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The Ear Thermometer is intended to measure human body temperature of people over three months from surface of eardrum. It applies to both professional use and home use.

The ear thermometer is a handheld device that displays the temperature of the measured patient by measuring the thermal radiation of the eardrum. Measurement unit: °C or °F. The results can be displayed on LCD. The thermometers are powered by 1.5V×2 (AAA or AA) alkaline batteries, which can be used for people over three months. A thermopile sensor is employed to detect or monitor the infrared thermal energy emitted from the eardrum, which is converted into temperature measurement with the unit of °C or °F. All the models share the same critical components, intended use, working principle and similar product design, and compose of a sensor, PCB, buttons, LCD display and housing. Functions include temperature measurement, memory reading recall, unit switch, low battery detection and high temperature indicator.

The FDA 510(k) clearance letter and accompanying 510(k) Summary for the Ear Thermometers (EAR-E101, EAR-E102, EAR-E103) provide information on acceptance criteria and supporting studies.

1. Table of Acceptance Criteria and Reported Device Performance:

The document primarily focuses on demonstrating substantial equivalence to a predicate device (Jiangsu Yuyue Medical Equipment & Supply Co., Ltd, Infrared Ear Thermometers YHT101 and YHT200, K203583). Thus, the "acceptance criteria" are largely framed as demonstrating equivalence or adherence to relevant standards. The performance data is presented in comparison to the predicate and overall compliance with standards.

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

• Non-clinical Data (Bench Testing): The document does not specify a "sample size" in terms of number of devices for bench testing. It states that "The device has been tested according to the following standards," implying tests were performed on representative samples to ensure compliance.
• Clinical Data: The summary states, "The clinical testing has been conducted per 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." However, the specific sample size (number of patients/measurements) and data provenance (e.g., country of origin, retrospective/prospective) for this clinical study are NOT provided in the given document.

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

• Clinical Data: The document does not specify the number of experts or their qualifications for establishing ground truth in the clinical study. As it's an ear thermometer, the "ground truth" would typically come from a reference temperature measurement method (e.g., rectal thermometry) rather than expert interpretation of an image or signal.

4. Adjudication method for the test set:

• Clinical Data: Given that the device measures a quantitative value (temperature), an adjudication method in the context of expert consensus (like multiple readers for an image) is generally not applicable. The comparison would be between the device's reading and the reference method's reading. The document does not describe any specific 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, an MRMC comparative effectiveness study was NOT done. This type of study (MRMC) is relevant for diagnostic imaging devices where human interpretation plays a significant role, sometimes aided by AI. This document is for an ear thermometer, a direct measurement device, not an AI-assisted diagnostic tool.

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

• Yes, a standalone performance was done for the ear thermometer. The device itself is designed to provide temperature readings directly, without requiring human interpretation or input to calculate the core measurement. The bench and clinical testing described aim to quantify this standalone performance in terms of accuracy and adherence to standards.

7. The type of ground truth used:

• Clinical Data: While not explicitly stated, for a clinical thermometer, the ground truth for performance testing is typically established by comparison against a standardized, highly accurate reference thermometer (e.g., a rectal thermometer or an oral thermometer with known accuracy) or a specialized blackbody calibrator in a controlled environment as specified by standards like ISO 80601-2-56. The document mentions "clinical accuracy test" and "performance test," strongly implying such a comparative methodology.

8. The sample size for the training set:

• Not applicable / Not provided. The device is an ear thermometer, which is a sensor-based measurement tool, not an AI/machine learning algorithm that requires a "training set" in the conventional sense. The device's performance is determined by its design, calibration, and adherence to physical principles and engineering specifications, which are validated through bench and clinical testing.

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

• Not applicable. As noted above, the concept of a "training set" and its associated ground truth establishment is not relevant for this type of medical device submission.

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Temperature Probes are intended to be used for monitoring temperature. The temperature probes are reusable or for single patient use and designed for use with Mindray monitor Model PM-8000 and other monitors compatible with YSI 400 series temperature probes.
These devices are used by qualified medical professional only.

