(112 days)
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
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Accuracy (Blood Pressure) | Pressure: ± 3mmHg |
| Accuracy (Pulse Rate) | Pulse: Within ± 3% |
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
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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.
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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.
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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).
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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.
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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.
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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.
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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.
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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.
§ 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).