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The Medical Electronic Thermometer (FC0). FC02) is intended to measure the human body temperature under the arm. The devices are reusable for clinical or home use for people of all ages.

The Medical Electronic Thermometer (FC01, FC02) is a hand-held device which can measure human body temperature at the site of the armpit. The devices are reusable for clinical or home use for people of all ages. The results can be displayed on the LCD. The FC01 and FC02 have only one operating mode which is direct mode. The Medical Electronic Thermometer measures human body temperature by placing the probe tip under the armpit with a measuring time of about 300 seconds. The Medical Electronic Thermometer consists of a temperature sensor (NTC), low power integrated circuit (IC), buzzer, and battery. The resistance of sensor changes with temperature and the integrated circuit (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 provided text is a 510(k) summary for a medical electronic thermometer. It details the device, its intended use, and a comparison to a predicate device to demonstrate substantial equivalence. However, it does not contain information about a study proving the device meets specific acceptance criteria for AI/ML performance, nor does it mention any AI or machine learning components within the device itself.

The document discusses the device's accuracy and performance in relation to established standards for clinical thermometers, which are relevant to device performance but not to the acceptance criteria of an AI/ML model.

Therefore, I cannot fulfill the request to provide acceptance criteria and a study proving an AI/ML device meets those criteria based on the provided text. The text describes a standard medical electronic thermometer and its regulatory clearance process, not an AI-powered device.

To answer your request, if this were an AI/ML medical device, the information you're asking for would typically be found in detailed clinical validation studies, often submitted as part of a 510(k) or PMA submission for AI-driven technologies.

Based only on the provided text, here’s what I can extract regarding device performance, acknowledging that it's for a traditional thermometer, not an AI/ML device:

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

The document refers to adherence to international standards for thermometer performance. The acceptance criteria for the thermometer's performance are defined by these standards, specifically ISO 80601-2-56 and ASTM E1112-00(2018).

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 does not specify sample sizes for performance testing. It states that "Performance data were provided in support of the substantial equivalence determination" and lists the standards adhered to. For a traditional thermometer, performance testing generally involves laboratory bench testing rather than large-scale clinical trials with "test sets" in the way an AI/ML model would use them. No information on data provenance (country, retrospective/prospective) is provided, as this is not detailed for a standard thermometer's testing.

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. This device is a standard medical electronic thermometer, not an AI/ML device requiring expert ground truth for image interpretation or diagnosis. Its performance is validated against physical reference standards and established protocols for temperature measurement.

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 device is a standard medical electronic thermometer and does not involve AI assistance for human readers/clinicians, nor does it process medical images.

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

Not applicable. The device itself is standalone in its function as a thermometer, but there is no "algorithm" in the sense of an AI/ML model being assessed for standalone performance. Its performance is evaluated against physical measurement standards.

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

The ground truth for thermometer performance is based on traceable temperature standards and established metrology principles, as outlined in the referenced ISO and ASTM standards. It's not based on expert consensus, pathology, or outcomes data in the context of diagnostic accuracy.

8. The sample size for the training set

Not applicable. This device does not use a training set as it is not an AI/ML model.

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

Not applicable. See point 8.

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The Electronic Thermometers are intended to measure the human body temperature under arm, and the devices are nonsterile, reusable for clinical or home use on people of all ages.

Electronic Thermometer, Model: AET-F331, AET-F332, AET-F334, AET-F345, AET-F346, AET-F354, AET-F355, AET-F356, AET-F361, AET-F362, AET-F363, AET-F371, AET-F372, AET-F373, AET-F381, AET-F382, AET-F383

I'm sorry, but this document does not contain the information required to answer your request. The provided text is an FDA 510(k) clearance letter for an electronic thermometer. It details regulatory information, product codes, indications for use, and compliance requirements. However, it does not include any details about:

• Acceptance criteria and reported device performance related to a study. The document lists the device models and their intended use (measuring human body temperature under the arm), but no specific performance metrics or thresholds are mentioned.
• Sample size and data provenance for a test set.
• Number and qualifications of experts for ground truth establishment.
• Adjudication method for a test set.
• Multi-Reader Multi-Case (MRMC) comparative effectiveness study results.
• Standalone algorithm performance data.
• Type of ground truth used.
• Sample size for the training set.
• How ground truth for the training set was established.

This type of information, particularly regarding studies, performance data, and ground truth establishment, is typically found in the 510(k) submission itself (which often includes a "Truth in Labeling" section or performance testing reports), but it is not presented in the FDA's clearance letter.

