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This product is intended to measure systolic and diastolic blood pressure and pulse on upper arm of population over 12 years old in household or medical facilities. (Not suitable for neonate, pregnancy or pre-eclampsia).

Electronic blood pressure monitor is a Noninvasive Blood Pressure Measurement System that is intended to measure blood pressure through oscillation mensuration. The proposed device will automatically start to take measurements after the inflation of the cuff is finished, the results will show the systolic pressure and diastolic pressure with pulse rate. The blood pressure monitor will store the measurements automatically; The record may be revisited. It measures blood pressure and pulse rate through inflating cuff which rounding the upper arm of patients. The electronic blood pressure monitor is small, portable and used in home or medical facilities environment. It consists of two parts: main unit and cuffs. The electronic blood pressure monitor is composed of PCBA, crystal oscillator, pump, valve, enclose, and LCD. Cuffs including cuff of size 22cm32cm and cuff of size 22cm42cm.

The provided text describes the acceptance criteria and the study that proves the device (Electronic Blood Pressure Monitor models D6606US, D6607US) meets these criteria, primarily by demonstrating substantial equivalence to a predicate device (HTD6602US, K223170).

Here's the breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are primarily derived from international standards and are met by the device. The reported device performance is that it meets these standards.

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

The document states that a clinical study was performed on the predicate device (HTD6602US, K223170). The results of this study were transferred to the subject device (D6606US, D6607US) because the subject device has the same specifications, intended use, method of measurement, measurement type, critical components (e.g., air pump, sensor, cuff), and algorithm as the predicate device.

• Sample Size for Clinical Accuracy Testing: The document does not explicitly state the sample size. It only refers to "all the relevant activities were performed by designate individual(s)" as per ISO 81060-2. ISO 81060-2 specifies requirements for clinical investigation of automated non-invasive sphygmomanometers, which includes specific sample size requirements (e.g., typically at least 85 subjects with a distribution across blood pressure ranges). However, the exact number is not provided in this submission summary.
• Data Provenance: The clinical study data originates from the testing done for the predicate device K223170. The country of origin and whether it was retrospective or prospective are not specified in this document, but "clinical investigation" usually implies a prospective study.

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

The document mentions that for the clinical accuracy testing (performed on the predicate device), "all the relevant activities were performed by designate individual(s)". It does not specify the number of experts or their qualifications for establishing ground truth, but implicitly, highly qualified medical professionals/technicians are required to perform and verify measurements according to ISO 81060-2.

4. Adjudication method for the test set

The document does not explicitly state an adjudication method (e.g., 2+1, 3+1). For blood pressure measurement studies following ISO 81060-2, ground truth is typically established by trained observers (often two) using a reference sphygmomanometer, with specific protocols for resolving discrepancies, although these details are not provided here.

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

• No MRMC Study: This device is an Electronic Blood Pressure Monitor, which is a standalone measurement device, not an AI-assisted diagnostic tool that requires human interpretation. Therefore, a multi-reader multi-case (MRMC) comparative effectiveness study comparing human readers with and without AI assistance was not done as it is irrelevant for this type of device.

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

• Yes, a standalone performance assessment was done (implicitly). The primary study cited is the clinical accuracy testing of the predicate device against ISO 81060-2. This standard evaluates the accuracy of the automated device (algorithm only) compared to a reference measurement performed by trained observers, effectively assessing its standalone performance. The results of this standalone performance were deemed acceptable for the predicate and transferred to the subject device.

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

The ground truth for the clinical accuracy testing (following ISO 81060-2) is established by simultaneous or sequential measurements using a standardized reference method (e.g., mercury sphygmomanometer with trained observers) against which the automated device's readings are compared. This is a form of expert measurement/consensus in a controlled clinical setting.

8. The sample size for the training set

This information is not applicable/provided. The device is an Electronic Blood Pressure Monitor based on oscillometric measurement, not a machine learning or AI device that typically requires a "training set" in the conventional sense. The development of its algorithm would involve engineering and calibration, not statistical training on a dataset of labeled cases in the AI context.

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

This information is not applicable/provided for the same reasons as point 8.

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The Electronic Nasal Aspirator is intended for intermittent removal of nasal secretions and mucus from children (age 2-12 years old). This device is used in a home environment.

