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

Not applicable. Adjudication methods like "2+1" are relevant for subjective image interpretation tasks, not for objective measurements like temperature.

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 not an AI-assisted diagnostic tool.

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

This refers to a traditional, non-AI medical device. Its "standalone" performance is its direct measurement output, as evaluated against the stated standards. The clinical test confirms its performance.

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

For a clinical thermometer, the ground truth for temperature measurement is typically derived from a reference standard thermometer (e.g., a highly accurate, calibrated electronic thermometer or sometimes a rectal mercury thermometer in a controlled clinical study).

8. The sample size for the training set

Not applicable. This is not an AI/ML device, so there is no "training set."

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

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

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Infrared Ear Thermometers, models ET-101D and ET-101H are indicated for the intermittent measurement and monitoring of human body temperature by consumers in a home use environment.It's intended for use on people of all ages.

The Infrared Ear Thermometers, models ET-101D and ET-101H are electronic thermometers using an infrared detector (thermopile detector) to detect body temperature from the auditory canal. The thermometer's operation is based on measuring the natural thermal radiation emanating from the tympanic membrane and the adjacent surfaces of the patient. Both thermometer models include probes, which are used to measure ear canal temperature, plastic enclosures enclosing the display window as well as buttons and a battery cover. The disposable probe cover of ET-101H is optional when measuring temperature while ET-101D does not utilize a disposable probe cover. The Infrared Ear Thermometers measure temperature by reading infrared radiation emitting from the eardrum tissue. The small cone-shape end of the thermometer is inserted into the ear canal, where the eardrum (tympanic membrane) and surrounding tissues give off heat. The thermometer converts the heat into a temperature value using software.

Here's a breakdown of the acceptance criteria and study information for the Infrared Ear Thermometer (models ET-101D and ET-101H) based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are primarily defined by the precision (laboratory accuracy) and clinical accuracy, which align with the ASTM E1965-98 standard.

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

The document states that "Clinical evaluation of Infrared Ear Thermometers was conducted by Sejoy Electronics & Instruments Co., Ltd in compliance with ISO 80601-2-56 and ASTME1965." However, specific sample sizes for the clinical test set are not provided in this document. The geographic provenance of the data (country of origin) is also not explicitly stated, but given the manufacturer is Sejoy Electronics & Instruments Co., Ltd. from China, it is highly probable the study was conducted there. The document does not specify if the study was retrospective or prospective, but clinical evaluations for device approvals are typically prospective.

3. Number of Experts Used to Establish the 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 evaluation. For temperature measurement devices, the ground truth is typically assessed against a highly accurate reference thermometer (e.g., rectal thermometer in a controlled setting) rather than subjective expert opinion.

4. Adjudication Method (e.g., 2+1, 3+1, none) for the Test Set

The document does not specify any adjudication method for the clinical 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

No MRMC comparative effectiveness study was mentioned or conducted. This device is a diagnostic tool (thermometer) and does not involve human readers interpreting images or data where AI assistance would be relevant in that context. The "readers" are the users of the thermometer, and the output is a direct temperature reading.

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

This is an inherently standalone device in terms of its core function: the device measures temperature and provides a reading. The clinical accuracy and precision tests are essentially standalone performance evaluations in a clinical setting. There is no "human-in-the-loop" performance in the sense of a human interpreting the device's output and making a further diagnosis/decision that needs to be assessed for improvement with AI. The user reads the temperature; the device algorithm calculates it.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc)

For clinical accuracy, the ground truth for temperature measurement devices is typically established by simultaneous measurements using a highly accurate and calibrated reference thermometer (often a rectal thermometer in a controlled environment) to which the investigational device's readings are compared. The document mentions compliance with ISO 80601-2-56 and ASTM E1965, which both define rigorous methods for establishing clinical accuracy against reference standards. While not explicitly stated as "rectal thermometer readings," this is the industry standard for such evaluations.

8. The Sample Size for the Training Set

The document does not specify a training set sample size. For a device like an infrared ear thermometer, there typically isn't a "training set" in the machine learning sense. The device's algorithm for converting infrared radiation to temperature is based on established physical principles and calibrated during manufacturing, rather than learned from a large dataset. The "training" for such a device would be more analogous to calibration and validation against physical standards.

