(205 days)
The subject device is intended to measure the diastolic, systolic blood pressures and pulse rate of an adult individual in hospitals, hospital-type facilities and home environments by using a non-invasive oscillometric technique in which an inflatable cuff(size: 12.5-21.5cm(4.9-8.5in) is wrapped around the single wrist.
The Subject device is not intended to be diagnostic device.
The Subject device is battery driven automatic non-invasive Blood Pressure Monitor. It consists of the Main Control Unit, LCD and attachments. The device can automatically complete the inflation, deflation and BP measurement, which intended to measure the diastolic, systolic blood pressures and pulse rate for an adult individual via the oscillometric technique.
The wrist style utilizes an inflatable cuff that is wrapped around the single wrist; the cuff circumference is limited to: 12.521.5cm(4.98.5in).
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Acceptance Criteria and Study for the Digital Blood Pressure Monitor-Wrist Style
The provided 510(k) summary indicates that the device was evaluated against the ISO 81060-2:2013 Non-invasive sphygmomanometers Part 2: Clinical validation of automated measurement type standard. This standard defines the acceptance criteria for accuracy in automated non-invasive sphygmomanometers.
1. Table of Acceptance Criteria and Reported Device Performance
Acceptance Criteria (Based on ISO 81060-2:2013)
| Measurement Parameter | Acceptance Criteria (Mean difference ± Standard Deviation) | Acceptance Criteria (Standard Deviation of differences from reference) | Reported Device Performance (Mean difference ± Standard Deviation) (for test group*) | Reported Device Performance (Standard Deviation) (for test group*) |
|---|---|---|---|---|
| Sistolic Blood Pressure | Mean difference ≤ ±5 mmHg | SD ≤ 8 mmHg | Within acceptable scope specified in ISO 81060-2 (Exact numbers not provided) | Within acceptable scope specified in ISO 81060-2 (Exact numbers not provided) |
| Diastolic Blood Pressure | Mean difference ≤ ±5 mmHg | SD ≤ 8 mmHg | Within acceptable scope specified in ISO 81060-2 (Exact numbers not provided) | Within acceptable scope specified in ISO 81060-2 (Exact numbers not provided) |
*Note: The document states "The results showed the accuracy of the blood pressure monitor is within acceptable scope specified in ISO 81060-2," but it does not provide the specific mean differences or standard deviations obtained from the clinical study.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size (Test Set): Eighty-seven (87) patients. This consisted of 36 males and 51 females.
- Data Provenance: Not explicitly stated, but given the manufacturer (Shenzhen Combei Technology Co., Ltd. in China) and the submission date, it is highly likely that the data originates from China. The study is described as a prospective clinical investigation since patients participated in the study.
3. Number of Experts Used to Establish Ground Truth and Qualifications
- Number of Experts: The document states that a "manual Mercury Sphygmomanometer was used as a reference device." This implies that the ground truth measurements were obtained by trained human operators using this reference device. However, the exact number of experts/operators and their specific qualifications (e.g., "physician with X years of experience," "trained technician") are not specified in the provided text.
4. Adjudication Method
- Adjudication Method: The document mentions a "Same arm sequential method" was adopted. This method typically involves taking measurements simultaneously or in rapid succession on the same arm by both the test device and the reference device. It does not explicitly describe an adjudication method for discrepancies between multiple readers, as the ground truth seems to be established by one or more operators using the reference manual device. Therefore, a specific adjudication method like "2+1" or "3+1" is not applicable or not specified in this context.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- Was an MRMC study done? No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is more common for diagnostic imaging AI systems where human readers interpret medical images with and without AI assistance. This document describes a clinical validation for a blood pressure monitor, focusing on its accuracy against a reference standard.
- Effect size of human readers improvement with AI vs. without AI assistance: Not applicable, as no MRMC study was conducted.
6. Standalone Performance Study (Algorithm Only)
- Was a standalone performance study done? Yes, the clinical investigation described is essentially a standalone performance study of the algorithm within the device. The study directly compares the device's measurements against a reference standard (manual mercury sphygmomanometer) without human intervention in the device's measurement process, beyond initiating the measurement.
7. Type of Ground Truth Used
- Type of Ground Truth: The ground truth was established by measurements obtained using a manual Mercury Sphygmomanometer as a reference device. This is considered an expert-derived reference standard as it relies on trained human operators properly using a calibrated, recognized reference instrument.
8. Sample Size for the Training Set
- Sample Size (Training Set): The document does not specify the sample size for any training set. Blood pressure monitors like this typically do not involve machine learning models that require explicit "training sets" in the same way AI algorithms for image analysis do. Their algorithms are usually based on established oscillometric principles and calibrated during manufacturing. Therefore, this question is likely not applicable to the device described.
9. How the Ground Truth for the Training Set Was Established
- How Ground Truth for Training Set was Established: Not applicable, as no specific "training set" or explicit machine learning training process is described or implied for this type of device in the document.
§ 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).