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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 42cm and 40cm-56cm.

The Arm-type Blood Pressure Monitor (BPM) series is an 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 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 per minute.

The DBP-6286B embed bluetooth module to transfer data to APP. With the use of software (including APP) and Bluetooth communication module, the wireless software function and hardware function are solely intended to transfer, store, convert formats, or display medical device data and results (blood pressure and pulse rate readings), without controlling or altering the functions or parameters of any connected medical devices, which is not be intended for active patient monitoring, therefore, based on the FDA guidance titled "Medical Device Data Systems, Medical Image Storage Devices, and Medical Image Communications Devices" (issued on September 28, 2022.), this software function is belong to Non-device-MDDS.

Based on the provided FDA 510(k) clearance letter for the JOYTECH Healthcare Co., Ltd. Arm-type Fully Automatic Digital Blood Pressure Monitors (DBP-6286B, DBP-6186), here's a description of the acceptance criteria and the study proving the device meets them:

Acceptance Criteria and Device Performance for Blood Pressure Monitors

The acceptance criteria for blood pressure monitors are typically defined by recognized international standards, primarily ISO 81060-2:2018+AMD2020, which pertains to the clinical investigation of intermittent automated measurement type for non-invasive sphygmomanometers. This standard specifies the accuracy requirements for blood pressure measurements.

The key acceptance criterion is that the accuracy of the blood pressure monitor must be within the acceptable scope specified in ISO 81060-2:2018+AMD2020. While the exact numerical thresholds for group means and standard deviations aren't explicitly stated in this clearance letter, the general requirement is clear.

The reported device performance confirms that the device meets these criteria.

Study Details Proving Device Meets Acceptance Criteria:

1. A table of acceptance criteria and the reported device performance: (See table above)

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

   • Cuff (22-42cm): 91 valid subjects' data were used for analysis.
   • Cuff (40-56cm): 85 valid subjects' data were used for analysis.
   • Data Provenance: The document does not explicitly state the country of origin of the data, but it implies a prospective clinical study ("All the subjects were volunteer to take part in the clinical study, all the subjects completed the clinical study without any AE or side-effect").

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

   • The document implies the use of human observers for the reference measurements, as it states: "The manual Mercury Sphygmomanometer was used as a reference device." This suggests that the ground truth was established by human operators taking readings from a mercury sphygmomanometer against which the automated device's readings were compared. However, the exact number and qualifications of these "experts" (human observers) are not specified in the provided document.

4. Adjudication method for the test set:

   • The document states, "Same arm sequential method was adopted during clinical testing." This method involves comparing simultaneous or near-simultaneous measurements from the test device and a reference device on the same arm. While this describes the measurement procedure, it does not describe an adjudication method for discrepancies between readings, as would be typical for expert consensus. Given that the ground truth is a direct measurement from a mercury sphygmomanometer, an adjudication process in the traditional sense (e.g., for image interpretation) is not directly applicable.

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. This is a medical device clearance for a blood pressure monitor, not an AI-assisted diagnostic imaging device. Therefore, an MRMC study and analysis of human reader improvement with AI assistance are irrelevant and were not performed.

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

   • The study design (clinical validation against a reference standard) inherently evaluates the "standalone" performance of the automated blood pressure monitor's algorithm. The device itself is designed to operate without continuous human intervention during the measurement process, making its performance essentially "algorithm only" in terms of blood pressure determination from the oscillometric data.

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

   • The ground truth was established by direct measurement using a manual Mercury Sphygmomanometer. This is considered the clinical gold standard for non-invasive blood pressure measurement in this context.

8. The sample size for the training set:

   • The document does not specify a separate training set or its sample size. For traditional medical devices like blood pressure monitors, the "training" (development and calibration) often occurs during the device engineering and manufacturing phases, and clinical validation is then performed on a separate, independent test set as described.

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

   • As no specific "training set" is mentioned in the context of a separate clinical dataset, the method for establishing ground truth for such a set is not provided. The device's underlying algorithms would have been developed and refined through engineering and calibration processes, likely using extensive internal testing and validation against standardized pressure sources and reference measurements, rather than a distinct "clinical training set" in the AI/ML sense.

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The Arm-type Fully Automatic Digital Blood Pressure Monitors are intended to measure blood Pressure (systolic and diastolic) of adults and adolescents over 12 years of age with circumference ranging from 22cm to 24cm.

