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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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The Digital Thermometer is intended to measure body temperature orally, rectally and under the arm (armpit). The devices are reusable in a clinical or home use setting on people of all ages, including children under the age of 8 with adult supervision.

Digital Thermometer

The provided text is a 510(k) clearance letter from the FDA for a Digital Thermometer. It does not contain the specific technical details, acceptance criteria, or study results that would typically be found in a performance study report.

Therefore, I cannot provide the requested information. The document focuses on regulatory approval based on substantial equivalence to a predicate device, not on the detailed scientific evidence of performance against specific acceptance criteria.

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The digital thermometer is intended for the measurement and monitoring of human body temperature through or axillary as the measurement site on people of all ages by doctor or user in the hospital or home.

Digital Thermometer, Model T28, T28L

The provided document is an FDA 510(k) clearance letter for a Digital Thermometer, Model T28, T28L. This device is a standard medical instrument for measuring body temperature and does not involve AI or complex algorithms requiring extensive studies as described in the prompt's request.

Therefore, most of the requested information regarding acceptance criteria, study details, sample sizes, expert involvement, and ground truth establishment, which are typical for AI/ML-driven medical devices, are not applicable to this specific product.

Here's a breakdown based on the characteristics of the device and the provided document:

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

• Not applicable in the context of AI/ML performance. For a digital thermometer, acceptance criteria would typically involve accuracy, precision, response time, and environmental operating limits, as defined by international standards (e.g., ISO 80601-2-56 for clinical thermometers). These technical performance specifications are usually provided in the device's design and testing documentation submitted to the FDA, but they are not detailed in this clearance letter. The letter confirms substantial equivalence, implying these technical specifications meet regulatory requirements.

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

• Not applicable for AI/ML performance. For a digital thermometer, testing would involve physical measurements on a range of test subjects or using calibrated thermal sources, not a "test set" of data in the AI sense. The document does not provide details on the sample sizes for these physical performance tests or their provenance.

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

• Not applicable. "Ground truth" in the context of expert consensus is not relevant for a digital thermometer. Accuracy is typically validated against highly calibrated reference thermometers (e.g., in a metrology lab) or in clinical trials against established methods, not by expert consensus on data interpretation.

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

• Not applicable. Adjudication methods are used to resolve disagreements among multiple experts interpreting complex data, which is not relevant for the direct measurement function of a digital thermometer.

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

• Not applicable. This device is not an AI-assisted diagnostic tool. An MRMC study is completely irrelevant.

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

• Not applicable. This device does not have an "algorithm only" component that operates independently for diagnosis or prediction. It's a measurement device.

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

• Not applicable in the context of expert consensus/pathology/outcomes data. For a digital thermometer, the "ground truth" for its accuracy and performance testing would be highly accurate reference measurements from certified calibration equipment or established clinical comparison methods, not subjective expert assessment.

8. The sample size for the training set

• Not applicable. This device does not use machine learning, therefore, there is no "training set."

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

• Not applicable. As there is no training set, there is no ground truth to establish for it in this context.

In summary: The FDA 510(k) clearance letter for the Digital Thermometer, Model T28, T28L, indicates a device that does not leverage AI/ML algorithms. Therefore, the detailed questions about acceptance criteria, study design, and ground truth establishment specific to AI-driven devices are not applicable to the information provided in this document. The clearance signifies that the device has demonstrated substantial equivalence to a legally marketed predicate device based on its intended use and conventional performance standards for clinical thermometers.

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The Digital Thermometer QT001 is intended to measure the human body temperature in armpit, orally or rectally, and the device is reusable for clinical or home use on people of all ages.

The digital thermometer QT001 is hand held device which can measure human body's temperature at the site of armpit, orally or rectally, the device is reusable for clinical or home use on people of all ages. The results can be displayed on LCD. The QT001 has only one operating mode: direct mode. The digital thermometer measures temperatures of human body by placing the probe tip into the armpit, oral, rectum directly with the measuring time about 3 minutes. The digital thermometer consists of a temperature sensor, low power consumption integrated circuit(IC),LCD display and buzzer. The resistance of sensor changes with temperature and the IC converts the resistance to frequency and calculates the temperature according to the relation of resistance and frequency. The calculated temperature is displayed on the LCD. The thermistor sensor(Type:503F) reacts to temperature. In different temperature, the thermistor has a different resistance value. The essence of temperature measurement is actually measuring the resistance of the sensor, usually is to change the resistance into voltage or current and other analog signals, and digital signals, and then the processor converts the signals to the corresponding temperatures. QT001 has several functions, such as beep alarm, unit switchable, low battery detection, memories, backlight, auto power off functions.

