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The non-contact forehead thermometer is an electronic thermometer using an infrared detector (thermopile detector) to detect body temperature from forehead center in people of all ages.

The thermometer (Mode: TH48FE, TH09F, THD2FE) are electronic thermometer using an IR sensor to measure infrared energy radiated from the forehead. This energy is collected through the lens and converted to an oral temperature value. The thermometer consists of an IR sensor with a built-in ambient temperature sensor, Application-Specific Integrated Circuitry including software, LCD display, buttons, and batteries.

The provided text describes a 510(k) premarket notification for a non-contact forehead thermometer. While it discusses the device's accuracy and clinical validation, it does not detail a study that proves the device meets complex acceptance criteria for an AI/ML-driven medical device, as typically outlined for such systems. The acceptance criteria and study described are for a traditional medical device (a thermometer), focusing on its accuracy and safety standards rather than AI performance metrics.

Therefore, for AI/ML specific criteria like MRMC studies, ground truth establishment for AI training/testing, or separate human-in-the-loop vs. standalone AI performance, the provided document does not contain this information. The questions will be addressed based on the information available in the document, and limitations will be noted where information is absent.

Here's an analysis of the acceptance criteria and the study proving the device meets them, based solely on the provided text:

The device in question is a Non-contact Forehead Thermometer (Models TH48FE, TH09F, THD2FE), which is a traditional electronic medical device, not an AI/ML system. Therefore, the "acceptance criteria" and "study" described in the document relate to the performance of a thermometer, primarily its accuracy and compliance with relevant standards, rather than the complex AI/ML evaluation metrics (like sensitivity, specificity, MRMC studies, etc.) typically associated with AI-driven devices.

Here's a breakdown of the requested information based on the provided FDA 510(k) summary:

1. Table of Acceptance Criteria and Reported Device Performance

For a non-contact forehead thermometer, the primary performance criterion is accuracy.

Note: The document implies these are "acceptance criteria" by stating the device "met all design specifications" and "complied with" or "meet" the standards.

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

• Sample Size for Clinical Accuracy Validation (Test Set): 113 subjects.
• Data Provenance: Not explicitly stated, but the submission is from a Taiwan-based manufacturer (Radiant Innovation Inc.). It also doesn't specify if the clinical trial was retrospective or prospective, but clinical accuracy validation trials per ISO standards are typically prospective.

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 or qualifications of experts used to establish ground truth for the thermometer's clinical accuracy. For thermometer testing, "ground truth" typically refers to core body temperature measured by a highly accurate reference method (e.g., rectal thermometer in a controlled setting) against which the test device's readings are compared. This usually involves clinical staff following a standardized protocol rather than a panel of "experts" as in AI image interpretation.

4. Adjudication method for the test set

Not applicable/not specified. For simple temperature measurement, "adjudication" in the sense of resolving disagreements between multiple readers (as in AI image analysis) is not relevant. The ground truth would be established by the reference standard measurement.

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 standalone non-AI thermometer. There is no AI component or human-in-the-loop aspect for which an MRMC study would be performed.

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

This device is a "standalone" device in the sense that it provides a temperature reading without human interpretation beyond reading the display. Its "algorithm" is the internal software that converts IR signals to an oral temperature value. The document states:

• "Software verification and validation testing were conducted and documentation was provided as recommended by FDA's Guidance for Industry and FDA Staff, "Content of Premarket Submissions for Device Software Functions"."
• "The software for this device was considered as a "Basic" documentation level."

This confirms that the device's internal software/algorithm performance was validated.

7. The type of ground truth used

The ground truth for the clinical accuracy validation would be a reference body temperature measurement, typically obtained using a highly accurate clinical thermometer (e.g., a rectal thermometer) under controlled clinical conditions, as per the methodology outlined in ISO 80601-2-56 for clinical accuracy validation of medical thermometers. This is implicit in "Clinical Accuracy Validation."

8. The sample size for the training set

Not applicable. This is a traditional medical device, not an AI/ML device that requires a "training set" for model development. The internal software/firmware is developed and verified, not "trained" on data in the AI sense.

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 RII Smart IR Thermometer, Model TMS-01A is a non-contact infrared forehead thermometer and can only be used with an APP since the display only on a device with the APP. It is intermittent measurement of human body temperatures and is to be used at home for people of all ages.

