(57 days)
Fudakang Arm Blood Pressure Monitor and Wrist Blood Pressure Monitor are non-invasive blood measurement system intended to measure the diastolic, systolic blood pressures and pulse rate of an adult individual in hospitals, hospital-type facilities and home environments.
The Fudakang BT series Blood Pressure Monitors are of Bluetooth transmission function, which enable user to transfer the measurement record from the device to a mobile phone or PC through Bluetooth.
Fudakang Arm Blood Pressure Monitor and Wrist Blood Pressure Monitor are not intended to be diagnostic device.
Fudakang Blood Pressure Monitor is battery driven automatic non-invasive Blood Pressure Monitor.
It consists of the Main Control Unit, LCD and attachments. The device can automatically complete the inflation, deflation and BP measurement, which intended to measure the diastolic, systolic blood pressures and pulse rate for an adult individual via the oscillometric technique.
Fudakang Blood Pressure Monitor includes two types of automatic non-invasive Blood Pressure Monitor, Arm Automatic Blood Pressure Monitor and Wrist Fully Automatic Blood Pressure Monitor. The Arm Blood Pressure Monitor utilizes an inflatable cuff that is wrapped around the upper arm; the cuff circumference is limited to 22cm-30cm (8.66 in - 11.8 in). The Wrist Blood Pressure Monitor utilizes an inflatable cuff wrapped around the wrist, the cuff circumference is limited to 13.5cm- 19.5cm (5.31in -7.67 in).
The BT series Blood Pressure Monitors are of Bluetooth transmission function, which enable user to transfer the measurement record from the device to a mobile phone or PC through Bluetooth.
Here's an analysis of the provided text to extract the requested information about acceptance criteria and studies for the Fudakang Arm Blood Pressure Monitor and Wrist Blood Pressure Monitor:
Acceptance Criteria and Device Performance
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Table of Acceptance Criteria and Reported Device Performance:
Acceptance Criteria Reported Device Performance Accuracy within acceptable scope specified in ISO 81060-2 Clinical study results "showed the accuracy of the blood pressure monitor made by Fudakang Industrial Co., Ltd. is within acceptable scope specified in ISO 81060-2." -
Sample Size Used for the Test Set and Data Provenance:
- Sample Size: 123 patients (65 males and 58 females).
- Data Provenance: Not explicitly stated, but the study was a clinical study conducted (likely for regulatory approval), suggesting it was prospective. The location of the study (country of origin) is not mentioned.
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Number of Experts Used to Establish Ground Truth and Qualifications:
- Not applicable in this context. The study uses a manual Mercury Sphygmomanometer as the reference device for ground truth, which is a widely accepted standard measurement. No "experts" are establishing a subjective ground truth.
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Adjudication Method for the Test Set:
- Not applicable. The ground truth is established by a reference device (manual Mercury Sphygmomanometer) rather than expert consensus requiring adjudication.
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Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- No, an MRMC comparative effectiveness study was not done. The study described is a comparison of the device against a reference standard (manual Mercury Sphygmomanometer), not a comparison of human reader performance with and without AI assistance.
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Standalone Performance Study:
- Yes, a standalone study was performed. The clinical test involved comparing the Fudakang device's measurements directly against those obtained from a manual Mercury Sphygmomanometer. This evaluates the algorithm's (device's) performance independently.
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Type of Ground Truth Used:
- Reference Device Measurement: The ground truth was established by readings from a manual Mercury Sphygmomanometer. This is considered a gold standard for blood pressure measurement.
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Sample Size for the Training Set:
- Not specified. The document only describes a clinical study, which generally serves as the validation (test) set for demonstrating performance against a standard, not the training set for developing the algorithm. Medical device approval documents often don't detail the training phases of algorithms unless they are a central part of the device's novelty or specific AI claims.
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How the Ground Truth for the Training Set Was Established:
- Not specified, as the training set details are not provided.
§ 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).