Electric nasal aspirator consists of main unit, and the suction portion working together as one unit. The Electronic Nasal Aspirator is a portable device which is intended for suction of nasal passages in children 2-12 years of age. The motor pump provides a negative pressure which removes nasal secretions. The motor pump operates on a rechargeable battery. The rechargeable battery can be charged from the external power adapter (not included in this device) through the provided charging line. The user interface consists of buttons and LED display, and the user can control the vacuum pressure through the button.

The provided text is a 510(k) summary for an Electric Nasal Aspirator. This document describes its substantial equivalence to a predicate device based on non-clinical testing. It explicitly states that "No clinical test data was used to support the decision of substantial equivalence."

Therefore, the requested information about acceptance criteria, study details, sample sizes, expert involvement, adjudication, MRMC studies, standalone performance, and ground truth establishment for a clinical study to prove the device meets acceptance criteria cannot be extracted from this document, as no such clinical study was conducted or presented.

The document focuses on demonstrating substantial equivalence through non-clinical testing, which includes various safety and performance benchmarks.

However, based on the non-clinical tests mentioned, we can infer the acceptance criteria and reported performance for those specific tests:

1. Table of Acceptance Criteria and Reported Device Performance (Based on Non-Clinical Tests)

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This product is intended to measure systolic and diastolic blood pressure and pulse on upper arm of population over 12 years old in household or medical facilities. (Not suitable for neonate, pregnancy or pre-eclampsia)

Electronic blood pressure monitor, model: HTD6602US is a Noninvasive Blood Pressure Measurement System that is intended to measuring blood pressure through oscillation mensuration. The proposed device will automatically start to take measurements after the inflation of the cuff is finished, the results will show the systolic pressure and diastolic pressure with pulse rate. The blood pressure monitor will store the measurements automatically; The record maybe revisited. It measures blood pressure and pulse rate through inflating cuff which rounding the upper arm of patients. The HTD6602US is small, portable and used in home or medical facilities environment. The Electronic blood pressure monitor consists of two parts: main unit and cuffs. The HTD6602US is composed of PCBA, crystal oscillator, pump, valve, enclose, and LCD. Cuffs including cuff of size 22cm32cm and cuff of size 22cm42cm.

Here's a breakdown of the acceptance criteria and the study details for the Electronic Blood Pressure Monitor, model: HTD6602US, based on the provided document:

Acceptance Criteria and Device Performance

Note: The primary acceptance criteria for accuracy are based on compliance with ISO 81060-2 Third Edition 2018-11, as indicated in the "Performance" row of the comparison table and the discussion of clinical accuracy testing. The specific numerical accuracy values are explicitly stated in the comparison table.

Study Details

The study that proves the device meets the acceptance criteria is a clinical accuracy test.

2. Sample Size and Data Provenance

• Sample Size for Test Set: 85 subjects
• Data Provenance: Not explicitly stated, but since the submission is by Hetaida Technology Co., Ltd. from China and it's a 510(k) submission to the US FDA, it likely refers to a prospective clinical trial conducted to meet ISO standards. The document doesn't specify if the subjects were from a particular country.

3. Number of Experts and Qualifications for Ground Truth

• Number of Experts: Not explicitly stated. The document refers to "reference equipment" (Sphygmomanometer - Stethoscope health box) and "Measuring Method: Auscultatory," which implies measurements were taken by trained personnel (e.g., medical professionals, technicians) using a standard, validated auscultatory method simultaneously with the device being tested.
• Qualifications of Experts: Not explicitly stated. However, for auscultatory measurements to establish ground truth in blood pressure studies, the personnel typically need to be trained clinicians or technicians adhering to standardized measurement protocols.

4. Adjudication Method for Test Set

• Adjudication Method: Not explicitly stated, but the method used for "ground truth" is "Auscultatory" measurements. In clinical blood pressure validation studies following ISO 81060-2, this usually involves at least two trained observers taking simultaneous readings (often blinded to each other's readings) and resolving discrepancies. The document mentions "Reference equipment used for measurements," implying a direct comparison to established, validated manual methods.

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

• Was an MRMC study done? No, this type of study is not applicable to a non-invasive blood pressure monitor that directly measures physiological parameters. MRMC studies are typically used for diagnostic imaging devices where human readers interpret images.

