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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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The device is an electronic clinical thermometer using an infrared sensor to detect body temperature. The device is intended for use on the pediatric and adult population used in the home setting.

The Radiant Innovation Inc., Infrared Ear Thermometer, Models TH00XY series are electronic clinical thermometers using an infrared detector (thermopile detector) to detect electromagnetic radiation. The operation is based on measuring the body temperature from the auditory canal 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 measured temperature then appears on a LCD display. The total operation takes a few seconds.

The provided text describes a Special 510(k) Summary for a Radiant Innovation Inc. Infrared Ear Thermometer TH00XY series. This is a submission to the FDA for a modification to an existing, previously cleared device. Therefore, the "study" referred to is primarily focused on demonstrating substantial equivalence to the predicate device and compliance with established standards, rather than a de novo clinical trial with new acceptance criteria.

The document does not contain a detailed study report with specific acceptance criteria beyond compliance with standard performance metrics for thermometers, nor does it explicitly state performance metrics in a summarized table format with reported values. It primarily references compliance with existing standards.

Here's an analysis based on the provided text, addressing your points where information is available:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly provide a table with specific acceptance criteria and reported device performance. Instead, it states compliance with recognized standards.

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

• Sample Size: The document does not specify a "test set" sample size in terms of patient data. The tests conducted appear to be bench testing as stated: "More are bench testing contained in this submission supplicd demonstrate that the modification of TH00XY do not raise any new [questions]."
• Data Provenance: The document does not refer to clinical data or patient data with provenance information (country of origin, retrospective/prospective). The tests mentioned are laboratory/bench tests.

3. Number of Experts Used to Establish Ground Truth and Qualifications

This information is not applicable as the document describes bench testing and compliance with standards, not a clinical study involving expert-established ground truth for patient data.

4. Adjudication Method for the Test Set

This information is not applicable as the document describes bench testing and compliance with standards, not a clinical study requiring adjudication of patient cases.

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

• Was it done? No, an MRMC comparative effectiveness study was not done. The submission is for an infrared ear thermometer, which is a standalone measurement device, not an AI-assisted diagnostic tool that would typically involve human readers.
• Effect Size of Human Readers Improve with AI vs without AI assistance: Not applicable, as no MRMC study or AI assistance is described.

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

• Was it done? Yes, in essence, the bench testing and compliance with ASTM E1965-98 can be considered a standalone performance assessment of the device (algorithm/hardware combination) without human intervention in the measurement process beyond operation. The thermometer itself provides a direct reading.

7. Type of Ground Truth Used

The ground truth for the performance claims is based on standardized measurement references and methodologies mandated by the cited standards (e.g., ASTM E1965-98). This involves calibrated heat sources and precision measurement techniques to assess accuracy, repeatability, and other performance characteristics. It is not expert consensus, pathology, or outcomes data.

8. Sample Size for the Training Set

This information is not applicable. Infrared ear thermometers rely on physical principles and calibration, not machine learning algorithms that require a "training set" in the conventional sense.

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

This information is not applicable for the reasons stated in 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 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):

• ASTM E1965-98
• IEC 60601-1
• EN 60601-1-2 | "Compliance to applicable voluntary standards includes ASTM E1965-98, as well as IEC 60601 -1 and EN 60601-1-2 requirements." (Implies successful compliance, but no specific performance data presented). |
  | Characteristics | Similar characteristics to predicate devices. | "The RII Infrared Ear Thermometer THxxN series, have the same intended use and similar characteristics as the cleared device TH1 and TH8 series." |

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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