(73 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 wrist.
Digital Automatic Wrist Blood Pressure Monitor SWBPM22 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 wrist 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 acceptance criteria and study relevant to the Digital Automatic Wrist Blood Pressure Monitor SWBPM22 Series, based on the provided text:
Device: Digital Automatic Wrist Blood Pressure Monitor SWBPM22 Series (Models MD2200 and MD2210)
1. Table of Acceptance Criteria and Reported Device Performance
The primary acceptance criteria for accuracy are based on ISO 81060-2. The document mentions blood pressure measurement accuracy of ± 3 mmHg and pulse rate measurement accuracy of ± 5% of the reading.
| Acceptance Criteria (According to ISO 81060-2 implied) | Reported Device Performance |
|---|---|
| Blood Pressure Measurement Accuracy: Mean difference ≤ 5 mmHg and Standard deviation ≤ 8 mmHg (AAMI/ISO 81060-2) | ± 3 mmHg |
| Pulse Rate Measurement Accuracy | ± 5 % of the reading |
Note: While the document explicitly states "± 3 mmHg" for BP accuracy and "± 5% of the reading" for pulse rate accuracy under the "Blood Pressure Measurement Accuracy" and "Pulse Rate Measurement Accuracy" rows respectively (Page 6, and in the table of comparison with predicate device at page 5), for blood pressure, the ISO 81060-2 standard (which is cited as the basis for the clinical test) typically uses criteria of mean difference ≤ 5 mmHg with a standard deviation ≤ 8 mmHg when assessing accuracy against a reference measurement.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: 100 patients (49 males and 51 females)
- Data Provenance: Not explicitly stated regarding country of origin, but the study was described as a "Clinical Test Summary" to insure clinical accuracy, suggesting a prospective study designed for this device.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- Number of Experts: Not explicitly stated.
- Qualifications of Experts: Not explicitly stated, though it mentions "Standard auscultation method was used as the reference blood pressure monitor," which implies trained medical professionals (e.g., physicians, nurses) performed the auscultation.
4. Adjudication Method for the Test Set
- Adjudication Method: Not explicitly stated. The document mentions "Blood pressure measurements were repeated alternatively with the device and auscultation in the same arm according to the sequence in [a likely document reference: 209008 051 which is cut off]." This suggests a direct comparison method rather than an adjudication process between multiple experts for ground truth. The "standard auscultation method" itself serves as the reference.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- Not done/Applicable: This type of study (MRMC) is generally not applicable to a device like a blood pressure monitor, which provides a direct measurement rather than an interpretation requiring human readers.
6. Standalone (Algorithm Only) Performance Study
- Yes: The clinical accuracy study, where the device's readings were compared against the standard auscultation method, is a standalone performance study of the algorithm (device) without human-in-the-loop performance improvement.
7. Type of Ground Truth Used
- Expert Consensus / Reference Standard: The ground truth was established using the "standard auscultation method" by a medical professional, which serves as a reference standard for non-invasive blood pressure measurement.
8. Sample Size for the Training Set
- Not Applicable / Not Mentioned: This device uses an oscillometric methodology and is likely based on established physiological principles and algorithms rather than a machine learning model requiring a separate "training set" in the conventional sense of AI/ML. The clinical study mentioned is for validating performance, not for training.
9. How the Ground Truth for the Training Set Was Established
- Not Applicable / Not Mentioned: As noted above, the concept of a "training set" and associated ground truth establishment is not typically relevant for this type of 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).