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FORA ComfortScan Ear Thermometer is an electronic thermometer using an infrared sensor to detect human body temperature from the ear canal on people of all ages and for use in the home. It is also available to detect object's surface temperature including human skin.

FORA ComfortScan Ear Thermometer is characterized by measuring human body temperature and object's temperature in the ear canal and at the surface, respectively. It utilizes infrared technology to measure either infrared energy emitted from the eardrum and surrounding tissues or the surface radiation of the object when making a temperature measurement. It is able to detect skin temperature (only as a reference) when aimed at the target surface of human body.

The provided document describes the acceptance criteria and the study conducted for the FORA ComfortScan Ear Thermometer, model TD-1261A/B.

Here's the breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

The document states that the device was validated by tests according to ASTM E1965-98 and met the requirements of prEN12470-5:2000 standards. While specific numerical acceptance criteria (e.g., maximum allowed error) are not explicitly stated in the provided text, the reported performance is that the device met the requirements of these standards for various tests. For the clinical accuracy test, the performance metrics reported are "Clinical bias" and "Clinical repeatability."

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

The document does not explicitly state the sample size used for the test set in either laboratory or clinical accuracy studies. It only mentions that the device was validated according to ASTM E1965-98 and prEN12470-5:2000. These standards typically outline requirements for sample sizes, but the specific numbers used in this particular study are not provided in the summary.

The data provenance (e.g., country of origin, retrospective or prospective) is also not specified in the provided text.

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

This information is not provided in the 510(k) summary. Given that the device is a thermometer for measuring body temperature, the "ground truth" for clinical accuracy would typically involve a reference thermometer (e.g., a highly accurate hospital-grade rectal thermometer or a calibrated blackbody for laboratory testing), rather than expert interpretation of images or clinical findings that would require a panel of experts.

4. Adjudication Method for the Test Set

The concept of an "adjudication method" (e.g., 2+1, 3+1) is typically relevant for studies involving subjective interpretations, such as medical imaging where multiple readers independently review cases and then reconcile their findings. For a device like an ear thermometer, which measures a physical quantity, this type of adjudication method is not applicable and therefore not mentioned in the document.

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

A Multi-Reader Multi-Case (MRMC) comparative effectiveness study, which assesses how human readers improve with AI assistance, is not applicable to a standalone medical device like an ear thermometer. This device directly measures temperature without human interpretation of complex data or AI assistance in diagnostic tasks. Therefore, no such study was done or reported.

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

The device itself is a standalone (algorithm only) device in the sense that it provides a direct temperature reading without requiring a human-in-the-loop for interpretation or modification of its core function. The performance assessment described (laboratory and clinical accuracy) evaluates the device's standalone capability to measure temperature. So, yes, the described performance characteristics are a standalone assessment of the device.

7. The Type of Ground Truth Used

For "Laboratory accuracy" and "Clinical accuracy" tests, the ground truth would typically be established using:

• Laboratory Accuracy: A highly accurate and calibrated reference thermometer or a blackbody temperature standard in a controlled laboratory setting.
• Clinical Accuracy: A reference body temperature measurement obtained from a primary site (e.g., rectal, oral) using a highly accurate and calibrated clinical reference thermometer, often performed by qualified medical personnel.

The document implicitly refers to these by stating compliance with ASTM E1965-98 and prEN12470-5:2000, which define how such ground truth is established for thermometer testing.

8. The Sample Size for the Training Set

The concept of a "training set" is relevant for machine learning or AI-based devices. As the FORA ComfortScan Ear Thermometer is an infrared sensor-based device that directly measures temperature and does not involve AI or machine learning algorithms that require a training phase, there is no training set in the conventional sense for this device.

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

Since no training set is applicable for this device (as explained in point 8), the question of how its ground truth was established is not relevant.

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The Fora ComfortScan Ear Thermometer is an electronic thermometer using an infrared sensor to detect human body temperature from the ear canal on people of all ages for home and professional use.

FORA ComfortScan Ear Thermometer is characterized by measuring human body temperature from the ear canal. It utilizes infrared technology to measure infrared energy emitted from eardrum tissue when making a temperature measurement.

Here's a summary of the acceptance criteria and the study details for the FORA ComfortScan Ear Thermometer, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Study Details:

The provided text describes a 510(k) summary for a modified medical device. The primary objective of the submission is to demonstrate substantial equivalence to a previously cleared predicate device, the FORA ComfortScan Ear Thermometer, model TD-1261 (K081445).

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

• The document states: "The performance of the FORA ComfortScan Ear Thermometer in the lab and clinical accuracy report demonstrated that the meter is safe and effective for home and professional use."
• Sample Size: The specific sample size for the test set (clinical accuracy report) is not provided in the given text.
• Data Provenance: The provenance of the data (e.g., country of origin, retrospective or prospective) is not explicitly stated. However, considering it's a 510(k) submission to the FDA, the clinical data would typically adhere to recognized standards for clinical accuracy.

