(182 days)
The FORA P30 Plus Multi-Mode Blood Pressure Monitoring System is a device intended to measure non-invasively the systolic and diastolic blood pressure and pulse rate of an adult individual. The blood pressure is measured by using an inflatable cuff wrapped around the arm. This system should be used for the testing on people over age of 18.
The device detects the appearance of irregular heartbeat during measurement, and gives a warning signal with the reading once the irregular heartbeat is detected.
The FORA P30 Plus Multi-Mode Blood Pressure Monitoring System.uses the oscillometric method to measure the systolic, diastolic blood pressure and pulse rate with a inflatable arm cuff on adults.
The device has single measurement mode, averaging mode and auscultatory mode of blood pressure measurements. The single measurement mode functions like a regular blood pressure monitor. The averaging mode is selected for performing three consecutive measurements with a fixed resting period between each measurement and displays the averaged result on LCD. The auscultatory mode is selected for trained persons to measure with a stethoscope.
The FORA P30 Plus Multi-Mode Blood Pressure Monitoring System was validated against the ANSI/AAMI SP10 standard for non-invasive blood pressure (NIBP) devices.
Here's a breakdown of the available information regarding its acceptance criteria and the study:
1. Table of Acceptance Criteria and Reported Device Performance
The provided document states that the device "met the requirements of ANSI/AAMI SP10" but does not explicitly list the specific numerical acceptance criteria or the precise reported device performance metrics (e.g., mean difference, standard deviation, percentage within 5 mmHg) from the ANSI/AAMI SP10 test.
| Acceptance Criteria (ANSI/AAMI SP10) | Reported Device Performance |
|---|---|
| Accuracy Requirements: | |
| - Mean difference: | Met requirements |
| - Standard deviation: | Met requirements |
| Other Requirements: | |
| - Software validation: | Performed, works functionally |
| - Electrical safety (IEC/EN 60601-1): | Met requirements |
| - EMC (IEC/EN 60601-1-2): | Met requirements |
| - Biocompatibility (ISO 10993-5, -10): | Met requirements |
2. Sample Size and Data Provenance
The document does not specify the sample size used for the test set or the data provenance (e.g., country of origin, retrospective/prospective). To meet ANSI/AAMI SP10, a clinical study on a human subject population typically involves a minimum number of subjects (usually at least 85 subjects with a well-defined distribution of blood pressures).
3. Number of Experts and Qualifications for Ground Truth
The document does not provide information on the number of experts used or their qualifications for establishing ground truth, as an expert consensus method is not explicitly mentioned for the blood pressure measurements. For clinical validation under ANSI/AAMI SP10, the ground truth is typically established by trained human observers using auscultation with a stethoscope, not through a panel of experts.
4. Adjudication Method
The document does not mention an adjudication method for the test set. In the context of ANSI/AAMI SP10, blood pressure measurements from the test device are compared against simultaneous auscultatory measurements obtained by trained observers. Discrepancies are handled within the statistical analysis prescribed by the standard, rather than through a separate adjudication process as might be seen for visual interpretation tasks.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No information is provided about a multi-reader multi-case (MRMC) comparative effectiveness study, nor is there any mention of an effect size for human readers improving with or without AI assistance. This type of study is not typically applicable to a blood pressure monitoring device validated by the ANSI/AAMI SP10 standard.
6. Standalone Performance Study
Yes, a standalone performance study was done. The validation against ANSI/AAMI SP10 assesses the algorithm's (device's) ability to accurately measure blood pressure against a reference method (auscultation), without human-in-the-loop assistance for the measurement itself.
7. Type of Ground Truth Used
The ground truth for blood pressure measurements under ANSI/AAMI SP10 is typically established by auscultation, performed by trained observers using a stethoscope and sphygmomanometer. This is considered the reference method for non-invasive blood pressure measurement.
8. Sample Size for the Training Set
The document does not explicitly mention a separate "training set" or its sample size. For medical devices, particularly those using traditional algorithms (as stated for this device), the development often involves engineering and physiological modeling, with validation on a test set (clinical study). If any machine learning or AI components were involved in the algorithm's development, a dedicated training set would be common, but the document describes the algorithm as "traditional."
9. How the Ground Truth for the Training Set Was Established
Since no separate training set is mentioned in the provided text, information on how its ground truth was established is not available.
§ 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).