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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 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.

The Wrist-type Fully Automatic Digital Blood Pressure Monitor is consist of sphygmomanometer main body and cuff. The mainbody contains ABS housing, LCD, keys, measurement control module, pneumatic control module, power supply module. The Wrist-type Fully Automatic Digital Blood Pressure Monitor is automatic, non-invasive, blood pressure measurement system for over-the-counter (OTC) use in home and clinical environment. The device with an inflatable cuff wrapping around the patient's wrist and 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 minutes. The cuff can measure pressure range from 0 to 300mmHg, and the pulse rate range from 30 to 180 beats/min.

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

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are derived from the ISO 81060-2:2018+AMD2020 standard for clinical investigation of automated noninvasive sphygmomanometers.

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

The wrist-type Fully Automatic Digital Blood Pressure Monitors with an inflatable cuff wrapping around the patient's wrist. 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 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.

Here's an analysis of the acceptance criteria and study details for the JOYTECH Healthcare Co., Ltd. Wrist-type Fully Automatic Digital Blood Pressure Monitor, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

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Measure blood pressure (systolic and diastolic) and pulse rate of adults and adolescents age 12 through 21 years of age with cuff circumference of 13.5 - 21.5 cm.

The wrist-type Fully Automatic Digital Blood Pressure Monitor uses an inflatable cuff which is wrapped around the patient's wrist. 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 in 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 minutes. There is a maximum pressure safety setting at 300 mmHg, the device will not inflate the pressure of cuff higher than 300 mmHg.

For BP-2220, BSP-22, 120 memories are divided into two groups as the predicate device BP-2206, with 60 memories each group. For BP-2116, BSP-21, 120 memories are for one group. For BP-2116, BP-2220, BSP-21, BSP-22, the blood pressure results are compared with WHO (World Health Organization) Blood Pressure classification, which are severe Hypertension, Moderate Hypertension, Mild Hypertension, High-normal, and Optimal. The corresponding LCD segment will be turned on along with the systolic, diastolic and pulse rate information. BP-2220 , BSP-21 , BSP-22 can calculate the average of the last three measurements as the predicate device BP-2206. BP-2220, BSP-21, BSP-22 will display an irregular heartbeat symbol "(♥)" if an irregular heartbeat was detected during the measurement process. BP-2116 cancels Irregular Heartbeat Detection and "Last 3 results average". For BP-2220, BSP-22, there are 3 optional functions and there is 2 optional functions for BSP-21 as BP-2206, and there is no optional function for BP-2116.

The devices are all designed and manufactured according to AAMI / ANSI / IEC 80601-2-30:2009, medical electrical equipment - part 2-30: particular requirements for the basic safety and essential performance of automated noninvasive sphygmomanometers.

The document describes a 510(k) submission for the Sejoy Electronics & Instruments Co., Ltd. Wrist - Type Fully Automatic Digital Blood Pressure Monitors (models BP-2116, BP-2220, BSP-21, BSP-22). The submission aims to demonstrate substantial equivalence to a predicate device (Blood Pressure Monitor, Model BP-2206, K121355).

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

1. Table of Acceptance Criteria and Reported Device Performance

The document states that clinical tests were performed to comply with the accuracy requirements of ISO 81060-2 Second edition 2013-05-01, non-invasive sphygmomanometers - part 2: clinical validation of automated measurement type.

While the specific numerical acceptance criteria (e.g., mean difference and standard deviation between device and reference measurements) are not explicitly stated in a table within this document, ISO 81060-2 outlines detailed requirements for blood pressure device accuracy. Generally, for blood pressure measurement devices, the acceptance criteria are related to:

• Mean Difference: The average difference between the device readings and reference measurements (typically auscultation with a sphygmomanometer performed by trained observers). The standard usually requires this to be within a few mmHg (e.g., ±5 mmHg).
• Standard Deviation (or Variance): The variability of these differences. The standard usually requires this to be below a certain threshold (e.g., 8 mmHg).
• Individual Differences: A certain percentage of individual differences must fall within predefined limits.

