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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, 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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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 THxxN 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 LCD display. The total operation takes a few seconds.

The provided text is a Special 510(k) Summary for a medical device called the "RII Infrared Ear Thermometer, Model THXXN Series." It details modifications to an existing device and argues for its substantial equivalence to previously cleared devices.

However, the document does not contain the level of detail required for a comprehensive description of acceptance criteria and the study that proves the device meets those criteria, as requested in your prompt. Specifically, it lacks:

• A table of acceptance criteria and reported device performance: While it mentions compliance with standards like ASTM E1965-98, it doesn't present specific performance metrics (e.g., accuracy, precision) against defined acceptance thresholds.
• Sample size and data provenance for a test set: There's no mention of a dedicated test set, its size, or where the data came from.
• Number and qualifications of experts for ground truth: No information on expert involvement in establishing ground truth.
• Adjudication method: Not mentioned.
• Multi-reader multi-case (MRMC) comparative effectiveness study: Not mentioned. The device is a thermometer, so this type of study is unlikely to be relevant.
• Standalone (algorithm only) performance: Not mentioned, although as a thermometer, its performance is inherently standalone.
• Type of ground truth used: Not explicitly stated, though for a thermometer, the "ground truth" would typically come from a reference standard thermometer.
• Sample size for the training set: Not mentioned.
• How ground truth for the training set was established: Not mentioned.

What the document does state regarding acceptance criteria and testing:

The primary "acceptance criteria" discussed in this document revolve around substantial equivalence to predicate devices and compliance with applicable voluntary standards.

Acceptance Criteria and Reported Device Performance (as inferred):

Regarding the "Study that Proves the Device Meets the Acceptance Criteria":

The document refers to "bench testing contained in this submission" as the study that demonstrates the device meets the safety and effectiveness criteria and supports the claim of substantial equivalence. However, no details of this bench testing are provided within the summary itself. We only know it was conducted and deemed sufficient by the submitter.

In summary, the provided text is a regulatory submission summary focused on demonstrating substantial equivalence, not a detailed technical report of a clinical or analytical study. It lacks the specific data points, methodologies, and participant details requested in your prompt.

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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 TH1 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 LCD display. The total operation takes a few seconds.

The provided document is a Special 510(k) summary for a medical device (Infrared Ear Thermometer, Models TH1 series). However, it does not contain the specific details about the acceptance criteria and the study that proves the device meets those criteria.

This document primarily focuses on establishing "substantial equivalence" to a predicate device (Radiant Innovation Infrared Ear Thermometer, Models TH8 series, FDA# K011059) by highlighting that the only differences are outer appearance and user manual, which do not significantly change safety or effectiveness.

While it mentions compliance with ASTM E1965 as an applicable voluntary standard, it does not provide the specific performance criteria from that standard, nor does it detail the results of the tests conducted to demonstrate compliance.

Therefore, I cannot fulfill your request for the tables and detailed information about acceptance criteria and study results based solely on the provided text.

To answer your request, I would need a document that includes:

• Specific performance specifications (e.g., accuracy, precision, response time) for the device.
• Data from a clinical or bench study demonstrating that the device meets these specifications.
• Details about the study design, sample sizes, ground truth establishment, and expert involvement.

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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 TH88 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 total operation takes a few seconds. The measured temperature then appears on a LCD display.

The provided text describes a Special 510(k) submission for the Radiant Innovation Inc. Infrared Ear Thermometer, Models TH88 series. This submission focuses on demonstrating substantial equivalence to a previously cleared device (Models TH8 series) based on minor modifications (outer appearance and probe cover installation instructions). As such, the submission primarily relies on compliance with voluntary standards rather than a detailed performance study with acceptance criteria and statistical analysis of device performance against a ground truth.

Therefore, many of the requested details about acceptance criteria and a comprehensive study showing the device meets them cannot be extracted directly from this document. The document states that the modifications "will not significantly change the safety and effectiveness" and that "bench testing contained in this submission supplied demonstrate that the modification of TH88 do not Thus, the RII Infrared Ear raise any new questions of safety or effectiveness."

However, I can extract information related to the standards the device complies with, which implicitly define performance expectations.

Here's what can be extracted and what cannot:

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

• Acceptance Criteria: The document explicitly states compliance with ASTM E1965 for clinical electronic thermometers. This standard defines performance requirements (e.g., accuracy, precision, stability).
• Reported Device Performance: The document does not provide specific performance metrics (e.g., mean bias, standard deviation of differences) for the TH88 series. It only states that the device complies with ASTM E1965, implying its performance meets the requirements of that standard.

Table of Acceptance Criteria (from ASTM E1965 compliance) and Reported Device Performance (implied):

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

• Sample Size for Test Set: Not specified in the document.
• Data Provenance: Not specified in the document. The document refers to "bench testing," which typically occurs in a laboratory setting.

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

• Not applicable/Not specified. The document does not describe a clinical study where ground truth would be established by experts. Performance is assessed against a standard (ASTM E1965), which would involve calibrating the device against known temperature references.

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

• Not applicable/Not specified. No human adjudication described for performance testing of a thermometer.

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

• Not applicable. This is a simple electronic thermometer, not an AI-powered diagnostic device requiring MRMC studies.

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

• Not applicable. While the thermometer operates "standalone" in function, the document does not describe a standalone algorithm performance study in the context of AI/software. Its performance is measured directly as a device.

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

• Type of Ground Truth: The ground truth for evaluating thermometer accuracy generally involves known, precisely controlled temperature references (e.g., a calibrated blackbody radiator or temperature bath) as specified by standards like ASTM E1965. The document implies this by stating compliance with ASTM E1965.

8. The sample size for the training set:

• Not applicable. This device is not an AI/machine learning model that would require a "training set."

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

• Not applicable. This device is not an AI/machine learning model that would require a "training set."

In summary, the document is a Special 510(k) for minor device modifications, and as such, it defers to compliance with established voluntary standards (primarily ASTM E1965) for demonstrating safety and effectiveness rather than presenting a novel, detailed performance study with clinical ground truth and expert adjudication.

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