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Infrared Thermometer is intended to detect body temperature from forehead in the population including infant (above 6 months), child, adolescent, and adult.

The proposed device, Infrared Thermometers, which includes model FR800 and FR850 are hand-held, reusable, battery powered device, which are intended to detect body temperature from forehead for infant (above 6 months), child, adolescent, and adult.

The proposed device is intended for non-contacting infrared temperature measurement. The distance of the measurement is 3cm~5cm.

The proposed device uses a temperature sensor, which can detect the object temperature [human body temperature], environment temperature and temperature of sensor itself; these temperatures are then transfer to electronic signal and amplified; and then it is transferred to digital signal by AD module in MCU of the proposed device. MCU will calculate the body temperature, and then transfer to screen for display.

The Infrared Thermometer, Models FR800 and FR850, underwent non-clinical and clinical testing to demonstrate its substantial equivalence to the predicate device, Microlife Digital Infrared Forehead Thermometer, Model FR1MN1-1 (K161728).

1. Acceptance Criteria and Reported Device Performance:

2. Sample Size for Test Set and Data Provenance:

• Sample Size: Not explicitly stated in the provided text for the clinical study. It mentions "Controlled human clinical studies were conducted," but not the number of subjects.
• Data Provenance: Not explicitly stated (e.g., country of origin). The testing was conducted in accordance with ASTM E 1965-98(2003) which is an American standard, implying the study might adhere to practices commonly found in regions where this standard is adopted, but specific origin is not mentioned. The sponsor and correspondent are based in China, suggesting the possibility of data collection there or involvement of Chinese entities in the study.

3. Number of Experts and Qualifications:

• This information is not provided in the given document. The document refers to non-clinical and clinical testing, but does not detail the specific involvement or qualifications of experts for establishing ground truth within the clinical trial context.

4. Adjudication Method for the Test Set:

• This information is not provided in the given document.

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

• No, a multi-reader multi-case (MRMC) comparative effectiveness study was not explicitly mentioned or performed. The clinical testing focused on the standalone performance of the device ("clinical accuracy of the proposed device is not inferior to that of predicate device") rather than its effect on human reader performance.

6. Standalone Performance Study:

• Yes, a standalone (algorithm only without human-in-the-loop performance) study was done. The non-clinical tests (Electrical Safety, EMC, Performance standards, Biocompatibility, Software V&V) and the clinical accuracy evaluation directly assess the device's inherent performance. The clinical study evaluated the device's standalone ability to measure body temperature accurately, comparing it to the performance requirements in standards and to the predicate device.

7. Type of Ground Truth Used:

• For the clinical study, the ground truth was based on clinical validation for infrared thermometer following ASTM E 1965-98(2003). This standard typically involves comparing the device's readings against a highly accurate reference thermometer (e.g., a mercury-in-glass or electronic contact thermometer in a controlled environment), often with a core body temperature measurement as the gold standard. The document states "clinical bias, clinical uncertainty and clinical repeatability have been evaluated per clinical validation."

8. Sample Size for the Training Set:

• This information is not applicable as this device (Infrared Thermometer) is a hardware medical device that directly measures a physical parameter. It does not use algorithms that require a "training set" in the context of machine learning. The "software verification and validation" mentioned refers to traditional software engineering processes, not machine learning model training.

9. How Ground Truth for Training Set Was Established:

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

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Infrared Thermometer is intended to detect body temperature from the forehead or auditory canal in the population including infant (above 6 months), child, adolescent, and adult

The proposed device, Infrared Thermometers IFR 600 is hand-held, reusable, battery powered device, which is intended to detect body temperature from forehead or auditory canal in the pediatric and adult population.

IFR 600 infrared thermometer can measure human body temperature by both ear and forehead measurement.

The provided document describes the acceptance criteria and a clinical study conducted for the Infrared Thermometer Model IFR 600 by Shenzhen Jiacom Technology Co., Ltd.

