(125 days)
The subject device 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 with a single upper arm cuff (22-42 cm).
The device detects the appearance of irregular heart beats during measurement and gives a warning signal with readings.
The Subject device is not intended to be diagnostic device.
Combei Blood Pressure Monitor are designed to measure the systolic and diastolic blood pressure and pulse rate of an individual by using a non-invasive technique in which an inflatable cuff is wrapped around the upper arm. Our method to define systolic and diastolic pressure is similar to the auscultatory method but uses an electronic pressure sensor rather than a stethoscope and mercury manometer. The sensor converts tiny alterations in cuff pressure to electrical signals, by analyzing those signals to define the systolic and diastolic blood pressure and calculating pulse rate, which is a well-known technique in the market called the "oscillometric method".
The main components of the Blood Pressure Monitor are the main unit and cuff unit. ABS is used to outer housing of the main unit. The preformed cuff unit, which is applicable to arm circumference approximately between 220 and 420 mm, includes the inflatable bladder and nylon shell. All models of the arm blood pressure monitor use a single size of cuff. The device consists of the microprocessor, the pressure sensor, the operation keys, the pump, the electromagnetic deflation control valve, Bluetooth tranismiision (optional) and the LCD. The subject devices are powered by four AA alkaline batteries or adatpter. The device also compares the longest and the shortest time intervals of detected pulse waves to mean time interval and displays a warning signal with the reading to indicate the detection of irreqular pulse rhythm when the difference of the time intervals is over a specified range.
The provided document contains information about the acceptance criteria and study that proves the device meets the acceptance criteria. Here's a summary of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance:
The document states compliance with ISO 81060-2:2013 Non-invasive sphygmomanometers - Part 2: Clinical validation of automated measurement type. This standard outlines the acceptance criteria for blood pressure monitor accuracy. While the specific numerical acceptance criteria (e.g., mean difference and standard deviation between the device and reference for systolic and diastolic blood pressure) are not explicitly detailed in the provided text, the document indicates that the results showed the accuracy of the blood pressure monitor is "within acceptable scope specified in ISO 81060-2."
From the "SE Comparison" table, the reported device accuracy is:
| Metric | Acceptance Criteria (per ISO 81060-2:2013) | Reported Device Performance |
|---|---|---|
| Pressure | (Not explicitly stated, but device claims compliance with ISO 81060-2) | ±3mmHg |
| Pulse | (Not explicitly stated, but device claims compliance with ISO 81060-2) | ±5% |
2. Sample size used for the test set and the data provenance:
- Sample size for the test set: 85 patients
- Data provenance: Not explicitly stated, but the study was conducted as a "clinical investigation" for regulatory submission, implying prospective data collection. The manufacturer is Shenzhen Combei Technology Co., Ltd. from China, so the study was likely conducted in China.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
The document mentions that "The manual Mercury Sphygmomanometer was used as a reference device" and that a "Same arm sequential method was adopted during the clinical testing." For non-invasive sphygmomanometer validation studies following ISO 81060-2, ground truth is typically established by trained observers using a reference manual sphygmomanometer. However, the exact number of experts/observers and their specific qualifications (e.g., radiologist with 10 years of experience) are not provided in this document.
4. Adjudication method for the test set:
The document states "Same arm sequential method was adopted during the clinical testing" using a manual Mercury Sphygmomanometer as a reference. This method involves taking simultaneous or sequential measurements by both the device under test and the reference method. For validation against ISO 81060-2, typically multiple observers take readings, and their readings are often averaged or adjudicated for the reference measurement. However, the specific adjudication method (e.g., 2+1, 3+1, none) is not explicitly detailed in the provided text.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done:
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This study focuses on validating the accuracy of the automated blood pressure monitor against a manual reference standard, not on comparing human readers with and without AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Yes, a standalone study was done. The clinical investigation described in section 8 (Brief discussions of clinical tests) evaluates the automated blood pressure monitor's performance directly against a reference device, without human interpretation of the device's output influencing the measurement. It's an algorithm-only (device-only) performance evaluation.
7. The type of ground truth used:
The type of ground truth used was measurements from a manual Mercury Sphygmomanometer, which serves as the reference standard for blood pressure measurement in accordance with ISO 81060-2.
8. The sample size for the training set:
The document does not provide information on the sample size for the training set. The clinical study mentioned (85 patients) is for validation/testing, not for training the algorithm. As a medical device that measures blood pressure using well-established oscillometric principles, it's possible that the core algorithm does not rely on a large, distinct "training set" in the same way a machine learning-based diagnostic algorithm would, or that such training data was internal to development and not disclosed in the 510(k) summary.
9. How the ground truth for the training set was established:
As no information is provided on a training set, the method for establishing its ground truth is also not mentioned.
§ 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).