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The Infrared Ear Thermometer is indicated for intermittent measurement of human body temperature from the ear canal. The device can be used by people of all ages except preterm babies or babies who are small for gestational age. The thermometer is intended for use in professional settings and the home environment. It is not for emergency clinical conditions.

YUWELL® Infrared Ear Thermometer is designed to measure human body temperature. This hand-held, no-contact device is battery-powered and utilizes infrared energy emitted in the subject's tympanic membrane to determine human body temperature. The thermometer provides temperature readings in just 2 seconds. It is suitable for individuals of all ages except preterm babies or babies who are small for gestational age. The Infrared Ear Thermometer YHT107 can transmit the temperature readings via Bluetooth, whereas the YHT100 does not have data transmission capability.

Here's a detailed breakdown of the acceptance criteria and study information for the YUWELL® Infrared Ear Thermometer, extracted from the provided FDA 510(k) clearance letter:

YUWELL® Infrared Ear Thermometer (YHT100; YHT107) Acceptance Criteria and Study Details

The YUWELL® Infrared Ear Thermometer (YHT100; YHT107) is indicated for intermittent measurement of human body temperature from the ear canal in professional and home environments, for people of all ages except preterm babies or babies who are small for gestational age.

1. Table of Acceptance Criteria and Reported Device Performance

The core performance acceptance criteria are related to temperature accuracy, as specified by the standards ISO 80601-2-56 and ASTM E1965.

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The Infrared Ear thermometer is intended for the intermittent measurement of body temperature from the ear canal on people of all ages except for babies under 3 months. It is suitable for home use and healthcare facilities use.

The iHealth PT5 Infrared Ear Thermometer is a hand-held, reusable, battery operated device, which can measure human body temperature on one's ear canal. Its operation is based on measuring the natural thermal radiation from the ear canal with a built-in correction algorithm to compensate the influence of ambient temperature using a heated tip. Put the probe of the thermometer into a patient's ear canal, after a self-check, pressing the activation button to start the measurement of proposed 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 LED display. It is recommended that adult take the measurement instead when infants and children cannot use the ear thermometer themselves.

The iHealth PT5 Infrared Ear Thermometer measures body temperature from the ear canal. The device's performance was evaluated through non-clinical and clinical tests to demonstrate substantial equivalence to a predicate device.

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not explicitly state the country of origin for the clinical data or whether it was retrospective or prospective. However, based on the testing being conducted to international standards (ASTM and ISO), it is likely to be a prospective clinical study specifically designed for regulatory submission.

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

This information is not explicitly provided in the document. The document states "Clinical accuracy validation test report included temperature readings," implying that a reference standard temperature measurement (often oral or rectal temperature by trained clinicians) was used as the ground truth, but the number or qualifications of experts involved in establishing this ground truth are not detailed.

4. Adjudication Method for the Test Set:

This information is not explicitly provided in the document.

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

This type of study is not applicable here as the device is an infrared ear thermometer, which measures a physical parameter (temperature) and does not involve human readers interpreting images or data to make a diagnosis that would be assisted by AI. The device operates in a standalone manner.

6. Standalone Performance:

Yes, a standalone performance study was done. The "Clinical Accuracy Validation Test" performed according to ASTM E1965-98 directly evaluated the iHealth PT5 Infrared Ear Thermometer's performance in measuring body temperature in a clinical setting without human interpretation or intervention in the temperature measurement itself. The non-clinical tests also evaluated the device's technical standalone performance.

7. Type of Ground Truth Used:

Based on the nature of a clinical accuracy validation test for thermometers, the ground truth would most likely be established by a reference standard temperature measurement (e.g., core body temperature measurements from oral or rectal thermometers) taken by trained medical personnel. This is implied by the reference to ASTM E1965-98, which outlines methods for clinical performance evaluation of intermittent thermometers.

8. Sample Size for the Training Set:

The document does not mention a training set in the context of this device. Thermometers typically rely on established physical principles and calibration, not machine learning algorithms that require a "training set" in the conventional sense. The "correction algorithm to compensate the influence of ambient temperature using a heated tip" mentioned in the device description refers to a predefined algorithm, not one trained on a dataset.

