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The Upper Arm Automatic Digital Blood Pressure Monitor, Model BP Progress (BP3T01-1B) is a device intended to measure the systolic and diastolic blood pressure and pulse rate of an adult individual by using a non-invasive oscillometric technique in which an inflatable cuff is wrapped around the upper arm for a circumference range from 22 to 40cm. The device detects the appearance of irregular heartbeat during measurement and gives a warning signal with the reading once the irregular heartbeat is detected. The device can be used in connection with a smart phone via Bluetooth. The measurement data can be transferred to a smart phone running the Microlife Connected Health+ mobile software (App).

The Upper Arm Automatic Digital Blood Pressure Monitor, Model BP Progress (BP3T01-1B) is designed to measure systolic and diastolic blood pressure, pulse rate of an individual with arm circumference sizes ranging from 22 to 40 cm by using a non-invasive technique in which one inflatable cuff is wrapped around the single upper arm. Our method to define systolic and diastolic pressure is similar to the auscultatory method but using a semiconductor sensor rather than a stethoscope and mercury manometer. The sensor converts tiny alterations in cuff pressure to electrical signals, by analyzing those signals to define the systolic and diastolic blood pressure and calculating pulse rate, which is a well - known technique in the market called the "oscillometric method". The device detects the appearance of irregular heartbeat during measurement, and the symbol " " is displayed after the measurement. In addition, the device can be used in connection with smart mobile devices running the Microlife Connected Health+ mobile software (App) via Bluetooth. The blood pressure monitor is a fully automatic digital blood pressure measuring device use by adults on the upper arm at home.

The provided FDA 510(k) clearance letter and summary for the Microlife Upper Arm Automatic Digital Blood Pressure Monitor, Model BP Progress (BP3T01-1B), include information about its testing and equivalence to a predicate device. However, it does not contain explicit acceptance criteria thresholds (e.g., specific accuracy ranges for blood pressure measurements) or detailed results beyond stating that the device "met all relevant requirements" and "results were passing."

Based on the provided text, here's an attempt to extract the requested information, with notable gaps where details are not explicitly stated.

Acceptance Criteria and Study Details for Microlife Upper Arm Automatic Digital Blood Pressure Monitor, Model BP Progress (BP3T01-1B)

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state numerical acceptance criteria for blood pressure accuracy (e.g., mean difference and standard deviation standards like those in ISO 81060-2). It only mentions that the device "met all relevant requirements" and "results were passing" according to the relevant standards.

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

• Sample Size: The document does not specify the exact sample size for the clinical validation study conducted in accordance with ISO 81060-2.
• Data Provenance: Not specified (e.g., country of origin, retrospective or prospective). Typically, such clinical validations are prospective, but this is not explicitly stated.

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

• The document does not provide details on the number or qualifications of experts used for establishing ground truth, as is typical for an oscillometric blood pressure monitor validation. For ISO 81060-2, readings are independently taken by multiple trained observers, but their specific qualifications (e.g., experience level) are not detailed here.

4. Adjudication Method for the Test Set

• The document does not explicitly state an adjudication method. For ISO 81060-2, the ground truth (reference blood pressure) is established by two or more trained observers using auscultation. Discrepancies between observers are typically handled by a predefined protocol (e.g., averaging, or a third observer if differences are significant), but these specifics are not mentioned in the provided text.

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

• No, an MRMC comparative effectiveness study was not done. This type of study (comparing human readers with and without AI assistance) is not relevant for a standalone blood pressure monitor. The device itself performs the measurement; it does not assist human readers in interpreting complex imagery or clinical data in the way an AI algorithm might.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

• Yes, a standalone performance assessment was effectively done. The clinical validation conducted according to ISO 81060-2 assesses the device's accuracy in measuring blood pressure independently, without human interpretation other than setting up the device and initiating the measurement. The device's measurement algorithm is evaluated directly against a reference standard.

7. The Type of Ground Truth Used

• Expert Consensus (Auscultation): For blood pressure monitor validation per ISO 81060-2, the ground truth for blood pressure measurements is established through simultaneous or closely timed readings by trained human observers using the auscultatory method (stethoscope and sphygmomanometer/mercury manometer), which is considered the clinical reference standard.

8. The Sample Size for the Training Set

• Not Applicable / Not Provided: The summary indicates that the subject device (BP3T01-1B) uses the "same oscillometric method" and "common blood pressure measurement technological architecture and algorithm" as the predicate device (BP3KV1-5K). It does not describe a new algorithm that required a specific training set. Blood pressure algorithms for oscillometric devices are typically developed based on physiological models and empirical data, rather than being "trained" in the machine learning sense with a discrete "training set" in the context described here. If iterative development was done, the size of data used for such development is not provided.