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

• This information is not provided in the document. The text refers to "clinical accuracy report" but does not detail the methodology for establishing ground truth or the involvement of experts in that process.

4. Adjudication Method for the Test Set

• The adjudication method is not provided in the document.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance

• This is not applicable to this device. The FORA ComfortScan Ear Thermometer is a standalone device for measuring body temperature and does not involve human readers for interpretation, nor does it incorporate AI assistance for human readers.

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

• Yes, this is a standalone performance study from the perspective of how the device operates. The thermometer itself provides the temperature reading directly, without human interpretation for the measurement output. The "clinical accuracy report" would assess the device's ability to accurately measure temperature on its own.

7. The Type of Ground Truth Used

• While not explicitly stated, for a clinical thermometer, the ground truth for accuracy studies typically involves simultaneous measurements using a highly accurate reference thermometer (often a rectal thermometer or a standardized probe in a controlled environment) or comparison to other clinically accepted temperature measurement methods. The document mentions "lab and clinical accuracy report," which implies comparison against a reliable standard.

8. The Sample Size for the Training Set

• This information is not provided in the document. The device uses infrared technology, which traditionally relies on established physics principles and calibration rather than a machine learning "training set" in the conventional AI sense. The "training set" concept is not relevant here for device function.

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

• This question is not applicable as there is no mention or indication of a "training set" in the context of machine learning for this device. The device's operation is based on physical principles of infrared detection. Its accuracy would be established through calibration and validation against known temperature standards.

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The Fora ComfortScan Ear Thermometer is an electronic thermometer using an infrared sensor to detect human body temperature from the ear canal on people of all ages and for use in the home. It is also available to detect object's surface temperature including human skin.

The Fora ComfortScan Ear Thermometer is characterized by measuring human body temperature and object's temperature in the ear canal and at the surface, respectively. It utilizes infrared technology to measure either infrared energy emitted from the eardrum and surrounding tissues or the surface radiation of the object when making a temperature measurement. It is able to detect skin temperature (only as a reference) when aimed at the target surface of human body.

The provided 510(k) summary for the Fora ComfortScan Ear Thermometer offers limited detail regarding specific acceptance criteria and the comprehensive study design. However, based on the available information, here's a breakdown:

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

The submission states compliance with voluntary standards, which inherently include acceptance criteria for accuracy and performance. Without the full standard documents, specific numerical criteria are not explicitly given in this summary. However, we can infer some general performance reporting.

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

• Sample Size: Not explicitly stated. The summary only mentions "clinical and non-clinical studies."
• Data Provenance: Not explicitly stated. Given the manufacturer's location (Taiwan), it's plausible the studies were conducted there, but this is an assumption. The summary does not specify if the studies were retrospective or prospective.

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 provided in the summary. For a clinical thermometer, "ground truth" for temperature is typically established using a reference thermometer (e.g., a mercury-in-glass thermometer or a highly accurate electronic thermometer calibrated to national standards), not human experts in the way medical image analysis might.

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

This information is not provided. Adjudication methods are typically relevant for subjective assessments, such as interpreting medical images. For a device measuring a quantitative physical parameter like temperature, adjudication by multiple experts isn't usually applicable for establishing the ground truth measurements. The "ground truth" would be the reading from a calibrated reference 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

• MRMC Study: No, an MRMC study was not done. This type of study is relevant for diagnostic devices involving human interpretation (e.g., radiologists reading images) and the impact of AI assistance. A clinical thermometer measures a direct physiological parameter and does not involve human "readers" or AI assistance in its primary function for interpretation.
• Effect Size: Not applicable.

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

Yes, the studies performed (clinical and non-clinical) were inherently standalone in nature for the thermometer. The device itself measures temperature, and its performance is evaluated based on the accuracy and repeatability of those measurements compared to a reference standard, without human interpretation of its internal "algorithm." The results "were compliance to applicable voluntary standards" and "differences were within clinical acceptability and repeatability was statistically and clinically acceptable," indicating standalone performance evaluation.

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

The ground truth for temperature measurement would be established by comparison to a calibrated reference thermometer. While not explicitly stated, this is the standard practice for evaluating the accuracy of clinical thermometers, as dictated by standards like ASTM E1965-98. The summary refers to "clinical acceptability," which implies a comparison to a known, accurate temperature.

8. The sample size for the training set

This information is not applicable and therefore not provided. Clinical thermometers are typically hardware-based devices with firmware that executes a measurement algorithm. They don't typically undergo a "training" phase in the machine learning sense with a "training set." Performance is validated through testing on actual measurements.

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

This information is not applicable as there is no "training set" in the context of this device.

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