Search Results

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 device intended to measure the diastolic, systolic blood pressures and pulse rate for adult population in home and hospital facilities by using a non-invasive oscillometric technique with a single upper arm cuff (22-36 cm). The device detects the appearance of irregular heats 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 18 or above) by using a non-invasive technique in which an inflatable cuff is wrapped around the upper arm. 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 arm circumference approximately between 220 and 360 mm, includes the inflatable bladder and nylon shell. All models of the arm 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 four AA alkaline batteries or adatpter.

The device has irreqular 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.

The provided text describes the 510(k) summary for the Digital Blood Pressure Monitor WBP Series. It details the device, its intended use, comparison to a predicate device, and the non-clinical and clinical tests performed to support substantial equivalence.

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

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

The primary standard for clinical validation of automated non-invasive sphygmomanometers, ISO 81060-2:2018, sets the acceptance criteria for accuracy.

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

• Sample Size: 85 patients (47 males and 38 females)
• Data Provenance: Not explicitly stated, but the submission is from a Chinese manufacturer (WEONY (SHENZHEN) TECHNOLOGY CO., LTD.), so it is highly probable the data was collected in China. The text does not specify if the study was retrospective or prospective, but clinical validation studies for device approval are almost always prospective.

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

The ground truth for blood pressure measurements in this context is established by a reference method, not by individual experts' interpretation of images or other subjective data.

• Reference Method: "The manual Mercury Sphygmomanometer was used as a reference device."
• Number of Experts/Operators: While not explicitly stated, clinical validation of automated sphygmomanometers according to ISO 81060-2 typically requires measurements by trained observers using the reference method. The standard mandates specific procedures for these measurements to ensure accuracy and minimize bias, often involving at least two trained observers taking simultaneous or sequential measurements. The document does not specify the number or qualifications of these observers.

4. Adjudication method for the test set

• Adjudication Method: "Same arm sequential method was adopted during the clinical testing." This indicates a direct comparison of the device's reading against the reference standard on the same arm, likely following strict protocols to minimize errors. This isn't an "adjudication" in the sense of resolving conflicting expert opinions, but rather a direct comparison to a gold standard.

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, an MRMC comparative effectiveness study was not done. This device is a blood pressure monitor, not an AI-powered diagnostic imaging tool that would typically involve human readers interpreting data with or without AI assistance. The study is a direct clinical validation of the device's accuracy against a known reference standard (manual mercury sphygmomanometer).

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

• Yes, in spirit. The device itself is an automated system based on the oscillometric method. Its primary function is to measure blood pressure without direct human interpretation of raw signals; humans only read the displayed results. The clinical study validates the performance of this automated algorithm in measuring blood pressure. However, the term "standalone" usually refers to AI algorithms in diagnostic contexts. In this case, the device essentially functions as a "standalone" measurement system.

7. The type of ground truth used

• Expert Consensus / Reference Standard: The ground truth was established using a manual Mercury Sphygmomanometer, which is considered the gold standard (or a highly accurate reference method) for blood pressure measurement in clinical validation studies. The measurements taken with this reference device are performed by trained personnel, effectively serving as an "expert consensus" or highly accurate reference.

8. The sample size for the training set

• Not applicable. This document describes the validation of a traditional medical device (blood pressure monitor) that operates on an established oscillometric principle, not an AI/machine learning model that would require a separate "training set" and "test set" in the conventional sense. The device's algorithm is based on well-understood physiological principles and signal processing, not on learning from a large dataset.

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

• Not applicable. As stated above, this device does not utilize a machine learning model that requires a "training set" with ground truth established for learning. Its operational principles are fixed and based on physics and established medical techniques.

Ask a specific question about this device

The subject device is intended to measure the diastolic, systolic blood pressures and pulse rate of an adult individual in hospitals, hospital-type facilities and home environments by using a non-invasive oscillometric technique in which an inflatable cuff(size: 12.5-21.5cm(4.9-8.5in) is wrapped around the single wrist.

The Subject device is not intended to be diagnostic device.

The Subject device is battery driven automatic non-invasive Blood Pressure Monitor. It consists of the Main Control Unit, LCD and attachments. The device can automatically complete the inflation, deflation and BP measurement, which intended to measure the diastolic, systolic blood pressures and pulse rate for an adult individual via the oscillometric technique.

