(189 days)
ABPM50 Automatic Blood Pressure Monitor is intended to monitor the systolic, diastolic and mean blood pressure as well as pulse rate via non-invasive oscillometric technique in which an inflatable cuff is wrapped around the upper arm. It can be used on adult, pediatric and neonatal individuals.
The proposed device, ABPM50 Automatic Blood Pressure Monitor, is battery driven automatic non-invasive Blood Pressure Monitor. It can automatically complete the inflation and BP measurement, which can measure systolic, diastolic and mean blood pressure as well as the pulse rate at upper arm within its claimed range and accuracy via the oscillometric technique. User can select the unit of the measurement: mmHg or kPa. ABPM50 can be used on adult, pediatric, and neonatal individuals.
The device has the data storage function for data review including measurement time, systolic blood pressure, diastolic blood pressure, mean blood pressure and pulse rate. These records can be uploaded to PC via USB and processed with the PC software.
ABPM50 has physiological alarm function which can be turned on or off by users. When the measurement results exceed the alarm limit, the physiological alarm function will be triggered. The alarm limit can be set by users, and the low limit must be lower than the corresponding high limit. In addition, it has technical alarm function which will be triggered when the battery voltage is lower than 2.3V , and this alarm can not be cancelled unless being closed or the power replaced.
Here's a breakdown of the acceptance criteria and the study details for the ABPM50 Automatic Blood Pressure Monitor, based on the provided text:
Acceptance Criteria and Device Performance
The provided document states that the clinical tests were conducted following the ANSI/AAMI SP10:2002+A1:2003+A2:2006 standard for manual, electronic, or automated sphygmomanometers. While the specific numerical acceptance criteria are not explicitly detailed in the provided text, this standard generally outlines requirements for accuracy of blood pressure measurements. The document does state that the device "complies with the standard requirements and the accuracy the manufacture declared." Without the explicit declared accuracy from the manufacturer, we can infer that the device meets the general accuracy requirements of the ANSI/AAMI SP10 standard.
General Acceptance Criteria (Inferred from ANSI/AAMI SP10):
The ANSI/AAMI SP10 standard typically requires that:
- The mean difference between the device measurement and reference measurement (mercury sphygmomanometer) should be ± 5 mmHg or less.
- The standard deviation of the differences should be ± 8 mmHg or less.
- A minimum number of subjects (e.g., 85 adult subjects) should be tested.
| Acceptance Criteria Category (Inferred from ANSI/AAMI SP10) | Reported Device Performance |
|---|---|
| Mean difference (device vs. reference) for BP | Complies with standard |
| Standard deviation of differences for BP | Complies with standard |
| Accuracy of measurement (Systolic, Diastolic, Mean BP, Pulse Rate) | Complies with standard and manufacturer's declared accuracy |
Study Details
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Sample size used for the test set and the data provenance:
- Sample Size: Not explicitly stated. The document refers to "clinical tests following ANSI/AAMI SP10:2002+A1:2003+A2:2006". This standard specifies a minimum number of subjects (e.g., 85 for adults, with specific requirements for pediatric and neonatal populations, including a minimum of 15 subjects for each age group within those populations). Given it covers "adult, pediatric, and neonatal individuals," it would involve multiple age cohorts.
- Data Provenance: The study was conducted in Qinhuangdao Maternal and Child Health Hospital. This indicates a prospective study conducted in China.
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Number of experts used to establish the ground truth for the test set and their qualifications:
- Not specified in the provided text. The ANSI/AAMI SP10 standard typically requires simultaneous auscultation by two trained observers for ground truth, often using a Y-tube and a third supervisor, but the exact number and qualifications are not detailed here.
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Adjudication method for the test set:
- Not specified. Assuming adherence to ANSI/AAMI SP10, the ground truth would typically be established by trained observers taking manual readings, often with a method to resolve discrepancies between observers, such as averaging or a third adjudicator.
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If a multi-reader multi-case (MRMC) comparative effectiveness study was done:
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No, a MRMC comparative effectiveness study was not conducted. This type of study is more common for diagnostic imaging AI systems where human reader performance is a key metric. This study focused on the standalone accuracy of the blood pressure monitor against a reference method.
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Effect size of human readers improvement with AI vs. without AI assistance: Not applicable, as no MRMC study was performed.
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If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Yes, the study described is effectively a standalone performance study of the ABPM50 device. It tested the device's accuracy in measuring blood pressure and pulse rate (algorithm only) compared to a reference standard (human-measured manual blood pressure, implied by ANSI/AAMI SP10).
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The type of ground truth used:
- Expert concensus / Manual auscultatory readings from trained observers. The ANSI/AAMI SP10 standard dictates that the reference blood pressure measurements are taken by trained observers using a mercury sphygmomanometer (or an equivalent validated reference device) simultaneously with the device under test.
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The sample size for the training set:
- Not applicable. The provided document describes a clinical validation study for a device, not a machine learning model that requires a distinct training set. The device operates based on oscillometric principles, not a deep learning algorithm trained on a large dataset in the typical sense.
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How the ground truth for the training set was established:
- Not applicable, as a training set for a machine learning model is not explicitly mentioned or implied for this device's function. The "training" for such a device would instead relate to the engineering and calibration processes during development, which aren't typically described with ground truth in the same way as AI models.
§ 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).