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

Since a "training set" in the machine learning context is not applicable here, the concept of establishing ground truth for it is also not relevant. The device's underlying physics and algorithms are validated through bench testing and calibration against known temperature standards in a laboratory setting, and then confirmed for clinical accuracy against reference thermometers in human subjects.

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The device is an electronic clinical thermometer using an infrared sensor to detect body temperature from the auditory canal in the neonatal, pediatric and adult population used in the home setting.

The Radiant Innovation Inc., Infrared Ear Thermometer, Models THP series are electronic thermometers that use an infrared detector (thermopile detector) to detect body temperature using infrared radiation from the auditory canal. Its operation is based on measuring the natural infrared thermal radiation emanating from the tympanic membrane and the adjacent surfaces of the patient. To measure ear temperature, the ear thermometer is inserted into a patient's outer ear canal. A start button is pressed to start the measurement through the radiation exchanges. The electrical signal read out from the detector is amplified by hardware and processed by the microprocessor. The temperature from the auditory canal in the neonatal, pediatric and adult population used for intermittent monitoring of human body temperature in the home setting.

Here's a breakdown of the acceptance criteria and study information for the Radiant Innovation Inc. Infrared Ear Thermometer THP Series, based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document states, "According the clinical report, the repeatability of THP series are less than 0.3degC. The result meets the criteria of EN12470-5 and ASTM 1965-98, so the THP series passes this clinical study."

• Sample Size: The sample size for the clinical study directly assessing repeatability is not specified in this document.
• Data Provenance: The document does not explicitly state the country of origin or whether the data was retrospective or prospective. It only refers to a "clinical report."

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

• Number of Experts: This information is not provided in the document.
• Qualifications of Experts: This information is not provided in the document.

4. Adjudication Method for the Test Set

The document does not specify any adjudication method for the clinical study.

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

• Was an MRMC study done? No, an MRMC comparative effectiveness study was not conducted or mentioned for this device. The study focused on the device's technical repeatability and compliance with standards.
• Effect size of human reader improvement: Not applicable, as no MRMC study was performed.

6. Standalone (Algorithm Only) Performance Study

• Was a standalone study done? Yes, in the sense that the clinical study evaluated the device's inherent repeatability (an algorithm-driven function for temperature detection and processing). The "repeatability of THP series are less than 0.3degC" refers to the device's performance directly.
  • Note: This is a physical device, and "standalone performance" refers to the device's ability to measure temperature accurately and repeatably, not an AI algorithm generating readings for human review.

7. Type of Ground Truth Used

The ground truth for the clinical study on repeatability was established by the criteria defined in the standards EN12470-5 and ASTM 1965-98. These standards likely specify reference temperature sources and methodologies for assessing thermometer accuracy and precision.

8. Sample Size for the Training Set

• Sample Size: This information is not provided in the document. As this is not an AI/ML device in the modern sense of requiring extensive training data, the concept of a "training set" as commonly understood for AI models is not directly applicable here. The device's calibration and design would have been based on established thermometry principles.

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

• Ground Truth Establishment: This information is not provided and is likely not applicable in the way it would be for a typical AI/ML system. The "ground truth" for the device's design and calibration would come from fundamental physics, engineering principles, and metrology standards for temperature measurement.

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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.

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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The Infrared Ear Thermometer, models IR-04MT are the 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 device is a reusable and intended for home use on people at all ages.

The Infrared Ear Thermometer, models IR-04MT is a 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(2xAAA 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. Regarding the performance of IR-04MT, they were designed and verified according to the US standard ASTM E 1965-2003.

Here's an analysis of the provided text regarding the acceptance criteria and study for the Infrared Ear Thermometer, models IR-04MT:

1. Table of Acceptance Criteria and Reported Device Performance

Despite multiple references to performance and compliance with ASTM E1965-2003, the document does not explicitly state specific numerical acceptance criteria for accuracy (e.g., a specific deviation tolerance) or the exact reported performance metrics from the clinical study in an easily quantifiable format. It broadly states the device "was 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."

To fulfill this section accurately, I can only infer the acceptance criteria are met by compliance with the referenced standard.

