(99 days)
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).
| Acceptance Criteria (AAMI/ESH/ISO Universal Standard) | Reported Device Performance (BPBIO750) |
|---|---|
| Criterion 1: Mean ± SD of differences between test device and reference BP readings | Systolic: 2.2 ± 6.1 mmHg |
| Diastolic: -2.2 ± 5.2 mmHg | |
| Criterion 2: SD of averaged BP differences between test device and reference BP per subject | Systolic: 5.00 mmHg |
| Diastolic: 4.63 mmHg |
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.
§ 870.1130 Noninvasive blood pressure measurement system.
(a)
Identification. A noninvasive blood pressure measurement system is a device that provides a signal from which systolic, diastolic, mean, or any combination of the three pressures can be derived through the use of tranducers placed on the surface of the body.(b)
Classification. Class II (performance standards).