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For T30: The Infrared Thermometer is a non-sterile, reusable, handheld device. It is intended for measuring human body temperature for people of all ages by detecting infrared heat from the forehead and auditory canal. When measuring forehead temperature, it is non-contact and the distance of measurement is 1-3cm. The device can be used by consumers in homecare environment.

For TE-82: The Infrared Thermometer is a non-sterile, reusable, handheld device. It is intended for measuring human body temperature for people of all ages by detecting infrared heat from the auditory canal. The device can be used by consumers in homecare environment.

For TE-102 and TE-79: The Infrared Thermometer is a non-sterile, reusable, handheld device. It is intended for measuring human body temperature for people of all ages by detecting infrared heat from the forehead. When measuring forehead temperature, it is non-contact and the distance of measurement is 3-5cm. The device can be used by consumers in homecare environment.

The Infrared Thermometer is a non-sterile, reusable device. Infrared thermometer are handheld, battery-powered devices designed to measure body temperature by receiving infrared energy radiation from the ears or forehead. When measuring forehead temperature, it is non-contact. The device can be used by consumers in homecare environment. There are four models. T30, which can measure body temperature by receiving infrared energy from the forehead or ear canal. TE-82 measure body temperature by receiving infrared radiation from the ears; TE-79 and TE-102 can measure body temperature by receiving infrared energy radiation from the forehead.

The thermometer has the result of measurement through the forehead temperature mode or ear temperature mode directly displayed on the LED or LCD display.

The results of measurements can also be transferred to the APP via Bluetooth for recording and display

The provided FDA 510(k) clearance letter and summary for K243082 details the acceptance criteria and the study that proves the device meets these criteria.

Here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

The primary acceptance criteria for the Infrared Thermometer are derived from the performance standard ISO 80601-2-56 for clinical thermometers.

Note: The 510(k) summary only generally states compliance with ISO 80601-2-56 for clinical performance. It does not explicitly list the detailed accuracy limits from the standard (e.g., ±0.2°C within a certain range) and then report the device's measured accuracy against those specific limits in a direct table format within the provided text, but rather confirms overall compliance. The "Measuring accuracy" in the comparison table is for the device's technical specification, not necessarily a direct clinical accuracy result from the ISO 80601-2-56 study itself.

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

• Sample Size for Test Set: A minimum of 150 subjects.
• Data Provenance: The document does not explicitly state the country of origin. It also doesn't specify if the data was retrospective or prospective, though clinical performance testing as described ("The testing is conducted pre ISO 80601-2-56") usually implies prospective data collection for the purpose of demonstrating performance.

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

This information is not provided in the document. For a thermometer, ground truth is typically established by comparative measurements against a highly accurate reference thermometer, rather than expert consensus on subjective interpretations.

4. Adjudication Method

This information is not applicable/provided as the ground truth for thermometer accuracy is established by a reference device, not by expert interpretation requiring adjudication.

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

An MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic devices where human readers interpret and classify images or data, often with and without AI assistance to measure the AI's impact on human performance. For a thermometer, the output is a direct numerical measurement, so this type of study is not applicable.

6. Standalone Performance Study

Yes, a standalone performance study was done. The document states:
"The testing is conducted pre ISO 80601-2-56 Particular requirements for basic safety and essential performance of clinical thermometers for body temperature measurement. This performance test consists of a minimum of 150 subjects... The test result demonstrated the clinical performance of the subject device complied with the requirement of standard ISO 80601-2-56."

This clinical performance test on subjects directly evaluates the Infrared Thermometer (algorithm/device only) against a reference, thus constituting a standalone performance study.

7. Type of Ground Truth Used

The type of ground truth used is comparative measurement against a reference standard. While not explicitly stated, the ISO 80601-2-56 standard for clinical thermometers mandates comparison of the device's temperature readings against a highly accurate reference thermometer simultaneously or sequentially on human subjects.

8. Sample Size for the Training Set

The document does not provide information on a training set sample size. This device is an infrared thermometer, which typically relies on established physical principles (infrared radiation detection) and calibration rather than a machine learning model that requires a "training set" in the conventional sense of AI. Calibration and functional testing are usually performed at the manufacturing stage.

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

As noted above, a separate "training set" and associated ground truth establishment (in the AI/machine learning sense) are not applicable to this type of device according to the provided documentation. The device's accuracy is established through calibration and verified through clinical testing against a reference standard.

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Infrared Thermometer is a non-sterile, reusable, non-contact and handheld device. It can be used by consumers in homecare environment and doctors in clinic as reference. It is intended for measuring human body temperature of people over one month old by detecting infrared heat from the forehead.