The subject devices are used for patient temperature measurement. The probes are reusable or disposable depending on models. These probes consist of a connector on the monitor end and a thermistor on the patient end. The working principle is resistance based on the metal conductor increases with temperature decrease, and the linear changes to the characteristics of the temperature measurement. The subject devices are designed to be used in healthcare facilities like hospital and compatible with a monitor of Mindray Model PM-8000 and other monitors compatible with YSI 400 series temperature probes.

The six models have two types of structure designs corresponding to reusable and disposable use which consists of different materials. The NTC of the six models are identical. Reusable models T1306, T2306, T3306, T4306 have a similar structure design with two different sensor shapes for different measure sites and consist of the same materials. Disposable models T5106 and T6106 have a similar structure design with two different sensor shapes for different measure sites and consist of the same materials.

Model: T1306, Description: Skin contact Temperature Probe, adult, reusable
Model: T2306, Description: Body cavity Temperature Probe, Esophageal/Rectal, adult, reusable
Model: T3306, Description: Skin contact Temperature Probe, pediatric, reusable
Model: T4306, Description: Body cavity Temperature Probe, Esophageal/Rectal, pediatric, reusable
Model: T5106, Description: Skin contact Temperature Probe, adult/ pediatric, disposable
Model: T6106, Description: Body cavity Temperature Probe, Esophageal/Rectal, adult/ pediatric, disposable

The provided FDA 510(k) clearance letter describes a medical device, the Reusable and Disposable Temperature Probes, but does not include information about AI/ML performance. Therefore, I will respond to the prompt by extracting the acceptance criteria and study information pertinent to this medical device, which focuses on traditional medical device performance rather than AI/ML.

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document presents "Accuracy" and "Measurement Range" as inherent characteristics of the device and states that bench testing was conducted to verify that design specifications were met, which implies these values are the acceptance criteria.

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

The document does not explicitly state the sample sizes used for the test sets (e.g., number of units tested, number of temperature measurements, or specific test configurations) for the bench testing or biocompatibility testing.

The document also does not provide information about the provenance of data in terms of country of origin or whether studies were retrospective or prospective. The testing described appears to be laboratory-based verification and validation.

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

This information is not applicable and not provided in the document. The device is a clinical electronic thermometer, and its performance is assessed against technical specifications and international standards, not against human expert interpretation of medical images or data. Ground truth for temperature measurement is typically established by reference standards or calibrated equipment.

4. Adjudication Method for the Test Set

This information is not applicable and not provided in the document. Adjudication methods like 2+1 or 3+1 are typically used in studies involving subjective assessment (e.g., image interpretation by multiple readers), which is not relevant for the objective performance testing of a temperature probe.

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

No. An MRMC comparative effectiveness study was not conducted as this is a medical device for objective temperature measurement, not an AI-assisted diagnostic tool requiring human-in-the-loop performance evaluation. The document does not mention any AI assistance.

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

No. This device is an electronic temperature probe, not an algorithm or software. Its performance is inherent to its physical and electrical properties, evaluated through bench testing against established standards.

7. Type of Ground Truth Used

The ground truth for the performance evaluations (accuracy, measurement range, electrical safety, etc.) would be established by:

• Reference Standards/Calibrated Equipment: For accuracy and measurement range, the device's readings would be compared against highly accurate and calibrated reference thermometers in controlled temperature environments.
• International Standards: Compliance with electrical safety (IEC 60601-1), EMC (IEC 60601-1-2), and thermometer-specific performance (ISO 80601-2-56) serves as the ground truth for safety and performance.
• Laboratory Analysis: For biocompatibility, laboratory tests (cytotoxicity, sensitization, irritation) are conducted to assess the biological response to the device materials according to ISO 10993 standards.

8. Sample Size for the Training Set

This information is not applicable and not provided. This device is a hardware medical device with no mention of machine learning or algorithms that would require a "training set."