Here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are generally based on compliance with specific international standards and the clinical accuracy of the device. The reported performance confirms this compliance.

Acceptance Criteria for Infrared Thermometer Model IFR 600

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

• Sample Size for Clinical Study (Test Set): "40 of each age range of subjects" were included. The document specifies the population as "infant (above 6 months), child, adolescent, and adult". It's unclear how many distinct age ranges were used, so the total exact sample size is not precisely specified but would be 40 multiplied by the number of age ranges. For example, if there were 4 age ranges (infant, child, adolescent, adult), the total would be 160.
• Data Provenance: Not explicitly stated (e.g., country of origin). The study is described as "Controlled human clinical studies," suggesting it was prospective research.

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

The document does not provide information on the number of experts used or their qualifications for establishing ground truth for the clinical study. It refers to "clinical validation for infrared thermometer" and compliance with ASTM E 1965-98 for evaluating clinical bias, uncertainty, and repeatability.

4. Adjudication Method for the Test Set

The document does not specify any adjudication method for the test set.

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

A multi-reader multi-case (MRMC) comparative effectiveness study was not explicitly mentioned. The study compared the device's clinical accuracy, bias, uncertainty, and repeatability to that of a predicate device, but not in the context of human readers improving with or without AI assistance. The device itself is a standalone infrared thermometer, not an AI-assisted diagnostic tool for human readers.

6. If a Standalone Study Was Done

Yes, a standalone study was done. The clinical tests were performed to evaluate the performance of the Infrared Thermometer Model IFR 600 by itself, specifically its clinical accuracy, bias, uncertainty, and repeatability, in comparison to a predicate device and against the requirements of ASTM E 1965-98.

7. The Type of Ground Truth Used

The ground truth for the clinical study was established by comparison with established methods or references for body temperature measurement, implicitly defined by the clinical validation requirements of ASTM E 1965-98 (Standard Specification for Infrared Thermometers for Intermittent Determination of Patient Temperature). The document refers to evaluating "clinical bias, clinical uncertainty and clinical repeatability." The ASTM standard typically outlines how to establish reference body temperatures against which the infrared thermometer's readings are compared.

8. The Sample Size for the Training Set

This question is not applicable as the device is a medical device (infrared thermometer) and not an AI/Machine Learning algorithm that requires a "training set" in the conventional sense. The "training" here refers to product development and testing, where the device's design is refined to meet the performance standards.

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

This question is not applicable for the same reason as point 8. The "ground truth" for the device's performance was established through compliance with recognized standards (ISO, ASTM) and clinical validation against these standards.

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Wrist Type Automatic Blood Pressure Monitor is a digital monitor intended for use in measuring blood pressure and pulse rate in adult patient population who can understand the instruction manual with the wrist circumference range printed on the wrist cuff. The intended wrist circumference is 13.5-19.5 cm.

The proposed device, Wrist Type Automatic Blood Pressure Monitor, is a battery driven automatic non-invasive blood pressure monitor. It can automatically complete the inflation and measurement, which can measure systolic and diastolic blood pressure and pulse rate of the adult person at wrist within its claimed range and accuracy via the oscillometric technique. User can select the unit of the measurement: mmHg or KPa.

The device has the data storage function in order for data reviewing, including the systolic pressure, diastolic pressure, pulse rate and measurement time. It has a bar indicating function, which can indicate the WHO (World Health Organization) Blood Pressure Classification of the measured blood pressure by referencing Diastolic Blood Pressure issued at Journal of Hypertension 1999. Vol 17, No.2.

The proposed device is intended to be used in medical facilities or at home. And it is provided non-sterile, and not to be sterilized by the user prior to use.

The proposed blood pressure monitor includes 5 models, which are BP165W, BP180W, BP186W and BP 188W. All models follow the same software, measurement principle and NIBP algorithm. The main differences are product appearance and key numbers.