The RII Smart IR Thermometer, Model TMS-01A is an electronic thermometer using an infrared sensor (thermopile) to detect body temperature from center of forehead. The principle of operation is based on measuring the natural thermal radiation from the center of forehead. The thermometer consists mainly of two parts - an IR sensor with a built-in ambient temperature sensor and an associated circuit. TMS-01A can only be used with an APP called "Radiant Forehead" which is available on APP store for iOS devices with version 7.0 or above. The APP is designed for use with TMS-01A to take forehead temperature by plugging the TMS-01A in the phone jack of the iOS devices. To measure body temperature, simply aim the device within 1 cm from the center of forehead. Press the "MEASURE" button on the smart phone touch screen, the temperature sensor detects the infrared thermal energy emitted from the targeted area. The electrical signal is sent to the circuit for amplification and calculation. The final measured temperature can be display on smart phone. The time consuming for measurement might be 1 second.

Here's a breakdown of the acceptance criteria and the study that proves the device meets them, based on the provided text:

Acceptance Criteria and Device Performance

The core acceptance criterion for the RII Smart IR Thermometer, Model TMS-01A, is its accuracy for body temperature measurement, aligned with established standards.

Table of Acceptance Criteria and Reported Device Performance:

Note: The FDA's 510(k) clearance process focuses on "substantial equivalence" to a predicate device. Therefore, the acceptance criteria are largely defined by the performance characteristics of the predicate device and relevant industry standards.

Clinical Study Details

The provided document describes a clinical performance test.

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

• Sample Size: 198 subjects.
• Data Provenance: Not explicitly stated regarding country of origin. The study was conducted as a "clinical performance test" which suggests prospective data collection for the purpose of this submission.
• Subject Groups: The 198 subjects were divided into three groups:
  • Infants: Newborn to one year
  • Children: Greater than one to five years
  • Adults: Greater than five years old

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

• This information is not provided in the document. For a thermometer, ground truth is typically established by highly accurate reference thermometers, not human experts in the same way it would be for an AI diagnostic algorithm.

3. Adjudication Method for the Test Set:

• This information is not applicable as the ground truth for thermometer accuracy is established by a reference standard, not through expert consensus requiring adjudication.

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

• No, an MRMC study was not done. This type of study is more relevant for diagnostic imaging AI where human readers interpret medical images with and without AI assistance. The RII Smart IR Thermometer is a direct measurement device.

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

• The clinical test evaluates the device's performance (i.e., algorithm/device only) against a reference standard. While the device requires connection to an APP and a smartphone for display, its core measurement capability is standalone. The study directly assesses this standalone performance.

6. The Type of Ground Truth Used:

• The ground truth for the clinical performance test was established based on the requirements of ASTM E1965-98. This standard specifies how the accuracy of infrared thermometers for intermittent determination of patient temperature should be evaluated, generally relying on highly accurate reference temperature measurements.

7. The Sample Size for the Training Set:

• This information is not applicable to this device. The RII Smart IR Thermometer is not an AI/ML algorithm that requires a "training set" in the conventional sense. It's a sensor-based device with embedded algorithms calibrated during manufacturing. The clinical test is for validation/performance assessment, not for training.

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

• As noted above, there is no "training set" in the context of this device. The device's internal calibration and algorithmic performance would be established during its development and manufacturing process, likely using traceable temperature standards.

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The RII Multi-function Infrared Thermometer, Model TH52Z is intermittent measurement of human body temperatures. The device is intended for the use at home by people of all ages including neonates and it can be selected Ear mode or Forehead mode.

The RII Multi-function Infrared Thermometer, Model TH52Z is an electronic thermometer using an infrared sensor (thermopile) to detect body temperature from the auditory canal or central forehead. Its operation is based on measuring the natural thermal radiation from the tympanic membrane or central forehead.

The end of ear canal is the tympanic membrane, which is thin and flooded with blood at the core temperature. The central forehead skin is thin & flat, and the temperature is uniform to cover the Whole FOV (Field of View) of the sensor.

The thermometer consists mainly of two parts - an IR sensor with a built-in ambient temperature sensor and the associated circuit. To measure body temperature, the probe of the thermometer is inserted into a patient's outer ear canal or put onto the skin of a patient's central forehead. Pressing the activation button (for ear or forehead) 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 be appeared on a LCD display. The total operation takes a few seconds.

