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Automatic Digital Blood Pressure Monitor is intended to measure the systolic and diastolic blood pressure as well as the pulse rate of adult person via non-invasive oscillometric technique in which an inflatable cuff is wrapped around the wrist or the upper arm. It can be used at medical facilities or at home. The intended wrist circumference is 12.520 cm and the intended arm circumference has several models: 2333 cm, 2535 cm, 2242 cm, 33~43 cm.

Automatic Digital Blood Pressure Monitor is a non-invasive blood pressure measurement system intended to measure the diastolic and systolic blood pressures and pulse rate of an adult individual via non-invasive Oscillometric technique in which an inflatable cuff is wrapped around the wrist or the upper arm.It can be used at medical facilities or at home. The Automatic Digital Blood Pressure Monitor main units have the operating elements of ON/OFF knob, SET key which can be user-friendly controlled. Arm type Blood Pressure Monitor is equipped with inflatable cuff, while The wrist type Blood Pressure Monitor`s cuff is attached to the device body itself.

This document is a 510(k) summary for an Automatic Digital Blood Pressure Monitor. It describes the device's characteristics, intended use, and comparison to predicate devices to demonstrate substantial equivalence.

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

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for the blood pressure monitor's accuracy are based on ISO 81060-2:2013 Non-invasive sphygmomanometers - Part 2: Clinical validation of automated measurement type.

Note: The document explicitly states the device meets the ISO 81060-2 standard but doesn't provide granular numerical data beyond the +/- tolerance levels. It confirms the device's accuracy specifications align with the standard.

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

• Sample Size (Test Set):
  • Arm Sphygmomanometer: 90 patients (divided by cuff size: 23-33cm: 49 males and 41 females; 25-35cm: 38 males and 52 females; 22-42cm: 48 males and 42 females; 33-43cm: 38 males and 52 females).
  • Wrist Sphygmomanometer: 90 patients (43 males and 47 females).
  • Total Patients: 180 (90 arm + 90 wrist).
• Data Provenance: The document does not explicitly state the country of origin. It indicates the clinical study was conducted, and "All the subjects were volunteer to take part in the clinical study." The study is described as a clinical investigation, implying a prospective study.

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

The document does not specify the number of experts or their qualifications. However, for blood pressure measurements, the "ground truth" is typically established by trained medical professionals (e.g., physicians, nurses) using a reference device.

4. Adjudication Method for the Test Set

The document states: "The manual Mercury Sphygmomanometer was used as a reference device." This implies a comparison method where the device's readings are compared against the gold standard (manual mercury sphygmomanometer readings). It does not describe an adjudication method with multiple readers deciding on a "ground truth" where there might be inter-reader variability, as would be common in diagnostic imaging studies. The reference device is the 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 typically performed for AI-assisted diagnostic devices to assess how AI impacts human reader performance. This device is a direct measurement device (automatic blood pressure monitor), not an AI-enabled diagnostic tool in the sense that an algorithm assists human interpretation of images. The study focused on the device's accuracy compared to a reference standard.

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

Yes, in a sense, the primary test conducted was a "standalone" performance test of the device. The clinical study evaluated the direct output of the Automatic Digital Blood Pressure Monitor against a manual mercury sphygmomanometer, without human interpretation of the device's output being a variable. The device itself performs the measurement and provides readings.

7. The Type of Ground Truth Used

The ground truth used was measurements from a manual Mercury Sphygmomanometer. This is considered a highly reliable and commonly accepted gold standard for blood pressure measurement.

8. The Sample Size for the Training Set

The document does not provide information about a separate "training set" or its sample size. This is typical for medical devices that perform a direct physical measurement (like a blood pressure monitor) and are validated against a known standard. The "training" for such a device is typically part of its engineering and algorithm development, not a discrete data set for a machine learning model submitted for regulatory review in the same way as AI software.

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

As no specific training set is mentioned in the regulatory document (likely because the device's function is a direct measurement and not an AI/ML model requiring a separate training data ground truth for submission), this information is not provided. The device's underlying algorithm is likely developed and refined through engineering and calibration processes based on known physiological principles of oscillometric measurement, rather than learning from a 'labeled training dataset' in the context of AI.

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Infrared Forehead Thermometer (Models: HA-610, HA-620, HA-630, HA-640, HA-650) is a non-sterile, reusable, clinical thermometer intent determination of human body temperature in a touch and no touch mode using the center of the forehead as the measurement site on people of all ages. The devices are reusable for home use only.

The Infrared Forehead Thermometer (Models: HA-610, HA-630, HA-640, HA-640, HA-650) is a hand-held, battery powered, infrared Thermometer that coverts a user's forehead temperature, using the infrared energy emitted from the area around the user's forehead, to an oral equivalent temperature when placed within 1-5 cm to the subject's forehead with no contact. It uses a thermopile sensor with integrated thermistor for ambient temperature readings.

It composed by a measuring sensor, set button, a start button, battery compartment, Buzzer, a LCD and a ABS plastic enclosure, and measuring without probe cover.

Here's an analysis of the provided text regarding the acceptance criteria and study for the Infrared Forehead Thermometer (Models: HA-610, HA-620, HA-640, HA-650).

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for clinical performance are derived from ISO 80601-2-56 and ASTM E1965-98 (2016). The document explicitly states that the device complied with the requirements of ISO 80601-2-56. Specific numerical acceptance criteria are directly mentioned for measurement accuracy.