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

This information is not applicable. As there is no training set for an AI/ML algorithm involved, no ground truth was established for a training set.

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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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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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The AION TempShield™ is a battery powered wearable thermometer intended for continuous measurement of human body temperature on the upper chest via wireless communication to a smart device application. AION TempShield™ is intended for single-use and for persons aged 1 year and older in either healthcare facilities or home environments.

The AION TempShield™ is a wearable device that senses body temperature and communicates with an app on a smartphone or tablet or certified gateway device. When the AION TempShield™ is connected to the device, it sends all temperature measurements automatically. The AION TempShield™ can be worn for up to 90 days to check current temperature and to allow viewing of historical temperature measurements. The device has the ability to share the data with the clinician if the clinician has established an AION account. The temperature measurements are in degrees Fahrenheit (°F), but can also be configured to display in degrees Celsius (°C). Circuit board with Bluetooth and NFC (near field communication chip). A phone with NFC is used to turn on the device. The device communicates with a phone that has the AION TempShield app installed. The circuit card has two digital temperature sensors and a 32 MHz clock. The device is designed to have a minimum operating range of 10 meters and provides a 2 dBm signal to the radio. The AION TempShield™ is shipped in a shelf mode power condition (4uA) and can be on the shelf for 24 months before the battery is depleted below the 90-day threshold. The Bluetooth transmissions are encrypted using the on-board encryption. Each device has a random pairing code that must be typed in before the sensor and the mobile device can communicate. The modulation for the low energy Bluetooth is QFSK and the device has been certified and registered with the FCC for a class II device (at home use). The hospital use is covered under this classification. The smart phone application requires that the user allow for notifications, has access to location services, and enables both NFC and Bluetooth services to fully activate the AION TempShield™ Each AION TempShield™ has a unique serial number (UUID) and a random pin assigned. This information is accessible via a barcode on the outside of the package and from an NFC read (Similar to apple pay or google pay type of contact with the back of the phone. The NFC read will wake up the AION TempShield™ from deep sleep and initiate the pairing. Once the initial Bluetooth contact has been made the mobile application will present the 6-digit pairing number that the user must type in. Once this is done the mobile device will go into operational mode and send out temperature every five minutes. The Mobile app will look for temperature every five minutes with appropriate guard bands. Every 4hours the mobile application will request a full data offload from the AION TempShield™ to collect previous data that was not collected from the AION TempShield™. The AION TempShield Application communicates with the AION Core (Cloud monitoring service). This service will provide NIH recommendations for fever to the shield to provide indications (alerts)in the data for visualization for the User. There is no PHI stored in the AION cloud. The application has a home screen that displays the last read temperature. The application allows the user to put in activities, to view historical temperature history, and to select time windows to display data. For example: the application will allow the user to only view data for the past 12 hours. The total viewable data window is 48 hours. The application in the settings window will allow the user to view the UUID and will allow the user to replace the AION TempShield™ with another one. The Application will provide the user with the percentage of charge left in the device (battery life indication). When the battery life reaches 10% of charge left, the application will provide an alert that the user should get a new AION TempShield 100 (there will be approximately 1 week of continuous life available. At 5% life the notifications are once per two hours to replace the shield. The AION TempShield TM requires that the user place medical grade silicone tape to hold the AION TempShield™ in place. The AION TempShield™ is provided with a patient user guide. The end user is expected to provide a mobile device (Android 10 or greater or iOS 11 or greater). The iPhone 6 and earlier will not work. The mobile device must have an NFC reader to fully operate.

This document pertains to the AION TempShield™, a wearable clinical electronic thermometer.

1. Acceptance Criteria and Reported Device Performance

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

The document indicates a "Usability" study which involved participants to verify accurate body temperature in different age groups. This might be considered a clinical test set.

• Sample Size (for Usability/Clinical test):
  • Original study: 137 participants (ages 5 years and older)
  • Addendum study: 39 participants (ages 1-4 years)
• Data Provenance: Not explicitly stated (e.g., country of origin, retrospective/prospective). However, the description of "clinical data" supports the expansion of the patient population, suggesting this was prospective clinical testing.

