(282 days)
It is a device intended to measure the systolic, diastolic blood pressure, pulse rate of an adult individual by using a non-invasive oscillometric technique in which an inflatable cuff (available sizes: 22cm to 44cm (8.7in to 17.3in)) is wrapped around the single upper arm.
Arm automatic blood pressure monitor is based on pressure vibration method. Blood pressure cuff uses the air pump to inflate, and then the arteries are extruded by the cuff with pressure. Pressure sensor collects the pressure in the cuff, and then converts it to digital signal to the CPU. Then the software calculates the systolic, diastolic blood pressure and pulse rate.
The provided document is a 510(k) summary for the Shenzhen Pump Medical System Co., Ltd.'s Arm Automatic Blood Pressure Monitor, Models BE6034 and BE6134. It details the device's substantial equivalence to a predicate device but does not contain a standalone clinical study on the subject device (BE6034, BE6134) for blood pressure measurement accuracy with defined acceptance criteria and reported performance.
Instead, the document states: "The subject device, Model BE6034, BE6134 is from the technical point of view, identical to the predicate blood pressure monitor. Model BF1112, BF1113 and BF1115. The differences between them do not relate to blood pressure measurement technology, so the clinical accuracy in terms of blood pressure detection will not be affected. Therefore repeated clinical test in accordance with the standard IEC 80601-2-30:2009 & A1:2013... is unnecessary."
The acceptance criteria and reported device performance for blood pressure measurement accuracy are inferred from the predicate device's specifications, as no new clinical study was conducted for the subject devices on this aspect.
Here's a breakdown of the requested information based on the provided text, with the understanding that clinical accuracy data is based on the predicate and not a new study of the subject device in isolation:
1. Table of Acceptance Criteria and Reported Device Performance
| Metric | Acceptance Criteria (Based on Predicate Device Specifications) | Reported Device Performance (Implied, as no new clinical study was required for the subject device for this metric) |
|---|---|---|
| Pressure Accuracy | ±3mmHg (±0.4kPa) | Meets ±3mmHg (±0.4kPa) (Implied, as subject device uses identical blood pressure measurement technology to the predicate which meets this) |
| Pulse Accuracy | ±5% | Meets ±5% (Implied, as subject device uses identical blood pressure measurement technology to the predicate which meets this) |
2. Sample size used for the test set and the data provenance
- Sample Size: Not applicable for a new clinical test on the subject device's blood pressure accuracy, as none was performed. The determination of device accuracy for blood pressure measurement was based on the predicate device's performance.
- Data Provenance: Not applicable for a new clinical test on the subject device's blood pressure accuracy.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable, as no new clinical study was performed for the subject device's blood pressure accuracy. The ground truth for the predicate device's original clinical validation would have been established according to the relevant standard (IEC 80601-2-30:2009 & A1:2013, which substituted ANSI/AAMI SP10). These standards typically involve simultaneous readings by trained observers (experts) using a reference sphygmomanometer.
4. Adjudication method for the test set
- Not applicable, as no new clinical study was performed for the subject device's blood pressure accuracy.
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
- No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This device is an automatic blood pressure monitor and does not involve human readers interpreting results in the context of AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- A standalone performance assessment for the subject devices (BE6034, BE6134) explicitly demonstrating blood pressure accuracy was not done or required by the FDA. The justification provided is that the "subject device... is from the technical point of view, identical to the predicate blood pressure monitor... The differences between them do not relate to blood pressure measurement technology, so the clinical accuracy in terms of blood pressure detection will not be affected." Therefore, the clinical performance of the subject device is considered equivalent to the predicate device.
7. The type of ground truth used
- For blood pressure monitors, the ground truth for clinical validation (as would have been applied to the predicate device) is typically established by simultaneous measurements by trained observers using a reference method (e.g., auscultation with a mercury or aneroid sphygmomanometer). This is a common requirement for validating blood pressure measurement accuracy according to standards like IEC 80601-2-30 (which substituted ANSI/AAMI SP10).
8. The sample size for the training set
- Not applicable to this device, as it is a medical device for vital signs measurement, not an AI model that requires a training set in the conventional sense of machine learning for image analysis or diagnostics. The software calculates blood pressure based on a pressure vibration method and an algorithm, but it's not described as an adaptive learning system.
9. How the ground truth for the training set was established
- Not applicable (see point 8).
§ 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).