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

As there is no mention of a training set for a machine learning algorithm, this question is not applicable based on the provided text.

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The YUWELL® Infrared ear thermometer is a non-sterile, reusable clinical thermometer. The device is to display the body temperature in the ear cavity by thermal radiation for people of all ages except preterm babies and newborns (1-29 days old).

The YUWELL® Infrared ear thermometer is designed for measuring the body's temperature, is a hand-held non-contact infrared thermometer, battery powered, using the infrared energy emitted in the subject's tympanic membrane that converts a user's body temperature.

The provided document describes the safety and effectiveness of the YUWELL Infrared Ear Thermometer (Models YHT101, YHT200) based on comparisons to a predicate device (Braun Thermoscan® PRO 6000 Ear Thermometer) and compliance with various standards.

Here's an analysis of the acceptance criteria and study information, based on the provided text:

1. Table of Acceptance Criteria and the Reported Device Performance

The document does not present a formal table of "acceptance criteria" for the device, but rather compares the subject device's specifications and performance to a predicate device and states compliance with recognized standards. The "Performance" row in the "Substantial Equivalence" table (page 4) indicates the key performance standards met.

Here's a table based on the key performance and accuracy criteria mentioned:

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

The document mentions "Clinical accuracy test requirements established in the standard ASTM E1965 (Clinical part only) and ISO 80601-2-56 (Clinical accuracy validation only)". However, it does not provide details on the specific sample size used for these clinical accuracy tests, nor does it specify the country of origin of the data or whether the study was retrospective or prospective.

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

The document states that "Clinical accuracy test requirements established in the standard ASTM E1965 (Clinical part only) and ISO 80601-2-56 (Clinical accuracy validation only)" were met. For clinical thermometers, ground truth is typically established by comparing the device's readings against a highly accurate reference thermometer (e.g., rectal thermometry in controlled environments or other gold standard methods) in actual patients.

However, the document does not specify the number of experts used or their qualifications.

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

The document does not provide any information regarding an adjudication method for establishing ground truth or evaluating the test set.

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

The device under review is an infrared ear thermometer, which is a standalone measurement device, not an AI-assisted diagnostic tool that involves human "readers." Therefore, a multi-reader multi-case (MRMC) comparative effectiveness study focusing on human reader improvement with AI assistance is not applicable and was not performed or mentioned.

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

Yes, the primary performance evaluation described is for the standalone device (algorithm only, without human-in-the-loop performance beyond operating the device). The "Performance test according to ASTM E 1965 and ISO80601-2-56" and "Clinical accuracy test" directly assess the device's ability to accurately measure temperature on its own.

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

For the clinical accuracy validation of a thermometer, the ground truth is typically established by comparison to a highly accurate reference method (e.g., a calibrated reference thermometer measuring core body temperature, often rectal or arterial temperature, in a controlled setting) as defined by the standards like ASTM E1965 and ISO 80601-2-56. The document mentions meeting these standards for clinical accuracy.

8. The sample size for the training set

The document does not provide information regarding a separate "training set" for the device. Clinical thermometers are calibrated and validated against standards; they don't typically undergo machine learning training in the same way an AI diagnostic device would.

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

As there's no mention of a traditional machine learning "training set" in the context of this infrared ear thermometer, this question is not applicable. The device's internal algorithm is likely developed based on physics principles of infrared radiation and calibrated against known temperature sources, rather than being "trained" on a dataset with ground truth in the AI sense.

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The Microlife Digital Infrared Ear Thermometer, Model IRIDNI (IR210) device is an electronic clinical thermometer using an infrared sensor to detect body temperature from the auditory canal in the neonatal, pediation used in the home setting.

The Microlife Digital Infrared Ear Thermometer, Model IR1DN1 (IR210) is an electronic thermometer using an infrared sensor (thermopile) 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.

The provided text describes the Microlife Digital Infrared Ear Thermometer, Model IR1DN1 (IR210), and its substantial equivalence to a predicate device. Here's a breakdown of the acceptance criteria and the study details:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: 114 subjects.
• Data Provenance: The study was a clinical investigation, implying prospective data collection specifically for this study. The location of the clinical study is not explicitly stated, but it's a "clinical investigation" and a "clinical study" was conducted.