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

This information is not provided in the document. The document mentions "clinical accuracy testing to the IEC 80601-2-56" and "Usability" studies that "verified accurate body temperature," but it does not detail how the ground truth temperature was established (e.g., gold standard thermometer, multiple medical professionals) or the qualifications of evaluators, if any.

4. Adjudication method 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 not applicable. The AION TempShield™ is a clinical electronic thermometer measuring body temperature, not an AI-assisted diagnostic imaging or decision support device that would involve "human readers" or "AI assistance" in the typical MRMC study context.

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

Yes, the device's accuracy and performance are evaluated in a standalone manner, independent of human interpretation or intervention for the core temperature measurement task. The clinical accuracy and performance bench testing described (e.g., ISO 80601-2-56) demonstrate the algorithm/device's ability to measure temperature. The device transmits measurements to an app, but the primary measurement is a standalone function.

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

For clinical accuracy testing, typically a gold standard reference thermometer (e.g., a highly accurate rectal thermometer or a calibrated laboratory reference standard) would be used to establish the ground truth for body temperature measurements following ISO 80601-2-56. While the document mentions "verified accurate body temperature" in the usability study, the specific method for establishing this "ground truth" is not detailed beyond conforming to the standard.

8. The sample size for the training set

This information is not provided in the document. The AION TempShield™ is a hardware-based thermometer with associated firmware/software, not an AI/ML model that typically undergoes a separate "training" phase with a large dataset in the sense of predictive algorithms. The software/firmware development involves verification and validation, but not "training data" in the AI/ML context.

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

This information is not provided for the reasons mentioned above (not an AI/ML model requiring a training set in that context).

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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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Wearable Digital Thermometer is a battery-operated electronic device with intended use of measuring and monitoring human armpit temperature continuously via wireless signal transmission of the measuring result. Wearable Digital Thermometer is reusable and intended for armpit temperature monitoring for persons of all age. The temperature data of device is not intended to replace the advice, diagnosis, nor treatment recommendations of doctor. Wearable Digital Thermometer can be used at home and healthcare center.

The Wearable Digital Thermometer consists of a host, App software and stickers. A comprehensive Android and iOS App are provided to access the host from a smart device. It is used for measuring and monitoring armpit temperature in real-time continuously and remotely via Bluetooth to smart device. The medical double-sided sticker are used to fix and stick the host in the user`s axilla. The NTC temperature sensor is located closely to the stainless steel sheet that make sure the accuracy of temperature data measured. The subject device could measure and monitor temperature in real-time continuously and remotely via Bluetooth to smart phone. The Temp Pal is the combination device of thermometer and Bluetooth communication unit intended to be worn at axilla to monitor the armpit temperature continuously. The subject device is a direct mode clinical thermometer where the output temperature is not adjusted. For the monitoring operation, switch the thermometer on and stick the thermometer in the user's axilla. The thermometer will make a Bluetooth connection between the thermometer and the receiver automatically (User should setup Bluetooth properly on receiver). Then the thermometer starts to measure the body temperature. The wireless thermometer uses a rechargeable battery for operation. When the battery is low, internal circuit will detect the low battery condition automatically and send "low battery" signal through Bluetooth communication unit to receiver.

The provided document is a 510(k) summary for the Wearable Digital Thermometer (T31). While it lists performance data and standards met, it does not contain a detailed study report with specific acceptance criteria beyond general accuracy requirements, nor does it provide sample sizes, ground truth establishment methods for a test set, or information about expert involvement typically found in clinical validation studies for AI/ML devices.

The document refers to the device as a "Clinical Electronic Thermometer" and a "Wearable Digital Thermometer." It doesn't describe an AI or Machine Learning component. The "Performance Data" section primarily focuses on engineering and regulatory compliance testing rather than clinical study results that would typically be detailed for an AI/ML product.