The wrist style utilizes an inflatable cuff that is wrapped around the single wrist; the cuff circumference is limited to: 12.521.5cm(4.98.5in).

Here's an analysis of the provided text to fulfill your request:

Acceptance Criteria and Study for the Digital Blood Pressure Monitor-Wrist Style

The provided 510(k) summary indicates that the device was evaluated against the ISO 81060-2:2013 Non-invasive sphygmomanometers Part 2: Clinical validation of automated measurement type standard. This standard defines the acceptance criteria for accuracy in automated non-invasive sphygmomanometers.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Based on ISO 81060-2:2013)

*Note: The document states "The results showed the accuracy of the blood pressure monitor is within acceptable scope specified in ISO 81060-2," but it does not provide the specific mean differences or standard deviations obtained from the clinical study.

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

• Sample Size (Test Set): Eighty-seven (87) patients. This consisted of 36 males and 51 females.
• Data Provenance: Not explicitly stated, but given the manufacturer (Shenzhen Combei Technology Co., Ltd. in China) and the submission date, it is highly likely that the data originates from China. The study is described as a prospective clinical investigation since patients participated in the study.

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

• Number of Experts: The document states that a "manual Mercury Sphygmomanometer was used as a reference device." This implies that the ground truth measurements were obtained by trained human operators using this reference device. However, the exact number of experts/operators and their specific qualifications (e.g., "physician with X years of experience," "trained technician") are not specified in the provided text.

4. Adjudication Method

• Adjudication Method: The document mentions a "Same arm sequential method" was adopted. This method typically involves taking measurements simultaneously or in rapid succession on the same arm by both the test device and the reference device. It does not explicitly describe an adjudication method for discrepancies between multiple readers, as the ground truth seems to be established by one or more operators using the reference manual device. Therefore, a specific adjudication method like "2+1" or "3+1" is not applicable or not specified in this context.

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

• Was an MRMC study done? No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is more common for diagnostic imaging AI systems where human readers interpret medical images with and without AI assistance. This document describes a clinical validation for a blood pressure monitor, focusing on its accuracy against a reference standard.
• Effect size of human readers improvement with AI vs. without AI assistance: Not applicable, as no MRMC study was conducted.

6. Standalone Performance Study (Algorithm Only)

• Was a standalone performance study done? Yes, the clinical investigation described is essentially a standalone performance study of the algorithm within the device. The study directly compares the device's measurements against a reference standard (manual mercury sphygmomanometer) without human intervention in the device's measurement process, beyond initiating the measurement.

7. Type of Ground Truth Used

• Type of Ground Truth: The ground truth was established by measurements obtained using a manual Mercury Sphygmomanometer as a reference device. This is considered an expert-derived reference standard as it relies on trained human operators properly using a calibrated, recognized reference instrument.

8. Sample Size for the Training Set

• Sample Size (Training Set): The document does not specify the sample size for any training set. Blood pressure monitors like this typically do not involve machine learning models that require explicit "training sets" in the same way AI algorithms for image analysis do. Their algorithms are usually based on established oscillometric principles and calibrated during manufacturing. Therefore, this question is likely not applicable to the device described.

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

• How Ground Truth for Training Set was Established: Not applicable, as no specific "training set" or explicit machine learning training process is described or implied for this type of device in the document.

Ask a specific question about this device

The subject device intended to measure the diastolic, systolic blood pressures and pulse rate of an adult individual in hospitals, hospital-type facilities and home environments by using a non-invasive oscillometric technique in which an inflatable cuff (size: 2232cm(8.712.6in) is wrapped around the single upper arm. The Subject device is not intended to be diagnostic device.

The Subject device is battery driven automatic non-invasive Blood Pressure Monitor. It consists of the Main Control Unit, LCD and attachments. The device can automatically complete the inflation, deflation and BP measurement, which intended to measure the diastolic, systolic blood pressures and pulse rate for an adult individual via the oscillometric technique. The Automatic Upper Arm style utilizes an inflatable cuff that is wrapped around the upper arm; the cuff circumference is limited to: 22cm32cm (8.7in12.6in).

The document is a 510(k) Pre-market Notification for a Digital Blood Pressure Monitor. It describes the device's characteristics, intended use, and comparison to a predicate device. The clinical validation data provided is specifically for demonstrating the accuracy of the blood pressure monitor.