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

• Test Set Sample Size: Not explicitly stated. The document mentions "A Clinical Test Report conducted according to ASTM E1965:2003" but does not provide the number of subjects or measurements included in this test.
• Data Provenance: The study was conducted by the "manufacturer," which is DONGGUAN DALANG VIGOR ELECTRONICS MFY in China. Therefore, the data provenance is China. It is a prospective study, as it was a "Clinical Test Report conducted... performed by the manufacturer" as part of the device's validation.

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

• The document does not provide information on the number or qualifications of experts used to establish ground truth. The nature of an ear thermometer's ground truth (e.g., a reference rectal or oral temperature measured by a calibrated clinical thermometer) typically doesn't involve "experts" in the sense of radiologists or pathologists. Instead, it relies on the accuracy of the reference device and the methodology for its use.

4. Adjudication Method for the Test Set

• The document does not mention any adjudication method. For a device like an ear thermometer, "adjudication" in the traditional sense of multiple reviewers resolving discrepancies is not typically applicable. The ground truth is generally a single, objectively measured value from a reference method.

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 (MRMC) is relevant for diagnostic imaging devices where human readers interpret medical images, sometimes with AI assistance. The Infrared Ear Thermometer is a direct measurement device, not an interpretative one, and does not involve AI assistance for human readers.

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

• Yes, this is effectively a standalone performance study. The device itself is an "algorithm only" (ASIC-controlled circuit) device that measures and displays temperature. Human involvement is limited to operating the device (placing it in the ear canal and reading the display), not interpreting complex output that would require a "human-in-the-loop" interaction in the typical sense of AI-assisted diagnostics. The clinical test measured the device's accuracy against a recognized standard without a human interpretation component that would require comparison to human-in-the-loop scenarios.

7. The Type of Ground Truth Used

• The ground truth used would be a reference temperature measurement obtained by a calibrated clinical thermometer following the guidelines of ASTM E1965:2003. This standard details how to conduct clinical performance evaluations for infrared thermometers. It implies a direct comparison to a known accurate temperature measurement from a standard clinical method (e.g., a rectal thermometer) under controlled conditions.

8. The Sample Size for the Training Set

• The document does not mention a specific training set or its sample size. This device is described as having an "ASIC (Application Specific IC) – controlled circuit," which is a "hard-wire control instead of programmable control." This implies a fixed, hardware-based algorithm rather than a software algorithm that would undergo a separate "training" phase with a dataset. Therefore, the concept of a "training set" as understood in machine learning/AI (which wasn't the focus of this device) does not apply here.

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

• As there is no indicated "training set" in the context of an ASIC-controlled, hard-wired device that is not an AI/machine learning product, this question is not applicable. The device's fundamental function is governed by its hardware design and integrated circuit, which are designed to comply with physical principles of thermometry.

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The device is an electronic clinical thermometer using an infrared sensor to detect body temperature from the auditory canal in the neonatal, pediatric and adult population used for intermittent monitoring of human body temperature in the home setting.

The Radiant Innovation Inc., Infrared Ear Thermometer, Models THK09, IRT 3020 are electronic thermometers that use an infrared detector (thermopile detector) to detect body temperature using infrared radiantion from the auditory canal. Its operation is based on measuring the natural infrared thermal radiation emanating from the tympanic membrane and the adjacent surfaces of the patient.

To measure ear temperature, the ear thermometer is inserted into a patient's outer ear canal. A start button is pressed to start the measurement through the radiation exchanges. The electrical signal read out from the detector is amplified by hardware and processed by the microprocessor. The temperature from the auditory canal in the neonatal, pediatric and adult population used for intermittent monitoring of human body temperature in the home setting.

Here's a breakdown of the acceptance criteria and the study details for the Radiant Innovation Infrared Ear Thermometer (Models THK09, IRT 3020) based on the provided text:

Acceptance Criteria and Device Performance

Study Details

The provided document describes a clinical evaluation to ascertain the accuracy of the THK09 Infrared Ear thermometer.

1. Sample size used for the test set and the data provenance:

   • The document does not explicitly state the sample size (number of participants or measurements) used for the test set.
   • The data provenance is not specified (e.g., country of origin). The study is described as a "clinical evaluation," implying it was prospective, but this is not explicitly stated.

