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The Arm-type Fully Automatic Digital Blood Pressure Monitors are intended to measure blood pressure (systolic and diastolic) and pulse rate of adults and adolescents over 12 years of age with circumference ranging from 22cm to 36cm or 22cm to 42cm or 32cm to 48cm.

The Wrist-type Fully Automatic Digital Blood Pressure Monitors are intended to measure blood pressure (systolic and diastolic) and pulse rate of adults and adolescents over 12 years of age with circumference ranging from 13.5cm to 21.5cm.

The Arm-type and Wrist-type Fully Automatic Digital Blood Pressure Monitor (BPM) series is automatic, non-invasive, blood pressure measurement system for over-the-counter (OTC) use in home and clinical environment . The systolic and diastolic pressures are determined using the oscillometric method, where the cuff is inflated with an integral controllable piezoelectric pump and deflates via an electric automatic rapid deflation valve. During measurements, an electric pump within the main unit slowly inflates the arm/wrist cuff, generating cuff pressure which is monitored and from which pulse waveform data is extracted. This waveform data is analyzed by software algorithms within the microprocessor to determine pulse rate, systolic pressure, and diastolic pressure. The cuff can measure pressure range from 0 to 299mmHg, and the pulse rate range from 30 to 180 beats/min.

The pulse rate measurement is compare the longest and the shortest time intervals of detected pulse waves to mean time interval and displays a warning signal with the reading to indicate the detection of irregular heartbeat when the difference of the time intervals is over 25%.

Meanwhile, these blood pressure monitor devices can be used as a stand-alone unit to finish the blood pressure measurement or in conjunction with the "JoyHealth" APP through the embed a 2.4GHz BLE module that allow users to connect with nearby BT receiving terminal. Once measurement is over, the LCD of the device displays results. And the device will start to transmit data to the pair-up terminal automatically. This app is only intended to display trend graphs of measured systolic and diastolic blood pressure and pulse rate, which does not provide any diagnostic or measurement functions, and does not interpret or analyze the data for medical decision making.

The provided document outlines the substantial equivalence of the "Arm-type Fully Automatic Digital Blood Pressure Monitor" and "Wrist-type Fully Automatic Digital Blood Pressure Monitor" to previously cleared predicate devices. The primary focus for proving substantial equivalence concerning performance criteria relies on adherence to the ISO 81060-2:2018+AMD2020 standard for non-invasive sphygmomanometers.

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

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are derived from the ISO 81060-2:2018+AMD2020 standard, which is a recognized standard for clinical validation of non-invasive sphygmomanometers. The reported performance is the conclusion that the devices meet these requirements.

Note: The document broadly states that "The results showed the accuracy of the blood pressure monitor is within acceptable scope specified in ISO 81060-2:2018+AMD2020." Specific numerical mean differences and standard deviations for systolic and diastolic pressures are not explicitly provided, but the statement confirms compliance with the standard's thresholds.

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

• Arm-type (Cuff 22cm~42cm): 88 patients (47 females and 41 males). This data was from a clinical investigation report from another submission. The provenance is not explicitly stated as retrospective or prospective, but the context of "clinical study" typically implies prospective data collection for validation. The country of origin is also not specified.
• Arm-type (Cuff 32cm-48cm): 85 patients (36 females and 49 males). This data was collected using Model DBP-6279B as a representative for testing. The provenance is not explicitly stated as retrospective or prospective, but the context of "clinical study" typically implies prospective data collection for validation. The country of origin is also not specified.
• Arm-type (Cuff 22cm~36cm) and all Wrist-type models: For these, the applicant states they "cite the clinical investigation report of K212115," implying the sample sizes and provenance from that prior submission. The specific sample sizes for K212115 are not detailed in this document.

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

The ground truth for blood pressure measurements in the clinical validation studies was established through the "same arm sequential method" using a manual Mercury Sphygmomanometer as a reference device. This method implies that trained healthcare professionals, likely physicians or nurses, would have been responsible for obtaining the reference measurements. However, the exact number of experts/operators and their specific qualifications are not explicitly stated in this document. The ISO 81060-2 standard would require trained observers, but the document does not elaborate on this.

4. Adjudication Method for the Test Set

The "same arm sequential method" involves taking measurements simultaneously or in quick succession using both the device under test and the reference device on the same arm. This method inherently minimizes the need for an adjudication method in the traditional sense, as the comparison is direct. The standard outlines specific procedures for discrepancies and ensuring observer blinding where appropriate, but no explicit "adjudication" of disagreements between device and reference (beyond the statistical analysis) is mentioned.