The Arm-type Fully Automatic Digital Blood Pressure Monitor (BPM) series is automatic, non-invasive, blood pressure measurement system for over-the-counter (OTC) use at 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 inflation measurements, an electric pump within the main unit slowly inflates the arm 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 systolic pressure, and diastolic pressure. The cuff can measure pressure range from 0 to 299mmHg.

Meanwhile, some models whith bluetooth function can be used as a stand-alone unit to finish the blood pressure measurement or in conjunction with the APP through 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 measurement results from the blood pressure monitor device, 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.

There are total 7 arm-type blood pressure monitor models we submitted: DBP-62D0L, DBP-62D0B, DBP-61D0, DBP-61D0L, DBP-6293L, DBP-6193 and they are both bodyworn medical devices.

Here's a breakdown of the acceptance criteria and the study proving the device meets them, based on the provided FDA 510(k) summary for the JOYTECH Arm-type Fully Automatic Digital Blood Pressure Monitor:

Acceptance Criteria and Reported Device Performance

The primary acceptance criteria for a non-invasive blood pressure monitor are its accuracy in measuring systolic and diastolic blood pressure. The relevant standard cited is ISO 81060-2:2018+AMD2020 (Non-invasive sphygmomanometers — Part 2: Clinical investigation of intermittent automated measurement type).

The document states: "The results showed the accuracy of the blood pressure monitor is within acceptable scope specified in ISO 81060-2:2018+AMD2020." While specific numerical performance values (e.g., mean difference and standard deviation for systolic and diastolic pressure) are not explicitly provided in this summary, the statement indicates that the device met the statistical requirements defined by this international standard for accuracy.

Table of Acceptance Criteria and Reported Device Performance

Details of the Study Proving Device Meets Acceptance Criteria:

1. Sample Size and Data Provenance:

   • Test Set Sample Size: A total of 90 subjects were included in the clinical validation study.
   • Data Provenance: The document does not explicitly state the country of origin of the data, but the manufacturer is based in China. The study appears to be prospective as it describes recruitment of subjects, their participation, and the measurement process.

2. Number of Experts and Qualifications:

   • The document mentions "The manual Mercury Sphygmomanometer was used as a reference device." This implies measurements were taken by trained observers (experts) using this reference device. However, the exact number of experts or their specific qualifications (e.g., "radiologist with 10 years of experience" is not applicable here) are not specified in the provided text. For blood pressure clinical validation, these would typically be trained clinicians or technicians.

3. Adjudication Method for the Test Set:

   • The study used a "Same arm sequential method." This means the test device measurements and reference device measurements were taken sequentially on the same arm.
   • The document does not describe a specific "adjudication method" in the sense of multiple experts reviewing and reaching consensus on an interpretation (as would be common in image-based AI studies). Instead, the comparison is made between the device readings and the reference standard readings.

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

   • No, an MRMC comparative effectiveness study was not done. This type of study is typically performed for AI devices that assist human readers in interpreting medical images (e.g., AI for chest X-rays assisting radiologists). The device in question is a standalone blood pressure monitor, not an AI-assisted diagnostic tool that requires human interpretation of complex data.

5. Standalone Performance:

   • Yes, a standalone performance study was done. The clinical validation detailed here assesses the accuracy of the blood pressure monitor itself (the algorithm and hardware) against a recognized gold standard (manual mercury sphygmomanometer). The device operates independently to provide blood pressure measurements.

6. Type of Ground Truth Used:

   • The ground truth used was manual Mercury Sphygmomanometer measurements. This is a widely accepted reference standard for validating automated blood pressure monitors, considered an expert consensus/reference standard method in this context.

7. Sample Size for the Training Set:

   • The document does not provide information regarding the sample size of a training set. This is typical for a traditional medical device like a blood pressure monitor where the "algorithm" is often based on well-established non-AI methods (oscillometric principles) and validated through clinical testing rather than trained on large datasets like deep learning models. If there are software algorithms involved, they are likely more deterministic or based on classical signal processing rather than machine learning that requires a separate "training set."

8. How Ground Truth for Training Set Was Established:

   • As no "training set" in the context of typical AI/machine learning is mentioned, this information is not applicable and therefore not provided in the document. The device's underlying measurement principles (oscillometric method) use known physical principles, not a data-driven training process that requires a labeled ground truth for learning.

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The Arm-type 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 with circumference ranging from 22cm to 42cm.

The Arm-type Fully Automatic Digital Blood Pressure Monitor (BPM) series, noninvasive, 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, the electric pump within the main unit slowly inflates the arm 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 measure pressure range from 0 to 299mmHg, and the pulse rate range from 30 to 180 beats/min.

