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The BPBIO750 is a digital monitor intended for use in measuring blood pressure and pulse rate in user population with left and right upper arm circumference ranging from 22 cm (8.7-inch to 16.5-inch). The systolic blood pressure and diastolic blood pressure are measured by non-invasive blood pressure ("NIBP") measuring method. The BPBIO750 may provide useful clinical information about the current health status of not only the users who are diagnosed with hypertension but also those who are not diagnosed with hypertension.

The InBody BPBIO750 is a kiosk-type, automated, single upper-arm cuff oscillometric BP monitor developed for self-measurement of BP in public spaces. It is designed for BP measurements on either the right or left upper arm and has a fixed tubular opening to insert the user's arm, with an integral single-arm cuff, which when inflated surrounds the upper arm. It is suitable for arm circumference range 22-42 cm. The device has an elbow groove to ensure correct positioning of the arm and measures BP during inflation. A wide LED screen presents systolic and diastolic BP, heart rate and time of measurement, and print-out of these data is provided automatically to the user. When the device is turned on, an auto zero calibration is performed, as well as a functional self-check of the air pressure change according to motor operation, the initial cuff position, and the motor load according to the cuff movement. Its weight is 7.1 kg, width 299 mm, depth 547 mm, height 485 mm, and has power supply through cable (AC 250 V, 10A). Calibration is recommended once every 12 months.

The InBody BPBIO750 is a digital monitor intended for measuring blood pressure and pulse rate. The information below details the acceptance criteria and the study proving the device meets these criteria, as derived from the provided text.

1. Table of Acceptance Criteria and Reported Device Performance

The device's performance was evaluated against the AAMI/ESH/ISO Universal Standard (ISO 81060-2:2018).

Conclusion: The InBody BPBIO750 device fulfilled all the requirements of the AAMI/ESH/ISO Universal Standard (ISO 81060-2:2018) in the general population.

2. Sample Size and Data Provenance for the Test Set

• Sample Size: 102 subjects were recruited, and 85 were analyzed for the test set.
• Data Provenance: The text does not explicitly state the country of origin for the data. The study was conducted retrospectively or prospectively as "Subjects were recruited to fulfil the age, gender, BP and cuff distribution criteria of the AAM/ESH/ISO Universal Standard in general population using the same arm sequential BP measurement method." This indicates a prospective clinical study design.

3. Number of Experts and Qualifications for Ground Truth Establishment

The document does not specify the number of experts or their qualifications for establishing the ground truth for the test set. It mentions "reference BP readings", implying a standard, accurate measurement method was used, but does not detail the personnel involved in generating these reference readings.

4. Adjudication Method for the Test Set

The document does not describe any specific adjudication method (e.g., 2+1, 3+1) for the test set. The study design followed the "same arm sequential BP measurement method" according to the AAMI/ESH/ISO Universal Standard, which implies direct comparison to a reference measurement rather than multi-reader adjudication of subjective interpretations.

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

A multi-reader multi-case (MRMC) comparative effectiveness study was not conducted. This study focused on the accuracy of the device itself against a reference standard, not on how human readers' performance might improve with or without AI assistance.

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

Yes, a standalone performance study was done. The study aimed to evaluate the accuracy of the InBody BPBIO750, which is an automated oscillometric BP monitor, in measuring blood pressure against established standards. The reported metrics (mean differences and standard deviations) reflect the device's inherent accuracy without human interpretation or intervention in the measurement process.

7. Type of Ground Truth Used

The ground truth used was expert consensus / reference blood pressure readings. The study design refers to "differences between the test device and reference BP readings," implying that highly accurate, validated blood pressure measurements served as the ground truth against which the device's performance was compared. This is typical for blood pressure device validation, where the reference is often obtained using a highly accurate, often invasive or a validated auscultatory method by trained personnel.

8. Sample Size for the Training Set

The document does not provide information regarding the sample size for a training set. As this is a medical device (blood pressure monitor) and not an AI/ML diagnostic system in the typical sense, there isn't an explicitly separate "training set" described in the provided context for algorithmic learning. The device's underlying algorithm is based on oscillometric principles, which are well-established and not typically "trained" on large datasets in the way modern AI models are. The testing described is validation of its accuracy.

9. How Ground Truth for the Training Set Was Established

As no specific "training set" is mentioned for the device's core functionality (see point 8), the document does not describe how ground truth for a training set was established.

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This blood pressure monitor is designed to measure (diastolic and systolic) and pulse rate in adult patients with arm circumference range between 22 cm - 42 cm.