The Non-contact Forehead Infrared Thermometer (Model FC-IR2000, FC-IR205, FC-IR202, FC-IR206, FC-IR207, FC-IR209) measures the body temperature based on the infrared energy emitted from the forehead. Users can get measurement results after properly scanning the forehead. The thermometer of a shell, an LCD, a measure button, a beeper, an infrared temperature sensor, and a Microprocessor.

The device is widely used for home healthcare, medical institutes and many other occasions.

The provided text describes the regulatory clearance of a Non-contact Forehead Infrared Thermometer (FC-IR2000, FC-IR205, FC-IR202, FC-IR206, FC-IR207, FC-IR209) and details the testing done to prove its substantial equivalence to a predicate device. This is not an AI/ML device, and thus, many of the requested elements for AI/ML device studies (e.g., number of experts for ground truth, adjudication methods, MRMC studies, training set details) are not applicable or not found in the provided document.

However, I can extract information related to the acceptance criteria and the study that proves the device meets (or is equivalent to) those criteria for a traditional medical device, specifically a thermometer.

Here's a breakdown of the requested information, adapted to the context of a thermometer and the provided document:

Acceptance Criteria and Device Performance for Non-contact Forehead Infrared Thermometer

1. Table of Acceptance Criteria and Reported Device Performance

For medical thermometers, the primary acceptance criteria revolve around measurement accuracy and clinical performance. The document refers to compliance with specific international standards.

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

• Sample Size: A minimum of 143 subjects were used for the clinical study. These subjects were divided into three age groups:
  • Group A1: 0 up to 3 months (Infant group)
  • Group A2: 3 months up to 1 year (Infant group)
  • Group C: Older than 1 to 5 years old (Child group)
  • Group B and C: Above 5 years old (Adult group) - Note: The document lists B Child group (Older than 1 to 5 years old) and C group older than 5 years old. This seems to be a minor typo in the extract formatting, grouping A and B as infant and child, and then C as older. The key is that multiple age groups were tested.
• Data Provenance: The document does not explicitly state the country of origin of the clinical data. It states the study was a "randomization, simple blind homologous control, pairing design of clinical investigation." It is a prospective clinical study as it involved conducting tests with human subjects.

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

This information is not applicable and not provided in the context of a non-contact infrared thermometer's clinical accuracy study. For such a device, a "ground truth" is typically established by comparative measurements against a highly accurate reference thermometer (e.g., a rectal thermometer) as per the ASTM E1965 standard, rather than expert consensus on images or interpretations. The expertise required would be in the conduct of the clinical study itself, ensuring proper procedure and data collection.

4. Adjudication Method for the Test Set

This information is not applicable and not provided. Adjudication methods (e.g., 2+1, 3+1) are typically used in studies involving subjective assessment by multiple readers, common in diagnostic imaging. For a thermometer, the "ground truth" is a measured temperature value, not a subjective interpretation requiring adjudication among experts. The study design mentions "simple blind homologous control, pairing design."

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 a Non-contact Forehead Infrared Thermometer, not an AI/ML-powered diagnostic imaging device involving human readers or AI assistance in interpretation.

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 AI algorithm. The device itself is the "standalone" product, measuring temperature. Its performance is evaluated directly through non-clinical and clinical testing, not as an algorithm interpreting data for a human.

7. The Type of Ground Truth Used

The ground truth for the clinical study was established by comparative temperature measurements against a reference method (likely rectal or oral temperature, as per ASTM E1965-98 standards for clinical thermometers). The study assessed the device's accuracy in relation to these established body temperature measurements. It is explicitly stated that the study followed ASTM E1965-98, which is a standard for clinical accuracy of infrared thermometers.

8. The Sample Size for the Training Set

This information is not applicable and not provided. The document describes a traditional medical device, not an AI/ML device that requires a "training set" in the machine learning sense. The device is hardware-based, relying on infrared physics, not trained on a dataset of images or other input data.

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

This information is not applicable. As stated above, this is not an AI/ML device with a "training set."

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Infrared Thermometer is intended for the intermittent measurement of body temperature from the forehead on people of all ages. It can be used by consumers in the household environment and by health care providers.

Infrared Thermometer is mainly composed of infrared probe components, main circuit board components, LCD display components and housing components. The Infrared Thermometer is intended for the intermittent measurement of body temperature from the forehead on people of all ages. Infants and children cannot operate the thermometer; it is recommended that adults take the measurement. The Infrared Thermometer can be used by consumers in the household environment and by healthcare providers. The operator should be an adult with relevant experience. The operator can replace the battery, transmit data, and measure temperature.