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

The document does not specify the number or qualifications of experts used to establish ground truth. It states that "clinical data, represented by clinical bias, with uncertainty of bias, and clinical repeatability, met the acceptance criteria of the clinical study protocol," which implies a comparison against a reference standard or method for temperature measurement, likely managed by clinical professionals, but their specific roles, number, or qualifications are not detailed.

4. Adjudication Method for the Test Set

The document does not explicitly state an adjudication method (e.g., 2+1, 3+1). It describes the clinical study as a "randomization, simple blind homologous control, pairing design," but this refers to the study design rather than a reader adjudication process. For temperature measurement, ground truth is typically established by high-precision reference thermometers rather than expert consensus on interpretation.

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

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The device is a digital infrared ear thermometer, and its performance is evaluated directly against known temperature standards and clinical correlations, not through human reader interpretation.

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

Yes, the performance testing described in the various standards (e.g., ASTM E1965-98, ISO 80601-2-56) and the accuracy in blackbody mode inherently represent standalone performance. The device provides a direct temperature reading. The clinical study then validated this standalone reading in a real-world setting.

7. The Type of Ground Truth Used

The ground truth for the device's accuracy is established through objective measurement against:

• Blackbody mode accuracy: For measuring the device's inherent precision against a controlled and known temperature source.
• Clinical Study Protocol: Which would involve comparing the device's readings to established clinical reference temperature measurement methods. The document mentions "clinical bias, with uncertainty of bias, and clinical repeatability," which are standard metrics for comparing a device to a reference measurement in a clinical setting.

8. The Sample Size for the Training Set

The document does not mention a training set or machine learning models. This device is a traditional electronic thermometer that uses an infrared sensor and an algorithm to convert infrared energy into a temperature value. It doesn't appear to use learning-based AI or require a training set in the conventional sense.

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

As no training set is indicated, this question is not applicable.

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

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

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

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

1. Table of Acceptance Criteria and Reported Device Performance

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

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

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

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

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

4. Adjudication Method for the Test Set

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

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

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

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

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

7. The Type of Ground Truth Used

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

8. The Sample Size for the Training Set

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

Not applicable. This device is not an AI-assisted diagnostic tool.

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

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

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

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

8. The sample size for the training set

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

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

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

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The Microlife Digital Infrared Ear Thermometer, Model IR1DR1-1 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 Microlife Digital Infrared Ear Thermometer, Model IR1DR1-1 is an electronic thermometer using an infrared sensor (thermopile) 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.

Mode of operation:

The unit measures the infrared energy emitting from the middle ear and the surrounding tissue. This energy is absorbed by lenses and converted into temperature values.

The Microlife Digital Infrared Ear thermometer, Model IR1DR1-1, consists of the following parts: a) Thermopile Sensor b) Application-Specific Integrated Circuit d) Lens e) LCD and Backlight f) 2 Keys (Start key, O/I key) g) 1 battery 3.0V

Here's an analysis of the provided text regarding the Microlife Digital Infrared Ear Thermometer, Model IR1DR1-1, based on your requested criteria:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for the device's accuracy are based on the ASTM E1965-98 (2009) standard for infrared thermometers. The reported performance for accuracy matches these criteria.

Other acceptance criteria implicitly met by the "Passed all testing requirements" statements for the listed standards (e.g., electrical safety, EMC, biocompatibility) are:

• Electrical Safety: Complies with IEC 60601-1: 2005 and A1:2012, ANSI/AAMI ES60601-1:2005/(R2012) and A1:2012, C1:2009/(R)2012 and A2:2010/(R2012), IEC 60601-1-11:2010.
• Electromagnetic Compatibility (EMC): Complies with IEC 60601-1-2: 2014.
• Biocompatibility: Complies with ISO 14971: 2007 (risk management), AAMI/ANSI/ISO 10993-1: 2010, AAMI/ANSI/ISO 10993-5: 2010, AAMI/ANSI/ISO 10993-10: 2010, AAMI/ANSI/ISO 10993-12: 2012 (biocompatibility standards).
• Software Verification and Validation: Complies with FDA Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices dated May 11, 2005.