Here's an analysis of the provided text to answer your questions:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for accuracy are based on ISO 81060-2:2013, which specifies the requirements for clinical validation of automated non-invasive sphygmomanometers. The document states that the device's accuracy is "within acceptable scope specified in ISO 81060-2."

While ISO 81060-2 provides specific statistical criteria (mean difference and standard deviation of differences between the device and reference measurements), the document does not explicitly list these numerical criteria or the exact calculated performance metrics but rather makes a summary statement of compliance.

However, a "Substantial Equivalence Comparison" table (Table 1) provides the following for the subject device and predicate device:

Note: The accuracy characteristic listed as "Pressure: ±3mmHg; Pulse: ±5%" for the subject device seems to be a design specification or internal target, rather than reported clinical performance data resulting from the ISO 81060-2 study. The ISO standard specifies a statistical method to declare accuracy, not a simple range. The statement under section 9 "Brief discussions of clinical tests" that "The results showed the accuracy of the blood pressure monitor is within acceptable scope specified in ISO 81060-2" is the key clinical performance outcome. Without the specific numerical results (mean difference and standard deviation) from the ISO 81060-2 test, a precise performance table cannot be constructed from this document.

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

• Sample Size for Test Set: Eighty-seven (87) patients.
• Data Provenance: Not explicitly stated (e.g., country of origin). The study is described as a "clinical investigation," which implies prospective data collection for this purpose.

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

• For blood pressure accuracy studies following ISO 81060-2, "experts" in the traditional sense of image interpretation for AI are not typically involved in establishing ground truth.
• Ground Truth: The ground truth for blood pressure measurements is established by a manual Mercury Sphygmomanometer as the reference device, with measurements performed by trained personnel according to the standard. The document states: "The manual Mercury Sphygmomanometer was used as a reference device."

4. Adjudication Method for the Test Set

• Adjudication Method: The document describes a "Same arm sequential method" for the clinical testing. This is a specific protocol for comparing automated blood pressure readings to a reference standard, not an adjudication method in the context of multiple human readers for AI. It implies direct comparison of measurements taken immediately after each other.

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

• No, an MRMC comparative effectiveness study was not done. This study is for the clinical validation of a blood pressure monitor's accuracy against a standard, not an AI-assisted diagnostic device where human reader improvement would be measured.

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

• Yes, in essence. The validation described is for the device (the automated blood pressure monitor) itself, which functions as a standalone algorithm (oscillometric technique) to measure blood pressure without human interpretation of complex data (like medical images). It's comparing the device's automated readings to a reference standard.

7. The Type of Ground Truth Used

• Type of Ground Truth: The ground truth was established using a manual Mercury Sphygmomanometer as the reference device. This falls under the category of a reference standard method (a gold/silver standard where applicable) for physiological measurements.

8. The Sample Size for the Training Set

• Not Applicable/Not Provided: This document describes the clinical validation of a physical medical device (blood pressure monitor), not an AI/machine learning model where a distinct "training set" would be used for algorithm development. The device's underlying oscillometric algorithm is presumably developed and optimized by the manufacturer using internal methods, but this document does not detail that process or any "training set."

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

• Not Applicable/Not Provided: As mentioned above, this document does not refer to a training set for an AI model. The "ground truth" for the device's function is inherent in its design and the physical principles of oscillometry, calibrated and validated against established standards.

Ask a specific question about this device

This device is intended to measure the blood pressure and pulse rate on upper arms of adults.

The Digital Blood Pressure Monitor is Arm-type fully automatic Digital Blood Pressure Monitor and used the oscillometric method for non-invasive measurement of blood-pressure at home.

The equipment is non-transit-operable, portable equipment, not used at the conditions of patient movement in normal use. The unit is powered by internal dry battery.

Digital Blood Pressure Monitor is based on pressure vibration method. Blood pressure cuff use the air pump to inflate, then the arteries are extruded by the cuff with pressure. Pressure sensor collects the pressure in the cuff, and then converts it to digital signal to the CPU. Then the software calculates the systolic and diastolic blood pressure and pulse rate.

Digital Blood Pressure Monitor, JDS-189, JDS-500A, JDS-500E, JDS-600, JDS-700, JDS-703, JDS-704, JDS-800, BM 20 in term of intended use measurement method, structure, and specifications are totally same, only the appearance, memory space has difference.