Here's an analysis of the acceptance criteria and study details for the Infrared Thermometer Model YJ600, based on the provided FDA 510(k) summary:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for the Infrared Thermometer Model YJ600 are primarily defined by the standards ISO 80601-2-56 and ASTM E1965-98. The 510(k) summary directly states that the device "meets the requirement of the standard" for these and other tests. The most critical performance criterion for a thermometer is its accuracy.

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The Infrared thermometer is intended to measure human body temperature of people over three months old from the eardrum or forehead. It is indicated to be used in homecare and healthcare environments.

The Infrared thermometer is a handheld device, which can measure human body's temperature either via the eardrum or the forehead for clinical or home use. The results can be displayed on LCD and can also be transmitted to a non-device APP to record and display through Bluetooth.
There are two models AOJ-20A and AOJ-20Y. Both models share the same construction except differences on product enclosure,PCB layout and button designs.

The provided text describes a 510(k) premarket notification for an Infrared Thermometer (AOJ-20A; AOJ-20Y). It details the device, its intended use, and the non-clinical testing performed to establish substantial equivalence to predicate devices.

However, the document does not contain the level of detail typically found in a clinical study report or a more comprehensive validation plan. Specifically, it lacks:

• Explicit acceptance criteria in a tabular format with corresponding performance results.
• Specific sample sizes for test sets beyond general statements of testing being conducted.
• Data provenance (country, retrospective/prospective) for clinical data.
• Number and qualifications of experts for ground truth.
• Adjudication methods.
• Information on Multi-Reader Multi-Case (MRMC) comparative effectiveness studies.
• Standalone algorithm performance details.
• Specific details on the type of ground truth (e.g., pathology, outcomes data) beyond "performance effectiveness."
• Training set sample size and ground truth establishment for training.

The document primarily focuses on non-clinical performance data to support the substantial equivalence claim, rather than a clinical study demonstrating acceptance criteria met in a real-world setting with human subjects. The tests mentioned are:

• Biocompatibility testing: Cytotoxicity, Skin Sensitization, Skin Irritation per ISO 10993-1.
• Electrical safety and electromagnetic compatibility (EMC): Compliance with IEC 60601-1, IEC 60601-1-11, and IEC 60601-1-2.
• Bench Testing: Compliance with ISO 80601-2-56 for performance effectiveness.
• Software Verification and Validation Testing: Conducted as per FDA's "Content of Premarket Submissions for Device Software" guidance, with the device considered "Basic" documentation level.

Given these limitations in the provided text, I can only extract the general types of tests and the standards they comply with, rather than specific acceptance criteria values and the device's measured performance against them. The information on "study that proves the device meets the acceptance criteria" is limited to the types of non-clinical tests conducted.

Therefore, direct answers to many of your questions cannot be provided from the given document as it does not contain clinical study data or a detailed validation report with specific performance metrics against acceptance thresholds.

Based on the provided text, here is what can be inferred and what is explicitly stated:

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

The document references compliance with ISO 80601-2-56 for "performance effectiveness" in bench testing. This standard likely specifies accuracy and precision requirements for clinical thermometers. However, the specific numerical acceptance criteria (e.g., ±0.2°C) and the actual measured performance values of the device against these criteria are not provided in this summary.

Inferred/General:

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 for test set: Not specified. The document states "Bench testing was conducted on the thermometer device, consisting of all the system." This suggests testing of the physical devices, but no numerical sample count (e.g., number of thermometers tested, number of measurements taken) is given.
• Data provenance: Not specified. The tests are non-clinical bench and lab tests, not clinical human subject data.

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

• Not applicable as the testing described is non-clinical/bench testing, not involving human expert interpretation for ground truth.

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

• Not applicable.

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 medical device (thermometer), not an AI imaging or diagnostic algorithm used by human readers.

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

• The document describes the performance of the device itself (sensor, electronics, software) in a standalone manner via bench testing, but not an "algorithm only" in the sense of a standalone AI model. The device's function is temperature measurement.

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

• For "performance effectiveness," the ground truth (or reference standard) would typically be calibrated reference thermometers or temperature sources compliant with the ISO standard used for test and measurement, not clinical outcomes or expert consensus.
• For biocompatibility, the ground truth is the chemical and biological assays.
• For electrical safety and EMC, the ground truth is the measurement against standard limits using appropriate test equipment.