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 is not applicable. The device is a fully automatic digital blood pressure monitor, not an AI-assisted diagnostic device involving human readers or interpretation of medical images. Therefore, an MRMC comparative effectiveness study involving AI assistance would not be performed 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 evaluation was done. The clinical validation studies described (using the "same arm sequential method" against a reference sphygmomanometer) directly assess the accuracy of the device's algorithm in measuring blood pressure and pulse rate without human-in-the-loop diagnostic interpretation. The device's primary function is automatic measurement, and the clinical studies validate this automatic function.

7. The Type of Ground Truth Used

The ground truth used was expert reference measurements obtained using a manual Mercury Sphygmomanometer. This is considered a gold standard (or a widely accepted clinical standard) for blood pressure measurement in clinical validation studies as per ISO 81060-2.

8. The Sample Size for the Training Set

The document does not explicitly mention a separate training set or its sample size. Medical devices like blood pressure monitors are typically developed using internal data and engineering principles, with clinical validation as the final step to demonstrate accuracy against a recognized standard. It's common for the development and optimization of the oscillometric algorithm to occur internally without public disclosure of a specific "training set" size in regulatory submissions for these types of devices. The filing focuses on the validation of the final product.

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

As no explicit "training set" is mentioned, the method for establishing its ground truth is also not provided. The focus of the submission is on the clinical validation of the finished device.

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The Fully Automatic Digital Blood Pressure Monitors are intended to measure (systolic and diastolic) and pulse rate of adults and adolescents over 12 years of age.

The Arm-type and Wrist-type Fully Automatic Digital Blood Pressure Monitor (BPM) series is automatic, non-invasive, blood pressure measurement system for over-the-counter (OTC) use in home and clinical environment . The systolic and diastolic pressures are determined using the oscillometric method, where the cuff is inflated with an integral controllable piezoelectric pump and deflates via an electric automatic rapid deflation valve. During measurements, an electric pump within the main unit slowly inflates the arm/wrist cuff, generating cuff pressure which is monitored and from which pulse waveform data is extracted. This waveform data is analyzed by software algorithms within the microprocessor to determine pulse rate, systolic pressure, and diastolic pressure. The cuff can measure pressure range from 0 to 299mmHg, and the pulse rate range from 30 to 180 beats/min.

The pulse rate measurement is compare the longest and the shortest time intervals of detected pulse waves to mean time interval and displays a warning signal with the reading to indicate the detection of irregular heartbeat when the difference of the time intervals is over 25%.

Meanwhile, these blood pressure monitor devices can be used as a stand-alone unit to finish the blood pressure measurement or in conjunction with the "JoyHealth" APP through the embed a 2.4GHz BLE module that allow users to connect with nearby BT receiving terminal. Once measurement is over, the LCD of the device displays results. And the device will start to transmit data to the pair-up terminal automatically. This app is only intended to display trend graphs of measured systolic and diastolic blood pressure and pulse rate, which does not provide any diagnostic or measurement functions, and does not interpret or analyze the data for medical decision making.

Unlimited readings can be stored in the app for archiving and review by the user.

The provided document is a 510(k) summary for Joytech Healthcare Co., Ltd.'s Fully Automatic Digital Blood Pressure Monitors. It describes the device, its intended use, comparison with predicate devices, and performance data to demonstrate substantial equivalence.

Based on the provided text, the device in question is a Fully Automatic Digital Blood Pressure Monitor (both arm-type and wrist-type). The study described is a clinical investigation to assess the accuracy of blood pressure and pulse rate measurements. This is not an AI/ML study, but rather a traditional medical device accuracy study. Therefore, several of the requested sections related to AI/ML specific criteria (like effect size of human readers with vs. without AI, training set details, ground truth establishment for training set) are not applicable or cannot be extracted from this document.

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

Device Under Evaluation: Joytech Healthcare Co., Ltd.'s Fully Automatic Digital Blood Pressure Monitors (Arm-type and Wrist-type models)

Purpose of the Study: To demonstrate the accuracy of the blood pressure monitor measurements against a reference device, in accordance with ISO 81060-2:2018+AMD2020. This is to support the substantial equivalence claim for 510(k) clearance.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are implicitly defined by the standard ISO 81060-2:2018+AMD2020 (Non-invasive sphygmomanometers --Part 2: Clinical investigation of intermittent automated measurement type). The document states that the results "showed the accuracy of the blood pressure monitor is within acceptable scope specified in ISO 81060-2:2018+AMD2020." Specific numerical performance metrics (e.g., mean difference and standard deviation of differences as per ISO 81060-2) and the exact acceptance thresholds are not explicitly listed in this summary, but rather referred to the standard.