Here's a breakdown of the information that can be extracted, and what is missing:

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

Study Details:

Since the device is a "Wearable Digital Thermometer" and not an AI/ML-driven diagnostic or prognostic tool, the "study" described is a series of engineering and regulatory compliance tests rather than a clinical trial in the traditional sense for AI/ML validation.

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

• Sample size for accuracy testing: Not specified. The document only states that "Performance test" was conducted and "meet the specification of the product and the relevant standards." It doesn't explicitly mention the number of subjects or measurements for clinical accuracy validation.
• Data provenance: Not specified if a specific clinical test set was used, beyond the general standards compliance.

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

• Not applicable / Not specified. For a digital thermometer, ground truth is typically established by comparing the device's readings against a highly accurate reference thermometer, rather than expert consensus on images or clinical assessments. The specific methodology for this comparison (e.g., how many reference measurements were taken) is not detailed.

4. Adjudication method for the test set:

• Not applicable / Not specified. Adjudication methods like 2+1 or 3+1 are relevant for interpreting subjective data (e.g., radiology images) where experts might disagree. For a quantitative measurement like temperature, the ground truth is typically a direct measurement from a calibrated reference.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done:

• No. An MRMC study is relevant for AI systems that assist human readers in interpreting complex data (e.g., medical images). This document describes a digital thermometer, not an AI-assisted diagnostic tool.

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

• Yes, in essence. The performance tests described (accuracy, electrical safety, EMC, biocompatibility, shelf life, usability) are evaluating the device's inherent function, without human interpretation as part of its core measurement capability. The "algorithm" here is the device's internal temperature measurement and display mechanism.

7. The type of ground truth used:

• Reference standard/calibration: For accuracy testing, the ground truth would be established by comparing the device's temperature readings against a certified reference thermometer or a temperature standard, as outlined in standards like ISO 80601-2-56 and ASTM E1112. The specific details beyond "met the requirement" are not provided.

8. The sample size for the training set:

• Not applicable / Not specified. This device, as described, is a traditional electronic thermometer. It does not appear to utilize machine learning or need a "training set" in the context of AI/ML. Its function is based on fixed physical principles (NTC resistor).

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

• Not applicable. As a non-AI/ML device, there is no "training set" for an algorithm.

In summary: The provided document is a regulatory submission for a conventional medical device (a digital thermometer), not an AI/ML-powered one. Therefore, many of the questions asking for specifics related to AI/ML study design (like training/test sets, expert adjudication, MRMC studies) are not applicable or not detailed in this type of submission. The performance data focuses on demonstrating compliance with relevant electrical, safety, biocompatibility, and measurement accuracy standards for clinical thermometers.

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FMT Disposable and Autoclavable Temperature Probes are intended to be used with YSI 400, GE, HP/Philips. Mindray, S& W, and Siemens/Drager temperature monitors for body temperature measurements.

FMT Autoclavable Temperature Probes are reusable and autoclavable. FMT Disposable Temperature Probes are provided sterile and single use.

FMT Disposable and Autoclavable Temperature Probes are intended by qualified medical professionals only.

FMT Disposable and Autoclavable Temperature Probes are intended to be used with YSI 400, GE, HP/Philips. Mindray, S& W, and Siemens/Drager temperature monitors for body temperature measurements.

FMT Autoclavable Temperature Probes are reusable and autoclavable. FMT Disposable Temperature Probes are provided sterile and single use.

I am sorry, but the provided text is a 510(k) clearance letter from the FDA for a medical device (FMT Disposable and Autoclavable Temperature Probes). It confirms that the device is substantially equivalent to legally marketed predicate devices.

However, this document does not contain the following information that you requested:

• A table of acceptance criteria and reported device performance.
• Details about a study proving the device meets acceptance criteria.
• Sample size for the test set or data provenance.
• Number or qualifications of experts for ground truth.
• Adjudication method for the test set.
• Information about a multi-reader multi-case (MRMC) comparative effectiveness study or related effect size.
• Information about a standalone (algorithm only) performance study.
• Type of ground truth used.
• Sample size for the training set.
• How ground truth for the training set was established.