8. The sample size for the training set

• Not applicable, as this is a traditional medical device (thermometer), not an AI/machine learning model requiring a training set for its core function. The "software verification and validation testing" refers to standard software engineering practices, not machine learning model training.

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

• Not applicable for the same reasons as point 8.

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The Infrared Thermometer (Model: IR8807) is intended for the intermittent measurement of human body temperature from the forehead. It is a non-contact clinical thermometer and intended for use on people of all ages except for neonates/newborns.

The Infrared Thermometer (Model: IR8807) is an electronic thermometer using an infrared sensor to measure infrared energy radiated from the forehead. This energy is collected through the lens and converted to a temperature value. The Infrared Thermometer (Model: IR8807) has a forehead measurement mode and an object measurement mode.

The Infrared Thermometer (Model: IR8807), consists of the following parts:
a) Thermopile Sensor
b) Application-Specific Integrated Circuitry
c) Erasable Programmable Read-Only Memory Integrated Circuit
d) Capacitance-touch Integrated Circuit
e) LCD display
f) 2 buttons (Scan button, Setting button,)
q) 2×1.5V AAA dry batteries

The operation principle is based on infrared sensor technology. The sensor in the thermometer detects the infrared energy, and the device processes the data to body temperature result with its internal microcontroller unit. It operates in an adjusted mode.

The main functions of Infrared Thermometer (Model: IR8807) are as followings:
Forehead temperature measure functions
Wide range of temperature readings: from 32.0ºCto 42.9ºC (89.6ºF ~ 109.2ºF)
The measurement results can be displayed in either °Cor °F units
The LCD display showing clear measurement result.
Memory data reading/removal function: The device can store a total of 32 groups of memorable values. All memory values can be removed after the battery is removed
Low battery indicator
Buzzer reminder function
Users can set temperature alarm value
Environment or object temperature measurement function
The reference body site of the output temperature is Oral.

The provided document describes the Infrared Thermometer, Model: IR8807, and its compliance with relevant standards and performance criteria. Here's a breakdown of the requested information based on the text:

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

Note: The document states that the device's accuracy requirements meet ASTM E1965-98. The specific ASTM E1965-98 requirements for measurement range, accuracy, measurement time, and measurement distance are not explicitly detailed in the provided text beyond what's shown for the device's performance. The table above uses the device's reported performance as the "reported device performance" and implies these meet the ASTM E 1965-98 criteria because the document explicitly states compliance.

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 for clinical test set: 169 subjects.
• Data Provenance: The document does not specify the country of origin. The test was a "clinical test" which implies a prospective study.

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 document. The document only mentions "clinical tests were conducted" and that the "clinical performance of the subject device complied with the requirement of ASTM E1965-98 (2016)." It does not describe the method or personnel used to establish the ground truth (reference temperature).

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

This information is not provided in the document.

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 is an Infrared Thermometer. The document describes clinical tests for device accuracy, not a comparative effectiveness study involving human readers or AI assistance. Therefore, no MRMC comparative effectiveness study was done in the context of human readers improving with or without AI.

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

Yes, a standalone performance study was done for the device. The "clinical tests" described in section 8 were conducted on the Infrared Thermometer (Model: IR8807) itself, evaluating its direct measurement performance against a ground truth (implied by compliance with ASTM E1965-98 for clinical accuracy). This assesses the algorithm/device's performance without human interpretation or intervention in the measurement process beyond standard use.

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

The document does not explicitly state the type of ground truth used. However, given that it's a clinical thermometer study and states compliance with ASTM E1965-98, the ground truth would most likely be a reference clinical thermometer (e.g., a highly accurate rectal, oral, or tympanic thermometer, depending on the standard's protocol for correlating to forehead temperature) used simultaneously or sequentially with the test device.

8. The sample size for the training set

This device is a physical thermometer, not an AI/ML model that typically requires a "training set." The concept of a training set is not applicable to this device.

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

As the concept of a training set is not applicable to this device, this question is not relevant.

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The Infrared Thermometer (model of AET-R612W.AET-R612G.AET-R612A.AET-R612B.AET-R612C) is intended for measuring human body temperature of people aged 3 months and above by detecting infrared heat from ear canal or non-contact (about 1.5-5.0cm distances) with the forehead in the home or hospital environment.

Not Found

The provided document is an FDA 510(k) clearance letter for an infrared thermometer. It outlines the regulatory approval for marketing the device. However, it does not contain the detailed technical study information typically found in a clinical study report or a 510(k) summary submission that would include acceptance criteria and a description of the study proving the device meets those criteria.