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The Electronic Thermometers (AET-F101, AET-F221, AET-F241) are intended to measure human body temperature orally or under the arm. The devices are reusable for clinical or home use on people of all ages.

Electronic Thermometer, Model: AET-F101, AET-F221, AET-F231, AET-F241

I am sorry, but the provided text is an FDA 510(k) clearance letter for an Electronic Thermometer. It does not contain information about the acceptance criteria, device performance, or any studies using AI or human readers. The document is a regulatory approval and does not detail the technical performance evaluation in the way requested in your prompt.

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The Electronic Thermometers(AET-E201, AET-E21, AET-E231, AET-E241, AET-E241, AET-E251, AET-E301, AET-E311) are intended to measure the human body temperature orally, or axillary, and the devices are non-sterile, reusable for clinical or home use on people of all ages.

Not Found

This is an FDA clearance letter for a medical device (Electronic Thermometer), not a study report. Therefore, the document does not contain the requested information regarding acceptance criteria and a study proving the device meets those criteria.

The letter confirms that the device is substantially equivalent to legally marketed predicate devices, meaning it has similar indications for use, technological characteristics, and safety and effectiveness. The FDA clearance process for a 510(k) often involves demonstrating compliance with recognized standards or conducting comparison testing against a predicate device, but the details of such testing (like specific acceptance criteria, sample sizes, ground truth, etc.) are typically found in the 510(k) submission itself, not in the clearance letter.

Therefore, I cannot provide the requested table and information based on the provided text.

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The Electronic Thermometer (XHF2001, XHF2002) is intended to measure the body temperature under the arm and to be used by consumers in household environments for the people of one month of age and above.

The Electronic Thermometer is hand-held, predictive, thermistor-based, stick themometer capable of measuring temperature. The thermometer uses a negative temperature coefficient thermistor embedded in a measurement tip that is in contact with the measurement site. As the themistor changes tem perature, the resistance of the thermistor also changes, which is measured by the thermometer and converted to a measurement of the temperature of the the thermometer.

This temperature, following the use of the predictive a lgorithm, is then displayed to theend user. Because the thermometer displays the measurement for the physiological site at which it is used, it does not need to convert this temperature via clinical offset.

The Electronic Thermometer comprises a probe which includes a thermistor for getting temperature signal, a buzzer for sounding effect, an build-in software for processing the target temperature digitally, battery compartment with cover, a LCD for displaying the temperature result and indicator information, and a Power (On/Off) switch key.

There are two models of Electronic Thermometer, XHF2002. The two models share same specification, main components (such as LCD, probe, electric circuit and CPU), the only differences are size and appearance.

The size XHF2001 is 105 x 22 x 12 mm, and the XHF2002 is 125 x 18 x 9.5 mm.

The provided document describes the 510(k) premarket notification for the Electronic Thermometer (XHF2001, XHF2002). The information regarding acceptance criteria and supporting studies is extracted and organized below.

1. Table of Acceptance Criteria and Reported Device Performance

The device is evaluated against the international standard 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.

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

• Test Set Sample Size: A total of 110 subjects were included in the clinical study. These were divided into three age groups:
  • 1 month - 1 year (35 subjects)
  • 1-5 years (35 subjects)
  • Above 5 years (40 subjects)
    The study also included both febrile and afebrile persons.
• Data Provenance: The document does not explicitly state the country of origin for the clinical study data or whether it was retrospective or prospective. However, the sponsor and correspondent are based in China, suggesting the study likely took place in China. The "Controlled human clinical studies were conducted" implies a prospective study.

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

The document does not provide details on the number or qualifications of experts used to establish the ground truth for the test set. The clinical study evaluated the device's performance against the requirements of ISO 80601-2-56, which typically involves comparing the device's readings to reference thermometer readings.

4. Adjudication Method for the Test Set

The document does not describe a specific adjudication method for the test set.

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

No MRMC comparative effectiveness study was mentioned. The study focused on the standalone performance of the device against a standard.

6. Standalone Performance

Yes, a standalone performance study was conducted. The "Controlled human clinical studies were conducted on proposed device with predicates in accordance with ISO 80601-2-56." This involved evaluating the clinical bias, clinical consistency, and clinical repeatability of the proposed device.

7. Type of Ground Truth Used

The ground truth used for the clinical study was based on the requirements and methodologies outlined in ISO 80601-2-56. This standard typically involves comparing the electronic thermometer's readings to those of a highly accurate reference thermometer, often under controlled clinical conditions, to determine accuracy, bias, and repeatability.