The provided text describes the acceptance criteria and a clinical study for the Wrist Type Automatic Blood Pressure Monitor (Models: BP165W, BP180W, BP186W, BP188W) by Shenzhen Jiacom Technology Co., Ltd.

Here's a breakdown of the requested information:

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

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 states that a clinical accuracy study was conducted according to ISO 81060-2:2013. This standard details the requirements for clinical validation of automated non-invasive sphygmomanometers. While the specific sample size, country of origin, and whether the data was retrospective or prospective are not explicitly stated in this document, adherence to ISO 81060-2:2013 generally implies:

• A minimum of 85 participants for clinical testing to ensure a statistically robust evaluation (as per the standard's requirements for phase II testing).
• A prospective study design, as the standard describes a protocol for conducting direct comparisons against a reference measurement.
• Data provenance would be from the site where the clinical validation was performed, but the specific country is not mentioned.

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)

Again, the document does not explicitly state the number or qualifications of experts. However, for a clinical validation study adhering to ISO 81060-2:2013, the ground truth (reference blood pressure measurements) is typically established by trained observers (experts) using a mercury or auscultatory sphygmomanometer. The standard requires the observers to be trained and qualified, often with specifications regarding their experience and successful completion of a training program to minimize inter-observer variability.

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

For clinical validation studies following ISO 81060-2:2013, the standard dictates that reference blood pressure measurements be taken simultaneously by at least two trained observers using an auscultatory method. If there is a significant discrepancy between the two observers' readings, a third observer might be involved (though the standard prioritizes agreement between the initial two). So, a 2 (two trained observers) method is implied, with potential for adjudication if specified by the study protocol compliant with the standard.

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

There is no indication that a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was conducted, nor is there any mention of "AI assistance" or "human readers" in the context of blood pressure measurement in this document. This device is an automatic blood pressure monitor, not an AI-assisted diagnostic tool requiring human interpretation.

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

Yes, the primary clinical validation conducted was a standalone performance study of the device's algorithm. The document states that the "clinical accuracy of the proposed device was evaluated per... ISO 81060-2 Second Edition 2013-05-01." This standard specifically assesses the automated device's ability to measure blood pressure without human intervention (other than proper placement and initiation of the measurement), comparing its readings to simultaneously obtained reference measurements.

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

The ground truth used for the clinical validation would be expert reference measurements obtained using a validated auscultatory method (e.g., mercury sphygmomanometer) as mandated by the ISO 81060-2:2013 standard.

8. The sample size for the training set

The document does not provide any information about a "training set" or algorithm development. The information focuses on the clinical validation of an already developed device. Automatic blood pressure monitors based on oscillometric techniques often rely on established algorithms and calibration methods rather than machine learning "training sets" in the contemporary sense.

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

As no training set is described in the provided information, the method for establishing its ground truth is also not mentioned.

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Arm Type Automatic Blood Pressure Monitor is a digital monitor intended for use in measuring blood pressure and pulse rate in adult patient population via non-invasive oscillometric technique in which an inflatable cuff is wrapped around the arm. It can be used at medical facilities or at home. The intended arm circumference is 22-32 cm.

The proposed device, Arm Type Automatic Blood Pressure Monitor, is a battery driven automatic non-invasive blood pressure monitor. It can automatically complete the inflation and measurement, which can measure systolic and diastolic blood pressure and pulse rate of the adult person at upper arm within its claimed range and accuracy via the oscillometric technique. User can select the unit of the measurement: mmHg or KPa.

The device has the data storage function in order for data reviewing, including the systolic pressure, diastolic pressure, pulse rate and measurement time. It has a bar indicating function, which can indicate the WHO (World Health Organization) Blood Pressure Classification of the measured blood pressure by referencing Diastolic Blood Pressure issued at Journal of Hypertension 1999. Vol 17, No.2.