Here's a breakdown of the acceptance criteria and study information for the Digital Thermometer (Model QT001), based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

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

The document does not explicitly state the sample size used for the test set or the data provenance (e.g., country of origin, retrospective/prospective). It only mentions that "performance testing shows the subject device complies with standard ISO 80601-2-56," and "performance test was conducted in accordance with ISO 80601-2-56." and "software verification and validation were conducted". These standards, particularly ASTM E1112:00 and ISO 80601-2-56, define methodologies and requirements for testing clinical thermometers, which would inherently involve a test set of measurements. However, the specific number of subjects, measurements, or the origin of this data is not detailed in this summary.

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. For a clinical thermometer, the "ground truth" for temperature measurements would typically be established by highly accurate reference thermometers or methods in a controlled laboratory setting, rather than human experts in the way AI/radiology studies utilize them.

4. Adjudication Method for the Test Set:

This information is not provided in the document. Adjudication methods are typically relevant for studies involving human interpretation or subjective assessment. For a device like a digital thermometer measuring a physical parameter against a standard, the "adjudication" is inherent in the comparison to the reference standard's reading and the pass/fail criteria of the specified accuracy.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and the effect size:

No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic devices that involve human interpretation and reader variability, such as medical imaging AI. The Digital Thermometer is a standalone measurement device; its performance is not evaluated in terms of how it "improves" human reader performance.

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

Yes, a standalone study was done. The entire "Test Summary" section describes the non-clinical tests conducted on the Digital Thermometer (Model QT001) to demonstrate its compliance with various international standards (ASTM E1112-00, IEC 60601-1, ISO 80601-2-56, etc.). This inherently means the device's performance was evaluated independently without human intervention influencing its measurement accuracy.

7. The Type of Ground Truth Used:

The ground truth used for calibration and accuracy verification is the readings from highly accurate reference thermometers or validated temperature sources that meet the requirements of the specified standards (e.g., ASTM E1112-00, ISO 80601-2-56). These standards outline the methods for generating and comparing measurements against known, precise temperatures.

8. The Sample Size for the Training Set:

The document does not mention a training set in the context of machine learning or AI models. This device is a traditional digital thermometer based on a thermistor and embedded firmware for calculation, not a machine learning algorithm that requires a "training set."

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

As there is no mention of a machine learning model or a training set, the establishment of ground truth for a training set is not applicable to this device described in the submission. The device's functionality relies on established physics and pre-programmed algorithms, not learned patterns from data.

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DT007 Digital Thermometer is intended for the measurement of human body temperature by doctors or customers in the hospital or at home. It can be used for axillary, oral temperature measurement at home, and used for axillary, oral and rectal temperature measurement in the hospital. The rectal body temperature measurement cannot be used for multi-patient use at home. The product is reusable and provided nonsterile. The device is intended for use on people of all ages.

DT008 Digital Thermometer is intended for the measurement of human body temperature by doctors or customers in the hospital or at home. It can be used for axillary, oral temperature measurement at home, and used for axillary, oral and rectal temperature measurement in the hospital. The rectal body temperature measurement cannot be used for multi-patient use at home. The product is reusable and provided nonsterile. The device is intended for use on people of all ages.

The basic principle of Digital Thermometer is that a change in thermistor resistance is caused by a change in temperature. The device measure body temperature by using a direct mode. The resistance is measured by a microcontroller unit, so that changes in temperature will correspond to changes in resistance. And the temperature value is displayed on the LCD screen. The device can be used for axillary, oral in the home, and used for axillary, oral and rectal temperature measurement in the hospital. The device is reusable and provided non-sterile. The device is intended for use on people of all ages. The probe cover is required when measuring the oral or rectal temperature, but not when measuring the axillary temperature.