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

• Test Set Sample Size:
  • Arm-type: 85 patients (46 females and 39 males)
  • Wrist-type (Model DBP-8278B representative): 85 patients (43 females and 42 males)
  • Wrist-type (Model DBP-8276H representative): 85 patients (41 females and 44 males)
• Data Provenance: The document does not explicitly state the country of origin. It indicates "clinical investigation," implying prospective data collection for the purpose of the study. All subjects were volunteers.

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

This information is not explicitly provided in the document. For blood pressure measurement accuracy studies following ISO 81060-2, the ground truth is typically established by trained and certified observers using a reference sphygmomanometer (e.g., manual mercury sphygmomanometer) following a strict protocol. The number of observers and their specific qualifications are not detailed here.

4. Adjudication Method for the Test Set

The document states, "The manual Mercury Sphygmomanometer was used as a reference device." It describes a "Same arm sequential method" (for arm-type) and "Same wrist sequential method" (for wrist-type) for the clinical testing. This implies direct comparison rather than an adjudication process typically seen in image-based AI studies where multiple readers interpret cases. The reference device measurement is considered the ground truth.

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 medical device accuracy study, not an AI/ML study, nor an MRMC study involving human readers and AI assistance.

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

N/A. The device is a blood pressure monitor that directly provides readings, not an AI algorithm that generates an interpretation for a human to review. The "standalone" performance here refers to the device's accuracy in measuring blood pressure against a reference.

7. The Type of Ground Truth Used

• Type of Ground Truth: Measurements obtained from a manual Mercury Sphygmomanometer.

8. The Sample Size for the Training Set

Not Applicable. This is a medical device accuracy study, not an AI/ML study that involves training a model.

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

Not Applicable. (See point 8)

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The Digital Thermometers DMT series(Except DMT-455) are intended to measure the human body temperature in regular mode orally, rectally or under the arm. And the devices are reusable for clinical or home use on people of all ages, including children under 8 with adult supervision.

The device model DMT-455 is intended to measure temperature orally, and the device is reusable for clinical or home use for children less than 4 years old with adult supervision.

The Digital Thermometers DMT series(Except DMT-455) are used to measure the human body temperature in regular mode orally, rectally, or under the arm.The device model DMT-455 is intended to measure temperature orally.

The Digital Thermometers DMT series consists of a temperature sensor, low power consumption integrated circuit (IC), LCD display, and buzzer. The resistance of sensor changes with temperature and the IC converts the resistance to frequency and calculates the temperature according to the relation of resistance and frequency. The calculated temperature is displayed on the LCD.Only model DMT-4726 and DMT-4735 are predictive optional thermometers.The patient contacting materials are Stainless Steel,TPE and Acrylonitrile Butadiene Styrene (ABS).

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

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

The clinical tests for the predictive optional thermometers (DMT-4726 and DMT-4735) were conducted on 450 subjects. The data provenance is not explicitly stated regarding country of origin or whether it was retrospective or prospective, but the context of a 510(k) submission for a new device typically implies prospective data collection for safety and effectiveness.

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

This information is not provided in the document. The document states that the "clinical performance test protocol and data analysis were conducted in accordance with the requirement of ISO 80601-2-56," which is a standard for clinical thermometers, but it does not detail the specific methodology for establishing ground truth or the qualifications of any experts involved in that process.

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

This information is not provided in the document. The document mentions compliance with ISO 80601-2-56 for clinical performance, but does not specify any adjudication method related to ground truth establishment.

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 is not applicable. The device is a digital thermometer, which directly measures temperature and does not involve "human readers" or "AI assistance" in the context of interpretation of medical images or other diagnostic data where MRMC studies are typically conducted.

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

The device itself is a standalone thermometer. The performance data presented refers to the direct measurement capabilities of the thermometer. The "clinical tests" described for models DMT-4726 and DMT-4735 assessed the device's ability to measure body temperature in living subjects against clinical standards, which inherently evaluates its standalone performance.

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

For clinical thermometers, the "ground truth" for temperature measurement is typically established by highly accurate reference thermometers or other established methods considered the gold standard, consistent with the requirements of standards like ISO 80601-2-56 and ASTM E1112. The document states the clinical tests were conducted in accordance with ISO 80601-2-56, which would imply the use of such a reference.