Here's a summary of the acceptance criteria and the study that proves the device meets them, based on the provided text:

Device: RII Multi-function Infrared Thermometer, Model TH52Z
Intended Use: Intermittent measurement of human body temperatures for home use by people of all ages, including neonates, with selectable Ear mode or Forehead mode.

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size for the Test Set and Data Provenance

The document states, "The clinical investigation report and data analysis is followed the requirements the ASTM E 1965-98." ASTM E 1965-98, "Standard Specification for Infrared Thermometers for Intermittent Determination of Patient Temperature," typically specifies minimum sample sizes for clinical accuracy studies, usually involving a certain number of subjects across different age groups. While the exact number of subjects is not explicitly stated in this document, the reliance on ASTM E 1965-98 implies that an appropriate sample size was used to meet that standard.

Data Provenance: The document does not explicitly state the country of origin or whether the data was retrospective or prospective. However, clinical investigations for medical devices are generally prospective.

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

This information is not explicitly stated in the provided text. For a clinical thermometer study, the "ground truth" (reference temperature) is typically established using a highly accurate, calibrated reference thermometer (e.g., a rectal or oral electronic thermometer as per ASTM standards), rather than expert consensus.

4. Adjudication Method for the Test Set

The document does not describe an adjudication method. For clinical accuracy studies of thermometers, an adjudication method in the typical sense (e.g., 2+1 for reviewing discordant readings) is not applicable. The comparison is against a physically measured reference temperature.

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

No. A MRMC comparative effectiveness study is not relevant for the evaluation of a clinical thermometer, as it is not an imaging device requiring human interpretation of cases. The device directly provides a numerical measurement.

6. Standalone Performance Study

Yes. A standalone performance study was conducted. The clinical investigation directly assessed the accuracy of the RII Multi-function Infrared Thermometer, Model TH52Z, by comparing its readings against a digital thermometer (acting as the reference/ground truth). The report states, "The clinical investigation report and data analysis is followed the requirements the ASTM E 1965-98. The test report shows the three group's temperature readings difference between digital thermometer and the subject device, TH52Z are within acceptable range."

7. Type of Ground Truth Used

Reference Standard Measurement. The ground truth for the clinical accuracy study was established using a "digital thermometer." This implies a comparison against a calibrated, highly accurate reference thermometer, as prescribed by standards like ASTM E1965-98 for clinical accuracy evaluation.

8. Sample Size for the Training Set

Not applicable. This device is a traditional infrared thermometer, not an AI / machine learning-based algorithm that requires a training set.

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

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

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The Non-contact Clinical Thermometer, Model THB0F is an infrared thermometer intended for the intermittent measurement of human body temperature in people of all ages.

The RII Non-contact Clinical Thermometer, Model THBOF is electronic thermometer using an infrared detector (thermopile detector) to detect body temperature from the Forehead. Its operation is based on measuring the natural thermal radiation emanating from the temples to hairline upper eyebrows. The thermometer consists mainly of the following parts: an IR sensor with a built-in ambient temperature sensor, a thermo-mass, and the associated circuit. The forehead skin, which is thin and beneath, which is the temporal artery, with blood very near to the core temperature. The forehead skin must cover the whole FOV(Field of View) of the sensor. When measuring, radiation fluxes transfer from the skin to the IR detector. The ambient sensor is mounted in the IR sensor package, and near the IR detector element to monitor the ambient temperature. To measure core temperature, the probe of the thermometer are slide through the skin of the a patient's forehead. A activation 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 appear on a LCD display. The total operation takes a few seconds.

The Radiant Innovation Inc. Non-contact Clinical Thermometer, Model THB0F, is an infrared thermometer intended for intermittent measurement of human body temperature in people of all ages.

Here's an analysis of its acceptance criteria and the study that proves its performance:

1. Table of Acceptance Criteria and Reported Device Performance:

Additional Acceptance Criteria (General Safety and Standards Compliance):

• Compliance to applicable voluntary standard ASTM E1965-98: Met.
• Compliance to recognized consensus standards for safety of medical electrical equipment: Met (EN 60601-1 (IEC 60601-1) for safety and EN 60601-1-2 (IEC 60601-1-2) for electromagnetic compatibility).
• Compliance to FDA Guidance On The Content of Premarket Notification 510(k) Submissions for Clinical Electronic Thermometers: Met.