The Digital Thermometer includes two models: DT007 and DT008. The differences of these two models are in appearance, PCB layout, external dimension and weight. All of them have the same function and they have the following basic functions:

• Data displayed on LCD
• Automatic stop (energy saver)
• Small, convenient, easy to use

The provided text describes the acceptance criteria and a study for a Digital Thermometer (Models DT007, DT008). Here's a breakdown of the requested information:

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

The acceptance criteria are generally implied by conformity to specific standards and the stated "Measuring Accuracy". The reported device performance is presented in the comparison table with the predicate device and the non-clinical test summary.

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

The document mentions "performance test" against standards like ASTM E1112 and ISO 80601-2-56. These typically involve rigorous testing of multiple units under controlled conditions. However, the specific sample size of devices tested and the number of measurements taken for these performance tests are not explicitly stated in the provided text. The document also does not provide details on data provenance (country of origin, retrospective/prospective).

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

This information is not applicable as the device is a digital thermometer, and the "ground truth" for temperature measurements is established against traceable reference standards and methods as defined by the performance standards (e.g., ASTM E1112, ISO 80601-2-56), not by human expert consensus or interpretation.

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

This information is not applicable for a digital thermometer as its performance is objectively measured against physical standards, not through expert adjudication of subjective interpretations.

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 as the device is a digital thermometer and does not involve AI assistance or human reader interpretation for its primary function.

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

This concept is not applicable to a digital thermometer in the context of diagnostic AI algorithms. The device itself is solely responsible for measuring temperature, and its performance is evaluated in a "standalone" manner (i.e., the device itself without human intervention affecting the measurement accuracy).

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

The "ground truth" for the performance evaluation of the digital thermometer is based on established metrological standards and reference temperatures as outlined in the technical standards ASTM E1112 and ISO 80601-2-56. These standards define the acceptable deviation from a true reference temperature.

8. The sample size for the training set

This information is not applicable as the digital thermometer is a hardware device with embedded firmware for measurement, not a machine learning or AI algorithm that requires a "training set" in the conventional sense.

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

This information is not applicable for the same reason as #8.

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The AOJ-25 series Digital Thermometer (except AOJ-25B) are designed as reusable battery-operated electronic device, and intended for the measurement of oral, armpit and rectal temperature for people of all ages at home.
The AOJ-25B is intended to measure temperature rectally only for people of all ages at home as well. The device is reusable.

The digital thermometer is designed as hand-held device which can measure human body's temperature orally, axillary (under the arm), or rectally. The results can be displayed on LCD.
The digital thermometers have several functions, such as beep indication, °C and °F unit switchable, low battery detection, memories, three-color backlight, auto automatic power off functions.
The device is a predictive digital thermometer. Users only need 10 seconds for quick reading, and will display the temperature value on the screen.

The provided FDA 510(k) K213485 submission describes the acceptance criteria and the study that proves the Digital Thermometer, Models: AOJ-25A, AOJ-25B, AOJ-25C, AOJ-25D and AOJ-25E meets these criteria.

Here's a breakdown of the requested information:

1. Table of acceptance criteria and the reported device performance

The submission primarily focuses on the clinical accuracy of the thermometer as a key performance criterion, referencing the ISO 80601-2-56 standard.

Note: The document also mentions other performance aspects like electrical safety, EMC, and biocompatibility, which are met through compliance with relevant IEC and ISO standards. However, specific "acceptance criteria" and "reported performance" are not detailed in a table format for these aspects within the provided text, beyond stating compliance.

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

• Sample Size: A minimum of 90 subjects were used for the clinical accuracy study.
• Data Provenance: The document does not explicitly state the country of origin. It indicates a "clinical study" was conducted, referring to it as a "randomization, simple blind homologous control, pairing design of clinical investigation." It is implied to be a prospective study due to the nature of a clinical investigation outlined by the standard.

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

The document does not specify the number or qualifications of experts used to establish the ground truth. It states that a "reference device is introduced as required by the standard," implying that the ground truth for temperature measurements during the clinical study was established by this validated reference device, not by human expert interpretation.

4. Adjudication method for the test set

The document mentions a "simple blind homologous control, pairing design of clinical investigation." This suggests a comparative design with a reference device. It does not describe an explicit adjudication method involving multiple human readers for differing interpretations, as the ground truth is based on the objective measurement of temperature by a reference device according to the standard.

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

No, an MRMC comparative effectiveness study was not done. This device is a digital thermometer, not an imaging device requiring human interpretation of clinical images. The study focuses on the accuracy of the temperature measurement itself, not on human readers' interpretation of output.