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

• Not Applicable / Not Provided: As in point 8, the concept of a "training set" with established ground truth as it applies to machine learning models is not explicitly relevant or described for this blood pressure monitor's algorithm development in the provided documentation. The algorithm's fundamental principles are stated to be the same as the predicate device, implying established and verified methods rather than a newly trained model requiring specific ground truth for training.

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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 Upper Arm Blood Pressure Monitor, Model BP3K V 1-5K is a device intended to measure the systolic and diastolic blood pressure and pulse rate of an adult individual by using a non-invasive oscillometric technique in which an inflatable cuff is wrapped around the upper arm for a circumference range from 17 to 52cm.

The device detects the appearance of irregular heartbeat during measurement and gives a warning signal with the reading once the irregular heartbeat is detected.

The device can be used in connection with a smart phone via Bluetooth or with a personal computer (PC) via USB. The measurement data can be transferred to a smart phone running the Microlife Connected Health+ mobile software (App) or a PC running the Microlife BP Analyzer+ (BPA+) software.

Microlife Upper Arm Automatic Digital Blood Pressure Monitor, Model BP3KV1-5K is designed to measure systolic and diastolic blood pressure, pulse rate of an individual with arm circumference sizes ranging from 17-52 cm by using a noninvasive technique in which one inflatable cuff is wrapped around the single upper arm. Our method to define systolic and diastolic pressure is similar to the auscultatory method but using a semiconductor sensor rather than a stethoscope and mercury manometer. The sensor converts tiny alterations in cuff pressure to electrical signals, by analyzing those signals to define the systolic and diastolic blood pressure and calculating pulse rate, which is a well - known technique in the market called the "oscillometric method".

The device detects the appearance of irregular heartbeat during measurement, and the symbol " " is displayed with the reading. The device can be used in connection with smart mobile devices running the APP and via Bluetooth.

The blood pressure monitor is a fully automatic digital blood pressure measuring device use by adults on the upper arm at home.

This document is a 510(k) Premarket Notification for a blood pressure monitor, not an AI/ML powered medical device. Therefore, the information typically requested regarding acceptance criteria, study design for AI models, and clinician performance with/without AI assistance cannot be extracted from this document, as it is not applicable.

The document discusses the substantial equivalence of the Microlife Upper Arm Automatic Digital Blood Pressure Monitor, Model BP3KV1-5K, to predicate devices. The acceptance criteria in this context refer to engineering and clinical performance standards for blood pressure monitors as defined by various international standards (e.g., AAMI/ANSI/IEC 80601-2-30 for non-invasive sphygmomanometers), rather than performance metrics for an AI algorithm.

Below, I'll structure the answer to address the prompt's points based on the information available in the document for a traditional medical device, noting where AI-specific information is not present.

Device: Microlife Upper Arm Automatic Digital Blood Pressure Monitor, Model BP3KV1-5K

This device is a traditional non-invasive blood pressure monitor that uses an oscillometric technique. It does not employ artificial intelligence or machine learning for its core blood pressure measurement function. Therefore, many of the questions asked, which are relevant to AI/ML powered devices, are not applicable here.

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

The document states that the device was tested to meet relevant national and international standards for electrical, mechanical, environmental performance, and basic safety and essential performance of automated non-invasive sphygmomanometers. While specific numerical acceptance criteria (e.g., mean difference and standard deviation per ISO 81060-2) are not provided in this summary, the document asserts that the device met all relevant requirements.

Table: General Acceptance Criteria and Stated Performance (Based on Document)

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

The document states that repeated clinical testing for the subject device (BP3KV1-5K) was not necessary. Instead, the clinical validation of the predicate devices (BP3MW1-4Y and BP3MS1-4A), performed according to ANSI/AAMI/ISO81060-2, was deemed applicable.

Therefore, the specific sample size for a test set for the subject device's core BP measurement accuracy is not mentioned as a new study was not performed. The data provenance would be from the original clinical validation studies performed for the predicate devices. The document does not specify country of origin or whether these prior studies were retrospective or prospective.

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

This question is not applicable to this device, as it is not an AI/ML device requiring expert consensus for ground truth or interpretation. The "ground truth" for blood pressure measurement devices is typically a reference measurement method (e.g., auscultatory method by trained observers) used during clinical validation studies (like those following ISO 81060-2). The document does not provide details on the number or qualifications of experts involved in the predicate device's clinical validation.