Therefore,Based on the provided text, I cannot provide the information requested regarding:

1. A table of acceptance criteria and the reported device performance: This document only states the device is "substantially equivalent" to predicate devices, but does not present specific performance metrics or acceptance criteria.
2. Sample size used for the test set and the data provenance: Not mentioned.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not mentioned.
4. Adjudication method for the test set: Not mentioned.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and its effect size: Not mentioned, and generally not applicable for a thermometer.
6. If a standalone performance was done: Not explicitly detailed, but implied by the device's function. No specific performance data is provided.
7. The type of ground truth used: Not mentioned.
8. The sample size for the training set: Not applicable as this is a physical device, not an AI/ML algorithm requiring a training set in the conventional sense.
9. How the ground truth for the training set was established: Not applicable.

The document is a regulatory communication, not a technical report detailing the performance validation study. For such information, one would typically look for a 510(k) Summary, which is often available through the FDA's public database after a device is cleared, or a detailed technical file submitted to the FDA by the manufacturer.

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The TRULYL Infrared thermometer TET-351 is intended for the intermittent measurement of human body temperature from the auditory canal and from the forehead for people of all ages used in the home setting. The non-contact thermometer detects infrared heat from the forehead at distance of about 1-2cm.

The TRULYL Infrared thermometer TET-351 is a hand-held, battery powered device designed to measure the body temperature through receiving infrared energy radiation via the ear canal or forehead. The thermometer has the capability to measure temperature via forehead temperature mode or ear temperature mode, and the temperature is directly shown on the LCD display. The results measured by TET-351 can also be transmitted to APP to record and display through Bluetooth.

This is an infrared thermometer (TET-351) that measures human body temperature from the auditory canal and forehead. The device is intended for home use for people of all ages.

Here's an analysis of the provided information regarding acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are primarily derived from the standard ASTM E1965-98 (Reapproved 2016) Standard Specification for Infrared Thermometers for Intermittent Determination of Patient Temperature. While the document states that the clinical study demonstrated compliance, it does not explicitly list the specific numerical acceptance criteria (e.g., accuracy limits) from ASTM E1965-98 within the provided text, nor does it provide detailed numerical results for the device's performance against those criteria beyond a general statement of compliance.

However, the comparison table with the predicate device does offer some insight into the accuracy specification, which would likely be the basis of the acceptance criteria:

Note: The "Different" note here implies that while the general accuracy ranges are similar, there might be slight variations in the specified temperature ranges where the higher accuracy applies. The report states that the clinical study demonstrated compliance with ASTM E1965-98 (Reapproved 2016), which would inherently define the specific acceptance criteria for accuracy.

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

• Sample Size for Test Set: A minimum of 150 subjects.
  • 1/3 children
  • 1/3 adults
  • The remaining 1/3 (implicitly infants) are not explicitly stated but are covered by the age categories: "Infants---newborn to one year; Children--- greater than one to five years; Adults--- greater than five years old."
• Data Provenance: The document does not explicitly state the country of origin of the data. It refers to "This clinical study" without specifying the location.
• Retrospective or Prospective: Not explicitly stated, but the description "This clinical study is a randomization, simple blind homologous control, pairing design of clinical investigation" strongly suggests a prospective study.

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

This information is not provided in the document. The study involves measuring patient temperature, which typically involves comparing the device's readings against a highly accurate reference thermometer (e.g., rectal or oral core temperature measurement, depending on the standard). The role of "experts" as ground truth adjudicators in the sense of image interpretation is not directly applicable here.

4. Adjudication Method for the Test Set

This information is not explicitly provided in the context of "adjudication" as it might apply to subjective assessments. For temperature measurement studies, the ground truth is typically established by measurements from a validated reference device, not by expert consensus or adjudication. The study design is described as "randomization, simple blind homologous control, pairing design," but this refers to the overall study methodology rather than a specific ground truth adjudication process.

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

A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not conducted in the traditional sense of evaluating human readers with and without AI assistance, as this device is a standalone thermometer, not an AI-powered diagnostic imaging tool.

6. Standalone (Algorithm Only) Performance

A standalone performance study was done. The entire clinical study for the Infrared Thermometer TET-351 is a standalone performance evaluation, as it assesses the accuracy of the device itself (algorithm + hardware) against a reference standard in patients.

7. Type of Ground Truth Used

The ground truth implicitly used for clinical accuracy assessment for thermometers is a reference temperature measurement obtained from a highly accurate clinical reference device (e.g., glass thermometer, electronic thermometer, or other gold-standard method for core body temperature measurement). The standard ASTM E1965-98 outlines how these reference measurements should be obtained. The document does not explicitly state the specific reference method used, but it's central to the standard's methodology.