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

Yes, the clinical accuracy study for the digital thermometer is essentially a standalone performance evaluation of the device in measuring temperature. While the device is used by a human, the performance measured is the accuracy of the device's output against a reference, not its performance in assisting human decision-making or interpretation.

7. The type of ground truth used

The ground truth for the clinical accuracy study was established by a reference device as required by the ISO 80601-2-56 standard. This reference device is used to measure the body temperature against which the subject device's measurements are compared.

8. The sample size for the training set

The document does not provide information about a separate "training set" or its sample size. For medical devices like digital thermometers, the development process typically involves calibration and validation against known standards, which is distinct from the machine learning "training set" concept often associated with AI/ML devices. The "clinical study" described serves as the validation of the final algorithm's accuracy.

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

As there is no mention of a traditional machine learning training set, the concept of establishing ground truth for it is not applicable here. The device's underlying "algorithm" (firmware) related to temperature measurement would be calibrated and developed based on the physical principles of thermistor resistance and validated through bench testing and the described clinical study against a precise reference thermometer.

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The Phoenix Digital Thermometer is intended to measure the human body temperature orally, rectally or under the arm. The Phoenix Digital Thermometer is reusable for clinical or home use on people of all ages.

Not Found

This document appears to be an FDA 510(k) clearance letter for a "Phoenix Digital Thermometer." As such, it grants market clearance based on substantial equivalence to a predicate device, but it does not contain the detailed acceptance criteria for device performance or the study details proving it meets those criteria, as typically found in a clinical study report or a more extensive submission summary.

The letter confirms the device is substantially equivalent to legally marketed predicate devices and is subject to general controls, but it does not describe a specific study proving the device meets particular acceptance criteria in the way you've outlined.

Therefore, I cannot provide the requested information in the structured format you've asked for based solely on the provided text. The document acts as an approval notice, not the validation study itself.

To answer your questions, I would need access to the actual 510(k) submission summary or supporting documentation that was reviewed by the FDA, which would detail the performance data, acceptance criteria, and study design used to demonstrate substantial equivalence.

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DT100 Digital thermometer is intended for the measurement of human body temperature by doctor or consumers in the hospital or home. It can be used for axillary, oral and rectal measurement. The product is reusable and provided non-sterile. The device is for people of all ages.

DT100 digital thermometer is a fast, highly accurate, and easy to use clinical instrument for measuring patient temperatures by oral, axillary or rectal means. The digital thermometer is a hand-held, reusable, multi-user, battery operated device. It has one model DT100.

The provided text is an FDA 510(k) summary for a digital thermometer (DT100). It focuses on demonstrating substantial equivalence to a predicate device rather than detailing specific clinical study results for novel AI-powered diagnostic devices. Therefore, a direct answer to the request regarding AI acceptance criteria, specific test set details, expert ground truth, MRMC studies, or standalone algorithm performance, as typically seen in AI/ML device submissions, cannot be fully provided from this document.

However, I can extract the relevant information from the document that pertains to the device's performance and the non-clinical testing performed to demonstrate its safety and effectiveness.

Here's a breakdown of the information that can and cannot be extracted:

Information that can be extracted related to acceptance criteria and performance:

• Acceptance Criteria (Accuracy) and Reported Device Performance: This is explicitly stated in the substantial equivalence table.
• Non-Clinical Performance Data: The document lists the standards the device was tested against (Biocompatibility, Electrical Safety/EMC, Performance Testing, Software V&V). While it doesn't give specific results for each test (e.g., exact current leakage values), it states the device was evaluated according to these standards, implying it met their requirements.
• Ground Truth Type for Non-Clinical Testing: For performance, it relies on established standards (e.g., ASTM E1112 for accuracy).

Information that cannot be extracted (as it's beyond the scope of this 510(k) for a conventional thermometer):

• Sample sizes for a test set (as no clinical test set in the AI/ML sense was used for performance evaluation).
• Data provenance (not applicable for a simple thermometer's non-clinical testing).
• Number of experts, qualifications, or adjudication methods (not applicable as no expert-review based ground truth was established for "cases").
• MRMC comparative effectiveness study (not applicable).
• Standalone algorithm performance (not applicable, as it's a hardware device, not an algorithm).
• Sample size for training set (not applicable, as it's not an AI/ML device).
• How ground truth for training set was established (not applicable).