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

Not applicable, as this refers to adjudication for expert labeling/ground truth in AI/ML model validation, which is not relevant for this traditional blood pressure monitor.

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 device is not an AI-powered diagnostic tool, so an MRMC study comparing human performance with and without AI assistance was not performed.

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

This refers to the performance of an AI algorithm intrinsically. For this traditional blood pressure monitor, the "algorithm" is the oscillometric measurement technique. Its performance is evaluated through clinical validation against a reference method (human observers using auscultation), which is essentially a standalone performance evaluation of the device's measurement accuracy. The document states that the clinical validation for the predicate devices is applicable and meets the ANSI/AAMI/ISO81060-2 standard.

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

For traditional blood pressure monitors, the ground truth in clinical validation studies is typically established by simultaneous measurements using a recognized reference method, such as the auscultatory method performed by trained human observers using a mercury sphygmomanometer or validated electronic reference device. This is the standard approach for studies structured according to ISO 81060-2.

8. The sample size for the training set

Not applicable. This device does not use an AI/ML algorithm that requires a "training set."

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

Not applicable, as there is no AI/ML training set for this device.

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The Upper Arm Blood Pressure Monitor, Model BP3KV1-5W is a device intended to measure the systolic and diastolic blood pressure and pulse rate of an adult individual by using a non-invasive oscillometric technique in which an inflatable cuff is wrapped around the upper arm for a circumference range from 22 to 52cm.

The device is suitable for use by adults with conditions of diabetes, pregnancy, or pre-eclampsia.

The device detects the appearance of irregular heartbeat during measurement and gives a warning signal with the reading once the irregular heartbeat is detected.

The device can be used in connection with a smart phone via Bluetooth or with a personal computer (PC) via USB. The measurement data can be transferred to a smart phone running the Microlife Connected Health+ mobile software (App) or a PC running the Microlife BP Analyzer+ (BPA+) software.

Microlife Upper Arm Automatic Digital Blood Pressure Monitor, Model BP3KV1-5W is designed to measure systolic and diastolic blood pressure, pulse rate of an individual with arm circumference sizes ranging from 22 -52 cm by using a non-invasive technique in which one inflatable cuff is wrapped around the single upper arm. Our method to define systolic and diastolic pressure is similar to the auscultatory method but using a semiconductor sensor rather than a stethoscope and mercury manometer. The sensor converts tiny alterations in cuff pressure to electrical signals, by analyzing those signals to define the systolic and diastolic blood pressure and calculating pulse rate, which is a well - known technique in the market called the "oscillometric method".

The device detects the appearance of irregular heartbeat during measurement, and the symbol " "\\ "is displayed after the measurement. In addition, the device can be used in connection with smart mobile devices running the APP and via Bluetooth.

The blood pressure monitor is a fully automatic digital blood pressure measuring device use by adults on the upper arm at home.

1. Table of Acceptance Criteria and Reported Device Performance

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

The document states that a clinical study was conducted using the BP3KT1-3N (European Device) for validation. This study was a "prospective, open-label, non-randomized, single-center validation study." The study followed the ANSI/AAMI/ISO 81060-2:2019 test standard.

While the exact sample size for the test set is not explicitly stated in the provided text, the ANSI/AAMI/ISO 81060-2:2019 standard typically requires a minimum of 85 subjects for validation of blood pressure devices (as referenced in the acceptance criteria regarding absolute differences).

The data provenance is prospective, single-center, and from a European Device (BP3KT1-3N). The specific country is not mentioned beyond "European Device."

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

The document does not specify the number of experts used or their qualifications for establishing the ground truth. However, for a clinical validation study following the ANSI/AAMI/ISO 81060-2:2019 standard, the ground truth for blood pressure measurements is typically established by at least two trained observers (experts) using a mercury sphygmomanometer or an equivalent reference device, meticulously following standardized auscultatory procedures. These observers are usually trained and certified in blood pressure measurement techniques.

4. Adjudication Method for the Test Set

The document does not explicitly state the adjudication method. In clinical validation studies conforming to the ANSI/AAMI/ISO 81060-2 standard, when multiple observers are used for ground truth, a common adjudication method involves taking the average of the observers' readings, or in cases of significant discrepancy, a third observer might be used to mediate or resolve differences. The standard itself outlines specific requirements for how observer readings should be handled.

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 conducted. The provided information describes a clinical validation study for the device's accuracy against a reference standard, not a study comparing human reader performance with and without AI assistance.

