(185 days)
The A&D Medical UA-789 digital blood pressure monitor is intended for used by adults with 12 years older to measure the systolic and diastolic blood pressure and pulse rate.
Indications For Use: Measure blood pressure (systolic and diastolic) and pulse rate.
The A&D Medical UA-789 digital blood pressure monitor is intended for used by adults with 12 years older to measure the systolic and diastolic blood pressure and pulse rate. UA-789 uses an inflatable cuff which is wrapped around the patient's upper arm. The cuff is inflated automatically by an internal pump in the device. The systolic and diastolic blood pressures are determined by oscillometric method. The deflation rate is controlled by the internal electronic-controlled exhaust valve. There is a quick exhaust mechanism so that the pressure of the cuff can be completely released. The arm distribution range is from 9.4" to 23.6" (24 cm to 60 cm).
Here's an analysis of the provided text regarding the A&D Medical UA-789 Digital Blood Pressure Monitor, incorporating the requested information:
Understanding the Device and its Validation
The A&D Medical UA-789 is a non-invasive digital blood pressure monitor that uses the oscillometric method to measure systolic and diastolic blood pressure and pulse rate. The validation of this device primarily relies on its adherence to established blood pressure monitor standards.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Accuracy and Effectiveness Standard: ANSI/AAMI SP-10 standard | Met (specifically for extra-large cuffs used in UA-789) |
| European Medical Products Directive: European Directive 93/42 EEC | Met |
| General Safety Provisions: EN60601 | Met |
| Safety of BP Monitor (Particular Requirements): EN60601-2-30 | Met |
| Electromagnetic Compatibility: EN60601-1-2 and EN55011 | Met |
2. Sample Size Used for the Test Set and the Data Provenance
The provided document does not explicitly state the sample size used for the test set or the data provenance (e.g., country of origin, retrospective/prospective). It only mentions that the accuracy and effectiveness of the extra-large cuffs have been "validated through the ANSI/AAMI SP-10 standard." The ANSI/AAMI SP-10 standard itself specifies requirements for clinical validation, including minimum sample sizes (typically a diverse group of subjects). However, the specific study details for the UA-789 are not present in this summary.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
The document does not specify the number of experts used or their qualifications for establishing ground truth for the clinical validation. The ANSI/AAMI SP-10 standard requires comparison against a reference method (e.g., auscultation by trained observers), but the details of who performed this for the UA-789 study are not provided in this summary.
4. Adjudication Method for the Test Set
The document does not specify the adjudication method used for the test set.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance
This question is not applicable to the A&D Medical UA-789 Digital Blood Pressure Monitor. This device is a standalone measurement device for blood pressure and pulse rate, not an AI-assisted diagnostic tool that would involve multi-reader multi-case studies or assessment of human reader improvement.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Yes, the testing described for the A&D Medical UA-789 is inherently a standalone performance evaluation. The device itself is designed to measure blood pressure and pulse rate without human intervention beyond proper application and operation. The validation against standards like ANSI/AAMI SP-10 assesses the accuracy of the device's measurements directly.
7. The Type of Ground Truth Used
Based on the reference to the ANSI/AAMI SP-10 standard, the ground truth would typically be established by a reference method, most commonly auscultation performed by trained observers (e.g., physicians or nurses) using a mercury sphygmomanometer or validated aneroid device, with readings taken according to a standardized protocol. The standard defines the acceptable difference between the device's readings and these reference measurements.
8. The Sample Size for the Training Set
The document does not provide information regarding a "training set" sample size. For traditional medical devices like blood pressure monitors, the concept of a distinct "training set" and "test set" in the machine learning sense is generally not directly applicable. The device's algorithm would have been developed and refined using internal methods and prior engineering knowledge, and then its performance validated against a clinical test set according to a standard.
9. How the Ground Truth for the Training Set Was Established
As noted in point 8, the concept of a "training set" with established ground truth as it applies to machine learning algorithms is likely not directly relevant here. The oscillometric algorithm for blood pressure measurement is based on established physiological principles and engineering. Its initial development and refinement would be based on comprehensive internal testing and optimization, rather than a distinct "training set" that requires external ground truth establishment in the same way an AI model does. The clinical validation then serves as the final proof of accuracy.
§ 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).