(70 days)
Upper Arm Electronic Blood Pressure Monitor is intended for used by a person older than twelve (12) years to measure the systolic and diastolic blood pressure and pulse rate.
The Upper Arm Electronic Blood Pressure Monitor uses the Oscillometric Measuring method to detect blood pressure. Before every measurement, the unit establishes a " zero pressure" equivalent to the atmospheric pressure. Then it starts inflating the arm cuff, meanwhile, the unit detects pressure oscillations generated by beat-to-beat pulsation , which is used to determine the systolic and diastolic pressure, and also pulse rate.
This document is a 510(k) summary for an Upper Arm Electronic Blood Pressure Monitor, aiming to demonstrate its substantial equivalence to a legally marketed predicate device. The information provided outlines the device's technical characteristics and the performance data submitted to support its safety and effectiveness.
Here's an analysis of the acceptance criteria and the study proving the device meets them, based on the provided text:
Key Acceptance Criteria and Reported Device Performance:
The primary performance criterion for a blood pressure monitor is its accuracy. The document states:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| BP Accuracy: ± 3mmHg | Meets criterion |
| PR Range: 40-199 bpm | Meets criterion |
Study Details:
The clinical validation was conducted according to ISO 81060-2:2018+A1:2020 Non-invasive sphygmomanometers - Part 2: Clinical validation of intermittent automated measurement type.
-
Sample Size Used for the Test Set and Data Provenance:
- Sample Size: Two clinical studies were performed. One study had 87 qualified subjects, and the other had 86 qualified subjects. The total combined sample size for the clinical test set is 173 (87 + 86).
- Data Provenance: The document does not explicitly state the country of origin for the data. It also does not specify if the studies were retrospective or prospective, but clinical validation studies for device clearance are typically prospective.
-
Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications:
- The document describes "Clinical validation," which for blood pressure monitors typically involves comparison against a reference standard (e.g., auscultatory measurements by trained observers using a mercury sphygmomanometer). However, the document does not explicitly state the number of experts or their qualifications (e.g., physicians, nurses, or specific training) used for establishing the ground truth. It states "all data's mean error and standard deviation of differences in systolic, diastolic pressure is not beyond the limits set as per ISO 81060-2:2020," implying the ground truth was established following the standard's methodology.
-
Adjudication Method for the Test Set:
- The document does not explicitly describe an adjudication method for the test set, such as 2+1 or 3+1. For blood pressure clinical validation, the ISO standard typically outlines a procedure for simultaneous measurements by multiple observers which inherently acts as a form of "adjudication" by seeking agreement or averaging.
-
Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- No, an MRMC comparative effectiveness study was not done. This type of study (comparing human readers with AI vs. without AI assistance) is relevant for diagnostic imaging devices where AI assists human interpretation. For a standalone measurement device like a blood pressure monitor, the performance is evaluated against a clinical standard, not human-AI collaboration.
-
Standalone Performance (Algorithm Only without Human-in-the-Loop Performance):
- Yes, a standalone performance evaluation was done. The entire clinical study described is a standalone evaluation of the device's accuracy in measuring blood pressure and pulse rate, independent of human interpretation assistance during the measurement process. The device's output (SYS, DYS, Pulse Rate) is the direct result of its algorithm and sensors.
-
Type of Ground Truth Used:
- The ground truth type is directly tied to the ISO 81060-2:2018+A1:2020 standard. This standard typically defines the ground truth as reference blood pressure measurements obtained by trained independent observers using a validated reference method (e.g., auscultation with a manometer), against which the automated device's readings are compared. It's a type of "expert consensus/reference measurement" ground truth.
-
Sample Size for the Training Set:
- The document does not provide information on the sample size used for the training set. For blood pressure monitors, the "training" (algorithm development) often happens with internal datasets or generalized physiological models, and the "test set" from clinical trials is for validation.
-
How the Ground Truth for the Training Set Was Established:
- As with the training set size, the document does not provide details on how the ground truth for an internal training set (if any specific to the algorithm's learning) was established. Assuming the device relies on established oscillometric principles and calibration, the "training" may refer more to engineering and calibration rather than a machine learning training dataset with labeled ground truth in the same sense as an AI diagnostic device.
Additional Performance Data:
Beyond clinical accuracy, the document lists several other performance data types provided:
- Biocompatibility testing: Cytotoxicity, Sensitization, Irritation.
- Electrical Safety, EMC, Performance testing: Compliance with IEC 60601-1, IEC 60601-1-11, IEC 60601-1-6, IEC 62366-1, IEC 60601-1-2, IEC 80601-2-30, and IEC 80369-5.
- Wireless testing: Compliance with ANSI C63.27-2021, AAMI TIR69:2020, FDA guidance, and FCC Part 15 Subpart C for its wireless module (Bluetooth and 4G for A01/A02 series respectively).
- Cybersecurity: Addressed according to relevant FDA guidance.
- Shelf-life: Evaluated for 5 years.
- Reprocessing: Information provided per ISO 17664.
In summary, the provided document focuses primarily on the clinical validation of blood pressure accuracy and other critical engineering aspects against recognized international standards. It clearly indicates that the device met the accuracy requirements set by ISO 81060-2:2020. However, specific details often found in AI/imaging device submissions regarding expert adjudication, multi-reader studies, and detailed training data provenance are not as prominent, as they are less relevant for this type of medical device.
§ 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).