(14 days)
Blood pressure monitor model BP series are designed to measure the systolic, diastolic pressure and pulse rate of people by using a non-invasive technique. which is a well-known technique in the market called the "oscillometric method". BP-102 and BP-103 are the arm-type Blood Pressure Monitors, which can measure the systolic, diastolic pressure and pulse rate at upper-arm, and BP-201 and BP-202 are the wrist-type Blood Pressure Monitors, which can measure the systolic, diastolic pressure and pulse rate at wrist, and the devices are reusable for clinical and home use.
Based on oscillometric and silicon integrate pressure sensor technology, blood pressure monitor model BP series ( BP-102, BP-103, BP-201, BP-202) are used to monitor systolic, diastolic blood pressure and pulse rate which will be shown on the LCD. BP-102 and BP-103 are the arm-type Blood pressure monitors, which can measure the systolic, diastolic pressure and pulse rate at upper-arm. BP-102 could measure the systolic, diastolic pressure and pulse, and it could display last measurement. Base on the BP-102, the BP-103 is designed as a function expanding product. which have 120 times memories with date and time and the date and time can be reset too. BP-201 and BP-202 are the wrist-type Blood pressure monitors, which can measure the blood pressure and pulse rate at wrist. The devices are reusable for clinical and home use. BP-201 could measure the systolic, diastolic pressure and pulse, and it could display last measurement. Base on the BP-201. the BP-202 is designed as a function expanding product, which have 120 times memories with date and time and the date and time can be reset
Here's an analysis of the acceptance criteria and study information for the Blood Pressure Monitor Model BP series, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document doesn't explicitly state the numerical acceptance criteria from ANSI/AAMI SP10:2002 in a table format, nor does it provide specific numerical performance results. However, it does state that the device meets or exceeds these accuracy requirements.
Acceptance Criteria (from ANSI/AAMI SP10:2002)
| Parameter | Acceptance Criteria (from ANSI/AAMI SP10:2002) | Reported Device Performance |
|---|---|---|
| Blood Pressure Accuracy | The ANSI/AAMI SP10:2002 standard dictates specific accuracy requirements for electronic sphygmomanometers, typically concerning the mean difference and standard deviation of blood pressure measurements when compared to a reference standard (e.g., auscultatory method). The standard specifies that the mean difference between the device and the reference method should be within ±5 mmHg, with a standard deviation of no more than 8 mmHg. | "meet or exceed the accuracy requirements of the standards" and "meet or exceed the accuracy requirements of ANSI/AAMI SP10-2002." |
| Clinical Bias | (Implicit in ANSI/AAMI SP10:2002 accuracy criteria) | Clinical data was presented which evaluated clinical bias, and the results meet or exceed the accuracy requirements of ANSI/AAMI SP10-2002. |
| Clinical Uncertainty | (Implicit in ANSI/AAMI SP10:2002 accuracy criteria) | Clinical data was presented which evaluated clinical uncertainty, and the results meet or exceed the accuracy requirements of ANSI/AAMI SP10-2002. |
| Clinical Repeatability | (Implicit in ANSI/AAMI SP10:2002 accuracy criteria) | Clinical data was presented which evaluated clinical repeatability per the Sejoy Clinical Test Protocol outline, and the results meet or exceed the accuracy requirements of ANSI/AAMI SP10-2002. |
Note: While the exact numerical criteria for ANSI/AAMI SP10:2002 are not provided in this document, the standard typically requires a mean difference of +/- 5 mmHg and a standard deviation of 8 mmHg when compared to a reference method. The submission explicitly states the device meets or exceeds these.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not explicitly stated in the provided text. The document only mentions "Controlled human clinical studies were conducted using the Blood Pressure Monitor model BP series."
- Data Provenance: Not explicitly stated in the provided text (e.g., country of origin, retrospective/prospective). It only mentions "Controlled human clinical studies were conducted." Given the submitter's location (China), it's plausible the studies were conducted there, but this is not confirmed.
3. Number of Experts Used to Establish Ground Truth and Qualifications
- Number of Experts: Not explicitly stated.
- Qualifications of Experts: Not explicitly stated. For blood pressure devices conforming to ANSI/AAMI SP10, ground truth is typically established by trained observers using the auscultatory method, but no details are provided here.
4. Adjudication Method for the Test Set
The adjudication method is not explicitly stated in the provided text.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- Was an MRMC study done? No. This type of study is more common for imaging devices where human readers interpret images with and without AI assistance. For a blood pressure monitor, the performance is typically evaluated as a standalone device against a reference method.
- Effect Size of Human Readers' Improvement: Not applicable, as no MRMC study was conducted.
6. Standalone (Algorithm Only) Performance Study
Yes, a standalone performance study was done. The "Clinical tests were performed and complied the accuracy requirements of ANSI/AAMI SP10:2002" indicates that the device's measurements were evaluated directly against a reference standard to assess its accuracy without human intervention in the measurement process itself (though human observers would be involved in obtaining the reference measurement). The "Performance Test according to ANSI/AAMI SP10:2002" also confirms a standalone performance evaluation.
7. Type of Ground Truth Used
For blood pressure monitors conforming to ANSI/AAMI SP10:2002, the ground truth is typically established using the auscultatory method (manual measurement by trained observers using a stethoscope and sphygmomanometer) as the reference standard against which the automated device's readings are compared. The document states "Clinical data was presented which evaluated clinical bias, clinical uncertainty and clinical repeatability per the Sejoy Clinical Test Protocol outline," which implies comparison against a gold standard.
8. Sample Size for the Training Set
- Sample Size for Training Set: Not explicitly stated. The document refers to "Controlled human clinical studies," which would be the test set for performance evaluation, but does not distinguish between training and testing data for algorithm development. For a device based on oscillometric technology, the "training" aspect is more about calibrating the underlying algorithm to accurately interpret pressure oscillations rather than a large-scale supervised learning dataset as seen in modern AI/ML applications.
9. How Ground Truth for the Training Set Was Established
- The document does not provide details on how ground truth was established for a "training set." Given the device's technology (oscillometric method), the "training" (or calibration) would likely involve comparing the device's derived blood pressure values against reference auscultatory measurements on a smaller set of subjects to optimize the oscillometric algorithm's interpretation parameters. However, this is not explicitly detailed in the provided text.
§ 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).