This document focuses on regulatory clearance based on substantial equivalence, not on the detailed results of performance studies that would include the information you've asked for. Such details would typically be found in a separate performance study report submitted as part of the 510(k) application, but they are not included in this FDA clearance letter.

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Aulisa Temperature Module (TM0002) is a battery-operated electronic device with indication for use in continuously measuring and monitoring armpit body temperature of adults, pediatrics, and infants and transmission of the measuring result via wireless signal. Aulisa Temperature Module (TM0002) is a non-invasive and reusable device for single patient use with intended environments of use are hospitals, medical facilities, home care, and subacute environments. The parameters derived by the Aulisa Temperature Module (TM0002) are transmitted to a commercially available mobile device that runs an Aulisa-developed application for display and review.

The Aulisa Temperature Module (TM0002) is indicated for continuous armpit body temperature monitoring of adults, pediatrics, and infants which measures body temperature and sends the physiological data to an Aulisa-developed software application as cleared through previous Premarket Notification 510(k) submissions under Guardian Angel Rx GA2000 Series Digital Vital Sign Monitoring System (K203208) using Bluetooth technology. If the physiological data sent from the subject device to the software application falls outside of pre-set limits or when a technical error is detected, both auditory and visual alarm signals are generated through the software application to alert the caregiver. The sensor module uses Bluetooth technology to interact with a commercial, thirdparty mobile device whether under iOS or Android operating system, such as iPad, iPhone, Google Pixel ... etc. which is not part of this submission. The vital-signs are transmitted to mentioned mobile device that runs Aulisa-developed application for display and review. The software application can be downloaded from an official APP store, such as iOS APP store or Google Play. The Subject Device is reusable, and its intended environments of use are hospitals, medical facilities, home care, and subacute environments.

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

1. Table of Acceptance Criteria and Reported Device Performance

Note on Performance (Temperature Measurement Accuracy): The document explicitly states the specific accuracy values for different temperature ranges, which are considered "Pass" when measured against the standards ISO 80601-2-56 and ASTM E1112. These are the acceptance criteria for the accuracy.

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

The provided document does not specify the sample size used for the test set for any of the reported performance tests. It also does not specify the data provenance (e.g., country of origin, retrospective or prospective) for the accuracy or other performance tests. It only states that "Clinical accuracy testing was conducted to ISO 80601-2-56."

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 regarding the number of experts used or their qualifications for establishing ground truth. For temperature measurement, the ground truth is typically established by reference thermometers or established methods defined within the testing standards (ISO 80601-2-56 and ASTM E1112), rather than expert consensus in the way it would be for image interpretation.

4. Adjudication Method for the Test Set

The document does not mention any adjudication method like 2+1 or 3+1. For objective performance tests like temperature accuracy, adjudication methods for expert consensus are generally not applicable. The standards themselves define the criteria for "passing" the test.

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 section is not applicable to the Aulisa Temperature Module (TM0002). This device is a clinical electronic thermometer and not an AI-assisted diagnostic tool that would involve human readers interpreting cases. Therefore, an MRMC comparative effectiveness study or analysis of human reader improvement with AI assistance would not be relevant.

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

The device is a hardware module that measures temperature and transmits it. Its "performance" as a standalone device is covered by the performance testing (e.g., accuracy, electrical safety, etc.) which are conducted independent of a human interpreting its output. The output is displayed via an application, but the core measurement accuracy is inherent to the device itself. The document states that "The output temperature of the Subject Device is derived directly from input signal without any adjustment," implying its core function is standalone.

7. The Type of Ground Truth Used

For the core performance claims (e.g., temperature accuracy), the ground truth is established through reference standards as defined by ISO 80601-2-56 and ASTM E1112. These standards specify how to establish laboratory-controlled "true" temperatures to compare against the device's readings. This is a form of scientific/methodological ground truth rather than expert consensus or pathology.