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

The document states, "The clinical investigation report and data analysis is followed the requirements the ASTM E 1965-98." However, it does not explicitly specify the sample size used for the clinical test set or the country of origin of the data. It also does not explicitly state whether the study was retrospective or prospective.

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

The document does not specify the number of experts used to establish the ground truth for the clinical test set, nor does it provide their qualifications. The clinical test compares the THB0F's readings against a "digital thermometer." It implies the "digital thermometer" serves as the reference or "ground truth" for the comparison.

4. Adjudication Method for the Test Set:

The document does not describe an adjudication method for the test set. The clinical test appears to be a direct comparison of temperature readings between the subject device and a digital thermometer.

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

A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not performed, nor is it applicable to this device. This device is a standalone thermometer, not an AI assistance tool for human readers.

6. Standalone (Algorithm Only) Performance:

Yes, the primary clinical test performed was a standalone performance study for the device. The study evaluated the accuracy of the THB0Fometer in measuring human body temperature independently. The document states: "The test report shows the three group's temperature readings difference between digital thermometer and the subject device, THB0F are within acceptable range."

7. Type of Ground Truth Used:

The ground truth used for the clinical test was based on measurements from a "digital thermometer." This implies a comparison against an established, accurate clinical thermometer.

8. Sample Size for the Training Set:

The document does not describe a training set for an algorithm, as this device is a hardware clinical thermometer dependent on an infrared sensor and associated circuitry, not a machine learning model.

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

As there is no mention of a training set or an algorithm in the context of machine learning, the question of how its ground truth was established is not applicable. The device's performance is validated through physical and clinical testing against established standards and other measurement devices.

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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 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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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, Model TH709L(E) is electronic thermometer 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, 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 fed to the circuit for amplification and calculation. The measured temperature then appears on a LCD display. The total operation takes a few seconds.

Here's an analysis of the acceptance criteria and supporting study for the Radiant Innovation Inc. Infrared Ear Thermometer TH709L(E), based on the provided document:

This document is a 510(k) summary for a Special 510(k) submission, meaning the device TH709L(E) is being asserted as substantially equivalent to a previously cleared predicate device (TH8 series) due to minor modifications. The focus of such submissions is typically demonstrating that the modifications do not raise new questions of safety or effectiveness, often through compliance with recognized standards and comparison to the predicate. Therefore, the "study" described is primarily about demonstrating compliance with accuracy standards rather than a comparative effectiveness study or a complex standalone algorithm validation.

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

Note: The document explicitly states "Compliance to applicable voluntary standards includes ASTM E1965-98 and EN12470-5;2003". These standards define the accuracy requirements for clinical infrared thermometers. The reported performance in the comparison table mirrors these standard accuracy criteria, implying the device met these thresholds.

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

The document does not explicitly state a specific "test set" sample size or data provenance in terms of human subjects for a clinical study. The evaluation appears to be based on bench testing ("bench testing contained in this submission supplied demonstrate that the modification of TH709L(E) do not raise any new questions of safety or effectiveness.") and compliance with voluntary standards (ASTM E1965-98 and EN12470-5;2003). These standards typically involve specified test procedures and equipment to verify accuracy under controlled conditions, rather than a clinical trial with a specific number of patients.

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

This information is not applicable as the evaluation focuses on compliance with technical standards through bench testing, not on interpreting medical images or data that would require expert adjudication. The "ground truth" for thermometer accuracy is established by highly accurate reference thermometers and controlled temperature environments as part of the standard testing protocols specified in ASTM E1965-98 and EN12470-5:2003.

4. Adjudication method for the test set

This information is not applicable for the same reasons as point 3.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

This information is not applicable. The device is an infrared ear thermometer, not an AI-powered diagnostic tool that assists human readers.

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

This information is not applicable in the context of an "algorithm only" performance as would be relevant for an AI device. The device performance itself (measuring temperature) is essentially a standalone function, and its accuracy is validated against established standards.

7. The type of ground truth used

The ground truth used for establishing the device's accuracy is derived from measurements taken by highly accurate reference instruments under controlled environmental conditions, as dictated by the specified voluntary standards (ASTM E1965-98 and EN12470-5:2003).

8. The sample size for the training set

This information is not applicable. This is not an AI/machine learning device that requires a training set.

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

This information is not applicable for the same reason as point 8.

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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, Model TH60N is electronic thermometer 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, 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 fed to the circuit for amplification and calculation. The measured temperature then appears on a LCD display. The total operation takes a few seconds.