8. The sample size for the training set

This is not applicable. The device is a digital thermometer, which operates based on physical principles of thermistor resistance. It is not an AI/ML-based device that would require a "training set" in the conventional sense of machine learning. The performance data relates to validation and verification against established standards and clinical performance for the manufactured product.

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

This is not applicable as the device is not an AI/ML-based device requiring a training set. The "ground truth" in the context of thermometer calibration and performance testing would be derived from laboratory standards and validated reference measurements.

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Infrared Thermometer DET series are intended for the intermittent measurement of human body temperature by people of all ages. The devices are reusable for home use only.

The Infrared thermometers are hand-held, battery powered devices designed to measure human body temperature from the auditory canal or forehead. Its operation is based on measuring the natural thermal radiation from the tympanic membrane or forehead. The thermometers use a thermopile sensor with integrated thermistor for the target reading, a thermistor mounted in the head of the thermometer for ambient temperature readings, a thermopile collect, the infrared energy emitted from the forehead. The Infrared thermometer included DET-205,DET-305,DET-305,DET-306 and DET-215. DET-205 and DET-206 units are contact Infrared forehead thermometer,DET-305 and DET-306 units are non-contact Infrared forehead thermometer(measurement distance is 2~3cm), DET-215 unit is multifunction infrared thermometer and it can be selected Ear mode or Forehead mode. In addition,all models have voice function that used to broadcast the measurement temperature results after complete the measurement. It's working principle is that Microcontroller Unit sends voice commands to the voice integrated circuit and then broadcast the measurement temperature results that display on the LCD.The voice function is use English language and actives after each measurement completed.

The provided document is a 510(k) premarket notification for a medical device (Infrared Thermometers). It details the substantial equivalence of the subject device to legally marketed predicate devices, focusing on technical specifications and conformance to standards. However, it does not include the specific details typically found in a study proving a device meets acceptance criteria related to AI/ML performance, especially those involving human expert review, MRMC studies, or clear ground truth establishment for a test set. This document describes the validation of a traditional hardware thermometer, not an AI-powered device.

Therefore, many of the requested items (e.g., sample size for test set provenance, number of experts for ground truth, adjudication method, MRMC study, standalone performance for AI, training set details) are not applicable to this document as it concerns a non-AI/ML device.

Here's an attempt to extract the relevant information based on the document, noting where the requested information is absent or not applicable:

Device Type: Infrared Forehead Thermometer, Infrared Ear/Forehead Thermometer
Models: DET-205, DET-206, DET-305, DET-306, DET-215

1. Acceptance Criteria and Reported Device Performance

The acceptance criteria for these thermometers are based on conformance to recognized standards, primarily ASTM E1965-98 for performance and ISO 80601-2-56 for general safety and essential performance of clinical thermometers. The key performance metric is accuracy of temperature measurement.

Additional Conformance Standards:

• IEC 60601-1:2012 (Safety)
• IEC 60601-1-2:2014 (EMC)
• ISO 10993-5:2009 (Biocompatibility - In Vitro cytotoxicity)
• ISO 10993-10:2010 (Biocompatibility - irritation and skin sensitization)
• IEC 60601-1-11:2015 (Home healthcare environment)

The document states that a clinical performance test protocol and data analysis were conducted as required by ASTM E1965-98 (2016), and "The test report showed the clinical performance of the subject device complied with the requirement of ASTM E1965-98 (2016)."

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

• Sample Size for Clinical Tests: 165 subjects.
• Data Provenance: Not explicitly stated regarding country of origin, but the submitting company is based in China. The study is described as "clinical tests were conducted," implying a prospective study for the device's performance evaluation.
• Subject Groups: Infants (newborn to one year), Children (greater than one to five years), and Adults (greater than five years old).

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

Not Applicable. For a traditional thermometer, "ground truth" for temperature measurement is typically established using highly accurate reference thermometers or through controlled calibration procedures traceable to national standards, not through human expert review or consensus as would be the case for AI image interpretation. The clinical study evaluates the device's reading against an established reference method.

4. Adjudication Method for the Test Set

Not Applicable. As "ground truth" is not established by human experts in this context, an adjudication method is not relevant.

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

No. This is a hardware thermometer, not an AI/ML device. Therefore, no MRMC comparative effectiveness study was conducted to evaluate human reader improvement with AI assistance.

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

Not Applicable. This is a hardware device; there is no AI algorithm to evaluate in a standalone manner. The device's performance is intrinsically its "standalone" performance.

