(248 days)
BP101 Digital Blood Pressure Monitor is intended to be used to measure blood pressure (systolic and diastolic) and heart rate from the upper arm using the oscillometric method. 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 arm has bleeding or wound to avoid the blood flowing from the wound in pressurizing. 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.
BP101 Digital 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 upper arm. BP101 Digital Blood Pressure Monitor uses an inflated cuff which is The systolic and diastolic blood pressures are determined by Oscillometric method. The deflation rate is controlled by an automatic air-release valve at a constant rate 2~7mmHg/second. The user can deflate 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 acceptance criteria and study for the BP101 Digital Blood Pressure Monitor:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Performance Standards: Conformity to applicable standards | Conformity to ANSI/AAMI SP-10:2002, EN 1060-1, EN-1060-3, and IEC60601-1-1-2 requirements. |
| Clinical Repeatability: Statistically and clinically acceptable | Comparison study demonstrated that the clinical repeatability of BP101 is statistically and clinically acceptable. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not explicitly stated. The document mentions "a comparison study," but does not provide the number of participants or measurements.
- Data Provenance: Not explicitly stated regarding country of origin or whether it was retrospective or prospective. It is implied to be a prospective clinical study given the nature of a "comparison study" to validate performance.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
- Number of Experts: Not explicitly stated. The document refers to "trained observers" who used the auscultatory method.
- Qualifications of Experts: "Trained observers." No further specific qualifications (e.g., years of experience, medical specialty) are provided.
4. Adjudication Method for the Test Set
- Not explicitly stated. The document mentions a "comparison study with a device that uses auscultatory method used by trained observers." This implies the auscultatory readings by trained observers served as the reference standard, but it doesn't detail any adjudication process (e.g., if multiple observers' readings were compared or averaged).
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance
- No. This was not an MRMC comparative effectiveness study involving AI assistance for human readers. This device is a standalone blood pressure monitor, not an AI-powered diagnostic aid for clinicians.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- Yes. The primary study described is a standalone performance validation of the BP101 device. The device itself (algorithm and hardware) performed the measurements, which were then compared to the auscultatory method.
7. The Type of Ground Truth Used
- Expert Consensus/Reference Standard: The ground truth for the comparison study was established using the auscultatory method performed by trained observers. This is widely considered a clinical reference standard for blood pressure measurement.
8. The Sample Size for the Training Set
- Not applicable/Not stated. The document does not describe the use of a training set as would be relevant for machine learning or AI algorithms that "learn" from data. This device likely relies on established oscillometric principles and hardware calibration, rather than a data-driven training approach.
9. How the Ground Truth for the Training Set Was Established
- Not applicable/Not stated. As mentioned above, a training set based on data with established ground truth is not described for this type of device and validation.
§ 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).