(169 days)
The Fully Automatic Blood Pressure Monitors BP series and BM 40 are intended for used by adults with 12 years and older to measure the systolic blood pressure and pulse rate.
Measure blood pressure (systolic and diastolic) 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-103H, BP-1304, BP-1305, BP-1307, BM 40, 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-103H, BP-1304, BP-1307, BM 40 will display an irregular heartbeat symbol "( if an irregular heartbeat was detected during the measurement process. BM 40, BP-1307 can display average results in three ways: 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. BP-103H, BP-1304, BP-1305 can calculates the average of the last three measurements. In addition, BP-1307 has LCD backlight. After three minutes without operation, the blood pressure monitors turn off automatically.
The provided document describes the Sejoy Electronics & Instruments Co., Ltd. Fully Automatic Digital Blood Pressure Monitor (BP series and BM 40 models) and its substantial equivalence to a predicate device.
Here's an analysis of the acceptance criteria and study information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The device performance is assessed against the requirements of the ANSI/AAMI SP10:2002/(R) 2008 & ANSI/AAMI SP10:2002/A1:2003/(R) 2008 & ANSI/AAMI SP10:2002/A2:2006/(R) 2008 standards for manual, electronic or automated sphygmomanometers. While the specific numerical acceptance criteria (e.g., mean difference and standard deviation between the device and a reference measurement) are not explicitly stated in the document, it does state that the device meets or exceeds these requirements.
| Acceptance Criteria (Standard) | Reported Device Performance |
|---|---|
| Accuracy requirements of ANSI/AAMI SP10:2002/(R) 2008 & ANSI/AAMI SP10:2002/A1:2003/(R) 2008 & ANSI/AAMI SP10:2002/A2:2006/(R) 2008 for "manual, electronic or automated sphygmomanometers". | "The test result all meet or exceed the requirement of the standards." (for Performance Test) and "Clinical tests were performed and complied the accuracy requirements of ANSI/AAMI SP10..." |
2. Sample Size Used for the Test Set and Data Provenance
The document states that "Clinical tests were performed and complied the accuracy requirements of ANSI/AAMI SP10:2002/(R) 2008 & ANSI/AAMI SP10:2002/A1:2003/(R) 2008 & ANSI/AAMI SP10:2002/A2:2006/(R) 2008 National Standard for Manual, Electronic or Automated Sphygmomanometers."
However, the specific sample size for the test set is not provided in this document.
The data provenance (country of origin, retrospective or prospective) is also not specified.
3. Number of Experts Used to Establish Ground Truth and Their Qualifications
The document does not provide details on the number of experts used or their qualifications for establishing the ground truth. It simply states that performance tests were conducted according to the ANSI/AAMI SP10 standard, which typically involves comparison against a reference measurement performed by trained observers (oscillometric vs. auscultatory method).
4. Adjudication Method for the Test Set
The document does not explicitly describe an adjudication method for the test set. In the context of blood pressure monitor accuracy testing per AAMI SP10, the "ground truth" is typically established by trained observers taking auscultatory measurements simultaneously or in strict sequence with the automated device. The standard itself specifies the statistical comparison methods.
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 type of study is more common for diagnostic imaging algorithms where human readers interpret medical images. Blood pressure monitors are standalone measurement devices, and their accuracy is typically evaluated by comparing their readings against a validated reference method (e.g., auscultation by trained professionals).
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Yes, a standalone performance evaluation was done. The document refers to "Performance Test according to ANSI/AAMI SP10:2002/(R) 2008..." and "Clinical tests were performed and complied the accuracy requirements of ANSI/AAMI SP10...". These tests assess the device's accuracy in measuring blood pressure and pulse rate without necessarily involving human interpretation of the device's output in the loop, beyond reading the displayed values. The device itself is designed to provide automated measurements.
7. The Type of Ground Truth Used
The ground truth used for performance testing (as implied by adherence to ANSI/AAMI SP10) would be reference blood pressure measurements obtained by trained observers using a validated method, typically auscultation with a mercury or aneroid sphygmomanometer. The standard specifies the requirements for this reference method.
8. The Sample Size for the Training Set
This information is not provided in the document. Blood pressure monitors like these do not typically have an "AI algorithm" in the sense of requiring a large, separate training set for a machine learning model. Their design is based on established oscillometric principles.
9. How the Ground Truth for the Training Set Was Established
As noted above, the concept of a "training set" in the context of an AI algorithm is largely not applicable to this device. The device operates based on a physical measurement principle (oscillometry) and its internal algorithms process these physical signals. Any calibration data or internal parameters would be established through engineering design and validation, not through a separate "training set" with ground truth in the AI sense.
§ 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).