(34 days)
PG-800B Electronic Blood Pressure Monitor is intended to measure the systolic and diastolic blood pressure as well as the pulse rate of adult person via non-invasive oscillometric technique in which an inflatable cuff is wrapped around the upper arm. It can be used at medical facilities or at home. The intended arm circumference is 22-32 cm.
The proposed device, PG-800B Electronic Blood Pressure Monitor, is a battery driven automatic non-invasive blood pressure monitor. It can measure systolic and diastolic blood pressure as well as the pulse rate of adult person at arm within its claimed range and accuracy via the oscillometric technique. The device has the data storage function. It has an bar indicating function, which can indicate the WHO (World Health Organization) Blood Pressure Classification of the measured blood pressure by referencing Diastolic Blood Pressure issued at Journal of Hypertension 1999. Vol 17, No.2.
Here's a breakdown of the acceptance criteria and the study details for the PANGAO® PG-800B Electronic Blood Pressure Monitor, based on the provided 510(k) summary:
1. Table of Acceptance Criteria and Reported Device Performance
The 510(k) summary references performance and clinical verification testing per ANSI/AAMI SP10:2002+A1:2003+A2:2006. This standard outlines the accuracy requirements for automated sphygmomanometers. While the exact numerical acceptance criteria and reported performance are not explicitly detailed in the provided text, the fact that the device was cleared implies it met these standards.
Based on the ANSI/AAMI SP10 standard, the general acceptance criteria for blood pressure monitors typically require:
- Mean difference: The average difference between the device's readings and a reference standard (e.g., auscultatory measurements by trained observers) should be within a specific range (e.g., ±5 mmHg).
- Standard deviation (or overall accuracy within a range): The standard deviation of these differences should also be within a specified limit (e.g., 8 mmHg).
- These criteria usually apply independently to both systolic and diastolic blood pressure measurements.
Without the specific test report, I cannot provide the exact reported device performance values. Therefore, the table below reflects the implied acceptance criteria from the referenced standard, noting that the reported performance would have met these.
| Measurement Parameter | Acceptance Criteria (Implied by ANSI/AAMI SP10) | Reported Device Performance (Not explicitly stated in provided document) |
|---|---|---|
| Systolic BP | Mean difference ≤ ±5 mmHg, Standard deviation ≤ 8 mmHg (typically) | Met the ANSI/AAMI SP10 standard requirements (implied by 510(k) clearance) |
| Diastolic BP | Mean difference ≤ ±5 mmHg, Standard deviation ≤ 8 mmHg (typically) | Met the ANSI/AAMI SP10 standard requirements (implied by 510(k) clearance) |
| Pulse Rate | Accuracy within a specified range (e.g., ±5% or ±5 beats/min) (varies by standard) | Met the ANSI/AAMI SP10 standard requirements (implied by 510(k) clearance) |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The provided document does not explicitly state the sample size used for the clinical verification test.
- Data Provenance: The document states the sponsor is "Shenzhen Pango Electronic Co., Ltd" in Guangdong, China. The submission correspondent is "Shanghai Mid-Link Consulting Co., Ltd" also in China. This strongly suggests the data was collected in China. The study type is a clinical verification test, which typically implies prospective data collection for accuracy validation against a reference method.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- The document does not specify the number of experts or their qualifications.
- In the context of ANSI/AAMI SP10 testing, ground truth for blood pressure measurements is typically established by at least two, and often three, trained observers using a standardized auscultatory method, calibrated sphygmomanometers, and following strict protocols. These observers are usually medical professionals (e.g., nurses, physicians, or trained technicians).
4. Adjudication Method for the Test Set
- The document does not explicitly state the adjudication method.
- For ANSI/AAMI SP10 standards, if multiple observers are used, discrepancies are often handled by:
- Averaging: Taking the average of the observers' readings if they are within a pre-defined acceptable range.
- Third observer: If the initial two observers disagree beyond the acceptable range, a third independent observer's reading might be taken, or the average of the two closest readings might be used. The 2+1 or 3+1 methods are common.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
- No, an MRMC comparative effectiveness study was not done. This type of study is more common for diagnostic imaging AI devices, where the AI assists human readers. For a blood pressure monitor, the primary effectiveness is its standalone accuracy.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done
- Yes, a standalone study was done. The clinical verification test per ANSI/AAMI SP10 is designed to assess the accuracy of the device (algorithm and hardware combined) against a reference standard without human intervention influencing the device's measurement. The device itself is the "algorithm only" in this context of a blood pressure monitor.
7. The Type of Ground Truth Used
- The ground truth used would be "expert consensus" or "reference measurement." Specifically, it would involve auscultatory blood pressure measurements taken by trained human observers using a mercury or aneroid sphygmomanometer as the gold standard, against which the automated oscillometric readings from the PG-800B device are compared.
8. The Sample Size for the Training Set
- The document does not provide any information regarding a training set sample size. For a physically-based device like a blood pressure monitor using an oscillometric technique, while calibration and internal algorithm development involve data, it's not typically a "machine learning" training set in the same way an image recognition AI would have. The "training" here would be part of the device's engineering and calibration processes.
9. How the Ground Truth for the Training Set was Established
- As above, the document does not provide details on a specific training set or its ground truth establishment. The development of oscillometric algorithms involves extensive engineering and physiological modeling. While large datasets of oscillometric waveforms and corresponding auscultatory readings might be used during the development and calibration phases, these are generally not described as "training sets" in regulatory documents for such devices in the same vein as AI/ML applications. The underlying physics and signal processing are the "ground truth" for the algorithm itself, validated against clinical standards like ANSI/AAMI SP10.
§ 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).