8. Sample Size for the Training Set

The document does not mention a separate "training set" in the context of machine learning. The device described (Electronic Thermometer XHF2001, XHF2002) is a medical device that relies on a thermistor and a predictive algorithm, not a machine learning algorithm that typically requires a large training set in the sense of AI. The software verification and validation were conducted according to general guidance for software in medical devices, not specific to AI/ML training data.

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

As there is no mention of a traditional machine learning "training set" in the context of this device, this question is not applicable. The "predictive algorithm" in the device is likely based on established physiological models and calibration rather than a trained AI model.

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The Medline Disposable Electronic Thermometer Probe Covers are intended for use as barriers between any SureTemp and SureTemp Plus digital thermometer probe and users' oral, rectal, or axillary measuring sites to avoid possible contamination and infection during temperature measuring. The probe covers are non-sterile and intended for single use only.

The proposed device is a disposable, single use, non-sterile shell-like device used to cover electronic thermometer probes of temperature taking devices. The Medline Disposable Electronic Thermometer Probe Cover is compatible with the intended use of all SureTemp and SureTemp Plus reusable digital thermometers probes, which require the use of probe covers for oral, axillary, or rectal temperature measurements.

The provided text describes a 510(k) premarket notification for the Medline Disposable Electronic Thermometer Probe Cover (K173113) and compares it to a predicate device, the Welch Allyn SureTemp Plus Thermometer (K030580). This document focuses on demonstrating substantial equivalence, not conducting a study to prove a device meets acceptance criteria as would be typical for a novel AI device.

Therefore, many of the requested elements are not applicable to this type of regulatory submission for a simple medical accessory. However, I can extract the information that is present regarding the non-clinical testing performed.

Here's the breakdown of the information that can be extracted from the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Test Set Sample Size: Not specified for any of the tests.
• Data Provenance: The tests are "Non-clinical verification" and "Performance Testing (Bench)", implying laboratory data. The country of origin is not specified, but the applicant (Medline Industries, Inc.) is based in Northfield, Illinois, USA. The data is prospective in the sense that these tests were conducted for this specific submission to demonstrate equivalence.

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

• Not applicable. These are standard engineering and biocompatibility tests conducted according to established procedures, not requiring expert consensus for ground truth on a 'test set' in the context of an AI device.

4. Adjudication method for the test set

• Not applicable. As above, these are standard engineering and biocompatibility tests.

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 a thermometer probe cover, not an AI device.

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

• Not applicable. This device is a thermometer probe cover, not an AI device.

7. The type of ground truth used

• For Performance Testing (ASTM E1104-98): The ground truth would be defined by the specified technical parameters and tolerances within the ASTM standard. This standard typically covers accuracy and response time of clinical electronic thermometers, and the probe cover's performance is evaluated against how it affects these parameters.
• For Biocompatibility Testing (ISO 10993 series): The ground truth is established by the specified biological responses (e.g., absence of cytotoxicity, irritation, or sensitization) as defined by the ISO standards and their acceptance criteria.

8. The sample size for the training set

• Not applicable. This device is a thermometer probe cover, not an AI device that requires a training set.

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

• Not applicable. This device is a thermometer probe cover, not an AI device that requires a training set and ground truth establishment in that context.

Summary of the Study:

The "study" described here is a series of non-clinical (bench and biocompatibility) tests conducted to demonstrate that the Medline Disposable Electronic Thermometer Probe Cover meets recognized standards and performs similarly to its predicate device's component. The primary standard referenced is ASTM E1104-98 (2016) for performance, and ISO 10993 series for biocompatibility. The results "demonstrated the overall performance of the proposed device and ultimately support a substantial equivalence determination." The tests confirm that the probe covers do not significantly impede the thermometer's performance according to the ASTM standard and are biologically safe according to ISO standards.

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Electronic Thermometer is intended for measuring and monitoring human body temperature orally and/or under arm for adult, pediatric and infant. It can be used in healthcare facility and home.

