(196 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 BPM41 Series and Digital Automatic Blood Pressure Monitor BPM45 Series (Subject Device) are non-invasive blood pressure measurement systems 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 Subject Device utilize 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 a summary 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
| Measure | Acceptance Criteria (Standard ISO 81060-2) | Reported Device Performance (BPM41 Series) | Reported Device Performance (BPM45 Series) |
|---|---|---|---|
| Blood Pressure Accuracy | ± 3 mmHg (Mean Difference) | Not explicitly stated in a table, but implied compliance based on the study details. | Not explicitly stated in a table, but implied compliance based on the study details. |
| Pulse Rate Measurement Accuracy | ± 5 % of the reading | Not explicitly stated in a table, but implied compliance based on the study details. | Not explicitly stated in a table, but implied compliance based on the study details. |
| Clinical Accuracy | Based on ISO 81060-2 | Assessed in a clinical study confirming compliance. | Assessed in a clinical study confirming compliance. |
2. Sample Size for Test Set and Data Provenance
- Sample Size:
- BPM41 Series: One hundred patients (50 males and 50 females)
- BPM45 Series: One hundred patients (51 males and 49 females)
- Data Provenance: Not specified in the provided text. The location of the clinical study (e.g., country of origin) is not mentioned. It is a prospective clinical study, as patients "were invited for the study."
3. Number of Experts Used to Establish Ground Truth for Test Set and Qualifications of Experts
- The ground truth was established using the "Standard auscultation method." This method typically involves trained medical professionals (e.g., doctors, nurses) taking manual blood pressure measurements.
- The exact number of experts and their specific qualifications (e.g., "radiologist with 10 years of experience") are not explicitly stated in the document. However, the use of "Standard auscultation method" implies measurement by qualified healthcare personnel.
4. Adjudication Method for the Test Set
- The adjudication method is described as "Blood pressure measurements were repeated alternatively with the device and auscultation in the same arm according to the sequence in ISO 81060-2." This suggests a direct comparison method rather than a formal expert consensus/adjudication. Each measurement from the device was compared against the corresponding auscultation measurement taken by the human observer.
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 explicitly described. The study focused on the device's accuracy against a gold standard (auscultation), not on comparing human reader performance with and without AI assistance.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
- Yes, the clinical study performed to evaluate the device's accuracy against the standard auscultation method can be considered a standalone performance evaluation. The device (algorithm) provides a measurement, and that measurement is compared to the ground truth. There isn't an explicit "human-in-the-loop" scenario described in the testing for accuracy.
7. The Type of Ground Truth Used
- The type of ground truth used was expert auscultation, which is considered the clinical gold standard for non-invasive blood pressure measurement.
8. The Sample Size for the Training Set
- The document does not specify the sample size for the training set. The clinical study described is for validation of the device's accuracy.
9. How the Ground Truth for the Training Set Was Established
- The document does not provide information on how the ground truth for any potential training set was established. The clinical study details are exclusively for the clinical validation of the 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).