8. Sample Size for the Training Set

This information is not provided. As this is a medical device and not an AI/ML imaging algorithm that requires a separate training set, the concept of a "training set" in this context is not directly applicable for the device's primary function of temperature measurement. Any internal calibration or algorithm development would have been done prior to the clinical validation.

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

Given that this is an infrared thermometer and not an AI/ML imaging algorithm, a separate "training set" with established ground truth in the AI sense is not applicable. The device's underlying physics and calibration would be based on established temperature measurement principles.

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The Medical Infrared Thermometer is a non-sterile. reusable clinical thermometer intended for the intermittent determination of human body temperature in no touch mode on the center of the forehead as the measurement site on people of one month and above.

The Medical Infrared Thermometer is a non-contact, hand-held, battery powered device designed to measure human body temperature, which has the feature of simple and easy use, rapid measurement and accurate temperature feedback. The Medical Infrared Thermometer is an infrared thermometer to measure human body temperature using the infrared energy emitted in the area around the subject's forehead. The reference body site of the temperature measurement is axillary. The temperature measurement distance is 1-5 cm. The product is composed of enclosure, control panel, LCD screen, infrared sensor, PCB board, battery pack and USB charging inlet. The thermometer has three functions of digital LCD display, buzzer indication for measurement results and three color back light indication for temperature (32.0℃ to 37.3℃ with green back light; 37.4℃ to 38.0℃ with yellow back light; 38.1℃ to 43.0℃ with red back light). The device is powered by Li-ion Battery (3.7VDC; 30mAh), which can be recharged through a computer with USB port or by switching power supply (100-240V, 50/60Hz) connected with a USB charging cable. The switching power supply is not provided with the subject device and the USB charging cable will be provided with the subject device as an accessory. There are two models RST-TC59-1001 and RST-TC60-1001 included in this document. Both models share the same construction except differences on product structure including appearance of enclosure, PCB design, sensor, MCU and working condition (ambient temperature). There are three buttons on control panel of both models, the first button is for power on/off and temperature measurement function, the second button is for temperature unit shift (°C and °F) function, the third button is for memory function.

Here's a breakdown of the acceptance criteria and the study proving the device meets them, based on the provided FDA 510(k) summary:

Acceptance Criteria and Device Performance

Device Name: Medical Infrared Thermometer (Model: RST-TC59-1001, RST-TC60-1001)

Study Details for Clinical Accuracy Validation Test:

The provided document describes a clinical accuracy validation test for the device.

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

   • Sample Size: A total of 165 subjects were selected for temperature measurement.
   • Data Provenance: The study was conducted in a clinical setting, but no specific country of origin is mentioned. It is described as a "clinical trial." The nature of the study (retrospective or prospective) is not explicitly stated, but the description "clinical accuracy validation is designed and performed" and "total of 165 subjects are selected to temperature measurement" strongly suggests a prospective study.

2. 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):

   • The document does not specify the number of experts or their qualifications for establishing ground truth.
   • Instead, the ground truth was established by a reference clinical thermometer (RCT), specifically a "mercury axillary thermometer (Geratherm Medical AG)." The accuracy of this reference thermometer itself is assumed to be the "ground truth."

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

   • The document does not mention an adjudication method. The ground truth was established by a reference device, not by multiple human readers needing adjudication.

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, an MRMC study was not done. This device is an infrared thermometer, which provides a direct temperature reading, not an AI-assisted diagnostic tool that would typically involve human readers interpreting outputs.

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

   • Yes, the clinical accuracy validation test described is effectively a standalone performance test of the thermometer. It compares the device's readings directly against a reference clinical thermometer. The device itself is an "algorithm only" in the sense that it processes infrared data to produce a temperature reading, without a human intermediary interpreting its output for diagnosis purposes.

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

   • The ground truth was established by comparison to a reference clinical thermometer (mercury axillary thermometer), which is a widely accepted standard for body temperature measurement.

7. The sample size for the training set:

   • The document does not provide information about a training set. This is a medical device that measures a physical parameter (temperature) using established principles of infrared thermometry, rather than an AI/Machine Learning model that typically requires a large training dataset. The "algorithm" mentioned refers to the internal calculations for converting infrared energy to a temperature reading, which is based on physics, not statistical learning from a training set in the modern AI sense.

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

   • As no training set is described in the context of typical AI/ML, this question is not applicable.

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The Infrared thermometer is intended to measure human body temperature of people over three months old from the eardrum or forehead. It is indicated to be used in homecare and healthcare environments.