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. The study compares the device to "legally marketed thermometers" rather than expert consensus on thermometry.

3. Adjudication method for the test set:

   • The document does not describe any adjudication method. The comparison appears to be direct against established reference thermometers.

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, this was not an MRMC comparative effectiveness study. This device is a medical thermometer, and the study focuses on its accuracy against reference thermometers, not on improving human reader performance with AI. The device itself is an IR thermometer, not an AI diagnostic tool.

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

   • Yes, in a sense. The clinical evaluation assesses the performance of the THK09 Infrared Ear thermometer as a standalone device. Its measurement output is directly compared to reference devices rather than being an input to a human interpretive process.

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

   • The "ground truth" was established by two legally marketed reference thermometers in the US:
     • MC 341 Omron Digital Thermometer (K091676)
     • Braun IRT 3020 Ear Thermometer (K983295)
   • The study was conducted in accordance with ASTM E1965:2003, which defines standards for clinical accuracy of IR thermometers.

7. The sample size for the training set:

   • This device is an infrared ear thermometer, which is a hardware device with embedded software for processing, not a machine learning or AI algorithm that typically requires a distinct "training set" in the computational sense. Therefore, the concept of a "training set" as understood in AI/ML is not applicable here.

8. How the ground truth for the training set was established:

   • As explained above, the concept of a training set for an AI/ML algorithm does not apply to this device. Therefore, no ground truth was established for a training set.

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Infrared Ear Thermometer (Dr. Schven ICT-1000) is intended for an electronic clinical thermometer using an infrared sensor to detect body temperature from the auditory canal in the neonatal, pediatric and adult population.

Not Found

The provided text is a 510(k) premarket notification letter from the FDA regarding an Infrared Ear Thermometer (Dr. Schven ICT-1000). It makes a "substantial equivalence" determination but does not contain any information about acceptance criteria, device performance studies, sample sizes, expert qualifications, or ground truth methods.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study proving the device meets them based on the provided input.

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Infrared Ear Thermometer (InnoTherm ICT-100 and InnoTherm ICT-200) is intended for an electronic clinical thermometer using an infrared sensor to detect body temperature from the auditory canal in the neonatal, pediatric and adult population.

Infrared Ear Thermometer offers easy, safe, accurate and fast temperature measurement in the ear. Temperature is more accurate core body temperature than other site of the body, since the eardrum shares blood vessels with the temperature control center in the brain (hypothalamus). Therefore, variations in body temperature are reflected sooner and more accurately in the ear than at the other sites on the body. Infrared Ear Thermometer is more convenient and safer than an oral thermometer, as it is unaffected by factors such as talking, eating, drinking and smoking.

Here's a breakdown of the acceptance criteria and study information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document provided does not contain a specific table of acceptance criteria for performance metrics (e.g., accuracy against a standard thermometer). Instead, it primarily focuses on comparing features and functionality to a predicate device and states that "Test results support the conclusion that actual device performance satisfies the design intent."

However, we can infer some key specifications and compare them to the predicate device, which implicitly serves as a benchmark for acceptability.

Note: The reported device performance generally meets or slightly expands upon the predicate's ranges for temperature measurements. The "Ambient range" and "Storage range" show variations, but the document doesn't explicitly state these as "acceptance criteria" against which the new device was measured; rather, they are presented as comparative specifications. The overall conclusion is "substantially equivalent," implying these differences are acceptable.

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

The document states: "Testing was performed according to 'Harmonized Standard and ASTM'." It does not specify:

• The exact sample size used for the test set.
• The country of origin of the data.
• 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 document. For a clinical thermometer, ground truth would typically be established by comparison to a highly accurate reference thermometer, not necessarily by human experts.

4. Adjudication Method for the Test Set

This information is not provided in the document. As mentioned above, for a clinical thermometer, adjudication by experts for ground truth is not typically applicable.

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 conducted or reported. This type of study is more common for diagnostic imaging devices where human interpretation plays a significant role. For a simple electronic thermometer, the objective is to measure temperature accurately, which is typically validated through direct comparison to a reference standard, not through reader studies.

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

Yes, a standalone performance evaluation was done. The document focuses on the device itself and its ability to measure temperature. The testing performed "according to 'Harmonized Standard and ASTM'" would assess the device's accuracy and performance independently.