6. Standalone Performance Study

• Was a standalone (algorithm only without human-in-the-loop performance) study done? Yes, the entire clinical accuracy study evaluates the device's (algorithm's) performance in measuring blood pressure and pulse rate autonomously against a gold standard (auscultatory measurements). The device operates without human interpretation of its internal measurements; it directly provides readings.

7. Type of Ground Truth Used

• Type of Ground Truth: Expert consensus via Auscultatory Measurement Method using a reference Sphygmomanometer - Stethoscope health box. This is the gold standard for clinical validation of automated blood pressure devices.

8. Sample Size for Training Set

• Sample Size for Training Set: Not applicable or not provided. This device is a hardware-based measurement system with an embedded algorithm, not a machine learning model that typically has a distinct training phase with labeled data in the same way. The algorithm's development (training) phase would occur during the device's engineering and calibration, not necessarily with a separate "training set" as understood in modern AI/ML contexts.

9. How Ground Truth for Training Set was Established

• How Ground Truth for Training Set was Established: Not applicable. As noted above, this isn't a typical AI/ML model where a training set with established ground truth is used for iterative learning. The accuracy of the device's algorithm would be refined through engineering and calibration processes based on physiological principles and potentially internal testing, not a "training set" of patient data in the same sense. The ISO 81060-2 clinical trial serves as the validation of the finalized algorithm's performance against clinical ground truth.

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The HeTaiDa electronic thermometers HTD8818A, HTD8808C are infrared thermometers which use infrared sensor to detect human body temperature of all ages. It is intended to be used on one's forehead to detect body temperature. The HTD8816C, HTD8816C, HTD8808C are intended for use in home and clinical environment.

The HeTaiDa infrared body thermometer, Models HTD8818A,HTD8816C,HTD8808C are hand-held device powered by batteries and designed to measure human body temperature without contacting patient's forehead. The thermometer can switch modes between "Body Mode" and "Surface Mode". The "Surface Mode" is DIRECT MODE and the "Body Mode" is ADJUSTED MODE. Forehead temperature of the ADJUSTED MODE is calculated by converting the measured temperature of the DIRECT MODE to an axillary equivalent temperature without contacting the patients' forehead.

The provided text describes the acceptance criteria and the studies conducted to prove that the "Non-contact Infrared Body Thermometer" (Models HTD8808C, HTD8818A, HTD8816C) meets these criteria.

Here's a breakdown of the requested information based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document refers to a clinical accuracy test (referenced as "Appendix 11" and compliant with ASTM E1965-98) for evaluating operating environment and measurement range changes.

• Sample Size: The document indicates that clinical bias was calculated for three groups:

  • Group I (Infants)
  • Group II (Children)
  • Group III (Adults)
    However, the specific number of subjects within each group or the total sample size for the clinical test is not explicitly stated in the provided text.

• Data Provenance: The document does not explicitly state the country of origin of the data or whether the study was retrospective or prospective.

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

The document provides very limited information regarding the clinical study, particularly concerning the establishment of ground truth. It states that "the bias of the test thermometer is non-inferior to the bias of the predicate thermometer when compared to the reference thermometer." This implies a comparison to a "reference thermometer," which would typically be a highly accurate, calibrated device used to establish true body temperature.

• Number of Experts: Not mentioned.
• Qualifications of Experts: Not mentioned.

4. Adjudication method for the test set

The document does not describe any adjudication method (like 2+1 or 3+1). The evaluation of clinical accuracy seems to be based on direct comparison to a "reference thermometer" and statistical analysis of bias and repeatability.

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 device is a non-contact infrared body thermometer, not an AI-assisted diagnostic tool involving "human readers" or "cases" in the typical sense of medical imaging or clinical decision support systems. Therefore, an MRMC comparative effectiveness study involving AI assistance for human readers is not applicable to this device and was not performed.

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

The device itself is a standalone thermometer. The "standalone" performance is assessed by various bench tests (IEC 60601-1, IEC 60601-1-11, IEC 60601-1-2, ISO 80601-2-56) and a clinical accuracy test comparing its readings directly to a reference thermometer. These tests evaluate the device's accuracy and functionality without human intervention outside of operating the device for measurement.

