(109 days)
The Wrist Blood Pressure Monitor is intended to measure and diastolic pressure and diastolic pressure, as well as the pulse rate of adult person via non-invasive oscillometric technique by an inflatable cuff wrapped around the wrist at medical facilities or at home.
AOJ-35 series wrist blood pressure monitor is designed as a battery driven automatic on-invasive blood pressure monitor. It can automatically complete the inflation, deflation and measurement, which can measure systolic and diastolic blood pressure as well as the pulse rate of adult person at wrist within its claimed range and accuracy via the oscillometric technique. The result will be displayed in the international unit mmHg. The device also has low voltage indication, which will be triggered when the battery is low. All the models included in this submission follow the same software, same measurement principle and same specifications. The main differences are color of the face shell and keys, which will not affect the safety and effectiveness of the device.
Here's a 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 (from ISO 80601-2-30 & ISO 81060-2:2013) | Reported Device Performance (as per Clinical Data) |
|---|---|
| Blood Pressure Accuracy: Mean value of difference between device and reference standard should be less than 5.0 mmHg. | Mean value is less than 5.0 mmHg |
| Blood Pressure Accuracy: Standard deviation of difference between device and reference standard should be less than 8.0 mmHg. | Standard deviation is less than 8.0 mmHg |
| Cuff Size Distribution Requirement (ISO 81060-2:2013 clause 5.1.4): | |
| - Upper half of the cuff: At least 40% | 54% (Complied) |
| - Lower half of the cuff: At least 40% | 46% (Complied) |
| - Upper quarter of the cuff: At least 20% | 29% (Complied) |
| - Lower quarter of the cuff: At least 20% | 24% (Complied) |
| - Upper octal of the cuff: At least 10% | 11% (Complied) |
| - Lower octal of the cuff: At least 10% | 10% (Complied) |
| Blood Pressure Distribution Requirement (ISO 81060-2:2013 clause 5.1.5): | |
| - Systolic Blood Pressure ≤100 mmHg: At least 5% | 12% (Complied) |
| - Systolic Blood Pressure ≥160 mmHg: At least 5% | 13% (Complied) |
| - Systolic Blood Pressure ≥140 mmHg: At least 20% | 33% (Complied) |
| - Diastolic Blood Pressure ≥100 mmHg: At least 5% | 16% (Complied) |
| - Diastolic Blood Pressure ≤60 mmHg: At least 5% | 10% (Complied) |
| - Diastolic Blood Pressure ≥85 mmHg: At least 20% | 38% (Complied) |
| Non-Invasive Sphygmomanometer Performance Effectiveness | Complies with ISO 80601-2-30 |
| Electrical Safety | Complies with IEC 60601-1, IEC 60601-1-11, and IEC 60601-1-2 |
| Biocompatibility | Complies with ISO 10993-1, ISO 10993-5, ISO 10993-10 (Cytotoxicity, Skin Sensitization, Skin Irritation) |
| Software Verification and Validation | Passed according to FDA Guidance for "major" level of concern |
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size: 100 subjects (49 female, 51 male).
- Data Provenance: The document does not explicitly state the country of origin of the data. It is a prospective clinical study, as it was conducted "per ISO 81060-2: 2013 Non-invasive sphygmomanometers - Part 2: Clinical validation of automated measurement type."
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications:
The document mentions that the clinical testing was conducted "per ISO 81060-2: 2013 Non-invasive sphygmomanometers - Part 2: Clinical validation of automated measurement type." This standard typically outlines the requirements for validation of automated non-invasive sphygmomanometers against a reference standard. While the document doesn't explicitly state the number of experts, ISO 81060-2 typically requires measurements by trained observers using a mercury-column or auscultatory device as the reference ground truth. The qualifications of these observers would be that they are trained to accurately perform manual blood pressure measurements according to the standard. No specific details about the number or precise qualifications (e.g., "radiologist with 10 years of experience") are provided in this summary, but the reference to the ISO standard implies adherence to its requirements for ground truth establishment.
4. Adjudication Method for the Test Set:
The document does not explicitly mention an adjudication method like 2+1 or 3+1. For blood pressure validation, ISO 81060-2 typically involves simultaneous or closely timed measurements by multiple trained observers (often two) and the device under test. The differences between the device readings and the average or adjudicated readings of the observers (or a specific protocol for handling discrepancies) form the basis of the accuracy assessment.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not conducted for this device. The study described focuses on the standalone accuracy of the blood pressure monitor against a reference standard, not its impact on human reader performance or diagnostic accuracy.
6. Standalone Performance Study:
Yes, a standalone study (algorithm only without human-in-the-loop performance) was done. The clinical data section explicitly details the performance of the "monitor" (the device) in measuring blood pressure and pulse rate against a reference standard. The "Bench Testing" section also describes tests conducted on the device's technical performance.
7. Type of Ground Truth Used:
The ground truth used for the clinical study was established according to ISO 81060-2: 2013 Non-invasive sphygmomanometers - Part 2: Clinical validation of automated measurement type. This standard mandates a clinical validation process where the automated device's measurements are compared to measurements taken by trained observers using a validated reference method (e.g., auscultation with a mercury sphygmomanometer). This constitutes an expert-based reference standard rather than pathology or outcomes data.
8. Sample Size for the Training Set:
The document does not provide information on the sample size for the training set. This is a premarket notification for a medical device, and the focus of the provided summary is on the clinical validation (testing) and non-clinical data, not on the development or training of an AI algorithm (though the device itself likely contains algorithms, their training data is not detailed here).
9. How the Ground Truth for the Training Set was Established:
As no training set information is provided, how its ground truth was established is not detailed in this 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).