The proposed device, Electronic Thermometer, is a handheld device with battery power supply, intended for measuring and monitoring human body temperature orally and/or under arm for adult, pediatric and infant. It can be used in healthcare facility and home. There is no specific use of this device other than temperature measurements, including conversion of temperatures. The proposed device is available in two models, which are WT1 and WT2. Similarities between models: a. Both of them incorporate a temperature sensitive sensor b. Both of them can measure and monitor human body temperature under arm; C. Neither the WT1 nor WT2 has display function, the measured or monitored temperature will be transmitted to a mobile application, Temp Sitter, installed under iOS system via the blue tooth to display the measured and monitored temperature; Differences between models: a. WT1 has an automatic power on/off feature; b. WT1 can be used with an adhesive tape, which could be fix the thermometer under arm for measuring and monitoring; c. WT2 can be used with a designated probe cover; d. WT2 can be used for measurement of oral temperature.

Here's an analysis of the provided text regarding the acceptance criteria and study information for the Electronic Thermometer (Models WT1 and WT2), formatted as requested.

Electronic Thermometer (Models WT1 and WT2)

1. Table of Acceptance Criteria and Reported Device Performance

Based on the provided document, the acceptance criteria are generally established by compliance with recognized standards and the reported performance is directly stated in the comparison table.

Notes on Acceptance Criteria: The document primarily relies on non-clinical testing against recognized national and international standards (ISO, IEC) to demonstrate substantial equivalence. The detailed accuracy claims are a performance specification that needs to be verified by testing.

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

The document explicitly states: "No clinical study is included in this submission."
Therefore, there is no information about:

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

The "test set" in this context refers to non-clinical tests (e.g., biocompatibility testing, electrical safety testing, EMC testing), which are performed on device samples, not human participants or clinical data. The precise number of device units or samples used for each non-clinical test (e.g., for biocompatibility or electrical safety) is not specified in this summary.

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

Not applicable as no clinical studies were performed, and thus no clinical ground truth was established by experts for a test set. Non-clinical tests establish "ground truth" based on standard protocols, calibrated equipment, and laboratory measurements.

4. Adjudication Method for the Test Set

Not applicable as no clinical studies were performed. Adjudication methods are typically employed in clinical trials or studies where human readers/experts independently assess cases, and a process is needed to resolve discrepancies.

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 an electronic thermometer, not an AI-assisted diagnostic tool involving human readers or interpretation of medical images/data. Therefore, an MRMC study is not relevant to this device.

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

The device itself is a standalone electronic thermometer. The performance described (accuracy, precision, response time) is for the device operating independently to measure temperature. There isn't an "algorithm" in the sense of AI or image processing, but the device's measurement functionality itself operates in a standalone manner to generate a temperature reading. The companion mobile application "Temp Sitter" serves for display and potentially trend monitoring, but the temperature measurement occurs directly by the physical device. The compliance with standards like ISO 80601-2-56 reflects this standalone performance.

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

For the non-clinical tests that were performed:

• Accuracy and Response Time: Ground truth would be established using calibrated reference thermometers and temperature sources as per the methodologies outlined in ISO 80601-2-56 or similar standards.
• Biocompatibility: Ground truth is established by laboratory testing results (e.g., cell viability assays for cytotoxicity, skin patch tests for sensitization, observation of tissue reactions for irritation) against specified limits.
• Electrical Safety and EMC: Ground truth is established by laboratory measurements taken by specialized equipment as per the IEC standards.

8. The Sample Size for the Training Set

Not applicable as no AI or machine learning algorithm requiring a "training set" is mentioned or implied for this device.

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

Not applicable, as no training set was used.

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It is intended for use in measuring temperature in the human body (Armpit or Oral).

The body temperature is converted into electronic signal by the temperature sensor, and then the electronic signal is converted into LCD digital display. The Electronic Thermometers TF3100, TF3101 and TF3102 have the same basic principles, main function, performance and intended use, and they are consistent in product structure and material.

The provided PDF outlines the acceptance criteria and a study demonstrating that the Electronic Thermometer (Models TF3100, TF3101, TF3102) meets these criteria.

1. Table of Acceptance Criteria and Reported Device Performance:

The primary performance characteristics addressed in the submission are accuracy and response time. The acceptance criteria are based on recognized international and national standards for clinical electronic thermometers.

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

The document states that "Clinical evaluation of Electronic Thermometers has been conducted by SHENZHEN PUMP MEDICAL SYSTEM CO., LTD." However, the specific sample size used for the test set and the data provenance (e.g., country of origin, retrospective or prospective) for this clinical evaluation are not provided in the given text.

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. For a clinical thermometer, the ground truth would typically be established by highly accurate reference thermometers and not by "experts" in the sense of medical professionals adjudicating images or cases.