7. The type of ground truth used

The ground truth for the clinical accuracy tests appears to be established by comparison to a "reference thermometer." This indicates a highly accurate, calibrated device used to obtain the true body temperature against which the performance of the non-contact infrared thermometer is measured.

8. The sample size for the training set

The document primarily focuses on substantiation of modifications and performance testing, not on the development of the core algorithm. It does not provide information on a "training set" in the context of machine learning, as this is an infrared thermometer and not a learning-based algorithm. The device's "algorithm" likely refers to its internal logic for converting infrared readings to a displayed temperature, which would be developed through engineering and calibration, not a machine learning training set.

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

As there is no mention of a traditional "training set" for a machine learning algorithm, this question is not directly applicable. The device's calibration and accuracy are established through laboratory and clinical testing against reference standards and methods, as detailed under points 1, 2, and 7.

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The Infrared Body Thermometer, Model: HTD8823US, is an electronic clinical thermometer using an infrared sensor to detect body temperature from the forehead in people of all ages for home setting use.

Infrared (IR) Body Thermometer, model: HTD8823US, is a hand-held, battery powered, infrared thermometer that measures human body temperature from forehead. The reference body site is oral. The device can measure temperature with two modes, forehead mode and forehead scan mode, and both modes measure forehead temperature. The forehead mode measures temperature from center of the forehead. Forehead scan mode measures temperature by gently positioning the probe flush (flat) on the center of the forehead, midway between the eyebrow and the hairline, press and hold the On/Scan button. Lightly slide the thermometer across the forehead keeping the sensor flat and in contact with the skin until reaching the right hairline, release the On/Scan button and remove the thermometer from the forehead, then the temperature will display on the screen, the whole process takes 3~10 seconds.

The provided document is a 510(k) Summary for the HeTaiDa Technology Co., Ltd. Infrared Body Thermometer, Model: HTD8823US. It outlines the device's characteristics and its substantial equivalence to predicate devices, supported by non-clinical and clinical testing.

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

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

The document references two primary performance standards for the Infrared Body Thermometer: ASTM E1965-98 (2016) and ISO 80601-2-56: 2017. While it states that the device "Meets" these standards, specific quantitative acceptance criteria from these standards and the device's reported performance against each of those specific numerical criteria (e.g., maximum permissible error at different temperature ranges) are not explicitly itemized in a table within the provided text.

However, the "Summary of technological characteristics of device compared to the predicate devices" (Pages 5-7) includes some key performance characteristics that imply acceptance criteria and performance, mostly by stating "Same" or "Similar" to predicates which are presumed to meet equivalent criteria.

Here's a curated table based on the available information, inferring acceptance criteria from the predicates and performance against those:

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

• Sample size for the test set: 140 subjects.
• Data provenance: The document does not explicitly state the country of origin of the data. It also does not explicitly state if the study was retrospective or prospective, but clinical accuracy studies for new devices are typically prospective. The text mentions "Each model was evaluated in 0 up to 3 months, 3 months up to one year, older than 1 year and younger than 5 years, and older than 5 years age groups," indicating a structured, likely prospective clinical trial.

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" for temperature measurement is typically established by using a highly accurate reference thermometer (e.g., laboratory-grade thermometer or a rectal/oral thermometer considered the gold standard in a clinical setting by trained medical professionals). The document only states "The clinical accuracy test report and data analysis followed the requirements of the ASTM E 1965-98 (2016)," which is a standard for infrared thermometers. It doesn't detail the personnel involved in supervised measurements.

4. Adjudication method for the test set

This information is not provided in the document. Adjudication methods like 2+1 or 3+1 are typical for subjective interpretations (e.g., radiology reads). For quantitative measurements like temperature, the ground truth is usually established by direct measurement with a reference standard, not typically through expert adjudication of images or subjective findings.

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, a multi-reader multi-case (MRMC) comparative effectiveness study was not done, nor would it be relevant for this type of device. This device is an infrared thermometer, not an AI-assisted diagnostic tool that involves human "readers" or interpretation of complex cases. Therefore, there's no mention of AI assistance or its effect size on human performance.

