(104 days)
The YA HORNG Digital Upper Arm Blood Pressure Monitor BP-700, BP-700T, BP-700U, BP-700B, BP-700TB, BP-700UB, BP-700TUB 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 upper arm. The cuff circumference is limited to be 9.0" ~ 13.0" for Arm type.
YA HORNG Digital Upper Arm Blood Pressure Monitor BP-700. BP-700T, BP-700U, BP-700B, BP-700TB, BP-700UB, and BP-700TUB 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.
The provided document describes the 510(k) summary for the YA HORNG Digital Upper Arm Blood Pressure Monitor (models BP-700 series). It primarily focuses on demonstrating substantial equivalence to a predicate device rather than providing a detailed study report with specific acceptance criteria and performance data for the device itself.
Based on the available information, here's an attempt to answer your questions, highlighting what is present and what is not:
Acceptance Criteria and Study for YA HORNG Digital Upper Arm Blood Pressure Monitor (BP-700 series)
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly present a table of specific numerical acceptance criteria (e.g., mean difference, standard deviation thresholds for blood pressure accuracy) or quantitative performance data from a clinical accuracy study for the BP-700 series.
Instead, it refers to overall compliance with standards:
- General Safety: EN 60601-1:1990+A1+A2+A11+A12+A13 – Reported as "PASS".
- EMC Conformity: EN 60601-1-2: 1993 – Reported as "PASS".
- FCC Conformity: ANSI C63.4: 2003 – Reported as "PASS".
- Blood Pressure Measurement Standard: EN 1060-1:1995, EN 1060-3:1997 – Reported as "PASS".
- Performance & Clinical Test Standard: AAMI / ANSI SP10 – The document states that the company "believes this information and referred document to be sufficient for the FDA to find our proposed device substantially equivalent." This implies that the device was tested against AAMI/ANSI SP10, and it passed, thereby meeting the clinical accuracy requirements outlined in that standard, but no specific numerical results are provided.
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 (i.e., the number of subjects). It also does not explicitly state the country of origin of the data or whether it was retrospective or prospective. Given that the company is based in Taiwan, it is plausible that the testing occurred there, but this is not confirmed.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
The document does not provide details on the number or qualifications of experts used to establish ground truth. For blood pressure monitors tested against AAMI/ANSI SP10, ground truth (reference blood pressure measurements) is typically established by trained and certified observers using auscultation with a mercury sphygmomanometer or validated reference device.
4. Adjudication Method for the Test Set
The document does not describe any specific adjudication method. In clinical studies for blood pressure monitors, if multiple observers are used for reference measurements, their readings are usually averaged or handled according to the specific protocol of the AAMI/ANSI SP10 standard.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
Not applicable. This device is an automated blood pressure monitor, not an AI-assisted diagnostic imaging device requiring human reader interpretation improvements.
6. Standalone (Algorithm Only) Performance Study
Yes, a standalone performance study was implicitly done. The "PERFORMANCE & CLINICAL TEST AAMI / ANSI SP10" indicates that the device's accuracy in measuring blood pressure was evaluated independently against reference measurements, without human intervention in the device's measurement process. The device operates as an "algorithm only" in generating the blood pressure readings.
7. Type of Ground Truth Used
The ground truth used for blood pressure monitors compliant with AAMI/ANSI SP10 would be reference blood pressure measurements obtained through a validated method, typically auscultation by trained observers using a mercury sphygmomanometer or an equivalent validated reference device.
8. Sample Size for the Training Set
Not applicable. This is an automated measurement device and the document does not suggest the use of a machine learning model that requires a separate "training set" in the conventional sense (e.g., for image classification). The device uses the Oscillometric method, which relies on a pre-programmed algorithm based on physical principles, not on a machine learning model trained on a large dataset.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no "training set" in the machine learning context for this device. The oscillometric algorithm is developed based on physiological principles and validated against known reference measurements.
§ 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).