The pulse rate measurement compares the longest and the shortest time intervals of detected pulse waves to the 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, this blood pressure monitor device can be used as a stand-alone unit to finish the blood pressure measurement or in conjunction with the APP through 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 measurement results from the blood pressure monitor device, 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 text describes the 510(k) submission for the "Arm-type Fully Automatic Digital Blood Pressure Monitor, Model: BM 92". The main study used to demonstrate the device meets acceptance criteria is a clinical investigation following the ISO 81060-2:2018+AMD2020 standard, which focuses on the clinical investigation of intermittent automated measurement type non-invasive sphygmomanometers.

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

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are implicitly defined by compliance with the ISO 81060-2:2018+AMD2020 standard, which specifies accuracy requirements for blood pressure monitors. The document states:
"The results showed the accuracy of the blood pressure monitor is within acceptable scope specified in ISO 81060-2:2018+AMD2020."

While specific numerical acceptance criteria (e.g., mean difference and standard deviation between device and reference measurements) are not explicitly stated in the document, the adherence to this ISO standard implies meeting its criteria. The general accuracy specifications are given in the comparison table:

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

• Sample Size: "A total of 90 patients participated in the clinical study (2 were excluded because they were part of other clinical trials)." So, the effective sample size for the test set was 88 patients.
• Data Provenance: The document does not explicitly state the country of origin. However, the manufacturer is JOYTECH Healthcare Co., Ltd. located in Hangzhou, Zhejiang, China. Given this, it's highly probable the study was conducted in China. The study was a prospective clinical investigation.

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

The document states: "A manual Mercury Sphygmomanometer was used as a reference device." This implies that the ground truth was established by human readers taking measurements using a mercury sphygmomanometer. However, the number of experts and their qualifications are not specified in the provided text. The ISO 81060-2 standard typically requires trained observers for reference measurements, but the details are omitted here.

4. Adjudication Method for the Test Set

The text mentions: "Same arm sequential method was adopted during the clinical testing. A manual Mercury Sphygmomanometer was used as a reference device." This suggests a comparative method, but it does not describe an adjudication method for discrepancies, which is usually relevant for subjective interpretations (e.g., image reading). For blood pressure measurements, the reference device readings are typically considered the objective ground truth; thus, a formal "adjudication" between multiple observers might not be explicitly detailed if the standard protocol for reference measurement was followed.

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 type of study is typically performed for AI-assisted image interpretation devices to assess the impact of AI on human reader performance. The device described is an automated blood pressure monitor, not an AI interpretation system. Its function is to directly measure and display blood pressure, not to assist human readers in interpreting complex data.

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

Yes, in essence, the device's accuracy was tested in a standalone manner. The device "determines" systolic and diastolic pressures using its internal algorithms (oscillometric method). The clinical study directly evaluated the accuracy of these measurements against a reference standard (manual mercury sphygmomanometer). The performance cited ("The results showed the accuracy of the blood pressure monitor is within acceptable scope specified in ISO 81060-2:2018+AMD2020") refers to the device's direct measurement capability.

7. The Type of Ground Truth Used

The ground truth used was comparative measurements against a manual Mercury Sphygmomanometer. The text states: "A manual Mercury Sphygmomanometer was used as a reference device." This is a standard method for establishing ground truth for automated blood pressure monitors.

8. The Sample Size for the Training Set

The document does not specify the sample size for a training set. This is common for traditional medical devices like blood pressure monitors, where "training" in the machine learning sense isn't explicitly detailed. The device likely relies on established oscillometric principles and algorithms developed over time, not a specific "training set" of patient data in the context of deep learning models.

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

As no specific "training set" for an AI model is mentioned or implied, the question of how its ground truth was established is not applicable in the context of the provided document. The device utilizes an "oscillometric method" and "software algorithms within the microprocessor," which are based on known physiological principles and traditional signal processing rather than data-driven machine learning training requiring a designated ground-truth dataset.

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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 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 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. An irregular heartbeats rhythm is defined as a rhythm that varies by 25% less or more than the average rhythm detected while the monitor is measuring the systolic and diastolic blood pressure. AND, these subject device can be used as a stand-alone unit to finish the blood pressure measurement or in conjunction with the "JOYTECH healthcare" 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, 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 text is a 510(k) Summary for a blood pressure monitor and does not contain detailed information about a specific study proving the device meets acceptance criteria. Instead, it states that clinical testing was not required because the device is considered equivalent to a previously cleared predicate device (Joytech DBP-1307, K173024) due to having the same core algorithm and cuff circumference.

