(143 days)
The YA HORNG Digital Upper Arm Blood Pressure Monitor BP-100J, BP-110J and Digital Wrist Blood Pressure Monitor BP-500, BP-510 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 wrist. The cuff circumference is limited to be 5.3" ~ 8.5" for Wrist type and 9.0" ~ 13.0" for Arm type.
YA HORNG Digital Upper Arm Blood Pressure Monitor BP-100J. BP-110J; and Digital Wrist Blood Pressure Monitor BP-500. BP-510 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 510(k) summary for the YA HORNG Digital Upper Arm Blood Pressure Monitor BP-100J, BP-110J and Digital Wrist Blood Pressure Monitor BP-500, BP-510 primarily focuses on demonstrating substantial equivalence to a predicate device and adherence to general safety and EMC standards. It makes a general claim about clinical performance but lacks detailed reporting to fully answer all the questions.
Here's a breakdown of what can be gleaned and what is missing:
1. Table of Acceptance Criteria and Reported Device Performance
The document explicitly states that the device meets AAMI / ANSI SP10 standards for performance and clinical testing. While it doesn't provide a table of precise acceptance criteria values and reported performance metrics for accuracy (e.g., mean difference and standard deviation in mmHg for systolic and diastolic pressure, as typically required by AAMI/ISO 81060-2), it implies that these standards have been met.
| Acceptance Criteria (Implied by AAMI / ANSI SP10 Adherence) | Reported Device Performance |
|---|---|
| Blood Pressure Measurement Accuracy: | |
| Mean difference and standard deviation for systolic BP | Met AAMI / ANSI SP10 |
| Mean difference and standard deviation for diastolic BP | Met AAMI / ANSI SP10 |
| (Specific thresholds for mean difference and standard deviation are not provided in this document, but are defined by AAMI/ANSI SP10.) |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The document does not explicitly state the sample size used for the clinical test (PERFORMANCE & CLINICAL TEST AAMI / ANSI SP10). AAMI SP10 typically requires a minimum of 85 subjects for validation.
- Data Provenance: The document does not specify the country of origin of the data or whether the study was retrospective or prospective. It just mentions "PERFORMANCE & CLINICAL TEST AAMI / ANSI SP10".
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 510(k) summary. For AAMI SP10, ground truth is typically established by trained observers (e.g., physicians or nurses) using a reference sphygmomanometer following a specified auscultatory method. The number and qualifications of these observers are usually detailed in a full clinical study report, which is not available here.
4. Adjudication Method for the Test Set
This information is not provided. For AAMI SP10 validation, typically two or more trained observers measure blood pressure concurrently, and their readings are compared to ensure agreement, establishing a "ground truth" reference measurement. The adjudication method would describe how discrepancies between observers are handled, but this level of detail is absent.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No MRMC comparative effectiveness study is mentioned. This type of study (comparing human readers with and without AI assistance) is not typically performed for a standalone blood pressure monitor like this, which operates without human interpretation of complex medical images or data. The device provides a direct measurement.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Yes, this device is a standalone blood pressure monitor. The clinical performance refers to the device's ability to accurately measure blood pressure independently, without human interaction beyond operating the device. The "PERFORMANCE & CLINICAL TEST AAMI / ANSI SP10" would assess this standalone performance against a clinical reference standard.
7. The Type of Ground Truth Used
Based on the reference to AAMI / ANSI SP10, the ground truth would have been established by expert auscultatory measurements (using a mercury or validated aneroid sphygmomanometer) typically by trained clinical personnel. This is the standard reference method for validating automated blood pressure devices.
8. The Sample Size for the Training Set
This information is not provided. Oscillometric blood pressure monitors rely on algorithms derived from physiological principles and extensive empirical data. There isn't typically a "training set" in the sense of machine learning models for image analysis. Instead, the algorithms are developed and refined using a large dataset of pressure waveforms and corresponding auscultatory reference measurements. The size of this underlying dataset used during the design and development of the oscillometric algorithm is not disclosed here.
9. How the Ground Truth for the Training Set Was Established
As with the test set, the ground truth for any data used in the development or "training" of the oscillometric algorithm would have been established through expert auscultatory measurements synchronized with cuff pressure oscillations.
§ 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).