The document reports that the "Clinical tests were performed and comply with the accuracy requirements of ISO 81060-2 Second edition 2013-05-01." This statement serves as the reported device performance, indicating that the device met the specified accuracy criteria defined by the ISO standard.

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

• Sample Size for Test Set: The document does not explicitly state the sample size used for the clinical validation study. ISO 81060-2, however, specifies minimum sample sizes for clinical validation (e.g., typically a minimum of 85 subjects with specific distributions across age, gender, and blood pressure ranges). The assertion of compliance implies these minimums were met.
• Data Provenance: The document does not explicitly state the country of origin or whether the data was retrospective or prospective. Clinical validation studies according to ISO 81060-2 are typically prospective.

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

• Number of Experts: The document does not explicitly state the number of experts used. However, for clinical validation studies of blood pressure devices generally performed according to ISO 81060-2, at least two trained observers (experts) are required to take independent auscultatory measurements simultaneously to establish the reference blood pressure.
• Qualifications of Experts: The document does not explicitly state the specific qualifications of the experts. In the context of ISO 81060-2, these experts would typically be trained clinicians (e.g., physicians, nurses, or technicians) competent in the auscultatory method of blood pressure measurement.

4. Adjudication Method for the Test Set

• Adjudication Method: The document does not explicitly describe the adjudication method. For blood pressure validation studies using two observers, if there are significant disagreements between their readings, a third observer might be involved, or a specific predefined method for resolving discrepancies is used (e.g., averaging, excluding outliers). ISO 81060-2 provides guidelines for such situations.

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

• MRMC Study: No, an MRMC comparative effectiveness study was not done. This type of study (MRMC) is typically used for diagnostic imaging devices where human readers interpret medical images with and without AI assistance. This document pertains to a blood pressure monitor, which is a measurement device, not an imaging interpretation tool. Therefore, an MRMC study with "human readers improve with AI vs without AI assistance" is not applicable in this context.

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

• Standalone Performance: Yes, the clinical validation described is essentially a standalone performance assessment of the device's accuracy against a known reference standard (auscultatory measurements). The device operates automatically without direct human intervention in the measurement process after initiation. The comparison is between the automated device's output and the expert human measurements, making it an assessment of the algorithm/device's performance on its own.

7. The Type of Ground Truth Used

• Type of Ground Truth: The ground truth used is expert auscultatory blood pressure measurements. These are considered the gold standard for clinical validation of automated blood pressure devices according to ISO 81060-2.

8. The Sample Size for the Training Set

• Training Set Sample Size: The document does not provide information about a training set size. Blood pressure monitors typically do not involve "training sets" in the same way as AI/ML algorithms that learn from data. The device's algorithm for determining blood pressure (oscillometric method) is typically pre-programmed and validated, rather than continuously "trained" on new data in the field.

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

• Training Set Ground Truth: As there's no mention of a traditional "training set" in the context of an AI/ML algorithm that learns from data, this question is not applicable in the same way it would be for an AI-powered diagnostic tool. The "ground truth" for calibrating or developing the oscillometric algorithm during its initial design would have been established through controlled experimental settings and comparisons to invasive arterial measurements or highly accurate auscultatory methods. However, this document pertains to the validation of a finished device against the ISO standard, not its internal development process.

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The Fully Automatic Blood Pressure Monitors BP series and BM 40 are intended for used by adults with 12 years and older to measure the systolic blood pressure and pulse rate.
Measure blood pressure (systolic and diastolic) and pulse rate.

