(410 days)
Automatic Digital Blood Pressure Monitor is intended to measure the systolic and diastolic blood pressure as well as the pulse rate of adult person via non-invasive oscillometric technique in which an inflatable cuff is wrapped around the wrist or the upper arm. It can be used at medical facilities or at home. The intended wrist circumference is 12.520 cm and the intended arm circumference has several models: 2333 cm, 2535 cm, 2242 cm, 33~43 cm.
Automatic Digital Blood Pressure Monitor is a non-invasive blood pressure measurement system intended to measure the diastolic and systolic blood pressures and pulse rate of an adult individual via non-invasive Oscillometric technique in which an inflatable cuff is wrapped around the wrist or the upper arm.It can be used at medical facilities or at home. The Automatic Digital Blood Pressure Monitor main units have the operating elements of ON/OFF knob, SET key which can be user-friendly controlled. Arm type Blood Pressure Monitor is equipped with inflatable cuff, while The wrist type Blood Pressure Monitor`s cuff is attached to the device body itself.
This document is a 510(k) summary for an Automatic Digital Blood Pressure Monitor. It describes the device's characteristics, intended use, and comparison to predicate devices to demonstrate substantial equivalence.
Here's a breakdown of the requested information based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for the blood pressure monitor's accuracy are based on ISO 81060-2:2013 Non-invasive sphygmomanometers - Part 2: Clinical validation of automated measurement type.
| Acceptance Criteria (from ISO 81060-2) | Reported Device Performance |
|---|---|
| Accuracy within acceptable scope specified in ISO 81060-2:2013 | "The results showed the accuracy of the blood pressure monitor is within acceptable scope specified in ISO 81060-2." |
| Pressure accuracy: ±3 mmHg | Pressure: ±3 mmHg |
| Pulse accuracy: ±5% | Pulse: ±5% |
Note: The document explicitly states the device meets the ISO 81060-2 standard but doesn't provide granular numerical data beyond the +/- tolerance levels. It confirms the device's accuracy specifications align with the standard.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size (Test Set):
- Arm Sphygmomanometer: 90 patients (divided by cuff size: 23-33cm: 49 males and 41 females; 25-35cm: 38 males and 52 females; 22-42cm: 48 males and 42 females; 33-43cm: 38 males and 52 females).
- Wrist Sphygmomanometer: 90 patients (43 males and 47 females).
- Total Patients: 180 (90 arm + 90 wrist).
- Data Provenance: The document does not explicitly state the country of origin. It indicates the clinical study was conducted, and "All the subjects were volunteer to take part in the clinical study." The study is described as a clinical investigation, implying a prospective study.
3. Number of Experts Used to Establish Ground Truth and Qualifications
The document does not specify the number of experts or their qualifications. However, for blood pressure measurements, the "ground truth" is typically established by trained medical professionals (e.g., physicians, nurses) using a reference device.
4. Adjudication Method for the Test Set
The document states: "The manual Mercury Sphygmomanometer was used as a reference device." This implies a comparison method where the device's readings are compared against the gold standard (manual mercury sphygmomanometer readings). It does not describe an adjudication method with multiple readers deciding on a "ground truth" where there might be inter-reader variability, as would be common in diagnostic imaging studies. The reference device is the ground truth.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
No, an MRMC comparative effectiveness study was not done. This type of study is typically performed for AI-assisted diagnostic devices to assess how AI impacts human reader performance. This device is a direct measurement device (automatic blood pressure monitor), not an AI-enabled diagnostic tool in the sense that an algorithm assists human interpretation of images. The study focused on the device's accuracy compared to a reference standard.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done
Yes, in a sense, the primary test conducted was a "standalone" performance test of the device. The clinical study evaluated the direct output of the Automatic Digital Blood Pressure Monitor against a manual mercury sphygmomanometer, without human interpretation of the device's output being a variable. The device itself performs the measurement and provides readings.
7. The Type of Ground Truth Used
The ground truth used was measurements from a manual Mercury Sphygmomanometer. This is considered a highly reliable and commonly accepted gold standard for blood pressure measurement.
8. The Sample Size for the Training Set
The document does not provide information about a separate "training set" or its sample size. This is typical for medical devices that perform a direct physical measurement (like a blood pressure monitor) and are validated against a known standard. The "training" for such a device is typically part of its engineering and algorithm development, not a discrete data set for a machine learning model submitted for regulatory review in the same way as AI software.
9. How the Ground Truth for the Training Set Was Established
As no specific training set is mentioned in the regulatory document (likely because the device's function is a direct measurement and not an AI/ML model requiring a separate training data ground truth for submission), this information is not provided. The device's underlying algorithm is likely developed and refined through engineering and calibration processes based on known physiological principles of oscillometric measurement, rather than learning from a 'labeled training dataset' in the context of AI.
§ 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).