The provided document is a 510(k) summary for a Digital Blood Pressure Monitor, aiming to demonstrate its substantial equivalence to a predicate device. It includes information on the device's intended use, technology, and applied standards, as well as testing data.

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:

1. Table of Acceptance Criteria and the Reported Device Performance

Note: The document states that "Laboratory testing was conducted to validate and verify that Digital Blood Pressure Monitor met all requirements of related international standards," and specifically lists the performance requirements for pressure and pulse accuracy. It also notes "clinical study has been evaluated according to ANSI/AAMI/ISO 81060-2." This implies that the device achieved accuracy within the limits specified by the accuracy requirement, which are typical for blood pressure monitors.

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

The document states: "Clinical study has been evaluated according to ANSI/AAMI/ISO 81060-2."

• Sample Size for Test Set: The document does not explicitly state the sample size used for the clinical study that followed ANSI/AAMI/ISO 81060-2. This standard generally requires a minimum number of subjects (e.g., typically 85 subjects with specific age and blood pressure distribution) for accuracy validation.
• Data Provenance: The document does not explicitly state the country of origin of the data or whether it was retrospective or prospective. Given the submitter's location (SUZHOU SUNSPIRIT CO., LTD., P. R. China), it is highly probable the study was conducted there. It is typically a prospective study to meet the requirements of ISO 81060-2.

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

The document mentions "Clinical study has been evaluated according to ANSI/AAMI/ISO 81060-2," but it does not provide details on the number of experts, their qualifications, or how ground truth was established within the context of that clinical study. For blood pressure measurement, the ground truth (reference measurements) would typically be established by trained observers using a calibrated sphygmomanometer following a standardized protocol, rather than "experts" in the sense of physicians establishing a diagnosis.

4. Adjudication Method (for the test set)

The document does not specify an adjudication method. In the context of blood pressure device validation, and specifically for ISO 81060-2, adjudication would usually involve comparing the device's readings against simultaneously obtained reference readings. The standard outlines specific procedures for taking these reference readings (e.g., using two trained observers auscultating simultaneously).

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

The document does not mention or imply that a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was done. MRMC studies are typically used to assess the impact of AI algorithms on human reader performance, which is not applicable to a digital blood pressure monitor that performs automatic measurements.

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

Yes, a standalone performance evaluation was done. The device itself is an "Arm-type fully automatic Digital Blood Pressure Monitor" that uses an "oscillometric method" to calculate systolic and diastolic blood pressure and pulse rate automatically. The clinical study according to ANSI/AAMI/ISO 81060-2 evaluates the accuracy of this automatic measurement against a reference standard, which is a standalone assessment of the device's algorithm.

7. The Type of Ground Truth Used

The ground truth used for the clinical evaluation, as per ANSI/AAMI/ISO 81060-2, would be simultaneously measured blood pressure readings obtained by trained observers using a reference sphygmomanometer (typically mercury or a validated equivalent) following a strict protocol. This method is often referred to as "reference measurement" or "expert auscultation" and is the gold standard for non-invasive blood pressure device validation.

8. The Sample Size for the Training Set

The document does not provide any information about a training set since this typically refers to data used to train a machine learning model. While the device utilizes an oscillometric method with software, it's not explicitly stated if it employs machine learning that would require a separate training dataset. The "clinical study" mentioned refers to the validation study for regulatory approval, not a training phase.

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

As no training set is explicitly mentioned in the context of machine learning, there is no information provided on how ground truth for a training set was established. The oscillometric method relies on established physiological principles and algorithms, rather than typically being "trained" in the modern machine learning sense with a distinct training dataset and corresponding ground truth.

Ask a specific question about this device

It can be used as medical assistant instrument at home or in medical center for adult population for measuring systolic and diastolic blood pressure and heart rate.

The device is intended for use in only adult population, not applied to ther populations such as neonatal baby.

It can not be used while the wrist (arm) has bleeding or wound to avoid the blood flowing from the wound in pressurizing.

Digital Blood Pressure Monitor is a fully automatic non-invasive blood pressure monitor which measures systolic and diastolic blood pressure and heart rate of adult population using the oscillometric method by inflating an inflatable cuff on the wrist. Digital Blood Pressure Monitor JWS-1000, JWS-970, JWS-950, JWS-940, JWS-706, JWS-705. JWS-704. JWS-703. JWS-701. JWS-700. JWS-600. BC20. BC40 have the same technology, main function, performance and intended use, and they are consistent in product structure and material.