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

Yes, a standalone performance study was done for the blood pressure measurement component. The clinical study for the BP3KT1-3N device validated its accuracy according to the ANSI/AAMI/ISO 81060-2:2019 standard. This standard assesses the device's ability to accurately measure blood pressure on its own, without direct human interpretation or modification of the measurement itself during the process (though a human activates the device and applies the cuff). The study concluded that "The Microlife device has passed the criteria of the ANSI/AAMI/ISO 81060-2:2019 test standard," which is a testament to its standalone measurement accuracy.

7. The Type of Ground Truth Used

The ground truth used for the clinical validation study was auscultatory measurement (reference sphygmomanometry). This is implied by the ANSI/AAMI/ISO 81060-2:2019 standard which compares the automated device's readings against a series of auscultatory measurements by trained observers.

8. The Sample Size for the Training Set

The document does not specify the sample size used for the training set. The clinical study mentioned is a validation study, which typically involves a separate set of subjects from any training data used for algorithm development.

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

The document does not provide information on how the ground truth for the training set was established, as details about the training process and data are not included.

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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 Automatic Digital Blood Pressure Monitor is intended to measure the blood pressure and pulse rate of adult at household. (Not suitable for neonate, pregnancy or pre-eclampsia).

The subject device, Automatic Digital Blood Pressure Monitor, is an automatic non-invasive Blood Pressure Monitor which can be driven by 4 AA batteries or AC adapter (optional). It uses an inflatable cuff which is wrapped around the patient's upper arm to measure the systolic and diastolic blood pressure as well as the pulse rate of adult at household, not for neonate or pregnancy.

This blood pressure monitor has the memory function of 60 reading of measuring data of two groups, which can save the data separately. It can display the average reading of the latest 3 groups of measurement results.

This blood pressure monitor has the function of blood pressure classification, which is convenient for you to judge whether your blood pressure is normal or not.

This blood pressure monitor has voice broadcast function (optional). During measurement and recall the memory, there will be voice operation tips.

Cuff supporting the use of Automatic Digital Blood Pressure Monitor is M5402(small adult)/M5403(adult) provided by Xuzhou Maikang Science and Technology Ltd., and cleared by the CE(Declaration of Conformity for Class I)/ISO and FDA(K151290).

The provided text describes the 510(k) summary for the AVICHE Automatic Digital Blood Pressure Monitor (K210152). Here's an analysis of the acceptance criteria and the study that proves the device meets those criteria:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: 150 subjects.
• Data Provenance: The text states "relevant volunteers were collected to conduct actual clinical trial of blood pressure measurement." This indicates a prospective study. The country of origin is not explicitly stated, but the submission is from a Chinese company, so it is likely derived from China.

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

The document does not specify the number of experts or their qualifications for establishing ground truth. It only mentions that "Auscultation was applied as gold standard" and "qualified calibrated mercurial sphygmomanometer used as control group." This implies a clinical setting where trained professionals would perform the auscultatory measurements, but specifics are missing.

4. Adjudication Method for the Test Set

The document does not describe any specific adjudication method (e.g., 2+1, 3+1). It simply states that auscultation was used as the "gold standard."

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was Done, What was the effect size of how much human readers improve with AI vs without AI assistance

This is an automated blood pressure monitor, not an AI-assisted diagnostic device that involves human readers interpreting results. Therefore, an MRMC comparative effectiveness study involving human readers with/without AI assistance is not applicable and was not conducted.

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

Yes, a standalone performance study was done. The device itself (the "Automatic Digital Blood Pressure Monitor") is the algorithm-only component in terms of its measurement capability. The clinical trial directly assessed the accuracy of the device's measurements against a gold standard (auscultation), without intervention or interpretation by "human readers" in the typical sense of AI-assisted image analysis.

7. The Type of Ground Truth Used

The ground truth used was auscultation with a qualified calibrated mercurial sphygmomanometer. This is considered a direct physiological measurement by a trained operator, serving as the clinical gold standard for blood pressure measurement.

8. The Sample Size for the Training Set

The document does not provide information about a separate training set or its sample size. The clinical trial described (150 subjects) is presented as the performance validation for the device's accuracy. For non-adaptive devices like this, there isn't typically a "training set" in the machine learning sense. The device's underlying measurement algorithm would have been developed and refined through engineering and calibration, not necessarily "trained" on a specific dataset in the way an AI model is.

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

As mentioned above, information on a specific "training set" and its ground truth establishment is not provided, as it's not directly applicable to the type of device described. The device's measurement principle (oscillometric method) and its calibration would be based on established physiological principles and engineering standards.

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