(38 days)
The upper arm blood pressure monitor is used to carry out non-invasive measurement and monitoring of the arterial blood pressure values in adults. This allows you to quickly and easily measure your blood pressure, save the measured values and display the development and average values of the measured values taken.
Digital Automatic Blood Pressure Monitor MD36 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.
The Subject Device equipped with Bluetooth transmission which enable user to transfer the measurement record from the device to a mobile platform through Bluetooth. User can manage the measurement record by using the mobile application.
Here's an analysis of the acceptance criteria and the study conducted for the Digital Automatic Blood Pressure Monitor MD36 Series, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The primary acceptance criteria for blood pressure monitors is accuracy. The document refers to ISO 81060-2 for clinical accuracy testing.
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Blood Pressure Measurement Accuracy | ± 3 mmHg |
| Pulse Rate Measurement Accuracy | ± 5 % of the reading |
| Compliance with ISO 81060-2 (Clinical Test) | Met: Clinical test conducted according to ISO 81060-2, documented in a Clinical Test report. While the specific numerical results of the ISO 81060-2 test are not detailed in this summary, the statement "Testing to ensure clinical accuracy of the device in accordance with ISO 81060-2 as documented in Clinical Test report" implies that the device met the standards set forth by ISO 81060-2. |
| Compliance with Non-Clinical Standards | Met: Various non-clinical tests conducted (e.g., EN 1060-3, IEC 60601-1, FCC Part 15) to demonstrate that all requirement specifications and standard requirements are met. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: 100 patients for each cuff size (standard: 49 males and 51 females; universal: 44 males and 56 females).
- Data Provenance: The document does not explicitly state the country of origin for the clinical study data or whether it was retrospective or prospective. Given that the manufacturer is Grandway Technology (Shenzhen) Limited, China, and the study was likely conducted to support a US FDA submission, it's possible the study was conducted in China or a region where clinical studies for international regulatory submissions are common. It is a prospective study, as patients were "invited for the study" and measurements were "repeated alternatively."
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
- Number of Experts: The ground truth was established using the "standard auscultation method." This method typically involves trained medical professionals. While the exact number isn't specified, it would imply at least one, and likely multiple, trained personnel performing the auscultation measurements.
- Qualifications of Experts: The document states "Standard auscultation method was used as the reference blood pressure monitor." This implies trained medical personnel (e.g., nurses, doctors) who are proficient in manual blood pressure measurement using a stethoscope and sphygmomanometer. Specific qualifications like experience level (e.g., "radiologist with 10 years of experience") are not provided.
4. Adjudication Method for the Test Set
The document does not describe an adjudication method for the test set beyond obtaining measurements from the "standard auscultation method" and directly comparing them to the device's readings. The study design mentions measurements were "repeated alternatively with the device and auscultation in the same arm according to the sequence in ISO 81060-2," suggesting a direct comparison without a separate adjudication panel.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not conducted. This type of study is more common for diagnostic imaging AI, where human readers interpret cases with and without AI assistance. This device is an automated blood pressure monitor, not an AI interpretation system for human readers.
6. Standalone (Algorithm Only) Performance
- Yes, a standalone performance study was conducted. The clinical accuracy testing described in "Clinical Test Summary" is a standalone performance study, assessing the device's accuracy (algorithm only, as it's an automated device) against a reference standard (auscultation) without human-in-the-loop interpretation adjustment.
7. Type of Ground Truth Used
- The type of ground truth used was expert consensus (via standard auscultation method). The auscultation method, performed by a trained professional, serves as the clinical reference standard against which the automated device's measurements are compared.
8. Sample Size for the Training Set
- The document does not explicitly mention a "training set" or its sample size. This is typical for a medical device that relies on established physical principles and calibrated hardware (oscillometric methodology) rather than a machine learning model that requires explicit training data. The development and internal validation of the device would have involved calibration and testing, but not in the same sense as "training data" for an AI algorithm.
9. How the Ground Truth for the Training Set Was Established
- As mentioned above, the concept of a "training set ground truth" as it applies to AI/ML is not directly applicable here. The device's underlying principles are based on the oscillometric method. The accuracy claims are validated through the clinical performance study against the auscultation method.
§ 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).