Based on the provided document for the DT100 Digital Thermometer:

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

Notes on Acceptance Criteria and Performance:
The document states that the DT100 Digital Thermometer's accuracy is the same as the predicate device (Fudakang Digital thermometer; Model: BTA41-CN). The non-clinical testing performed (against standards like ASTM E1112) would have implicitly confirmed that the device met this accuracy requirement.

2. Sample sized 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 applicable. For this type of conventional electronic thermometer, performance is demonstrated through non-clinical laboratory testing against recognized standards (e.g., ASTM E1112), not a "test set" in the context of an AI/ML algorithm requiring patient data.
• Data Provenance: Not applicable. The testing is laboratory-based and performed to international and national standards.

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

• Not applicable. Ground truth for a digital thermometer's accuracy is established by highly accurate reference temperature measurements in a controlled laboratory environment, not by expert consensus on clinical cases.

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

• Not applicable. See point 3.

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

• Not applicable. This is a standalone 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 a sense. The device's performance (accuracy, electrical safety, biocompatibility, etc.) was evaluated as a standalone product through non-clinical laboratory testing according to relevant standards. The "algorithm" here essentially refers to the device's internal temperature measurement and display mechanism, which operates without human intervention beyond taking the measurement.

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

• For performance (accuracy): The ground truth is established by highly precise and calibrated reference thermometers and temperature baths/devices, as per the requirements of standards like ASTM E1112. This is an objective, physical measurement standard rather than a subjective human interpretation.

8. The sample size for the training set

• Not applicable. This is not an AI/ML device that requires a training set.

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

• Not applicable. See point 8.

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These devices are indicated for use as a barrier accessory to digital thermometers while taking rectal, oral or axillary temperature measurements. These sheaths are non-sterile and intended for single use only. This accessory is contraindicated for use with broken skin.

The Medline Digital Thermometer Non-Lubricated Probe Sheath is an accessory to a clinical electronic thermometer, which is intended to measure body temperature. The Medline Digital Thermometer Non-Lubricated Probe Sheath is a flexible plastic sheath that is used to cover the transducer of clinical electronic thermometers while taking body temperature measurements from the oral, axillary, or rectal measurement sites and acts as a barrier to prevent possible contamination of the device during temperature measurement. The sheath is an over-the-counter (OTC), disposable, single use, nonlubricated, and non-sterile device that is compatible with most digital stick thermometers.

The Medline Digital Thermometer Non-Lubricated Probe Sheath is an accessionary to a clinical electronic thermometer. This device aims to prevent contamination of the thermometer during temperature measurement by acting as a barrier. The device is non-sterile and intended for single use only. This accessory is contraindicated for use with broken skin.

Here's the breakdown of the acceptance criteria and study information:

1. Table of Acceptance Criteria and Reported Device Performance:

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

The provided document does not explicitly state the sample sizes used for the non-clinical performance and biocompatibility testing. It only mentions that testing was conducted to demonstrate safety and effectiveness. The data provenance (e.g., country of origin, retrospective/prospective) is also not specified.

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

Not applicable. This device is a physical accessory and does not involve AI or human interpretation for diagnosis, thus no experts were used to establish ground truth in the context of clinical interpretation. Ground truth for its performance is established through adherence to engineering and biological safety standards.

4. Adjudication Method for the Test Set:

Not applicable. As no human interpretation for diagnosis or AI performance evaluation is involved, no adjudication method was used. Performance was assessed directly against pre-defined engineering and biological standards.

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

No. A MRMC comparative effectiveness study was not done as this is a non-AI medical device accessory.

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

No. This device is a physical accessory and does not involve an algorithm. Performance testing was purely on the physical properties and biological safety of the device.

7. Type of Ground Truth Used:

The ground truth for evaluating the device's performance relies on established engineering standards (ASTM E1104-98 and ASTM E1112 for compatibility and leakage, and general tensile strength properties) and biological safety standards (ISO 10993 series for cytotoxicity, skin sensitization, and skin irritation).

8. Sample Size for the Training Set:

Not applicable. As this is a physical medical device accessory and not an AI algorithm, there is no training set in the typical sense.

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

Not applicable, as there is no training set.

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