The provided text describes a 510(k) premarket notification for a Digital Blood Pressure Monitor. It focuses on demonstrating substantial equivalence to a predicate device rather than providing a detailed study report with specific acceptance criteria and performance metrics.

Therefore, many of the requested details, such as specific performance metrics with acceptance criteria, sample sizes for test and training sets, details on expert qualifications, adjudication methods, MRMC studies, standalone performance, and ground truth establishment for training, are not explicitly provided in this type of regulatory document.

However, based on the information available, here's what can be extracted and inferred:

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

The document states that the device conforms to several standards, implying that the acceptance criteria are those specified in these standards. The device's performance is reported as meeting these standards and being "statistically and clinically acceptable."

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

• Sample Size: Not explicitly stated in the document. The document only mentions "A comparison study" was performed. Standards like ANSI/AAMI/ISO 81060-2 usually specify minimum sample sizes for validation (e.g., typically at least 85 subjects).
• Data Provenance: Not explicitly stated. The manufacturer is based in China, so it's possible the study was conducted there, but this is not confirmed.
• Retrospective or Prospective: Not explicitly stated. Clinical validation studies for blood pressure monitors are typically prospective.

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

• The clinical study involved a "comparison study with a device that uses auscultatory method used by trained observers."
• Number of Experts/Observers: Not explicitly stated (the standard ANSI/AAMI/ISO 81060-2:2009 typically requires at least two trained observers).
• Qualifications of Experts: Described as "trained observers." No further details on their specific qualifications or years of experience are provided.

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

• The document implies adherence to ANSI/AAMI/ISO 81060-2:2009, which outlines specific methodologies for comparing automated blood pressure measurements with those obtained by trained observers using a reference method (auscultation). This typically involves multiple readings and a procedure for handling discrepancies, often implicitly using a consensus or comparison against a standard. However, the specific adjudication method (e.g., 2+1, 3+1) is not detailed in this summary.

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 study was mentioned. This device is a standalone blood pressure monitor, not an AI-assisted diagnostic tool for interpretation by human readers. Therefore, this question is not applicable to this submission.

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

• Yes, a standalone performance study was done. The entire clinical study described is a standalone validation of the device's accuracy ("clinical repeatability") against a reference method (auscultatory method by trained observers). The device itself operates as an algorithm determining blood pressure without human intervention in the measurement process.

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

• Expert comparison/reference method: The ground truth was established by "a device that uses auscultatory method used by trained observers." The auscultatory method, employing a stethoscope and manometer, is the traditional reference standard for non-invasive blood pressure measurement.

8. The sample size for the training set

• Not applicable / not provided. This document describes a medical device clearance based on demonstrable performance against a predicate and recognized standards. It's not a submission for an AI/ML model that typically details training sets for deep learning or similar algorithms. The "training" for such a device is in its design and calibration, not in a separate machine learning training set as might be asked for an AI diagnostic algorithm.

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

• Not applicable / not provided. As mentioned above, this is not an AI/ML model submission that would involve a distinct "training set" with ground truth established through labeled data for an algorithm to learn from.

Ask a specific question about this device

The Electronic Blood Pressure Monitor LD-568, LD-520, LD-522, LD-587 & LD-528 is device intended to measure the systolic and diastolic blood pressure and pulse rate of an adult individual by using a non-invasive technique in which an inflatable cuff is wrapped around the arm.

Not Found

The provided text is related to a 510(k) premarket notification for an Automatic Digital Blood Pressure Monitor. It includes information about the device's regulatory classification, intended use, and substantial equivalence determination. However, this document does not contain the detailed study information regarding acceptance criteria, reported device performance, sample sizes, ground truth establishment, expert qualifications, or comparative effectiveness studies that you requested.

The letter from the FDA confirms that the device is substantially equivalent to legally marketed predicate devices, meaning it has been determined to be as safe and effective as a previously cleared device. This regulatory clearance often relies on demonstrating that the new device meets the same performance standards as the predicate, which would involve testing. However, the specific details of those tests, including the acceptance criteria and study results, are not present in this publicly available document.

To provide the information you requested, access to the full 510(k) submission document or related performance testing reports would be necessary.

Ask a specific question about this device