7. The Type of Ground Truth Used

The ground truth for temperature measurement would typically be established by:

• Comparison with a traceable reference thermometer (e.g., in a laboratory setting for accuracy testing against a known temperature).
• In the context of the "clinical performance test," it refers to the device's ability to accurately measure human body temperature as determined by standardized clinical protocols (e.g., comparison to rectal temperature as a gold standard in some contexts, or high-accuracy reference thermometers within a controlled clinical environment). The document explicitly states the test "complied with the requirement of ASTM E1965-98 (2016)," which outlines the methodology for clinical accuracy testing of infrared thermometers against a reference thermometer.

8. The Sample Size for the Training Set

Not Applicable. This is a hardware device, not an AI/ML model that requires a training set.

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

Not Applicable. No training set was used.

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The Fully Automatic Blood Pressure Monitors are intended to measure blood pressure (systolic and diastolic) and pulse rate of adults and adolescents age 12 through 21 years of age.

The arm-type series use an inflatable cuff which wraps around the patient's upper arm. The cuff is inflated automatically by an internal pump in the device. The systolic and diastolic blood pressures are determined by oscillometric method and silicon integrate pressure sensor technology. The deflation rate is controlled by a preset mechanical valve at a constant rate. The pressure of the cuff is completely released automatically at the end of the measurement. At the same time, the measurements are displayed on the LCD display for three minute. There is a maximum pressure safety setting at 300 mmHg. The device will not inflate the cuff higher than 300 mmHg.

The provided document describes the acceptance criteria and a clinical study conducted to demonstrate the substantial equivalence of the JOYTECH Fully Automatic Digital Blood Pressure Monitor (K173024) to its predicate devices. The study aimed to prove the accuracy of the blood pressure monitors.

Here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are based on the ISO 81060-2 Standard.
There are two methods for evaluation:

Method 1: Mean difference and standard deviation of differences.

Method 2: Standard deviation of averaged paired determinations.

Note on Method 2 Acceptance Criteria: The specific maximum permissible standard deviation (Sm) values are derived from "Tab 1" in the document, which provides a lookup table based on the averaged mean difference ($\overline{x}_n$). The reported values for the device performance (e.g., 3.71 mmHg for arm-type systolic) are compared against the corresponding values from this table (e.g., < 6.91 mmHg if the mean difference is around -0.57 mmHg). The document states that "the averages difference... and the corresponding standard deviation fall are within the range of the standard."

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

• Sample Size: 85 subjects for the arm-type blood pressure monitor and 85 subjects for the wrist-type blood pressure monitor.
• Data Provenance: The studies were conducted "in the hospital." The country of origin is implied to be China, as JOYTECH Healthcare Co., Ltd. is based in Hangzhou, China. The studies are prospective in nature, as they involved actively recruiting and measuring subjects for the clinical validation.

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

• Number of Experts: Two doctors were used to perform the simultaneous and blinded blood pressure determinations.
• Qualifications of Experts: The document does not explicitly state the specific qualifications (e.g., years of experience, specialization like radiologist) of these "two doctors." However, by performing manual blood pressure measurements using a standard mercury sphygmomanometer in a clinical validation setting, it is implied they are medically trained professionals competent in such procedures.

4. Adjudication method for the test set

• The ground truth was established by "Simultaneous and blinded blood pressure determinations were performed by two doctors." This implies a form of dual-reader reading with a reference standard, where both doctors likely took independent measurements, and these were then compared against each other and the test device. The document does not specify a formal adjudication process if there were discrepancies between the two doctors' readings, such as a third reader or a specific consensus method. However, the ISO 81060-2 standard typically requires such a process or agreement between observers.

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. This study is a clinical validation of the device's accuracy against a reference standard, not a study evaluating human reader performance with or without AI assistance. The device is a blood pressure monitor, not an AI-driven diagnostic tool that assists 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 study directly tested the accuracy of the automated blood pressure monitor (the algorithm/device itself) against manual measurements by human experts (using a standard mercury sphygmomanometer). The results provided in the tables above represent the standalone performance of the device without human intervention in the measurement process itself, other than applying the cuff and initiating the measurement.

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

• The ground truth used was expert measurements (made by two doctors) using a standard mercury sphygmomanometer, which serves as the reference method in accordance with clinical validation standards for blood pressure devices (ISO 81060-2). This is a form of expert consensus or highly accurate direct measurement.

8. The sample size for the training set

• The document does not provide information on a training set sample size. This is expected because the device in question is a traditional blood pressure monitor, not an AI/ML-based device that typically requires a distinct training set. The clinical study described is for validation/testing, not for training.

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

• As the document does not refer to a training set or an AI/ML component requiring training, this information is not applicable to the provided context.

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