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

• Sample Size: 240 subjects.
• Data Provenance: The document does not explicitly state the country of origin. However, the manufacturer is Xiamen Ants Bro Technology Co., Ltd. in China, and the application correspondent is Guangzhou GLOMED Biological Technology Co., Ltd. in China. It is highly probable the study was conducted in China. The study appears to be prospective as it describes the conduct of "clinical tests."

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 the ground truth. It states that "clinical performance test protocol and data analysis were conducted in accordance with the requirement of ISO80601-2-56." This standard would typically dictate the methodology for ground truth establishment (e.g., using a reference thermometer).

4. Adjudication Method for the Test Set

The document does not specify any adjudication method (e.g., 2+1, 3+1, none). Given the nature of a clinical thermometer study, ground truth is typically established by physical measurement with a highly accurate reference device, rather than expert review requiring adjudication among multiple experts.

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 typically performed for AI-driven diagnostic imaging devices where human readers interpret cases with and without AI assistance. This submission concerns a clinical thermometer, which is a direct measurement device not involving human interpretation in the same manner.

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

Yes, the clinical study performed for the Infrared Forehead Thermometer is a standalone performance evaluation of the device itself. The device takes a measurement independently, and its accuracy is compared against a reference standard. There is no "human-in-the-loop" component in the direct temperature measurement.

7. The Type of Ground Truth Used

The ground truth for the clinical study was established by reference measurements as dictated by the ISO 80601-2-56 standard for clinical thermometers. This typically involves comparing the device's readings to those obtained from a highly accurate, calibrated reference thermometer. The document implies this by stating the study complied with ISO 80601-2-56.

8. The Sample Size for the Training Set

This information is not provided and is generally not applicable in the typical sense of AI/ML models. The Infrared Forehead Thermometer is a measurement device that functions based on physical principles (infrared radiation detection) and calibration, not on a "training set" of data in the way an AI algorithm learns. While the device's internal algorithms or calibrations might have been developed using some data, it's not structured as a distinct "training set" in the context of this regulatory submission.

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

This information is not provided and not applicable for the reasons mentioned in point 8. The ground truth for calibrating the device would be established through highly controlled laboratory measurements using known temperature sources and reference thermometers, following metrological standards.

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Digital Thermometer (models TM-2011, TM-3002, TM-3102) intended for the measurement and monitoring of human body temperature by users for home use. It can be used for axillary measurement and oral measurement.

Digital Thermometers comprises a thermistor for getting temperature signal, a reference resistor for comparing the resistance of the thermistor, an ASIC for processing the target temperature digitally, and a LCD for displaying the temperature. The design principle of thermometer is based on thermosensor and ASIC technology. A thermistor is used as thermosensor. The ASIC gets the sensor's signal from human body, then processes the signal and calculates the result, after that displays the temperature result by a LCD. There is buzzing noise occurs when the device turns on and when the measurement is completed (for model TM-3002 and TM-3102 only.

The provided document describes the 510(k) premarket notification for a Digital Thermometer. It includes a summary of tests performed to demonstrate safety and performance.

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

1. Table of Acceptance Criteria and Reported Device Performance

The document refers to adherence to specific standards rather than explicitly listing acceptance criteria with numerical targets in a table against which the device performance is reported. However, the "Remark" column in the comparison table indirectly indicates that the device meets the criteria by stating "SE" (Substantially Equivalent) or by providing explanations if there are differences.

Note 1: The document states that "Although there is a little difference between the 'measurement accuracy' and 'Measurement Speed', the subject device accuracy is compliance with ISO 80601-2-56 and ASTM E 1112 requirements. So, the difference of accuracy will not raise any safety of effectiveness issue." This implies that the specific performance values meet the acceptance criteria defined by these standards.

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

• Sample Size for Clinical Tests: 240 subjects were evaluated for the clinical tests performed on Model TM-3102.
• Data Provenance: The document does not explicitly state the country of origin or whether the data was retrospective or prospective. It only mentions that the clinical performance test protocol and data analysis were conducted "in accordance with the requirement of ISO 80601-2-56."

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

Not applicable. This device is a digital thermometer, and the ground truth for temperature measurement is typically obtained directly from the device's reading or a reference standard, not through expert interpretation of images or other subjective data. No experts were used to establish ground truth in the context of diagnostic interpretation.

4. Adjudication method for the test set

Not applicable, as this is a digital thermometer and not an AI/imaging device requiring expert adjudication for ground truth. The performance is assessed against physical standards and clinical measurements.

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

Not applicable. This is a standalone medical device (digital 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

Yes, a standalone performance evaluation was done. The "Test Summary" and "Discussion of Clinical Tests Performed" sections describe various lab bench tests and clinical tests to evaluate the safety and performance of the device itself (Models TM-2011, TM-3002, TM-3102) against established standards (e.g., IEC 60601-1, ISO 80601-2-56, ASTM E1112-00). This indicates the algorithm (or the device's internal processing) only performance was assessed.

7. The type of ground truth used

The ground truth for the clinical performance tests (temperature measurements) would primarily be the actual body temperature measurements obtained through a reference standard or the device's readings compared against such standards, as required by ISO 80601-2-56 and ASTM E1112-00 for clinical electronic thermometers.

8. The sample size for the training set

Not applicable. This is not an AI/machine learning device that requires a training set. Its functionality is based on established thermistor and ASIC technology.

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

Not applicable, as there is no training set for this type of device.

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