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

This information is not applicable and therefore not provided in the context of evaluating a clinical electronic thermometer. Adjudication methods like 2+1 or 3+1 are typically used in studies involving expert review of medical images or diagnoses, not for the direct measurement of physical parameters like temperature.

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

This information is not applicable and therefore not provided. The device is an electronic thermometer, not an AI-assisted diagnostic tool that would involve human readers.

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

The device itself is a standalone electronic thermometer, designed to provide direct temperature readings. The "clinical evaluation" conducted would have assessed the device's accuracy in measuring human body temperature without human subjective interpretation. The document, however, does not explicitly describe the methodology or results of this standalone performance assessment beyond stating that "clinical evaluation... has been conducted."

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

For a clinical electronic thermometer, the ground truth would most likely be established by a highly accurate reference thermometer (e.g., a laboratory-grade mercury-in-glass thermometer or a highly calibrated electronic reference thermometer) under controlled conditions. The document does not explicitly state the type of ground truth used for the clinical evaluation, but it is inferable given the nature of the device.

8. The sample size for the training set:

This information is not applicable as the device is not an AI/ML product that would require a "training set." The submission describes a traditional electronic thermometer.

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

This information is not applicable as the device is not an AI/ML product that would require a "training set."

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The Microlife Digital Electronic Thermometer MT16K1 is used for the intermittent measurement and monitoring of human body temperature, oral, rectal and under the arm. The device is for the adult and pediatric population.

This Digital Electronic Thermometer enables easy and highly accurate readings over the body temperature range and has been designed to provide maximum user-friendliness. The body temperature is measured by the thermistor and displayed as numbers on the LCD (liquid crystal display) through microprocessor of IC.

The basic principle of this thermometer is that change of thermistor resistance, caused by changes of temperature, are converted to changes of frequency of R-C oscillator circuit, Therefore, temperature can be given by measuring the frequency of oscillator.

For a given time period, by applying the R-C oscillator circuit, changes of temperature will correspond to changes of pulse number.

The provided document is a 510(k) summary for the Microlife Digital Electronic Thermometer, Model MT16K1. It primarily focuses on demonstrating substantial equivalence to a predicate device rather than providing detailed acceptance criteria and a robust study report as might be seen for novel AI/software devices. Therefore, some of the requested information, particularly regarding AI-specific criteria like multi-reader multi-case studies, ground truth establishment for training data, and expert qualifications, is not applicable or not present in this document.

Here's an analysis based on the provided text:

Acceptance Criteria and Reported Device Performance

The core of the acceptance criteria is compliance with recognized voluntary standards for clinical electronic thermometers and a demonstration of substantial equivalence to a predicate device.

Note: The document does not provide specific numerical thresholds for "acceptance" for clinical bias, uncertainty, or repeatability, only that they were evaluated according to a standard.

Study Details

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

   • Test Set Sample Size: Not explicitly stated in the provided summary. The document mentions "Controlled human clinical studies were conducted in accordance with ASTM E1965-03," but does not give the number of subjects or measurements.
   • Data Provenance: Not explicitly stated (e.g., country of origin). The studies appear to be prospective clinical studies as they are described as "controlled human clinical studies" using the device.

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

   • Not applicable/Not mentioned. For a digital electronic thermometer, the ground truth for temperature is typically established using a reference standard thermometer, not expert consensus as would be the case for image interpretation.

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

   • Not applicable/Not mentioned. Adjudication methods are typically used when subjective interpretations are involved, such as in image reading. For a medical device measuring a physical parameter, the "truth" is typically determined by a reference measurement instrument.

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:

   • Not applicable. This device is a digital electronic thermometer, not an AI-powered diagnostic imaging tool that would involve human readers and AI assistance.

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

   • Yes, in essence. The study evaluates the device's performance (temperature measurement algorithm) directly against a reference standard. The "algorithm only" performance is the core of the evaluation for this type of device.

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

   • The ground truth for temperature measurement would be established by a highly accurate and calibrated reference thermometer or established methods for taking body temperature, in accordance with standards like ASTM E1965-03. This is an objective measurement rather than expert consensus or pathology.

7. The sample size for the training set:

   • Not applicable/Not mentioned. For a simple electronic thermometer, there isn't typically a "training set" in the machine learning sense. The device's algorithm for converting thermistor resistance to temperature is based on physical principles and calibration, not learned from a dataset.

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

   • Not applicable. As there's no training set in the AI sense, there's no ground truth established for one. The device is calibrated and its algorithm is fixed.

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