The AOJ-20 series Infrared thermometer is a handheld device, which can measure human body's temperature either via the eardrum or the forehead, for clinical or home use. The results can be displayed on LCD. The device operates in adjusted mode, and the reference body site of output temperature is oral. The measurement distance for forehead mode is 0 cm ~ 3 cm. The thermometers are powered by AAA 1.5V×2 alkaline batteries. A thermopile sensor is employed to detect or monitor the infrared thermal energy emitted from the eardrum or the surface of the skin of forehead, which is converted to the equivalent oral temperature with the unit of °C or ºF. All the models share the similar design and the same critical components. The major differences include: - Mechanical changes and the corresponding hardware adjustment happened to AOJ-20A, AOJ-20B, AOJ-20C, AOJ-20D, AOJ-20E, AOJ-20F, AOJ-20H, AOJ-20M, AOJ-20T, AOJ-20R and AOJ-20Y - In the measurement function, two measurement modes are distinguished between children and adults for AOJ-20B and AOJ-20E.

The provided text describes the regulatory clearance of an Infrared Thermometer (AOJ-20 series) and includes detailed performance testing against acceptance criteria. Here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

The device is an Infrared Thermometer, and its primary performance criterion is accuracy. The relevant standard for accuracy is ISO 80601-2-56.

The text explicitly states: "The system complies with the ISO 80601-2-56 Medical electrical equipment — Part 2-56: Particular requirements for basic safety and essential performance of clinical thermometers for body temperature measurement for performance effectiveness." and "Clinical accuracy validation was carried out on people over three month indicated in the instructions for use. The number of subjects in each age group met the minimum number requirements."

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

The "test set" in this context refers to the clinical study subjects for accuracy validation.

• Sample Size: The sample sizes vary per model, but generally around 135-138 subjects per model. The specific breakdown is provided in the table:
  • AOJ-20A: 138 subjects
  • AOJ-20B: 136 subjects
  • AOJ-20C: 137 subjects
  • AOJ-20D: 138 subjects
  • AOJ-20E: 137 subjects
  • AOJ-20F: 137 subjects
  • AOJ-20H: 135 subjects
  • AOJ-20M: 137 subjects
  • AOJ-20T: 137 subjects
  • AOJ-20R: 137 subjects
  • AOJ-20Y: 137 subjects
• Data Provenance: The document does not specify the country of origin for the clinical data. It also does not explicitly state whether the study was retrospective or prospective, but clinical accuracy validation per ISO standards is typically done in a prospective manner.

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 given document. For clinical thermometers, ground truth for body temperature is typically established using a highly accurate reference thermometer (e.g., rectal or oral thermometer depending on the standard's requirements for reference body site), not necessarily by human experts.

4. Adjudication Method for the Test Set

This information is not provided in the given document. Adjudication methods like 2+1 or 3+1 are more common in studies involving subjective assessments (e.g., image interpretation by radiologists), which is not directly applicable to a thermometer's clinical accuracy validation where objective measurements against a reference are typically performed.

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 explicitly mentioned or performed. This type of study is more relevant for diagnostic aids where human interpretation is involved. The document describes clinical accuracy validation of the device itself.

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

The device is an Infrared Thermometer, which is a standalone measurement device. Its performance is inherently standalone. There is no "algorithm only" component separate from human interaction, as a human user operates the device to take a temperature reading. The clinical and bench testing described assess this standalone performance.

7. The Type of Ground Truth Used

The ground truth used for clinical accuracy validation of a thermometer is typically based on a reference body temperature measurement obtained by a highly accurate, calibrated reference thermometer (e.g., a specific type of oral or rectal thermometer). The document states the device "operates in adjusted mode, and the reference body site of output temperature is oral," implying oral temperature is the reference for adjusted readings. The study was conducted "per Section 201.102 of ISO 80601-2-56," which would define the exact method for establishing ground truth.

8. The Sample Size for the Training Set

This information is not applicable and therefore not provided. Infrared thermometers are hardware devices with embedded algorithms, but they are not typically "trained" on large datasets of temperature readings in the way AI/ML models are. The device relies on physical principles of infrared detection and calibrated conversion algorithms, not a training set in the AI sense.

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

This information is not applicable as there is no mention of a "training set" in the context of this infrared thermometer. The device's internal algorithms and calibrations are developed and verified through engineering principles and bench testing, not machine learning training on a ground truth dataset.

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The Infrared Thermometer (Model: Y2001, Y20002) is intended for the intermittent measurement and monitoring of human body temperature from forehead. The device is indicated for use for people of two months and above at homecare and in hospital.

