(42 days)
The MYTECH / HAPPY LIFE / MAXIAIDS Arm Blood Pressure Monitor,, Model HPL-301, HPL-302, HPL-310, 180310 are noninvasive blood pressure measurement systems intended to measure the systolic and diastolic blood pressures and pulse rate of an adult individual, over age 18, at home by using a non-invasive technique in which an inflatable cuff is wrapped around the arm.
The cuff circumference is limited to be 7"-15".
Basically, the subject device and the predicated device are the same in intended use, technological characteristics, power supply, LCD display, range, accuracy, and operating environments, dimensions, weight, and storage environments. The minor differences are the memory and display layout. That means the predicate device has 60 memory capacities and the new devices have 60 memory capacities. Besides, the new devices add 3 colors LED warming lights for the visional appearance.
The main differences of the new devices are:
- HPL-301 is the representative model of the new devices;
- HPL-302 is same as the HPL-301, add USB port for PC-LINK function; ●
- HPL-310 is same as the HPL-301, add voice prompt function for arm; ●
- 180310 is all the same as HPL-310, just using another model name. ●
Acceptance Criteria and Device Performance for MYTECH / HAPPY LIFE / MAXIAIDS Arm Blood Pressure Monitor
1. Table of Acceptance Criteria and Reported Device Performance
The submission for the MYTECH / HAPPY LIFE / MAXIAIDS Arm Blood Pressure Monitor (models HPL-301, HPL-302, HPL-310, 180310) references adherence to specific standards for its performance. The primary standard mentioned for clinical performance is AAMI/ANSI SP10.
| Acceptance Criteria / Standard | Reported Device Performance |
|---|---|
| AAMI/ANSI SP10 (Clinical Performance for non-invasive automated sphygmomanometers) | "PERFORMANCE & CLINICAL TEST AAMI / ANSI SP10" - Implied PASS (Although "PASS" is not explicitly stated next to AAMI/ANSI SP10 as it is for safety and EMC, the overall context of the submission and the finding of substantial equivalence implies that the device met the requirements of this standard.) |
| EN 60601-1:1990+A1+A2+A11+A12+A13 (General Safety for Medical Electrical Equipment) | PASS |
| EN 60601-1-2: 2001 (Electromagnetic Compatibility for Medical Electrical Equipment) | PASS |
2. Sample Size and Data Provenance
The document does not explicitly state the sample size used for the clinical performance test (AAMI/ANSI SP10). It also does not specify the country of origin of the data or whether the study was retrospective or prospective.
3. Number and Qualifications of Experts for Ground Truth
The provided document does not detail the number or qualifications of experts used to establish ground truth for the clinical performance testing. AAMI/ANSI SP10 typically requires trained observers for reference blood pressure measurements.
4. Adjudication Method
The document does not describe the adjudication method used for the clinical performance test set.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No MRMC comparative effectiveness study is mentioned. This device is a standalone blood pressure monitor, not an AI-assisted diagnostic tool that would typically involve human readers.
6. Standalone Performance
Yes, a standalone performance assessment was done. The device's clinical accuracy was evaluated against the AAMI/ANSI SP10 standard, which assesses the accuracy of the automated blood pressure monitor in measuring blood pressure and pulse rate without human-in-the-loop assistance.
7. Type of Ground Truth Used
For the AAMI/ANSI SP10 standard, the ground truth for blood pressure measurements is typically established through simultaneous or closely timed measurements taken by trained observers using a auscultatory method (e.g., stethoscope and manometer) or other reference methods as defined by the standard. The document itself does not explicitly state the ground truth method but refers to the standard, which dictates it.
8. Sample Size for the Training Set
This device does not appear to utilize machine learning or AI that would require a separate "training set" in the conventional sense of AI models. It relies on established oscillometric algorithms for blood pressure measurement. Therefore, no information on a training set sample size is provided.
9. How the Ground Truth for the Training Set Was Established
As noted in point 8, there is no mention of a "training set" in the context of AI/ML for this device. The underlying algorithms are based on established physiological principles and engineering, not typically on a "training set" with established ground truth in the way a deep learning model would be trained. The fundamental accuracy is verified through clinical validation against the AAMI/ANSI SP10 standard, which serves as the "testing" of its inherent design and algorithm.
§ 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).