(135 days)
The YA HORNG Upper Arm Blood Pressure Monitor, model BP-700NW and Bluetooth Transmission BP-700W are noninvasive blood pressurement 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 upper arm. The cuff circumference is limited to be 9.0" for Arm type.
YA HORNG Upper Arm Blood Pressure Monitor, model BP-700NW and Bluetooth Transmission BP-700W use the Oscillometric method to measure the blood pressure. The Oscillometric method is adopted clinically to measure the blood pressure recently. It is not needed to use the stethoscope, as in the traditional measuring method, to monitor the Korotkov sound when deciding the systolic or diastolic pressure. The Oscillometric method senses the vibrating signal via the closed air pipe system and utilizes the microcomputer to automatically sense the characteristics of the pulse signal. Through simple calculation, the reading can reflect the accurate real blood pressure, and the systolic pressure is defined as the pressure when the cuff pressure oscillating amplitude begins to increase and the diastolic pressure as the pressure when the cuff pressure oscillating amplitude stops decreasing.
Here's the breakdown of the acceptance criteria and study information for the YA HORNG Upper Arm Blood Pressure Monitor, model BP-700NW and Bluetooth Transmission BP-700W, based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Standard | Reported Device Performance |
|---|---|
| IEC/EN 60601-1:2007 (General Safety) | PASS |
| EN 1060-1:2009, EN 1060-3:2009 | PASS |
| IEC/EN 60601-1-2: 2010 (EMC Conformity) | PASS |
| ANSI C63.4: 2003 (FCC Conformity) | PASS |
| FCC 47 part 15 subject B class B | PASS |
| EN 30148-1:2008, EN 30148-17:2009 (ERM Conformity) | PASS |
| EN 300328:2006 (RF Conformity) | PASS |
| ANSI / AAMI SP 10: 2002 (Performance & Clinical Test) | Not explicitly stated as "PASS" but implied through the statement "YA HORNG Electronic Co. Ltd. believes this information and referred document to be sufficient for the FDA to find our proposed device substantially equivalent..." |
| ANSI / AAMI ISO 81060-2:2009 (Performance & Clinical Test) | Not explicitly stated as "PASS" but implied (see above). |
| EN 1060-4:2004 (Performance & Clinical Test) | Not explicitly stated as "PASS" but implied (see above). |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify the sample size used for the clinical test set. It mentions the application of standards like ANSI / AAMI SP 10: 2002 and ANSI / AAMI ISO 81060-2:2009, which typically outline sample size requirements for blood pressure monitor validation. However, the exact number of subjects tested is not provided.
The data provenance (country of origin, retrospective/prospective) is not specified in the provided text.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not provided in the document. For blood pressure monitor validation, ground truth is typically established by trained observers (healthcare professionals) using a reference method, but the details are absent.
4. Adjudication Method for the Test Set
The adjudication method is not described in the provided text.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
A multi-reader multi-case (MRMC) comparative effectiveness study was not performed or described. This type of study is more common for diagnostic imaging AI systems to evaluate the impact of AI assistance on human reader performance. This document concerns a standalone blood pressure monitor.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
A standalone performance study was conducted. The device (BP-700NW and BP-700W) is designed to operate as a standalone device, taking measurements and displaying them. The performance tests against standards like ANSI / AAMI SP 10: 2002 and ANSI / AAMI ISO 81060-2:2009 are evaluations of its automated measurement capabilities. No human-in-the-loop component is described for its fundamental operation or accuracy evaluation.
7. Type of Ground Truth Used
The ground truth used for the performance and clinical tests (i.e. those conforming to ANSI / AAMI SP 10: 2002, ANSI / AAMI ISO 81060-2:2009, EN 1060-4:2004) would typically be invasive blood pressure measurements or auscultatory measurements by trained observers using a validated reference method. However, the document does not explicitly state the type of ground truth.
8. Sample Size for the Training Set
The document does not mention a "training set" in the context of machine learning, as this device uses the oscillometric method with microcomputer processing, not explicitly a deep learning or AI model that requires a separate training set. So, this information is not applicable in the traditional sense.
9. How the Ground Truth for the Training Set Was Established
Since there is no "training set" described for a machine learning model, this information is not applicable. The oscillometric method relies on established physiological principles and algorithms, not necessarily on a training set in the AI sense.
§ 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).