(43 days)
The iDoc Upper Arm attached Blood Pressure and Pulse Rate Monitor provide intended to use non-invasive measure the systolic and diastolic blood pressure and pulse rate or an adult individual, over age 16, at home by using a non-invasive technique in which an inflatable cuff is wrapped around the arm. The cuff circumference is limited to 9"~14" (23cm ~ 36cm).
The iDoc™ iD-42A/ iD-43A Upper Arm Attached Blood Pressure and Pulse Rate Monitors are arm blood pressure monitors and use the oscillometric method to measure the blood pressure. The device includes setting button, function button, LCD display, start/stop button, recall memory button, and arm cuff. The symbols display on LCD include month, date, hour, minute, systolic rate, diastolic rate, pulse rate, pulse symbol, blood pressure unit, battery display, error symbol, memory record. Both devices determine values of blood pressure by using oscillometric method. In this method, pulse waves are detected by using pressure sensors. Then the diastolic blood pressure, mean average pressure, and pulse pressure are derived. Furthermore, the systolic blood pressure and pulse rate are computed based on the information.
Here's a summary of the acceptance criteria and study information for the iDoc™ iD-42A/iD-43A Upper Arm Attached Blood Pressure and Pulse Rate Monitor, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Conformance to SP10 standard for blood pressure monitors | The clinical test results met the criteria in the SP10 standard. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the specific sample size for the clinical test set. It only refers to "clinical test results." The data provenance is not specified, but the submitter is based in Taiwan. It's likely a prospective study as it's a clinical test.
3. Number of Experts Used to Establish Ground Truth and Qualifications
This information is not provided in the document. For blood pressure monitors, ground truth is typically established by trained medical professionals using a reference device (e.g., a mercury sphygmomanometer) following specific protocols (like those outlined in SP10). The document mentions adherence to the SP10 standard, which would imply such a methodology, but details on personnel are absent.
4. Adjudication Method for the Test Set
The adjudication method is not explicitly mentioned. Given the nature of blood pressure measurement where devices are compared against a reference standard, independent adjudication of individual measurements by multiple experts might not be a primary requirement in the same way it would be for image interpretation.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The document describes a standalone clinical performance study against a standard, not a study comparing human readers with and without AI assistance.
6. Standalone Performance Study (Algorithm Only Without Human-in-the-Loop Performance)
Yes, a standalone performance study was done. The document states that the device's "clinical test results... showed the functions of the device met the criteria in the SP10 standard." This refers to the device itself performing measurements and being evaluated against a recognized standard (SP10).
7. Type of Ground Truth Used
The ground truth used was conformance to the SP10 standard. This standard dictates precise measurement protocols and acceptable levels of accuracy when compared to a reference method (often a trained observer using a mercury sphygmomanometer).
8. Sample Size for the Training Set
The document does not provide information about a separate training set or its sample size. For simple oscillometric blood pressure monitors, dedicated "training sets" in the AI/machine learning sense are less common, as the algorithms are based on established physiological principles rather than complex pattern recognition from large datasets. The device's underlying algorithm is described as using the "oscillometric method."
9. How the Ground Truth for the Training Set Was Established
Since a distinct "training set" in the context of machine learning is not described, the method for establishing ground truth for a training set is not applicable or provided. The device's operation is based on the inherent principles of the oscillometric method, likely validated against known physiological responses during its development, rather than being "trained" on a specific dataset.
§ 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).