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The product automatically measures human being's Systolic blood pressure and pulse rate by oscillometric method. The measurement results are displayed on the LCD. Measurement position is at human being's upper arm. The intended use of this over-the-counter device is for adults with upper arm circumference ranging from 150 mm to 520 mm (Approx.6 ~ 21 inches) and for home use. When the device detects the appearance of irregular heartbeats during measurement, an indicated symbol will appear with measuring readings. This device is designed only for adults.

The AVITA Arm Type Blood Pressure Monitor (Model BPM82) consists of a main unit with an LCD display and four buttons, along with a cuff component. The device is designed for accurate and convenient monitoring of an individual's blood pressure and pulse rate through the application of oscillometric methodology. Specifically engineered for use on the upper arm, this over-the-counter device is tailored to adults with upper arm circumferences ranging from 150 mm to 520 mm (Approx. 6~ 21 inches) for in-home use.

Here's a breakdown of the acceptance criteria and study information for the AViTA Arm Type Blood Pressure Monitor (BPM82), based on the provided document:

Acceptance Criteria and Device Performance

Note: The document only explicitly states the fulfillment of the required limits for mean difference and standard deviation, rather than providing the exact numerical values for these metrics.

Study Information

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

• Test Set Sample Size: 90 adult subjects, resulting in 255 valid paired measurements.
• Data Provenance: The document does not explicitly state the country of origin. It indicates it was a "clinical investigation," which is typically prospective.

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

• Number of Experts: Two observers.
• Qualifications: Not explicitly stated, but they used a "mercury sphygmomanometer," implying they were trained and qualified to expertly obtain blood pressure readings using this method, which serves as the ground truth.

4. Adjudication method for the test set:

• The document implies a direct comparison between the two observers using the mercury sphygmomanometer as the reference. It doesn't explicitly state an adjudication method like 2+1 or 3+1, but rather that "sequential measurements were taken... using a mercury sphygmomanometer (two observers) and the AVITA Blood Pressure Monitor." This suggests a direct comparison of the device's readings against these two expert readings.

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:

• A multi-reader multi-case (MRMC) comparative effectiveness study comparing human readers with and without AI assistance was not performed. This device is a standalone blood pressure monitor, not an AI-powered diagnostic imaging tool that assists human readers.

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

• Yes, a standalone performance study was done. The clinical study tested the AViTA Arm Type Blood Pressure Monitor (BPM82) itself against the ground truth reference measurements. It's an automated device, so its performance is inherently "algorithm only" in its measurement function.

7. The type of ground truth used:

• Expert Consensus / Reference Standard Measurement: The ground truth was established by two observers using a traditional mercury sphygmomanometer, which is the accepted gold standard for blood pressure measurement in clinical validation protocols like ISO 81060-2.

8. The sample size for the training set:

• The document does not specify a sample size for a training set. This is a medical device validation study for a physical device, not an AI/machine learning model that typically has distinct training and test sets. The "clinical investigation" referred to here is for validating the final device.

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

• As no distinct training set is mentioned for this type of device, the method for establishing ground truth for a training set is not applicable in this context.

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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 with a single upper arm cuff (22-42 cm).

The device detects the appearance of irregular heart beats during measurement and gives a warning signal with readings.

The Subject device is not intended to be diagnostic device.

Combei Blood Pressure Monitor are designed to measure the systolic and diastolic blood pressure and pulse rate of an individual 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 420 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, Bluetooth tranismiision (optional) and the LCD. The subject devices are powered by four AA alkaline batteries or adatpter. The device also 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 irreqular pulse rhythm when the difference of the time intervals is over a specified range.

The provided document contains information about the acceptance criteria and study that proves the device meets the acceptance criteria. Here's a summary of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance:

The document states compliance with ISO 81060-2:2013 Non-invasive sphygmomanometers - Part 2: Clinical validation of automated measurement type. This standard outlines the acceptance criteria for blood pressure monitor accuracy. While the specific numerical acceptance criteria (e.g., mean difference and standard deviation between the device and reference for systolic and diastolic blood pressure) are not explicitly detailed in the provided text, the document indicates that the results showed the accuracy of the blood pressure monitor is "within acceptable scope specified in ISO 81060-2."

From the "SE Comparison" table, the reported device accuracy is:

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

• Sample size for the test set: 85 patients
• Data provenance: Not explicitly stated, but the study was conducted as a "clinical investigation" for regulatory submission, implying prospective data collection. The manufacturer is Shenzhen Combei Technology Co., Ltd. from China, so the study was likely conducted in China.

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

The document mentions that "The manual Mercury Sphygmomanometer was used as a reference device" and that a "Same arm sequential method was adopted during the clinical testing." For non-invasive sphygmomanometer validation studies following ISO 81060-2, ground truth is typically established by trained observers using a reference manual sphygmomanometer. However, the exact number of experts/observers and their specific qualifications (e.g., radiologist with 10 years of experience) are not provided in this document.