8. The Sample Size for the Training Set

The document does not mention a training set sample size. This is because the Aulisa Temperature Module (TM0002) is a direct measurement device rather than a machine learning or AI-based device that would require a "training set." Its accuracy is based on its sensor technology and calibration, not learned from data.

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

As there is no mention of a training set for this device, the question of how its ground truth was established is not applicable.

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The Mon-a-Therm™ General Purpose Temperature Probe 400TM is indicated for use in the routine monitoring of temperature in an anesthetized patient. The device is intended primarily for insertion into the esophagus or rectum, although medical judgment may dictate the selection of other anatomical sites such as the nasopharynx for some patients.

The Mon-a-Therm™ General Purpose Temperature Probe 400TM is a finished medical device that monitors temperature and are versatile probes that may be used for esophageal, nasopharyngeal or rectal placement.

Features and benefits:

• Fully enclosed sensor helps ensure patient safety
• Satin Slip™ finish for easy insertion ●
• Compatible with most multifunction patient monitors. Refer to Table 1: Summary of Mon-a-. Therm™ 400 Series Thermistor Interface Cables.

The Mon-a-Therm™ General Purpose Temperature Probe 400TM is packaged individually as a sterile, single-use device and is available in the following sizes: 9 Fr 100/case CFN 90050 and 12 Fr 100/case, CFN 90050.The device and its packaging are not made with natural rubber latex or phthalates. The type of probe and device size are designated on the unit package.

The Mon-a-Therm™ General Purpose Temperature Probe 400TM components are illustrated in Figure 2.

• 1. Tube Blue
• 2. Sleeve GP
• 3. Thermistor Assembly
• 4. Slurry Mixture

The structure of Mon-a-Therm™ General Purpose Temperature Probe 400TM is illustrated in Figure 3 below. The tip of the probe is sealed with PVC and silicone at the end of the thermistor which is where the sealed tube directly contacts the mucosa as shown in "Detail A".

A temperature probe is located near the distal tip. Refer to Figure 3: Structure of Subject Device. The catheter of the subject device features a frosted external surface, referred to as Satin Slip surface. This specialized surface coating extends across the entire external area of the subject device.

Each probe is electrically connected to a compatible reusable cable which is specified in Table 1: Summary of Mon-a-Therm™ 400 Series Thermistor Interface Cables and compatible monitors by the connector in the tail of the probe. The reusable connects the probe to a patient monitor, which is compatible with YSI-400 Series thermistor, so that the temperature measurement value is displayed on the screen of monitor. All patient monitors that meet the specifications for YSI-400 thermistor, temperature accuracy, and compatible interface cables are compatible. Refer to Figure 4: Illustration of Patient Monitor Compatibility.

The provided text is a 510(k) summary for the Mon-a-Therm™ General Purpose Temperature Probe 400TM. This document primarily focuses on demonstrating substantial equivalence to a predicate device based on benchtop performance testing and adherence to relevant standards. It does not describe an AI/ML-based device or a study involving human readers or ground truth established by experts for image analysis.

Therefore, many of the requested details regarding acceptance criteria for an AI/ML device, and studies involving human readers, ground truth establishment, or multi-reader multi-case (MRMC) studies, are not applicable or described in this document.

However, based on the provided text, I can infer the acceptance criteria for the temperature probe's performance and what demonstrates that the device meets those criteria for certain aspects, primarily focusing on its temperature measurement accuracy.

Here's a breakdown of the available information:

Implied Acceptance Criteria and Reported Device Performance for the Mon-a-Therm™ General Purpose Temperature Probe 400TM

Since this is a thermal probe and not an AI/ML device, the acceptance criteria are not for diagnostic performance metrics like sensitivity, specificity, or AUC, but instead for physical and performance characteristics of a temperature measurement device.

1. Table of Acceptance Criteria and the Reported Device Performance:

The document states that the subject device (Mon-a-Therm™) has been updated to align with the latest regulation EN ISO 80601-2-56:2017, which expanded the required temperature range.

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