Radiant Infrared Ear Thermometer TH60N is an ear thermometer without probe cover with some sub-functions such as: temperature unit switchable, recall memory, scan function, last reading display, ambient temperature, and backlight.

The provided text is a 510(k) summary for the Radiant Innovation Inc. Infrared Ear Thermometer TH60N. It does not contain detailed acceptance criteria and a study proving the device meets those criteria in the way typically found for AI/ML medical devices. Instead, it focuses on substantial equivalence to a predicate device based on regulatory compliance and non-clinical testing.

Therefore, I cannot extract the specific information requested in your bullet points because the document does not contain that level of detail for a performance study.

Here's what I can extract and what is missing:

1. Table of Acceptance Criteria and Reported Device Performance

• Acceptance Criteria/Performance Standards: The document states compliance with "applicable voluntary standards includes ASTM E1965-98 and EN12470-5:2003, as well as EN 60601-1 (IEC 60601-1) and EN 60601-1-2 (IEC 60601-1-2) requirements."
  • However, it does not provide the specific quantitative acceptance criteria within those standards (e.g., maximum allowable error in temperature readings) nor does it report the device's specific performance against these criteria (e.g., "Our device had an accuracy of X degrees Celsius, which is within the Y degrees Celsius specified by ASTM E1965-98"). The document only states that "bench testing contained in this submission supplied demonstrate that the modification of TH60N do not raise any new questions of safety or effectiveness." This implies the device met the standards, but the specific data is not in this summary.

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

• Not explicitly stated for clinical performance. The document mentions "bench testing" but doesn't specify sample sizes for any clinical validation or the origin of data beyond "bench testing." For a thermometer, a "test set" would typically refer to a clinical study measuring human body temperatures, which is not described.

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

• Not applicable/Not stated. This type of information is typically for diagnostic devices where expert consensus (e.g., radiologists, pathologists) is needed to establish ground truth. For a thermometer, "ground truth" would be established by a reference thermometer or a controlled environment, not expert interpretation. This document does not describe how ground truth was established, only that it complies with standards.

4. Adjudication method for the test set

• Not applicable/Not stated. Similar to point 3, adjudication methods (like 2+1) are used for interpretive tasks in diagnostic imaging or similar fields. They are not relevant for a simple temperature measurement device like an ear thermometer.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done

• No. This type of study is for evaluating human performance (e.g., radiologists) with and without AI assistance in diagnostic tasks. It is not relevant for an infrared ear thermometer.

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

• Yes, in essence. A thermometer is inherently a standalone device; the "algorithm" (its internal processing) produces a direct measurement. The "bench testing" mentioned would be evaluating this standalone performance against reference standards. However, specific details of this testing (e.g., number of measurements, temperature ranges tested, results) are not provided in this summary.

7. The type of ground truth used

• Implied by compliance to standards: For a thermometer, ground truth is typically established using highly accurate reference thermometers in controlled environments (e.g., blackbody cavities for infrared calibration, or direct contact thermometry for clinical validation). The document does not explicitly state the specific ground truth used but relies on adherence to standards like ASTM E1965-98 and EN12470-5:2003 which would specify such methods.

8. The sample size for the training set

• Not applicable/Not stated. This device is a traditional electronic thermometer, not an AI/ML device that requires a "training set."

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

• Not applicable/Not stated. As it's not an AI/ML device, there's no training set or associated ground truth for training.

In summary, this 510(k) submission focuses on meeting established regulatory standards and demonstrating substantial equivalence to a predicate device through "bench testing." It is not a clinical study report for an AI/ML device, and therefore the detailed performance metric breakdown you're looking for is absent from this specific document.

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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, Model TH01BN are 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, 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 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 is a 510(k) summary for the Radiant Innovation Inc. Infrared Ear Thermometer TH01BN. It primarily focuses on demonstrating substantial equivalence to a predicate device based on compliance with voluntary standards and bench testing, rather than a clinical study with detailed acceptance criteria and performance data as typically seen in AI/ML medical devices.

Therefore, much of the requested information (e.g., sample size for test set, data provenance, number of experts, adjudication method, MRMC study, standalone performance, training set details) is not present in this document because it describes a traditional medical device (thermometer) and not an AI or machine learning-based device. The "study" referenced is primarily conformance to relevant standards for clinical thermometers.

However, I can extract information related to the acceptance criteria and reported device performance based on the standards mentioned.

