(30 days)
Measure blood pressure (systolic and diastolic) and pulse rate.
The Fully Automatic Blood Pressure Monitors BP series are intended for used by adults with 12 years and older to measure the systolic and diastolic blood pressure and pulse rate.
The arm-type uses an inflatable cuff which is wrapped around the patient's upper arm. The cuff is inflated automatically by an internal pump in the device. The systolic and diastolic blood pressures are determined by oscillometric method and silicon integrate pressure sensor technology. The deflation rate is controlled by a preset mechanical valve at a constant rate. The pressure of the cuff is completely released automatically at the end of the measurement. At the same time, the measurements are displayed on the LCD display for three minute. There is a maximum pressure safety setting at 300 mmHg. The device will not inflate the cuff higher than 300 mmHg. For BP-1305, BP-1307,BP-1211, BP-1312, BP-1318, BP-1319, BP-1326, BSP-11, BSP-12, BSP-13, the blood pressure results are compared with WHO (World Health Organization) Blood Pressure classification, which are severe Hypertension, Moderate Hypertension, Mild Hypertension, High-normal, Normal, and Optimal. The corresponding LCD segment will be turned on along with the systolic, diastolic, and pulse rate information. BP-1305,BP-1307,BP-1312, BP-1318, BP-1319, BP-1326, BSP-11, BSP-12, BSP-13will display an irregular heartbeat symbol " " if an irregular heartbeat was detected during the measurement process. BP-1305,BP-1318, BP-1319, BP-1326, BSP-11, BSP-12, BSP-13 can display average results in three ways: BP-1307 can display the average of all measurements, the average of all AM (5:00 AM-8:59AM) measurements, and the average of all PM (18:00 PM-19:59 PM) measurements.
The Sejoy Electronics & Instruments Co., Ltd. Arm-type Fully Automatic Digital Blood Pressure Monitor (multiple models listed) underwent a clinical study to demonstrate its accuracy and substantial equivalence to a predicate device.
1. Acceptance Criteria and Reported Device Performance:
The device aimed to meet the accuracy requirements of ISO 81060-2:2013, "Non-invasive sphygmomanometers - Part 2: Clinical validation of automated measurement type."
| Acceptance Criteria (from ISO 81060-2:2013) | Reported Device Performance (Implied by meeting the standard) |
|---|---|
| Criterion 1: Mean difference (device - reference) ≤ 5 mmHg | Met (Implied by clinical test results adhering to the standard) |
| Criterion 2: Standard deviation of the differences ≤ 8 mmHg | Met (Implied by clinical test results adhering to the standard) |
| Criterion 3: Percentage of differences within 5, 10, and 15 mmHg of the reference measurement (accuracy zone) | Met (Implied by clinical test results adhering to the standard) |
Note: The detailed numerical results for each criterion were not explicitly provided in the document, but the statement "Clinical tests were performed and complied the accuracy requirements of ISO 81060-2 Second edition 2013-05-01" implies that all these criteria were successfully met.
2. Sample Size Used for the Test Set and Data Provenance:
The document does not explicitly state the sample size used for the clinical test set. However, a clinical validation study following ISO 81060-2:2013 typically requires a minimum of 85 participants for accuracy assessment. Given the nature of a 510(k) submission, it is highly probable that the study was prospective and conducted with participants whose blood pressure measurements were taken specifically for the validation of this device. The country of origin of the data is not specified.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
The document does not explicitly state the number or qualifications of experts used to establish the ground truth. According to ISO 81060-2:2013, oscillometric blood pressure monitor validation requires measurements by trained observers (typically two or more) using a mercury sphygmomanometer or an equivalent reference device. These observers usually have specific training and certification in blood pressure measurement to ensure accuracy and inter-observer reliability.
4. Adjudication Method for the Test Set:
The document does not explicitly state the adjudication method. In clinical validation studies for blood pressure monitors following ISO 81060-2:2013, the ground truth is typically established by simultaneous or sequential measurements by two or more trained observers. Discrepancies between observers are often resolved by a third trained observer, or through averaging if within an acceptable range, or by re-measurement. This often aligns with a "2+1" or similar consensus-based method.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not conducted or reported for this device. The purpose of this submission was to demonstrate substantial equivalence and meet specific accuracy standards for a medical device, not to compare human reader performance with and without AI assistance.
6. Standalone Performance (Algorithm Only Without Human-in-the-Loop Performance):
Yes, a standalone performance evaluation was done. The clinical validation study described, which complied with ISO 81060-2:2013, assesses the device's ability to accurately measure blood pressure independently, without human intervention in the measurement process itself. The device is an "Arm-type Fully Automatic Digital Blood Pressure Monitor," implying it operates without a human 'in the loop' for the actual pressure measurement and reading.
7. Type of Ground Truth Used:
The ground truth used was expert consensus (or highly accurate reference measurements). Specifically, for blood pressure monitor validation according to ISO 81060-2:2013, the reference standard for comparison is typically simultaneous auscultatory measurements by trained observers using a mercury sphygmomanometer or another validated reference blood pressure device.
8. Sample Size for the Training Set:
The document does not specify a separate training set or its sample size. For medical devices like blood pressure monitors, the "training" (i.e., algorithm development and internal testing) is typically conducted by the manufacturer using internal data or publicly available physiological datasets. The clinical validation study, as described, serves as the independent test set for regulatory submission.
9. How the Ground Truth for the Training Set Was Established:
As no specific training set and its ground truth establishment are detailed in the document, this information is not available from the provided text. However, for internal development, manufacturers would likely use similar methods as the test set: expert auscultatory measurements against which the device's algorithms are refined.
§ 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).