4. Adjudication method for the test set:

The document states "Same arm sequential method was adopted during the clinical testing" using a manual Mercury Sphygmomanometer as a reference. This method involves taking simultaneous or sequential measurements by both the device under test and the reference method. For validation against ISO 81060-2, typically multiple observers take readings, and their readings are often averaged or adjudicated for the reference measurement. However, the specific adjudication method (e.g., 2+1, 3+1, none) is not explicitly detailed in the provided text.

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

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This study focuses on validating the accuracy of the automated blood pressure monitor against a manual reference standard, not on comparing human readers with and without AI assistance.

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

Yes, a standalone study was done. The clinical investigation described in section 8 (Brief discussions of clinical tests) evaluates the automated blood pressure monitor's performance directly against a reference device, without human interpretation of the device's output influencing the measurement. It's an algorithm-only (device-only) performance evaluation.

7. The type of ground truth used:

The type of ground truth used was measurements from a manual Mercury Sphygmomanometer, which serves as the reference standard for blood pressure measurement in accordance with ISO 81060-2.

8. The sample size for the training set:

The document does not provide information on the sample size for the training set. The clinical study mentioned (85 patients) is for validation/testing, not for training the algorithm. As a medical device that measures blood pressure using well-established oscillometric principles, it's possible that the core algorithm does not rely on a large, distinct "training set" in the same way a machine learning-based diagnostic algorithm would, or that such training data was internal to development and not disclosed in the 510(k) summary.

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

As no information is provided on a training set, the method for establishing its ground truth is also not mentioned.

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BPM64R automatically measures human's Systolic, Diastolic blood pressure and heart rate by using the oscillometric method during inflation. All values can be read out in one LCD panel. Measurement position is at human being's Arm. The intended use of this over-the-counter device is for adults aged 18 years and older with Arm circumference ranging 220 ~ 420 mm (approx. 9 ~ 17 inch) and for home use.

Blood Pressure Monitor is a device intended for use in automatically measures human's Systolic, Diastolic blood pressure and heart rate. The Blood Pressure Monitor, BPM64R uses an inflatable cuff which is wrapped around the patient's upper arm. The cuff is inflated automatically by an internal pump in the device. The systolic and diastolic blood pressures are determined by oscillometric method and silicon integrate pressure sensor technology. The deflation rate is controlled by a preset mechanical valve at a constant rate. The pressure of the cuff is completely released automatically at the end of the measurement. At the same time, the measurements are displayed on the LCD display for three minute. There is a maximum pressure safety setting at 300 mmHg. The device will not inflate the cuff higher than 300 mmHg.

Here's an analysis of the provided text regarding the acceptance criteria and study for the AViTA Arm Type Blood Pressure Monitor BPM64R:

Based on the provided 510(k) summary, the device is a non-invasive blood pressure monitor, and its performance is evaluated against the ISO 81060-2 standard for clinical validation of automated measurement type.

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

Note: The document states that the "results of this clinical investigation show that the required limits for mean difference and standard deviation are fulfilled by the subject device." However, specific numerical values for the mean difference and standard deviation are not provided in this summary. To get these exact values, one would typically need to refer to the full study report or the detailed submission.

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

The document does not explicitly state the sample size used for the clinical validation. It mentions a "clinical investigation" and refers to "the subject device" fulfilling the required limits.

Regarding data provenance:

• Country of Origin: Not specified in the provided text for the clinical study.
• Retrospective or Prospective: Not specified. Clinical validations for devices like 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 document does not provide details on the number of experts or their qualifications for establishing the ground truth. For blood pressure monitors, the "ground truth" (reference measurements) is usually established by highly trained technicians or physicians using a validated reference sphygmomanometer, often with protocols like auscultatory measurements by two independent observers.

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

The document does not specify the adjudication method. Clinical validation studies for blood pressure monitors following ISO 81060-2 typically involve multiple observers. For example, two observers taking sequential measurements, with a third if there's a significant discrepancy.

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 to this device. The AViTA Arm Type Blood Pressure Monitor BPM64R is a standalone automated measurement device; it is not an AI-powered diagnostic tool requiring human readers for interpretation, nor does it provide "assistance" to human readers in the way an AI algorithm might in imaging diagnostics.

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 premise of this device is "automatically measures human's Systolic, Diastolic blood pressure and heart rate." The clinical investigation described is explicitly for the automated measurement type and demonstrates the device's ability to operate without human intervention for the measurement itself, though a human initiates the process and reads the display.

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

The ground truth for blood pressure monitor validation studies, as per ISO 81060-2, typically involves simultaneous or near-simultaneous auscultatory measurements performed by trained observers using a calibrated mercury or an equivalent reference sphygmomanometer. This would fall under a form of expert reference measurement rather than pathology or outcomes data.

8. The sample size for the training set

This device is an automated measurement system, likely based on traditional oscillometric principles. It does not appear to employ a machine learning or AI model that requires a distinct "training set" in the conventional sense of AI development. Therefore, a sample size for a training set is not applicable in the context of this device as described.

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

As there is no indication of a "training set" for a machine learning model, this question is not applicable. The device's underlying algorithms are likely based on established physiological models for oscillometric measurements, rather than being "trained" on a dataset in the AI sense.

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