However, the summary does list the standards that were utilized for testing to demonstrate safety and effectiveness. The most relevant standard for performance claims is ISO 81060-2:2013, which covers the clinical validation of automated non-invasive sphygmomanometers. The document states that the clinical validation was performed according to ISO 81060-2:2013 for the predicate device.

Therefore, the information I can extract regarding the acceptance criteria and a study demonstrating compliance is limited. I will present the information available based on the provided text, primarily focusing on what ISO 81060-2:2013 generally entails for blood pressure monitors, as the detailed study specific to this device is not present but is referenced through the predicate.

Here's the breakdown of the information requested, based on the provided text and general knowledge of ISO 81060-2:2013:

1. Table of acceptance criteria and the reported device performance

Since the document states "clinical testing was not required to establish equivalency of the device" because it is based on the predicate device's validation per ISO 81060-2:2013, the acceptance criteria and performance would be those defined by this standard. The document does provide performance specifications for the device, which are implicitly stated to meet the requirements of the standards listed, including ISO 81060-2:2013 via the predicate.

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

The document explicitly states that "clinical testing was not required" for the new device because it is considered equivalent to the predicate device K173024 (Joytech DBP-1307), which had undergone clinical validation.

• Test Set Sample Size: Not provided in the document for the new device. For the predicate device, a clinical validation study adhering to ISO 81060-2:2013 would typically require a minimum of 85 subjects with specific distributions of age, sex, and blood pressure ranges.
• Data Provenance: Not provided for the new device. For the predicate device's clinical validation, it would have been prospective clinical data. The country of origin is not specified but is typically mentioned in clinical study reports.

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

This information pertains to the clinical validation of the predicate device (DBP-1307, K173024) under ISO 81060-2:2013.

• Number of Experts: For ISO 81060-2:2013, ground truth is typically established by three trained observers taking sequential auscultatory measurements according to a defined protocol.
• Qualifications of Experts: The standard requires trained observers who are blinded to the device readings and are experienced in taking auscultatory blood pressure measurements. Specific medical qualifications (e.g., cardiologist, certified BP measurement technician) are usually detailed in the study protocol. The document does not specify their exact qualifications but implies they meet the standard's requirements.

4. Adjudication method for the test set

For the clinical validation of the predicate device under ISO 81060-2:2013:

• Adjudication Method: The standard specifies a method where the three observers conduct measurements. The ground truth (reference blood pressure) is derived from the average of the two closest readings among the three observers, or if there's a significant disagreement, specific rules are followed for exclusion or further measurement. This is a form of consensus-based 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

• MRMC Study: No, an MRMC comparative effectiveness study is not applicable to this device. This is a standalone blood pressure monitor, not an AI-assisted diagnostic imaging device requiring human reader interpretation. The device provides automatic blood pressure readings.

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

• Standalone Performance: Yes, the fundamental performance of the blood pressure measurement algorithm is evaluated in standalone mode as part of the clinical validation process (for the predicate device). The device itself performs the measurement and displays the result without direct human interpretation of waveforms for diagnosis. While a human initiates the measurement and reads the display, the accuracy assessment is of the device's algorithmic output against a reference.

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

• Type of Ground Truth: For the clinical validation of the predicate device (following ISO 81060-2:2013), the ground truth for blood pressure measurements is established by expert auscultatory measurements (Korotkoff sounds) by trained observers, as stated in point 3. This is a form of expert consensus derived from a gold standard manual method.

8. The sample size for the training set

• Training Set Sample Size: Not applicable/Not provided. The document describes a medical device leveraging an established oscillometric method for blood pressure measurement, not a machine learning or AI model that requires a distinct training set in the conventional sense. The "core algorithm" of the device is validated against the predicate and established standards, rather than "trained" on a dataset in the way an AI model would be.

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

• Ground Truth for Training Set: Not applicable. As mentioned, this is not an AI/ML device that uses a distinct training set. The underlying oscillometric algorithm's principles are based on known physiological responses and signal processing, not on labeled training data. The validation of its performance (for the predicate device) uses auscultatory reference measurements as ground truth.

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Measure blood pressure (systolic and diastolic) and pulse rate of adults and adolescents age 12 through 21 years of age.