The proposed device is intended to be used in medical facilities or at home. And it is provided non-sterile, and not to be sterilized by the user prior to use.

The proposed blood pressure monitor includes 9 models, which are BP310A, BP351A, BP362A, BP366A, BP369A, BP380A, BP389A, and BP-JC312. All models follow the same software, measurement principle and NIBP algorithm. The main differences are product appearance and key numbers.

The provided document describes the acceptance criteria and a clinical study conducted for the Arm Type Automatic Blood Pressure Monitor to demonstrate its substantial equivalence to a predicate device.

Here's the breakdown of the information requested:

1. Table of Acceptance Criteria and Reported Device Performance

The clinical accuracy of the device was evaluated according to the standard ISO 81060-2:2013, "Non-Invasive Sphygmomanometers - Part 2: Clinical Validation Of Automated Measurement Type." While the document states the device complies with the standard requirements, it does not explicitly list the detailed acceptance criteria and reported device performance from the ISO 81060-2:2013 standard within the provided text.

However, based on the general information provided for blood pressure monitors, the key performance metrics and their accuracies are stated:

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

The document states that a clinical investigation was conducted according to ISO 81060-2:2013. The ISO 81060-2 standard specifies a minimum of 85 subjects for clinical validation. Although the exact number used in this specific study is not explicitly mentioned, it can be inferred that at least 85 subjects were used to comply with the standard.

• Sample Size for Test Set: Not explicitly stated, but ISO 81060-2:2013 requires a minimum of 85 subjects.
• Data Provenance: Not specified (e.g., country of origin, retrospective or prospective). The document only states "clinical investigation... has been conducted."

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

The ISO 81060-2 standard requires that the simultaneous auscultation method, performed by human observers, serves as the reference standard (ground truth). This typically involves multiple trained observers.

• Number of Experts: Not explicitly stated in the document, but ISO 81060-2:2013 generally requires at least two experts (trained observers) for simultaneous auscultation.
• Qualifications of Experts: Not explicitly stated. For ISO 81060-2, the observers must be trained and validated against a mercury sphygmomanometer.

4. Adjudication Method for the Test Set

The ISO 81060-2 standard (which this study followed) uses a simultaneous auscultation method where mercury sphygmomanometers are used in conjunction with the test device. This involves multiple observers (typically two) taking measurements simultaneously and independently. If there's a significant discrepancy between their readings, a third observer might be involved or the measurement discarded.

• Adjudication Method: Implicitly, the method follows the procedures outlined in ISO 81060-2 for simultaneous auscultation, which includes specific rules for reconciling or handling differences between observers' readings to establish the reference blood pressure. This could be considered akin to a 2-observer consensus (or 2+1 if required) process for establishing ground truth.

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

No, an MRMC comparative effectiveness study was not done. This type of study is more common for diagnostic imaging AI systems where human readers interpret medical images with and without AI assistance. This document describes the validation of a non-invasive blood pressure monitor, which is a standalone measurement device, not an AI-assisted interpretation tool for human readers.

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

Yes, a standalone performance evaluation was done. The clinical investigation directly assessed the accuracy of the automated blood pressure monitor against the reference standard (human auscultation) without human interpretation of the device's output influencing the measurement. The device's "algorithm only" performance (the oscillometric technique's ability to measure blood pressure) is what was validated.

7. The Type of Ground Truth Used

The ground truth used for the clinical validation was expert consensus (or reference) measurements obtained via simultaneous auscultation using mercury sphygmomanometers, as mandated by the ISO 81060-2 standard.

8. The Sample Size for the Training Set

The document does not provide information about a specific training set or its sample size. This type of blood pressure monitor relies on a pre-defined oscillometric algorithm. While the algorithm itself would have been developed and potentially refined using a dataset, information on this "training set" is not part of this medical device submission document, which focuses on the validation of the final product.

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

As no information is provided about a training set, the method for establishing its ground truth is also not available in this document.

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