The arm-type uses an inflatable cuff which is wrapped 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. For BP-103H, BP-1304, BP-1305, BP-1307, BM 40, the blood pressure results are compared with WHO (World Health Organization) Blood Pressure classification, which are severe Hypertension, Moderate Hypertension, Mild Hypertension, High-normal, Normal, and Optimal. The corresponding LCD segment will be turned on along with the systolic, diastolic, and pulse rate information. BP-103H, BP-1304, BP-1307, BM 40 will display an irregular heartbeat symbol "( if an irregular heartbeat was detected during the measurement process. BM 40, BP-1307 can display average results in three ways: the average of all measurements, the average of all AM (5:00 AM-8:59AM) measurements, and the average of all PM (18:00 PM-19:59 PM) measurements. BP-103H, BP-1304, BP-1305 can calculates the average of the last three measurements. In addition, BP-1307 has LCD backlight. After three minutes without operation, the blood pressure monitors turn off automatically.

The provided document describes the Sejoy Electronics & Instruments Co., Ltd. Fully Automatic Digital Blood Pressure Monitor (BP series and BM 40 models) and its substantial equivalence to a predicate device.

Here's an analysis of the acceptance criteria and study information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The device performance is assessed against the requirements of the ANSI/AAMI SP10:2002/(R) 2008 & ANSI/AAMI SP10:2002/A1:2003/(R) 2008 & ANSI/AAMI SP10:2002/A2:2006/(R) 2008 standards for manual, electronic or automated sphygmomanometers. While the specific numerical acceptance criteria (e.g., mean difference and standard deviation between the device and a reference measurement) are not explicitly stated in the document, it does state that the device meets or exceeds these requirements.

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

The document states that "Clinical tests were performed and complied the accuracy requirements of ANSI/AAMI SP10:2002/(R) 2008 & ANSI/AAMI SP10:2002/A1:2003/(R) 2008 & ANSI/AAMI SP10:2002/A2:2006/(R) 2008 National Standard for Manual, Electronic or Automated Sphygmomanometers."

However, the specific sample size for the test set is not provided in this document.
The data provenance (country of origin, retrospective or prospective) is also not specified.

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

The document does not provide details on the number of experts used or their qualifications for establishing the ground truth. It simply states that performance tests were conducted according to the ANSI/AAMI SP10 standard, which typically involves comparison against a reference measurement performed by trained observers (oscillometric vs. auscultatory method).

4. Adjudication Method for the Test Set

The document does not explicitly describe an adjudication method for the test set. In the context of blood pressure monitor accuracy testing per AAMI SP10, the "ground truth" is typically established by trained observers taking auscultatory measurements simultaneously or in strict sequence with the automated device. The standard itself specifies the statistical comparison methods.

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

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is more common for diagnostic imaging algorithms where human readers interpret medical images. Blood pressure monitors are standalone measurement devices, and their accuracy is typically evaluated by comparing their readings against a validated reference method (e.g., auscultation by trained professionals).

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

Yes, a standalone performance evaluation was done. The document refers to "Performance Test according to ANSI/AAMI SP10:2002/(R) 2008..." and "Clinical tests were performed and complied the accuracy requirements of ANSI/AAMI SP10...". These tests assess the device's accuracy in measuring blood pressure and pulse rate without necessarily involving human interpretation of the device's output in the loop, beyond reading the displayed values. The device itself is designed to provide automated measurements.

7. The Type of Ground Truth Used

The ground truth used for performance testing (as implied by adherence to ANSI/AAMI SP10) would be reference blood pressure measurements obtained by trained observers using a validated method, typically auscultation with a mercury or aneroid sphygmomanometer. The standard specifies the requirements for this reference method.

8. The Sample Size for the Training Set

This information is not provided in the document. Blood pressure monitors like these do not typically have an "AI algorithm" in the sense of requiring a large, separate training set for a machine learning model. Their design is based on established oscillometric principles.

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

As noted above, the concept of a "training set" in the context of an AI algorithm is largely not applicable to this device. The device operates based on a physical measurement principle (oscillometry) and its internal algorithms process these physical signals. Any calibration data or internal parameters would be established through engineering design and validation, not through a separate "training set" with ground truth in the AI sense.

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The Wrist-type Fully Automatic Blood Pressure Monitors BP series are intended for used by adults with 12 years and older to measure the systolic blood pressure and pulse rate.

