(58 days)
The BPro system is intended for use on patients who are eighteen (18) years and older and who have a palpable radial pulse.
The BPro system is intended only for measurement, recording, and display. It makes no diagnosis.
HealthSTATS BPro® is a noninvasive ambulatory blood pressure monitoring system based on arterial tonometry at the radial artery of the wrist. The system consists of three main elements:
- BPro/BPal wrist-mounted tonometric monitor.
- BProSoft report management software, a PC-based computer program.
- BPCalibrator MC3000 oscillometric blood pressure monitor [listed . device, K051546] for calibration of BPro/BPal monitors.
Once the BPro is calibrated using the BPcalibrator oscillometric device, it is capable of measuring and recording systolic pressure, diastolic pressure and pulse rate over a period of 24 hours.
Here's the breakdown of the acceptance criteria and the study that proves the device meets them, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria (Standard) | Reported Device Performance |
|---|---|
| AAMI-SP10 for stationary tests | Requirements of the standard were met. |
| AAMI-SP10 for ambulatory tests | Recommendations of the standard were met. |
2. Sample Size Used for the Test Set and Data Provenance:
The document does not specify the exact sample size used for the clinical test set. It only states that the BPro system "was clinically tested in accordance with AAMI-SP10."
The data provenance (e.g., country of origin of the data, retrospective or prospective) is also not explicitly mentioned.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
The document does not provide details on the number or qualifications of experts used to establish ground truth. For blood pressure monitoring, "ground truth" typically refers to reference measurements taken by trained personnel using a validated method against which the device's readings are compared.
4. Adjudication Method for the Test Set:
The document does not describe any specific adjudication method (e.g., 2+1, 3+1). For a blood pressure monitoring device, the "adjudication" would typically involve comparing the device's readings to reference readings obtained by the standard method.
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 AI systems where human readers interpret cases with and without AI assistance. This device is a blood pressure monitor, not an AI for image interpretation.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:
Yes, a standalone performance assessment was effectively done. The clinical tests evaluated the accuracy of the BPro system (which includes its underlying algorithms for measurement) against a standard, without requiring active human interpretation of its outputs beyond what's typically involved in blood pressure measurement (e.g., ensuring proper device placement, initiating measurement). The device's output is directly a blood pressure reading.
7. The Type of Ground Truth Used:
For blood pressure monitoring device validation against standards like AAMI-SP10, the ground truth is typically established by simultaneous measurements using a recognized reference method, often involving auscultation by trained observers or another validated oscillometric device, especially during the "stationary" and "ambulatory" tests. The document implies this by stating conformity to AAMI-SP10.
8. The Sample Size for the Training Set:
The document does not provide any information about a training set size. This is common for devices like this that primarily rely on established physical measurement principles and calibration rather than complex machine learning models that require extensive "training" data.
9. How the Ground Truth for the Training Set Was Established:
Since a training set is not mentioned or implied for this type of device, the method for establishing its ground truth is not applicable and not provided in the document.
§ 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).