Search Results

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.

Ask a specific question about this device

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.

Ask a specific question about this device

The Wrist Digital Blood Pressure Monitor (Model: BSX313, BSX315, BSX322, BSX323, BSX353, BSX355) is a digital and non-invasive monitor intended to measure the diastolic, systolic blood pressure and pulse rate in adult with an inflatable wrist cuff circumference ranging from 13.5 to 19.5cm. It is intended for clinical and home use.

The Wrist Digital Blood Pressure Monitor (Model: BSX312, BSX313, BSX315, BSX322, BSX323, BSX353, BSX355) is a digital and non-invasive monitor that uses the cuff oscillometric method to measure diastolic and systolic blood pressure and pulse rate. It has an LCD digital display, is powered by two "AAA" batteries, and uses automatic inflation with an electric pump and automatic rapid deflation valve.

The provided text describes the 510(k) submission for a Wrist Digital Blood Pressure Monitor. I will extract the information requested regarding acceptance criteria and the study that proves the device meets them.

Acceptance Criteria and Device Performance

A digital blood pressure monitor's primary acceptance criteria are its accuracy in measuring blood pressure and pulse rate. The relevant standard cited is ISO 81060-2: 2018 (Non-invasive sphygmomanometers - Part 2: Clinical validation of automated measurement type) for clinical performance, and specific accuracy values are mentioned.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size:
  • Enrolled: 130 subjects
  • Selected (met inclusion requirements): 85 subjects (44 males and 41 females)
• Data Provenance: The document does not explicitly state the country of origin. It describes a "validation study" which implies a prospective clinical study rather than retrospective. The study was conducted as part of the regulatory submission process for a device from Shenzhen, China, suggesting the study might have been conducted there or in a region that supports compliance with international standards.

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

The document does not provide any information about the number or qualifications of experts used to establish ground truth for this device, nor does it mention experts in the context of ground truth for a blood pressure monitor. For blood pressure devices, ground truth is typically established by simultaneous readings from a reference manometer (mercury sphygmomanometer) as per ISO standards, not expert readers.

4. Adjudication method for the test set

The document does not describe any adjudication method. For blood pressure monitor validation studies by ISO 81060-2, adjudication by multiple readers is not typically part of the ground truth establishment process in the same way it would be for image interpretation tasks. The standard relies on simultaneous measurements by trained personnel using reference devices.

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 MRMC comparative effectiveness study was done or is applicable here. This document pertains to a digital blood pressure monitor, which is a standalone measurement device, not an AI-assisted diagnostic tool that human readers would interact with.

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

Yes, a standalone performance evaluation was performed. The device itself, which performs blood pressure and pulse rate measurements using an algorithm, was clinically validated against a ground truth (established by trained observers using a reference method as per ISO 81060-2) without human intervention in the device's measurement process.

7. The type of ground truth used

The ground truth used was based on clinical validation as per ISO 81060-2: 2018. This standard specifies that simultaneous auscultatory measurements by trained observers using a mercury sphygmomanometer (or an equivalent reference standard) serve as the ground truth. The document states: "All data's mean error and standard deviation of differences for systolic, diastolic pressure is not over the limits of ISO 81060-2: 2018." This directly refers to the comparison of the device's readings against this established ground truth.

8. The sample size for the training set

The document does not mention a training set or any machine learning/AI training process. This device is a traditional oscillometric blood pressure monitor, not an AI/ML-based device that would require a separate training set.

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

As there is no mention of a training set for an AI/ML model, this question is not applicable.

Ask a specific question about this device

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.

Ask a specific question about this device

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.

Ask a specific question about this device

The Digital Blood Pressure Monitor is intended to measure the systolic and diastolic blood pressure, as well as the pulse rate of adults via non-invasive oscillometric technique in which an inflatable CUFF (22-32cm) is wrapped around the upper arm at medical facilities or at home, it's supplied for OTC use.

The arm-type electronic blood pressure monitor uses fuzzy logic intelligence to detect both upper and lower pressure value simultaneously. The personalized optimal inflation level determines the result of each measurement. This equipment is composed of a main body and a cuff. The main body is composed of a central processing unit, a pressure sensor, an air pump, a solenoid valve, a uniform speed vent valve, a PCB board, and an LCD liquid crystal display.

The provided text describes the regulatory clearance of a Digital Blood Pressure Monitor (Model: YB-800) and includes information about its performance testing. I will extract the requested information based on the provided document.

1. Table of Acceptance Criteria and Reported Device Performance

The document refers to the ISO 81060-2:2018 standard for clinical validation of automated non-invasive sphygmomanometers. For this standard, the acceptance criteria for accuracy are typically:

• Mean difference: ≤ ±5 mmHg for both systolic and diastolic blood pressure.
• Standard deviation of differences: ≤ 8 mmHg for both systolic and diastolic blood pressure.

The document states: "All data's mean error and standard deviation of differences for systolic, diastolic pressure is not over the limits of ISO 81060-2: 2018." This confirms the device met these criteria.