The BPBIO480KV is a digital monitor intended for use in measuring blood pressure and pulse rate in user population with upper arm circumference ranging from 22cm (8.6-inch to 16.5-inch). The systolic blood pressure and diastolic blood pressure are measured by non-invasive blood pressure ("NIBP") measuring method and also by utilizing the Auto auscultation method and Oscillometric method. The BPBIO480KV may provide useful clinical information about the current health status of not only the users who are diagnosed with hypertension but also those who are not diagnosed with hypertension. Warnings and cautions described in the user's manual should be observed at all times. Automated Auscultation is a method that combines the accuracy of auscultation, and the convenience of the Oscillometric method. To measure the blood pressure, wrap the cuff around the upper arm and inflate it to a pressure above the systolic pressure. Then slowly release the air to detect the Korotkoff sound signal and the pressure sensor signal, which you can listen with the stethoscope attached to the cuff, to measure the systolic and diastolic blood pressure. The Automated Auscultation applied to BPBIO480KV combines the accuracy of the auscultation method with the convenience of easy measurement. The signals are electronically processed to compensate for the possible errors in the auscultation method caused by movement, external noise, etc., enabling a more accurate blood pressure measurement. Included components are the main unit, a large and a medium size cuff, a users manual, an AC adapter, a power cord, and an internal rechargeable lithium rechargeable battery. Measurement methods: Auscultation and Oscillometric.

Here's an analysis of the provided text regarding the acceptance criteria and study for the BPBIO480KV device:

Acceptance Criteria and Device Performance

Note: The text explicitly states these accuracy metrics as both "Accuracy" in the comparison table and also references conformity to ISO 81060-2:2018, which sets similar accuracy requirements. The "Validation Results" section states: "The system passed the deviation limits initially set by the protocol," which implies these criteria were met.

Study Details

1. Sample Size for Test Set and Data Provenance:

   • Sample Size: 85 total subjects (also stated as "among 93 participants" for both cuff sizes). This discrepancy might refer to 85 subjects contributing to the core data and 93 participants being enrolled to test both cuff sizes. Given the context of ISO 81060-2, a typical minimum sample size for validation is around 85 for a general population.
   • Data Provenance: Not explicitly stated (e.g., country of origin, retrospective or prospective). However, the mention of "European Society of Hypertension recommendations" and "ISO 14155:2020 principles for Good Clinical Practice" suggests a prospective clinical investigation.

2. Number of Experts and Qualifications for Ground Truth:

   • Number of Experts: Not explicitly stated.
   • Qualifications of Experts: Not explicitly stated. However, ISO 81060-2:2018 implicitly requires trained observers (auscultators) for reference measurements. The text mentions "medical staffs hear directly" when describing the auscultation method, implying human expert involvement in establishing ground truth.

3. Adjudication Method for Test Set:

   • Adjudication Method: Not explicitly stated. The description mentions "A 'V' tube was used to connect both the automated meter and the standard mercury sphygmomanometer to the cuff." This standard methodology for blood pressure validation typically involves simultaneous measurements by the device under test and human observers using a reference method (mercury sphygmomanometer and stethoscope), with statistical analysis of the differences. It doesn't explicitly describe an adjudication process for discrepancies between human observers, but ISO 81060-2:2018 often details such procedures (e.g., blinded observers, averaging, or a third arbitrator).

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

   • No, a MRMC comparative effectiveness study was not reported. The study focused on the standalone accuracy of the device against a reference standard, not its impact on human reader performance.

5. Standalone Performance (Algorithm Only without Human-in-the-Loop):

   • Yes, a standalone performance study was conducted. The "Clinical Testing" section describes measuring the BPBIO480KV's performance against a reference standard (mercury sphygmomanometer) using a "V" tube setup, which is a direct validation of the device's accuracy.

6. Type of Ground Truth Used:

   • Expert Consensus / Reference Standard Measurement: The ground truth was established by simultaneous measurements using a "standard mercury sphygmomanometer" and presumably auscultation by human observers, which is considered the gold standard for non-invasive blood pressure measurement in such validation studies.

7. Sample Size for Training Set:

   • Not explicitly stated. The document focuses on the validation study (clinical testing), not the development or training process of the device's algorithms.

8. How Ground Truth for Training Set Was Established:

   • Not explicitly stated. As with the training set size, the document does not elaborate on the development phase or how any internal algorithms were trained. The focus is solely on the validation demonstrating the device's accuracy against recognized standards.

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