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

The document mentions "Controlled human clinical studies were conducted in accordance with ASTM E1965-98, IEC80601-2-56 Test Report." However, specific sample sizes (number of subjects/measurements) for the clinical test set are not provided in the document. The data provenance (e.g., country of origin, retrospective or prospective) is also not explicitly stated, though the nature of "Controlled human clinical studies" implies a prospective design.

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

This information is not provided in the document. For a clinical thermometer, the "ground truth" (reference temperature) is typically established by another calibrated reference thermometer, not by human experts adjudicating readings.

4. Adjudication Method for the Test Set

This information is not applicable in the context of a clinical thermometer's performance evaluation, as "adjudication" typically refers to the resolution of disagreements among expert reviewers for image-based diagnostics. The ground truth for temperature measurement is an objective reading from a reference device.

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

No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic devices where human readers interpret output (e.g., images), which is not the case for a digital ear thermometer. The comparison is against a reference temperature.

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

Yes, the device performance was evaluated in a standalone manner. The "Accuracy Tested (blackbody)" refers to testing the device in a controlled environment against known temperature sources without human interpretation influencing the measurement itself. The clinical studies also evaluate the device's ability to measure temperature in humans without human intervention in the device's measurement process, though a human operates the device.

7. The Type of Ground Truth Used

For the accuracy testing, the ground truth was established using blackbody radiators (controlled temperature sources) for in-vitro testing. For clinical studies, the ground truth would typically be established by simultaneously taking readings with a calibrated reference thermometer – most likely a traditional clinical thermometer known for high accuracy or another accepted medical standard. The document states "Clinical data was presented evaluating clinical uncertainty and clinical repeatability," which implies comparison against a reference.

8. The Sample Size for the Training Set

The document describes the device as a physical thermometer using an infrared sensor and an Application-Specific Integrated Circuit (ASIC). It does not mention any machine learning or AI algorithms that would require a "training set" in the conventional sense. The device's operation is based on physical principles of infrared measurement and conversion to temperature values. Therefore, a "training set" as understood in AI/ML is not applicable.

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

As explained in point 8, a "training set" is not applicable for this device.

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

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

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

1. Table of Acceptance Criteria and Reported Device Performance

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

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

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

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

The document does not provide information on the number of experts used or their qualifications for establishing ground truth in the clinical evaluation. For temperature measurement devices, the ground truth is typically assessed against a highly accurate reference thermometer (e.g., rectal thermometer in a controlled setting) rather than subjective expert opinion.

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

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

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was Done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

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

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

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

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

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

8. The Sample Size for the Training Set

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

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

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

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The E-Care Infrared Ear Thermometer, models: LCT-300 and LCT-600, is an electronic clinical thermometer using an infrared sensor to detect body temperature from auditory canal for people of all ages in the home.

The E-Care Infrared Ear Thermometer, models LCT-300 and LCT-600 is a hand-held, battery-powered electronic thermometer which uses an infrared sensor (thermopile) to detect body temperature from auditory canal. Its operation is based on measuring infrared radiation from the tympanic membrane and the surrounding tissue. The signal of sensor is calculated and display by an ASIC controlled circuit. This device consists of a thermopile for the measuring sensor, an ASIC controlled circuit for calculating the electrical signal and an LCD to display the measured temperature.

By inserting the probe of this infrared ear thermometer into the outer canal, press the measurement button to start measurement. The electronic circuits amplify and calculate the signal of sensor, then display the temperature on LCD display. The total operation takes a few seconds.

The provided document describes the 510(k) summary for the E-Care Infrared Ear Thermometer (models LCT-300 and LCT-600) and its substantial equivalence to a predicate device.

Here's an analysis of the acceptance criteria and study information, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

The document primarily focuses on demonstrating substantial equivalence to the predicate device Braun Thermoscan Infrared Ear Thermometer model: IRT3520 (K983295), rather than setting explicit new acceptance criteria that the device must meet independently. However, the comparison table implicitly uses the predicate device's performance as the benchmark for acceptance.