Note: The "Static Pressure" and "Pulse Rate" accuracy in the comparison table of the 510(k) summary (Table 1, page 5) refers to the technical specification of the device, not necessarily the clinical accuracy determined by ISO 81060-2 which focuses on differences compared to a reference measurement.

2. Sample Size for the Test Set and Data Provenance

• Sample Size: 85 adult subjects (41 females, 44 males).
• Data Provenance: Not explicitly stated (e.g., country of origin). The study is described as "clinical data" testing the device, implying a prospective study specifically for this clearance.

3. Number of Experts and Qualifications for Ground Truth

The document does not specify the number of experts used to establish ground truth or their qualifications. ISO 81060-2, which was used for validation, requires comparison to reference blood pressure measurements (e.g., auscultation by trained observers), but the specific details of these observers are not provided in this summary.

4. Adjudication Method for the Test Set

The document does not explicitly state the adjudication method used for the clinical validation study. For ISO 81060-2, it typically involves comparing the device's readings to those obtained by multiple trained observers (e.g., two observers) using a standardized method, with an agreed-upon difference or resolution process if discrepancies occur. However, the specific method (e.g., 2+1, 3+1) is not detailed here.

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

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not conducted or described. This type of study typically assesses human readers' performance with and without AI assistance, which is not relevant for a standalone blood pressure monitor.

6. Standalone Performance Study

Yes, a standalone performance study was done. The "Clinical data" section explicitly states: "YB-800 was tested to ISO 81060-2: 2018 Non-invasive sphygmomanometers - Part 2: Clinical validation of automated measurement type." This standard evaluates the accuracy of automated non-invasive blood pressure monitors on their own, without human intervention in the measurement process (beyond positioning the cuff and starting the device).

7. Type of Ground Truth Used

The ground truth used for the clinical validation was established by reference blood pressure measurements as mandated by the ISO 81060-2:2018 standard. This standard requires "simultaneous determination of blood pressure by a reference method (e.g. auscultation by trained observers) and by the automated measurement type under test."

8. Sample Size for the Training Set

The document does not provide information about a separate "training set" or its sample size. This type of information is typically relevant for machine learning algorithms where data is split into training, validation, and test sets. For a traditional medical device like a blood pressure monitor, the "clinical data" described generally serves as the primary validation/test set for regulatory submission.

9. How Ground Truth for the Training Set Was Established

As no training set is described, this question is not applicable. The clinical validation focused on the performance against reference measurements in a test population.

Ask a specific question about this device

The Digital Blood Pressure Monitor is intended to measure (systolic and diastolic) and pulse rate of adults.

Not Found

This FDA 510(k) clearance letter for the Digital Blood Pressure Monitor, Model GT-701, does not contain the detailed information required to describe acceptance criteria and a study proving the device meets those criteria.

The document is a regulatory clearance stating that the device is substantially equivalent to legally marketed predicate devices. It lists the regulation number, name, and product code, along with general information about FDA regulations and contact information.

Specifically, the following information is NOT available in the provided text:

1. A table of acceptance criteria and the reported device performance: This document does not present any performance data, acceptance criteria (e.g., accuracy standards like ISO 81060-2 limits), or a direct comparison.
2. Sample size used for the test set and the data provenance: There is no mention of a test set, sample size, or the origin of any data (country, retrospective/prospective).
3. Number of experts used to establish the ground truth for the test set and their qualifications: No information about expert involvement or ground truth establishment is present.
4. Adjudication method: Not discussed.
5. Multi-reader multi-case (MRMC) comparative effectiveness study: This type of study is typically for evaluating AI-assisted interpretation, which is not applicable to a blood pressure monitor. As such, no such study or its effect size is mentioned.
6. Standalone performance study: While the device is a standalone product, the document does not describe the study itself or its results.
7. Type of ground truth used: Not specified, as no study details are provided. For a blood pressure monitor, the "ground truth" would typically come from a highly accurate reference measurement method.
8. Sample size for the training set: Not applicable for this type of device, as blood pressure monitors do not typically use machine learning training sets in the same way AI algorithms do. Even if it did, the information is not provided.
9. How the ground truth for the training set was established: Not applicable and not provided.

In summary, the provided FDA clearance letter confirms the regulatory status of the device but does not include the detailed technical study results or acceptance criteria that would typically be found in a performance study report or a summary of safety and effectiveness data (SSED). To answer your questions, one would need access to the actual 510(k) submission or relevant performance study reports conducted by the manufacturer.

Ask a specific question about this device

The devices are intended to measure the systolic blood pressure, and pulse rate of an adult more than 12 years old individual by using a non-invasive technique, in which an inflatable cuff (220mm ~ 320mm) is wrapped around the arm. It can be used in medical facilities or at home. It is supplied for OTC use.

Digital Blood Pressure Monitor (Arm Type)

I am sorry, but based on the provided document, the acceptance criteria and study details you requested are not available. The document is an FDA 510(k) clearance letter for a "Digital Blood Pressure Monitor (Arm Type)," which confirms the device's substantial equivalence to a predicate device and outlines regulatory requirements. It does not contain information about specific performance acceptance criteria or details of a study proving the device meets them.

