(118 days)
This device is for use by medical professional or home users. It is intended to measure the systolic and diastolic blood pressure of an adult individual by using a non-invasive technique, in which an inflatable cuff is wrapped around the upper arm.
Digital Automatic Blood Pressure Monitor BPM25 & BPM26 Series is a non-invasive blood pressure measurement system for use by medical professional or at home. It is designed to measure the systolic and diastolic blood pressure, and pulse rate of an individual in each measurement and then display the readings on a digital panel. The device utilizes the oscillometric methodology, in which an inflatable cuff is wrapped around the upper arm of an individual, for blood pressure measurement. This means the monitor detects your blood's movement through your brachial artery and converts the movement into a digital reading.
Here's an analysis of the provided text to fulfill your request regarding acceptance criteria and the study proving compliance.
Disclaimer: This document is a 510(k) summary for a blood pressure monitor. It focuses on demonstrating substantial equivalence to a predicate device, not necessarily a comprehensive clinical trial report. Therefore, some of your requested information, particularly regarding advanced aspects like MRMC studies, may not be explicitly detailed or even applicable to this type of device submission.
Acceptance Criteria and Device Performance
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for the blood pressure monitor are primarily based on the accuracy standards outlined in ISO 81060-2:2013 and the inherent accuracy specifications of the device itself.
| Acceptance Criteria (from ISO 81060-2:2013 & Device Spec) | Reported Device Performance (from Clinical Test Summary) |
|---|---|
| Blood Pressure Measurement Accuracy | |
| Mean difference and standard deviation of differences of test device versus reference standard (auscultation) for Systolic BP (SBP) and Diastolic BP (DBP) measurements within acceptable limits defined by ISO 81060-2:2013. | The document states "Testing to insure clinical accuracy of the device in accordance with ISO 81060-2:2013 as documented in Clinical Test report." and "no differences in the technological characteristics and questioning on safety or effectiveness to be raised." This implies the device met the ISO 81060-2:2013 statistical accuracy requirements, though specific mean differences or standard deviations are not explicitly stated in this summary. The device's stated accuracy from the comparison table is ± 3 mmHg for Blood Pressure and Pulse Rate: ± 5 % of the reading. |
| Pulse Rate Measurement Accuracy | |
| Mean difference and standard deviation of differences of test device versus reference standard (auscultation) for pulse rate measurements within acceptable limits defined by ISO 81060-2:2013 (or equivalent). | As above, implied compliance with ISO 81060-2:2013. The device's stated accuracy from the comparison table is ± 5 % of the reading. |
Study Proving Device Meets Acceptance Criteria:
The study proving the device meets the acceptance criteria is a Clinical Test conducted in accordance with ISO 81060-2:2013.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: One hundred (100) patients (54 males and 46 females).
- Data Provenance: Not explicitly stated (e.g., country of origin). The study seems to be prospective as it involved inviting patients for the study.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
The ground truth was established using the Standard Auscultation method. The document does not specify the number of expert clinicians (e.g., physicians, nurses) who performed the auscultation measurements. It also does not provide their specific qualifications or years of experience. It simply refers to the "Standard Auscultation method" as the reference.
4. Adjudication Method for the Test Set
The document states: "Blood pressure measurements were repeated alternatively with the device and auscultation in the same arm according to the sequence in ISO 81060-2:2013." This suggests a direct comparison method rather than a separate adjudication process. No specific adjudication method like 2+1 or 3+1 for resolving discrepancies is mentioned, likely because the reference standard (auscultation) is considered the definitive ground truth for each measurement.
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 devices where human interpretation plays a significant role in assessing diagnostic accuracy. For a blood pressure monitor, the performance is assessed against a physical reference measurement (auscultation), not typically against multiple human readers interpreting data.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
Yes, the described clinical test essentially represents a standalone performance evaluation of the algorithm built into the device. The device takes readings automatically and displays them, and these readings are directly compared to the auscultation reference. There is no human intervention in "interpreting" the device's output to make a diagnosis; the device itself provides the measurement.
7. The Type of Ground Truth Used
The type of ground truth used was expert reference standard (Standard Auscultation method). For blood pressure measurement devices, direct auscultation by a trained professional is the established gold standard for determining actual blood pressure values in a clinical setting.
8. The Sample Size for the Training Set
The document does not specify a separate training set sample size. For medical devices like this blood pressure monitor, particularly those using oscillometric methodology, the core internal algorithms are often developed and validated through extensive engineering, mathematical modeling, and internal testing during the design phase, rather than a "training set" in the machine learning sense. The clinical test described is a validation or test set activity.
9. How the Ground Truth for the Training Set Was Established
As no separate training set is explicitly mentioned or detailed in the document, information on how its ground truth was established is not provided. If an internal "training" or development process involved ground truth measurements, these details are not part of this 510(k) summary, which focuses on the final validation study against the predicate device and relevant standards.
§ 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).