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

The document states that the device demonstrated compliance to applicable voluntary standards ASTM E1965-98 and EN12470-5:2003 for clinical electronic thermometers. These standards define the acceptance criteria for accuracy.

Note: The specific numerical values for accuracy and other parameters from these standards are not detailed in the provided summary, only that the device "compli(ed) to applicable voluntary standards." The device performance is "reported" as being compliant with these standards.

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

This information is not provided in the document. The "tests performed" refer to bench testing for compliance with standards, not detailed clinical trial data with patient samples.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not applicable and not provided. The ground truth for a physical measurement device like a thermometer is established through traceable calibration standards, not expert consensus in the way an AI model's ground truth for medical images would be.

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

This information is not applicable and not provided. Adjudication methods are typically used in studies involving human interpretation or annotation, which is not the case for a thermometer's performance testing.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

This information is not applicable and not provided. An MRMC study is relevant for AI-assisted diagnostic tools involving human readers, which this device is not.

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

This information is not applicable in the context of an infrared ear thermometer. The device itself is a "standalone" instrument for measuring temperature. There is no "algorithm only" performance separate from the device's function.

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

For a thermometer, the "ground truth" for its accuracy is typically established by comparing its readings against a calibrated reference thermometer in a controlled environment, traceable to national/international standards (e.g., against a black body radiator or a liquid-in-glass thermometer of known accuracy). This is part of the bench testing implied by compliance with ASTM and EN standards.

8. The sample size for the training set

This information is not applicable and not provided. This device is an infrared ear thermometer, a hardware device, not an AI/ML model that requires a training set.

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

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

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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 TH5XY series are 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, 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 fed to the circuit for amplification and calculation. The measured temperature then appears on a 1.CD display. The total operation takes a few sconds.

The provided text is a 510(k) summary for the Radiant Innovation Inc. Infrared Ear Thermometer TH5XY series. The document primarily focuses on establishing substantial equivalence to a predicate device based on similar intended use and characteristics, and compliance with applicable voluntary standards. It does not present a study with specific acceptance criteria and detailed device performance data in the format requested.

Therefore, many of the requested fields cannot be directly extracted from the provided text. However, I can infer some information based on the type of document.

Here's the breakdown of what can and cannot be answered:

1. Table of acceptance criteria and the reported device performance:

• Acceptance Criteria: The document mentions "Compliance to applicable voluntary standards includes ASTM E1965-98 and EN12470-5:2003, as well as IEC 60601-1 and EN 60601-1-2 requirements." These standards define the performance and safety requirements for clinical electronic thermometers, and adherence to them would constitute the acceptance criteria. Specific numerical values for criteria (e.g., accuracy +/- X degrees) are not explicitly stated in this summary document.
• Reported Device Performance: The document only states that "bench testing contained in this submission supplied demonstrate that the modification of TH5XY do not raise any new questions of safety or effectiveness." It does not provide the specific results of these bench tests or how they directly compare to the numerical acceptance criteria of the standards.

Without the specific numerical criteria from ASTM E1965-98 or EN12470-5:2003, and the corresponding performance data from the "bench testing," a table as requested cannot be constructed.

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

• Sample Size: Not specified in the provided text.
• Data Provenance: The document refers to "bench testing," which typically means testing conducted in a laboratory environment, not necessarily involving human subjects from a specific country or in a retrospective/prospective study.

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

• Not applicable as the text describes "bench testing" against standards, not a clinical study involving expert ground truth.

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

• Not applicable as the text describes "bench testing" against standards.

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, this device is an Infrared Ear Thermometer, not an AI-assisted diagnostic tool. Therefore, an MRMC study related to AI assistance would not be relevant.

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

• While the device functions in a "standalone" manner (it takes a temperature reading without a human interpreting an algorithm's output), the document does not describe "standalone algorithm performance" in the context of typical AI/software device evaluations. The "bench testing" would assess the device's accuracy and adherence to standards.

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

• For a thermometer, the "ground truth" for accuracy would typically be a highly accurate reference thermometer or temperature standard used during bench testing. This is not explicitly stated but implied by compliance to accuracy standards (e.g., ASTM E1965-98).

8. The sample size for the training set:

• Not applicable. This is a hardware device, and the summary does not indicate any machine learning or AI components that would require a "training set."

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

• Not applicable (see point 8).

Summary of available information:

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