7. The Type of Ground Truth Used

The document implies that testing was done against "Harmonized Standard and ASTM," which would mean the device's measurements were compared against established reference standards (e.g., highly accurate standard thermometers or controlled temperature environments) as defined by those standards. It is not expert consensus, pathology, or outcomes data.

8. The Sample Size for the Training Set

This information is not applicable and therefore not provided. This device is an infrared ear thermometer, a hardware device that directly measures a physical property (temperature). It does not use algorithms that require a "training set" in the context of machine learning or AI.

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

This information is not applicable as there is no "training set" for this type of device.

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Infrared Ear Thermometer ET-101A is indicated for the intermittent measurement and monitoring of human body temperature by consumers in a home use environment. It's intended for use on people of all ages.

Infrared Ear Thermometer ET-101A is electronic thermometers using an infrared detector (thermopile detector) to detect body temperature from the auditory canal. Its operation is based on measuring the natural thermal radiation emanating from the tympanic membrane and the adjacent surfaces of the patient.
To measure ear temperature, put a new clean probe cover on the infrared ear thermometer, then insert it into a patient's outer ear canal. A test button is pressed to start the measurement through the radiation exchanges. The electrical signal read out from the detector is fed to the circuit for amplification and calculation. The measured temperature then appears on a LCD display. The total operation takes a few seconds.

The provided text describes a 510(k) summary for the Infrared Ear Thermometer ET-101A, comparing it to a predicate device and outlining non-clinical and clinical tests. However, it does not explicitly state detailed acceptance criteria with numerical targets or specific performance metrics that were compared against those criteria.

Here's an analysis based on the information provided:

1. Table of Acceptance Criteria and Reported Device Performance:

The document states compliance with ASTM E1965-98 for non-clinical standards and implies that clinical studies evaluated clinical bias, clinical uncertainty, and clinical repeatability. However, specific numerical acceptance criteria (e.g., maximum allowable bias, precision limits) for these parameters and the reported performance values are not explicitly detailed in the provided text. The document concludes that the device is "substantially equivalent" to the predicate, implying it meets comparable performance levels.

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

• Sample Size for Test Set: Not explicitly stated. The document mentions "Controlled human clinical studies were conducted using the Infrared Ear Thermometer ET-101A" but does not give a number for participants.
• Data Provenance: Not explicitly stated. The document indicates "human clinical studies were conducted," but details like country of origin or whether the data was retrospective or prospective are not provided. Given it's a clinical study, it's typically prospective.

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

This information is not provided in the document. For a thermometer, "ground truth" would typically refer to a reference temperature measurement method, not expert consensus on an image or diagnosis.

4. Adjudication Method for the Test Set:

This information is not provided. As "ground truth" for a thermometer is usually a reference device, a human adjudication method like 2+1 or 3+1 for diagnostic interpretation is not applicable here.

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

No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic imaging devices where human readers interpret results, and an AI provides assistance. For a thermometer, the output is a numerical temperature reading, not an interpretation by a human reader.

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

Yes, the clinical evaluation of the thermometer's performance (clinical bias, uncertainty, repeatability) would inherently be a standalone performance evaluation of the device itself, as it directly measures a physical parameter. There is no "human-in-the-loop" influencing the temperature reading provided by the device.

7. The Type of Ground Truth Used:

The type of ground truth used for clinical studies of a thermometer would typically be comparison to a precisely calibrated reference thermometer or a "gold standard" clinical thermometry method (e.g., rectal thermometer, central venous temperature) under controlled conditions. The document states "Clinical data was presented which evaluated clinical bias, clinical uncertainty and clinical repeatability per the Sejoy Clinical Test Protocol outline," implying such a comparison was performed, but the specific "gold standard" used is not mentioned.

8. The Sample Size for the Training Set:

This information is not applicable/provided. Thermometers like the ET-101A typically do not employ machine learning or AI algorithms that require a "training set" in the conventional sense. Their operation is based on established physical principles (infrared detection) and calibration procedures. If any internal calibration or adjustment uses data, it's not described as a "training set" in this context.

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

This information is not applicable/provided for the reasons stated in point 8.

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