Infrared thermometer (Model: Y20001 , Y20002) are a hand-held, battery powered, infrared Thermometer that coverts a user's forehead temperature, using the infrared energy emitted in the area around the user's forehead when measure from 1-3cm of the subject's forehead with no contact. The temperature will displayed on the screen, and the reference body site is axilla. Infrared thermometer (Model: Y20001, Y20002) use a thermopile sensor with integrated thermistor for the target reading and a thermistor mounted in the thermometer for ambient temperature readings. The device consists of measuring sensor, PCB, buttons, a LCD and an enclosure.

The difference between two models are size, weight and button settings. Y20001 has four buttons(Test button, °C/°F button, "B/S"button, "M" key) and Y20002 has two buttons(Function button, Measurement button). The functions of the two models are same. Infrared thermometer (Model: Y20001,Y20002) have the following features:

1. The device is intended to be reusable for home use and clinical use.
2. Switching of temperature unit between °C and °F.
3. The latest 32 sets of memory for measuring human body and object; the user can view or delete the previous measurement results.
4. Buzzer on or off to set the prompt tone on or off.
5. Prompt tone function.
6. Low battery indication, and auto power-off

Here's a breakdown of the acceptance criteria and study details for the Infrared Thermometer (Models: Y20001, Y20002), based on the provided FDA 510(k) summary:

1. Table of Acceptance Criteria and Reported Device Performance

The core performance acceptance criteria for this medical device revolve around its accuracy in measuring body temperature. These are primarily derived from recognized international and national standards.

Note on Accuracy: While the table states "± 0.3°C / 0.5°F", the comparison table (Note 4) mentions the subject device's accuracy being wider than the predicate within the range of 36.0°C - 39.0°C. However, the overall claim is that it still meets the performance standards based on the test reports. This implies that the ±0.3°C/0.5°F stated is the overarching acceptable tolerance.

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

• Sample Size: Each clinical study evaluated 150 subjects.
• Data Provenance: Not explicitly stated regarding the country of origin of the data. The studies were designed to evaluate subjects across specific age groups and a portion of fever patients, suggesting it was a prospective study conducted for regulatory submission.

The subjects were divided into three age groups with 50 subjects in each group:
* Infants: two months to one year
* Children: greater than one to five years
* Adults: greater than five years old

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

The document does not explicitly state the number of experts or their specific qualifications (e.g., "radiologist with 10 years of experience") used to establish the ground truth for the clinical accuracy test. However, for clinical thermometers, the "ground truth" (reference temperature) is typically obtained using a highly accurate, calibrated reference thermometer according to the specified standard (ISO 80601-2-56). The measurement itself, and hence the ground truth, relies on the precision of the reference device and adherence to standardized measurement protocols, rather than expert interpretation of an image or similar data.

4. Adjudication Method for the Test Set

Not applicable/Not mentioned. For a clinical thermometer's accuracy assessment, adjudication methods like 2+1 or 3+1 are typically used for subjective evaluations (e.g., image interpretation). Here, the comparison is quantitative: the device's reading versus a reference standard's reading.

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 more relevant for diagnostic imaging where human readers interpret results, and the AI's impact on their performance is being evaluated. For a thermometer, the performance is measured purely on its accuracy against a known standard.

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

Yes, the primary clinical accuracy testing described is a standalone performance test of the device. The "clinical accuracy testing" evaluates the device's ability to measure human body temperature accurately as per ISO 80601-2-56 requirements, without human intervention affecting the measurement result itself. It compares the thermometer's reading directly to a reference method, acting as an algorithm-only performance assessment in the context of a medical device that outputs a direct measurement.

7. The Type of Ground Truth Used

The ground truth for the clinical accuracy test was established by comparing the infrared thermometer's readings to reference temperature measurements obtained according to the requirements of ISO 80601-2-56:2017. This typically involves a highly accurate, calibrated reference thermometer measuring core body temperature from a different site or a more invasive method, or using a specified (e.g., oral or rectal) reference thermometer, against which the non-contact device is compared. This is a type of objective measurement standard ground truth.

8. The Sample Size for the Training Set

The document does not provide any information about a training set. This device is a measurement tool, not an AI/ML algorithm that requires a separate training data set for model development. The performance is based on the physical design, sensors, and firmware logic, which are validated through bench and clinical testing.

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

Not applicable, as no training set is mentioned or implied for this type of device. The device's operational parameters and calibration would be established through engineering design and bench testing, not through supervised learning with a specific "training set" in the AI/ML sense.

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