The Arm-Type Fully Automatic Digital Blood Pressure Monitor 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-46 and BP-1304, 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, and pulse rate information. They will display an irregular heartbeat symbol "《♥》" if an irregular heartbeat was detected during the measurement process. BP-46 can display average results in three ways.

The device is 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 provided text describes a 510(k) submission for a blood pressure monitor, focusing on demonstrating substantial equivalence to a predicate device. However, it does not contain the detailed information typically found in an AI/Software as a Medical Device (SaMD) study regarding acceptance criteria, performance metrics, ground truth establishment, or multi-reader studies.

Therefore, I cannot extract the specific information requested in your prompt as it pertains to a different type of medical device clearance and study methodology. The document is for a non-AI, hardware-based blood pressure monitor and focuses on compliance with general safety and performance standards for such devices, rather than AI model performance or clinical utility compared to human readers.

Specifically, the following points cannot be answered from the provided text:

1. A table of acceptance criteria and the reported device performance: The document states "The test result all meet or exceed the requirement of the standards" for non-clinical tests and "Clinical tests were performed and comply with the accuracy requirements of ISO 81060-2 Second edition 2013-05-01" for clinical tests, but it does not provide specific numerical acceptance criteria or reported performance values.
2. Sample sizes used for the test set and the data provenance: Not mentioned.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable for this type of device and study.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
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 as there is no AI component or human reader element.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable as this is a device for direct measurement, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): For a blood pressure monitor, "ground truth" typically refers to reference measurements (e.g., from an oscillometric or auscultatory method) rather than expert consensus on images or pathology. The document mentions compliance with ISO 81060-2, which dictates clinical validation methods for non-invasive sphygmomanometers, implying a comparison to a referencestandard, but the specific details are not provided.
8. The sample size for the training set: Not applicable as there is no AI or machine learning model for training.
9. How the ground truth for the training set was established: Not applicable.

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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 arm circumference of 22- 42cm.

The Arm-Type Fully Automatic Digital Blood Pressure Monitor 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-35, 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-35 will display an irregular heartbeat symbol " (♥) " if an irregular heartbeat was detected during the measurement process. It can display average results in three ways.

The provided text describes the Arm-Type Fully Automatic Digital Blood Pressure Monitor, BP-35. Here's a breakdown of the acceptance criteria and the study information:

Acceptance Criteria and Reported Device Performance

The device's performance is assessed against the accuracy requirements of ISO 81060-2:2013-05-01, "Non-invasive sphygmomanometers - Part 2: Clinical validation of automated measurement type."

Study Details

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

   • Sample Size: Not explicitly stated in the provided text for the clinical test set.
   • Data Provenance: Not explicitly stated in the provided text (e.g., country of origin, retrospective/prospective). However, the clinical validation study would inherently be prospective in nature.

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

   • Not explicitly stated in the provided text. ISO 81060-2 typically requires measurements from trained observers using mercury sphygmomanometers or an equivalent calibrated standard device as the reference (ground truth).

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

   • Not explicitly stated in the provided text. ISO 81060-2 specifies a protocol for obtaining reference blood pressure measurements, often involving multiple observers.

4. 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 MRMC comparative effectiveness study was not done. This device is a standalone blood pressure monitor, not an AI-assisted diagnostic tool for human readers.

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

   • Yes, a standalone performance study was done. The clinical tests were performed to validate the accuracy of the automated device itself, which operates without human intervention during the measurement process.

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

   • The ground truth for blood pressure monitor validation studies is typically established by trained observers using a calibrated reference method, such as a mercury sphygmomanometer or an equivalent standard. This is an implied requirement of ISO 81060-2.

7. The sample size for the training set:

   • This is not applicable as the device is a standalone blood pressure monitor based on oscillometric technology and does not involve machine learning algorithms that require a separate training set. The "training" in this context refers to the development and calibration of the device's internal algorithms, not a data-driven machine learning training set.

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

   • Not applicable for the reason stated above. The device's internal algorithms are based on established physiological principles and engineering design, not a machine learning training process with an external ground truth dataset.

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Measure blood pressure (systolic and diastolic) and pulse rate.
The Fully Automatic Blood Pressure Monitors BP series are intended for used by adults with 12 years and older to measure the systolic and diastolic blood pressure 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-1305, BP-1307,BP-1211, BP-1312, BP-1318, BP-1319, BP-1326, BSP-11, BSP-12, BSP-13, 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-1305,BP-1307,BP-1312, BP-1318, BP-1319, BP-1326, BSP-11, BSP-12, BSP-13will display an irregular heartbeat symbol " " if an irregular heartbeat was detected during the measurement process. BP-1305,BP-1318, BP-1319, BP-1326, BSP-11, BSP-12, BSP-13 can display average results in three ways: BP-1307 can display 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.