Note on Accuracy: The accuracy specification for the subject devices is more detailed than the predicate, showing a slightly looser tolerance in the extreme ranges (±0.3°C vs ±0.2°C for the predicate). However, it matches in the core temperature range. The submission argues this difference does not affect safety or effectiveness.

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

The document states: "A clinical test report was conducted accord ASTM E1965." However, it does not specify the sample size used for this clinical test.

Regarding data provenance: The document does not explicitly state the country of origin. The submitter is E-Care Technology Co.,Ltd. based in Taiwan. It's safe to assume the testing was conducted in a location accessible to them, but this is not explicitly stated. The study is described as a "clinical test report," which implies a prospective study design to gather data on the device's accuracy.

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

The document does not provide information on the number of experts used or their qualifications for establishing ground truth in the clinical test.

4. Adjudication Method for the Test Set:

The document does not specify any adjudication method used for the clinical test data.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:

No, an MRMC comparative effectiveness study was not done. The study described is a comparison of the subject device against a predicate device, focusing on accuracy, not the improvement of human readers with AI assistance. This device is a thermometer, not an AI-assisted diagnostic tool.

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

Yes, indirectly. The clinical test compares the E-Care Infrared Ear Thermometer (the "algorithm only," meaning the device's inherent measurement capability) against the predicate device. Since it's a standalone thermometer, its performance is its standalone performance without a human-in-the-loop directly interpreting the output beyond reading the temperature.

7. The Type of Ground Truth Used:

The ground truth used for these clinical tests would typically be a rectal thermometer or other highly accurate core body temperature measurement device as defined by the ASTM E1965 standard for infrared thermometers. The document does not explicitly state the specific ground truth method, but "clinical test report was conducted accord ASTM E1965" implies adherence to the methodology outlined in that standard for determining accuracy.

8. The Sample Size for the Training Set:

This information is not applicable and not provided. Infrared ear thermometers (like the E-Care devices) are not typically "trained" in the machine learning sense. Their accuracy is based on their physical design, infrared sensor, and calibration, not on a training data set for an algorithm.

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's operation. Calibration would be performed against known temperature standards.

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The Thermo Pal Infrared Ear Thermometer (Model no.: ETH-101) is an infrared thermometer intended for the intermittent measurement of human body temperature in people of all ages.

The Thermo Pal Infrared Ear Thermometer (Model no.: ETH-101) is hand-held, non-sterile, reusable, battery operated device that can measure human body temperature via the human ear. Operation is based on the measuring of the natural thermal infrared radiation emitted from the ear tympanic.

1. Table of Acceptance Criteria and Reported Device Performance:

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

The document mentions "A Clinical Test Report conducted according to ASTM E1965: 2003" but does not specify the sample size used for the test set.

The data provenance is described as "conducted by manufacturer," suggesting it was conducted by Digio2 International Co., LTD. The country of origin of the data is not explicitly stated, but the manufacturer is based in Taipei Hsien, Taiwan. The study appears to be prospective as it was "carried out in such a way that compared the accuracy performance between Thermo Pal Infrared Ear Thermometer (Model no.: ETH-101) and the predicate device."

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

The document does not provide information on the number of experts used or their qualifications for establishing the ground truth in the clinical test.

4. Adjudication method for the test set:

The document does not specify any adjudication method used for the test set.

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. The device described is an infrared ear thermometer, which is a standalone measurement device and does not involve human readers or AI assistance in the context of diagnostic interpretation.

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

Yes, a standalone performance test was done, as the device is an infrared ear thermometer. The "Clinical Test Report" assessed the device's accuracy against a predicate device without human-in-the-loop performance.

7. The type of ground truth used:

The type of ground truth used for checking the accuracy of the Thermo Pal Infrared Ear Thermometer was comparison with a predicate device (BRAUN THERMOSCAN IRT 4000 series). Specifically, the report "compared the accuracy performance between Thermo Pal Infrared Ear Thermometer (Model no.: ETH-101) and the predicate device according to the method recommended in ASTM E1965 standard." This implies that the predicate device's readings served as the reference or "ground truth" for comparison.

8. The sample size for the training set:

The document does not mention a training set as this device is a hardware measurement instrument and not an AI/machine learning algorithm that requires training data.

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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