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

The device itself is a standalone algorithm, in the sense that it automatically measures and displays temperature without requiring human interpretation of an output from an underlying AI (beyond reading the numerical display). The "clinical accuracy testing" evaluates the device's performance in this standalone capacity.

7. The type of ground truth used

The ground truth for the clinical accuracy testing was established by comparing the device's measurements against a reference standard of body temperature measurement, as specified by ASTM E1965-98 (2016). While not explicitly stated, this usually involves a core body temperature measurement method (e.g., rectal, oral, or an equivalent highly accurate reference thermometry system) performed by trained personnel.

8. The sample size for the training set

This information is not applicable and therefore not provided. Infrared thermometers like the HTD8823US are hardware-based measurement devices that employ fixed algorithms and calibrations, not machine learning or AI models that require "training sets" in the conventional sense. Any "training" would refer to internal calibration and validation data used during the device design and manufacturing process, which is distinct from a machine learning training set.

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

As inferred above, this information is not applicable as the device does not utilize a machine learning model that requires an external "training set" with established ground truth. The device is calibrated and validated against physical temperature standards and clinical performance requirements.

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

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

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

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

1. Table of Acceptance Criteria and Reported Device Performance

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

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

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

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

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

4. Adjudication Method for the Test Set

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

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

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

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

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

7. The Type of Ground Truth Used

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

8. The Sample Size for the Training Set

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

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

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

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The HeTaiDa non-contact infrared body thermometers HTD8818A,HTD8816C, HTD8808C are non-sterile, reusable thermometers intended for the intermittent determination of human body temperature measured at the patients' forehead without contact. The devices are intended for use on people of all ages. The HTD8818A, HTD8816C, HTD8808C are intended for use in clinical and home use environment.

The HeTaiDa infrared body thermometer, Models HTD8818A, HTD8816C, HTD8808C are hand-held device powered by batteries and designed to measure human body temperature without contacting patient' forehead. The thermometer can switch modes between "Body Mode" and "Surface Mode". The "Surface Mode" is DIRECT MODE and the "Body Mode" is ADJUSTED MODE. Forehead temperature of the ADJUSTED MODE is calculated by converting the measured temperature of the DIRECT MODE to an axillary equivalent temperature without contacting the patients' forehead.

The thermometers HTD8818A, HTD8816C and HTD8808C infer temperature from the blackbody radiation emitted from the patient. Temperature is calculated from the knowledge of the amount of infrared energy emitted from the human body. The thermometer design consists lens to focus the infrared thermal radiation on to a detector, which converts the radiant power to an electrical signal that can be displayed in units of temperature. This permits temperature measurement from a distance without contact with the object to be measured.

The provided document describes the acceptance criteria and the study that demonstrates the performance of the HeTaiDa non-contact infrared body thermometers (Models HTD8818A, HTD8816C, HTD8808C).

Here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are generally implied by adherence to standards like ISO 80601-2-56:2009 and ASTM 1965-68 (Reapproved 2009) for clinical bias, clinical accuracy, and clinical repeatability. The document provides specific accuracy ranges for body and surface modes.

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

• Sample Size for Test Set: The document states "The four groups of subjects being tested were: (1) 0-3 months, (2) 3 months-1 year old, (3) 1-5 years old, and (4) >5 years older." However, the specific number of subjects within each group or total number of subjects is not provided.
• Data Provenance: The document does not explicitly state the country of origin or whether the data was retrospective or prospective. It describes a "clinical investigation was performed," which typically implies prospective data collection, but this is not explicitly confirmed.

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

• Number of Experts: This information is not provided.
• Qualifications of Experts: This information is not provided. The ground truth was established by a "reference contact clinical electronic thermometer BT-21H," implying a standardized measurement rather than expert interpretation.

4. Adjudication Method for the Test Set

• Adjudication Method: This information is not applicable/provided. The ground truth was based on measurements from a reference contact clinical electronic thermometer (axillary temperature) rather than subjective assessments requiring adjudication.

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

• MRMC Study: This information is not applicable. The device is a thermometer, not an AI-assisted diagnostic tool that would involve human readers interpreting images or results. No MRMC study was conducted or is relevant for this type of device.

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

• Standalone Performance: Yes, the clinical investigation evaluates the device's standalone performance directly by comparing its readings to a reference thermometer. The "clinical bias, clinical accuracy and clinical repeatability" are measures of the device's inherent performance.

