(13 days)
It can be used as medical assistant instrument at home or in medical center for adult population for measuring systolic and diastolic blood pressure and heart rate.
The device is intended for use in only adult population, not applied to the other populations such as neonatal baby.
It can not be used while the wrist (arm) has bleeding or wound to avoid the blood flowing from the wound in pressurizing.
BP201 Wrist Blood Pressure Monitor is a fully automatic non-invasive blood pressure monitor which measures systolic and diastolic blood pressure and heart rate of adult population using the oscillometric method by inflating an inflatable cuff on the wrist.
BP201 Wrist Blood Pressure Monitor uses an inflated cuff which is wrapped around the wrist .The cuff is inflated by a built-in air pump. The systolic and diastolic blood pressures are determined by Oscillometric method. The inflation rate is controlled by MCU at a constant rate 2~5mmHg/second. The user can release the cuff to stop measuring by pressing the "START/STOP" button at any time while measuring. The measuring result is displayed in LCD.
Here's an analysis of the provided text regarding the BP201 Wrist Blood Pressure Monitor, outlining the acceptance criteria and study details:
Acceptance Criteria and Device Performance for BP201 Wrist Blood Pressure Monitor
1. Table of Acceptance Criteria and Reported Device Performance
The core acceptance criteria for blood pressure monitors generally revolve around accuracy standards set by organizations like ANSI/AAMI, and the provided document confirms adherence to these.
| Acceptance Criteria Category | Specific Standard/Requirement | Reported Device Performance |
|---|---|---|
| Accuracy (Clinical) | ANSI/AAMI SP10:2002 | Device complies with the standard. |
| BS EN1060-4: 2004 | Device complies with the standard. | |
| Safety | IEC60601-1:1998+A1:1991+A2:1995 | Device conforms to the standard. |
| EMC (Electromagnetic Compatibility) | IEC 60601-1-2:2001/A1:2004 | Device conforms to the standard. |
| Clinical Repeatability | Not explicitly stated as a numerical threshold, but implied by compliance with accuracy standards. | "The comparison study demonstrated that the clinical repeatability of BP201 is statistically and clinically acceptable." |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: The document does not explicitly state the numerical sample size (number of subjects/measurements) used for the clinical comparison study. It only mentions that "A comparison study with a device that uses auscultatory method used by trained observers was performed".
- Data Provenance: The document does not explicitly state the country of origin of the data or whether the study was retrospective or prospective. Given the submitter's location in Shenzhen, PR China, it is probable the study was conducted there, likely as a prospective study for regulatory submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
- Number of Experts: The document states that the comparison study involved "trained observers" using an auscultatory method. It does not specify the number of these observers (experts).
- Qualifications of Experts: The experts are described as "trained observers" using an auscultatory method. Their specific qualifications (e.g., medical doctors, nurses, years of experience) are not detailed.
4. Adjudication Method for the Test Set
The document describes a "comparison study with a device that uses auscultatory method used by trained observers." This implies the auscultatory measurements served as the reference standard against which the BP201 was compared. It does not describe an explicit adjudication method for discrepancies between multiple readers, as the ground truth seems to have been established by the trained observers directly.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
There is no indication of a Multi-Reader Multi-Case (MRMC) comparative effectiveness study being performed. The study described focuses on the comparison of the device against a reference method, not on human readers' improvement with or without AI assistance.
6. Standalone Performance Study (Algorithm Only)
Yes, a standalone performance study was done. The entire submission focuses on the performance of the BP201 Wrist Blood Pressure Monitor itself (the "algorithm only," in this context meaning the device's automated oscillometric measurement) compared against a recognized reference standard (auscultatory method). The device's automated measurements are validated against these established methods.
7. Type of Ground Truth Used
The type of ground truth used was expert concensus (implicitly, as "trained observers" using the "auscultatory method") measurements. The auscultatory method is a widely accepted clinical standard for blood pressure measurement, and its execution by trained observers serves as the ground truth.
8. Sample Size for the Training Set
The document does not provide information on a training set or its sample size. This is typical for medical devices that are not "AI/ML-enabled" in the modern sense but rather rely on established algorithms (like oscillometric) and hardware. Such devices are typically validated against standards rather than "trained" on data.
9. How the Ground Truth for the Training Set Was Established
As there is no mention of a training set in the context of an AI/ML model, there is no information on how its ground truth was established. The device utilizes an oscillometric method, which is an established principle, and its performance is assessed through clinical validation against a reference standard.
§ 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).