Measure blood pressure (systolic and diastolic) and pulse rate.

The wrist-type fully automatic digital blood pressure monitors uses an inflatable cuff which is wrapped around the patient's wrist. 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. For BP-202H, BP-2208, the blood pressure results are compared with WHO (World Health Organization) Blood Pressure classification, which are severe Hypertension, Moderate Hypertension, Mild Hypertension, High-normal, Normal, and Optimal. The corresponding LCD segment will be turned on along with the systolic, diastolic, and pulse rate information. BP-202H, BP-2206, BP-2208 will display an irregular heartbeat symbol " if an irregular heartbeat was detected during the measurement process. BP-2208 can display average results in three ways: the average of all measurements, the average of all AM (5:00 AM-8:59AM) measurements, and the average of all PM (18:00 PM-19:59 PM) measurements. BP-202H, BP-2206 can calculate the average of the last three measurements. In addition, BP-2208 have LCD backlight. After three minutes without operation, the blood pressure monitors turn off automatically.

Here's an analysis of the provided information regarding the acceptance criteria and the study proving the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

The submission references the ANSI/AAMI SP10:2002/(R) 2008 & ANSI/AAMI SP10:2002/A1:2003/(R) 2008 & ANSI/AAMI SP10:2002/A2:2006/(R) 2008 standard for performance and clinical accuracy requirements. However, the document does not explicitly list the specific numerical acceptance criteria from this standard nor does it present a detailed table of the device's reported performance against these criteria. It only states:

"The test result all meet or exceed the requirement of the standards." (Non-clinical tests)
"Clinical tests were performed and complied the accuracy requirements of ANSI/AAMI SP10..." (Clinical tests)

To provide a hypothetical example of what such a table would look like if the specific values were provided in the submission (based on general knowledge of NIBP standards like AAMI SP10):

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

• Sample Size for Test Set: Not explicitly stated in the provided document. The document only mentions that "Clinical tests were performed."
• Data Provenance: Not explicitly stated. Given the manufacturer's location (Hangzhou, China), it is plausible the data was collected there, but this is not confirmed. The document does not specify if the study was retrospective or prospective.

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

• Number of Experts: Not explicitly stated. The ANSI/AAMI SP10 standard typically requires a minimum of two trained observers to establish reference blood pressure measurements.
• Qualifications of Experts: Not explicitly stated. The standard generally requires observers to be trained and validated in auscultatory blood pressure measurement using a mercury sphygmomanometer.

4. Adjudication Method for the Test Set

• Adjudication Method: Not explicitly stated. For clinical validation according to ANSI/AAMI SP10, referent blood pressure is typically determined by trained observers using an auscultatory method. If multiple observers are used, their readings are usually averaged or adjudicated if they differ significantly. The document does not detail this.

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

• MRMC Study: No, this type of study was not conducted or mentioned. The device described is an automated blood pressure monitor, 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

• Standalone Performance: Yes, the clinical tests performed evaluate the standalone performance of the device itself (the "algorithm only," as it's an automated device). The accuracy requirements of ANSI/AAMI SP10 validate the device's ability to measure blood pressure independently.

7. The Type of Ground Truth Used

• Type of Ground Truth: For the clinical accuracy studies (as per ANSI/AAMI SP10), the ground truth for blood pressure measurements is established by expert auscultatory measurements (typically using a mercury sphygmomanometer) conducted by trained observers.

8. The Sample Size for the Training Set

• Sample Size for Training Set: The document makes no mention of a "training set" in the context of machine learning or AI. This device is a traditional oscillometric blood pressure monitor, not an AI/ML-driven device that typically requires distinct training and testing datasets for algorithm development. The "training" of such a device is inherent in its design, calibration, and manufacturing process based on established oscillometric principles.

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

• Ground Truth for Training Set: Not applicable, as there is no mention of a separate training set or AI/ML algorithm development in the provided document. The device operates on established physiological principles and engineering.

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