7. The Type of Ground Truth Used

• Type of Ground Truth: The ground truth for the clinical study was established using measurements from a reference contact clinical electronic thermometer BT-21H, which measured axillary temperatures. This serves as a point of comparison for the non-contact infrared thermometer.

8. The Sample Size for the Training Set

• Sample Size for Training Set: This information is not provided and is generally not applicable in the context of a non-AI based medical device like a thermometer. Thermometers are typically designed and calibrated based on physical principles and standards, not through machine learning training data.

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

• Ground Truth for Training Set: This information is not provided and is generally not applicable for a non-AI device. Calibration and design validation would follow established metrological practices and standards rather than a "training set" with ground truth in the machine learning sense.

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The Infrared Body Thermometer, Model: HTD8216C, is an electronic clinical thermometer using an infrared sensor to detect body temperature from the forehead or auditory canal in people of all ages for home setting use.

Infrared Body Thermometer, model: HTD8216C, is an electronic thermometer using an infrared sensor (thermopile) to detect body temperature from the central forehead or auditory canal. Its operation is based on measuring the natural thermal radiation emanating from the central forehead or tympanic membrane.

The forehead mode of Infrared Body Thermometer measure temperature by reading infrared radiation emitting from the central forehead skin. The central forehead skin is thin & flat, and the temperature is uniform to cover the Whole FOV (Field of View) of the sensor.

The ear mode of Infrared Body Thermometer measure temperature by reading infrared radiation emitting from the eardrum tissue. The ear mode of Infrared Body Thermometer measure temperature by reading infrared radiation emitting from the eardrum tissue when the thermometer is inserted into the ear canal.

To measure body temperature, the probe of the thermometer is inserted into a patient's outer ear canal or put onto the skin of a patient's central forehead. Pressing the activation button (for ear or forehead) to start the measurement of target's infrared radiation. The electrical signal read out from the detector is fed to the circuit for amplification and calculation. The final measured temperature will be appeared on a LCD display. The total operation takes a few seconds.

Here's a summary of the acceptance criteria and the study proving the device meets them, based on the provided text:

Device: Infrared Body Thermometer, Model: HTD8216C

1. Table of Acceptance Criteria and Reported Device Performance:

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

• Sample Size: The document states that the clinical investigation report and data analysis followed the requirements of ASTM E 1965-98 and ISO 80601-2-56. These standards typically specify patient cohorts and measurements for clinical accuracy testing. However, the exact sample size for the test set is not explicitly stated in the provided text. It only mentions "three group's temperature readings difference".
• Data Provenance: Not explicitly stated. The document is from a Chinese company (HeTaiDa Technology Co., Ltd. in Guangdong, China) and was submitted to the FDA. It does not clarify if the clinical study was conducted in China, the US, or elsewhere, nor whether it was retrospective or prospective.

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 study compares the device's readings to a "digital thermometer" (referred to as the "ground truth" or reference, typically a rectal or oral thermometer), but does not mention experts establishing a ground truth for individual cases. For clinical thermometer accuracy, the ground truth is usually established by a validated reference thermometer.

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

• None explicitly mentioned. For clinical accuracy studies of thermometers, an adjudication method for human interpretation is not typically required, as the ground truth is a direct temperature measurement from a reference device.

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 infrared body thermometer, not an AI-assisted diagnostic tool that involves human readers interpreting images or data. Therefore, an MRMC comparative effectiveness study involving human readers and AI assistance was not performed.

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

• Yes, this is essentially a standalone device performance study. The device itself measures and displays temperature. The clinical study evaluated the accuracy of the device's measurements relative to a reference (digital thermometer) without directly involving a human-in-the-loop for interpretation of the device's output.

7. The type of ground truth used:

• Clinical temperature measurements from a reference device. The "digital thermometer" serves as the ground truth for comparison. This implies a standard clinical measurement method that is widely accepted for accuracy.

8. The sample size for the training set:

• This information is not provided as there is no mention of a "training set" in the context of this device. Thermometers are typically calibrated during manufacturing and their accuracy is demonstrated through performance testing against established standards, rather than machine learning training.

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

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

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