The sections of the document discuss:

• The FDA's 510(k) review and substantial equivalence determination.
• General controls and additional regulations applicable to the device.
• Instructions for contact and further regulatory information.
• Indications for Use for the device.

There is no mention of:

• A table of acceptance criteria and reported device performance.
• Sample sizes for test or training sets.
• Data provenance.
• Number or qualifications of experts for ground truth establishment.
• Adjudication methods.
• Multi-reader multi-case (MRMC) comparative effectiveness studies.
• Standalone algorithm performance studies.
• Type of ground truth used.
• How ground truth for a training set was established.

Blood pressure monitor clearances typically rely on adherence to recognized consensus standards for accuracy and performance (e.g., ISO 81060-2 for non-invasive sphygmomanometers) rather than complex ground truth establishment studies with expert consensus or pathology data, which are more common for diagnostic imaging or AI-based devices. However, the specific details of such compliance are not included in this general clearance letter.

Therefore, I cannot provide the requested information based on the text provided.

Ask a specific question about this device

The device is a digital monitor intended for use in measuring blood pressure and pulse rate in adult patient population with wrist circumference ranging from 13.5cm to 21.5cm in home and hospital facilities by using a non-invasive oscillometric technique. The device detects the appearance of irregular heartbeats during measurement and gives a warning signal with readings.

Weony Digital Blood Pressure Monitor WBP Series are designed to measure the systolic and diastolic blood pressure and pulse rate of an individual (at least 12 or above) by using a non-invasive technique in which an inflatable cuff is wrapped around the wrist. Our method to define systolic and diastolic pressure is similar to the auscultatory method but uses an electronic pressure 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 main components of the Blood Pressure Monitor are the main unit and cuff unit. ABS is used to outer housing of the main unit. The preformed cuff unit, which is applicable to wrist circumference approximately between 135 and 215 mm, includes the inflatable bladder and PU shell. All models of the wrist blood pressure monitor use a single size of cuff. The device consists of the microprocessor, the pressure sensor, the operation keys, the pump, the electromagnetic deflation control valve, and the LCD. The subject devices are powered by two AAA alkaline batteries or adatpter.

The device has irregular heart beat (IHB) indicator which compares 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 pulse rhythm when the difference of the time intervals is over a specified range.

This document describes the FDA 510(k) clearance for the Digital Blood Pressure Monitor WBP Series (K231542) by Weony (Shenzhen) Technology Co., Ltd. The information provided focuses on demonstrating substantial equivalence to predicate devices, particularly regarding performance and accuracy.

Here is an analysis of the requested information based on the provided text:

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

The primary acceptance criteria for blood pressure monitors is typically defined by the ISO 81060-2 standard for clinical validation of automated measurement type. This standard specifies limits for the difference between the device's measurements and reference measurements. The document states the device was tested against this standard and the results show the accuracy is "within acceptable scope specified in ISO 81060-2."

While the document references the standard for acceptance, it does not provide a specific table of numerical acceptance criteria alongside the actual reported device performance (e.g., mean difference and standard deviation). However, the "SE Comparison" table includes:

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

• Sample Size for Test Set: 85 patients (41 males and 44 females)
• Data Provenance: The document does not explicitly state the country of origin. However, the manufacturer is Weony (Shenzhen) Technology Co., Ltd. in China, and the study was likely conducted in China. The study was a prospective clinical validation as it involved patients participating in a new study.

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

The document states that a "manual Mercury Sphygmomanometer was used as a reference device" for ground truth. It does not mention the number of experts or their qualifications for establishing this ground truth. Typically, for such studies, trained clinical personnel (e.g., doctors, nurses) would perform the manual measurements.

4. Adjudication method for the test set

The document does not describe any specific adjudication method for the test set. The ground truth was established by direct comparison to a manual mercury sphygmomanometer.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done

No, an MRMC comparative effectiveness study was not conducted. This refers to studies where multiple human readers assess cases with and without AI assistance. The device is a direct measurement device (blood pressure monitor), not an AI-assisted diagnostic imaging tool.

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

Yes, the primary clinical validation described is a standalone performance study. The device, as an automated non-invasive sphygmomanometer, inherently performs its measurements and calculations without human intervention in the core measurement process. The study validates the device's accuracy against a gold standard (manual mercury sphygmomanometer).

7. The type of ground truth used

The ground truth used was reference measurements from a manual Mercury Sphygmomanometer.

8. The sample size for the training set

The document does not specify a separate "training set" sample size. For medical devices like blood pressure monitors, the validation typically involves extensive bench testing and a clinical validation study (as described) rather than a machine learning "training set" in the conventional AI sense. If there was any internal algorithm development or calibration, the data used for that is not detailed.

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

As there's no explicitly mentioned "training set" in the AI sense, this information is not applicable. The device's underlying "algorithm" is the oscillometric method, which is a well-established physiological principle, not a machine learning model that requires a distinct, labeled training dataset from scratch. The performance is validated through the clinical study against a gold standard.

Ask a specific question about this device

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.

Ask a specific question about this device