The Sejoy Electronics & Instruments Co., Ltd. Arm-type Fully Automatic Digital Blood Pressure Monitor (multiple models listed) underwent a clinical study to demonstrate its accuracy and substantial equivalence to a predicate device.

1. Acceptance Criteria and Reported Device Performance:

The device aimed to meet the accuracy requirements of ISO 81060-2:2013, "Non-invasive sphygmomanometers - Part 2: Clinical validation of automated measurement type."

Note: The detailed numerical results for each criterion were not explicitly provided in the document, but the statement "Clinical tests were performed and complied the accuracy requirements of ISO 81060-2 Second edition 2013-05-01" implies that all these criteria were successfully met.

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

The document does not explicitly state the sample size used for the clinical test set. However, a clinical validation study following ISO 81060-2:2013 typically requires a minimum of 85 participants for accuracy assessment. Given the nature of a 510(k) submission, it is highly probable that the study was prospective and conducted with participants whose blood pressure measurements were taken specifically for the validation of this device. The country of origin of the data is not specified.

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

The document does not explicitly state the number or qualifications of experts used to establish the ground truth. According to ISO 81060-2:2013, oscillometric blood pressure monitor validation requires measurements by trained observers (typically two or more) using a mercury sphygmomanometer or an equivalent reference device. These observers usually have specific training and certification in blood pressure measurement to ensure accuracy and inter-observer reliability.

4. Adjudication Method for the Test Set:

The document does not explicitly state the adjudication method. In clinical validation studies for blood pressure monitors following ISO 81060-2:2013, the ground truth is typically established by simultaneous or sequential measurements by two or more trained observers. Discrepancies between observers are often resolved by a third trained observer, or through averaging if within an acceptable range, or by re-measurement. This often aligns with a "2+1" or similar consensus-based method.

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

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not conducted or reported for this device. The purpose of this submission was to demonstrate substantial equivalence and meet specific accuracy standards for a medical device, not to compare human reader performance with and without AI assistance.

6. Standalone Performance (Algorithm Only Without Human-in-the-Loop Performance):

Yes, a standalone performance evaluation was done. The clinical validation study described, which complied with ISO 81060-2:2013, assesses the device's ability to accurately measure blood pressure independently, without human intervention in the measurement process itself. The device is an "Arm-type Fully Automatic Digital Blood Pressure Monitor," implying it operates without a human 'in the loop' for the actual pressure measurement and reading.

7. Type of Ground Truth Used:

The ground truth used was expert consensus (or highly accurate reference measurements). Specifically, for blood pressure monitor validation according to ISO 81060-2:2013, the reference standard for comparison is typically simultaneous auscultatory measurements by trained observers using a mercury sphygmomanometer or another validated reference blood pressure device.

8. Sample Size for the Training Set:

The document does not specify a separate training set or its sample size. For medical devices like blood pressure monitors, the "training" (i.e., algorithm development and internal testing) is typically conducted by the manufacturer using internal data or publicly available physiological datasets. The clinical validation study, as described, serves as the independent test set for regulatory submission.

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

As no specific training set and its ground truth establishment are detailed in the document, this information is not available from the provided text. However, for internal development, manufacturers would likely use similar methods as the test set: expert auscultatory measurements against which the device's algorithms are refined.

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

Not Found

The provided document is a 510(k) clearance letter from the FDA for a blood pressure monitor, not a study report. Therefore, it does not contain the detailed information required to describe the acceptance criteria and the study that proves the device meets them.

The letter confirms that the device, Arm-Type Fully Automatic Digital Blood Pressure Monitor, Model BP-35, is substantially equivalent to legally marketed predicate devices. This determination is based on a review of the manufacturer's 510(k) submission, which would have included performance data, but that data is not present in this regulatory correspondence.

To answer your request, I would need access to the actual 510(k) submission or a separate study report for the Sejoy BP-35 device. The current document only provides:

• Device Name: Arm-Type Fully Automatic Digital Blood Pressure Monitor, Model BP-35
• Intended Use: Measure blood pressure (systolic and diastolic) and pulse rate.
• Regulatory Class: Class II
• Product Code: DXN

Without the actual performance data and study details, I cannot fill out the requested table or address the specific points about sample size, ground truth, expert qualifications, adjudication methods, or MRMC studies.

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