(45 days)
The YA HORNG PC COMPATIBLE WRIST BLOOD PRESSURE MONITOR, Model AK-4000T, is a noninvasive blood pressure measurement system 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".
YA HORNG AK-4000T uses 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 an analysis of the provided text regarding the acceptance criteria and study for the YA HORNG PC COMPATIBLE WRIST BLOOD PRESSURE MONITOR, AK-4000T:
1. Table of Acceptance Criteria and Reported Device Performance
The provided document primarily focuses on establishing substantial equivalence to a predicate device and fulfilling electrical safety and EMC standards. It makes a general statement about clinical performance but does not explicitly lay out detailed numerical acceptance criteria for blood pressure measurement accuracy. However, it does refer to a recognized standard.
| Acceptance Criteria (Standard) | Reported Device Performance |
|---|---|
| Electrical Safety (EN 60601-1:1990+A1+A2+A11+A12+A13) | PASS |
| EMC Conformity (EN 60601-1-2: 1993) | PASS |
| Performance & Clinical Test (AAMI / ANSI SP10) | Implicitly claimed to meet this standard, no specific numerical results presented in the summary. |
| Substantial Equivalence to Predicate Device (AMLUCK AK-3000 / AK-4000) | Claimed: "The technological characteristics of AMLUCK AK-4000T is substantially equivalent to AMLUCK AK-3000 / AK-4000." Adds PC connection, passed EMC/Safety. |
2. Sample Size Used for the Test Set and Data Provenance
The provided text does not explicitly state a sample size for any clinical test set. It only mentions "PERFORMANCE & CLINICAL TEST AAMI / ANSI SP10" without providing details of such a study.
Similarly, the data provenance is not specified. We do not know if the clinical data (if any was collected) was retrospective or prospective, or the country of origin.
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. As no detailed clinical test results are presented, there's no mention of how ground truth (e.g., reference blood pressure measurements) would have been established or by whom.
4. Adjudication Method for the Test Set
This information is not provided. Without details of a clinical test, no adjudication method is mentioned.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not conducted or reported in these documents. This type of study is more relevant for diagnostic imaging or interpretation tasks, not typically for an automated blood pressure monitor.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
The device itself is a standalone device in that it automatically measures blood pressure without direct human intervention in the measurement process. The document describes it as using the "Oscillometric method" where it "utilizes the microcomputer to automatically sense the characteristics of the pulse signal." However, the document does not report on a specific standalone performance study in isolation from the complete device functioning. It refers to the AAMI / ANSI SP10 standard, which would entail performance testing of the device as a whole.
7. The Type of Ground Truth Used
The document refers to the AAMI / ANSI SP10 standard for "PERFORMANCE & CLINICAL TEST." For blood pressure monitors, this standard typically requires simultaneous or near-simultaneous measurements using a recognized reference standard, such as a mercury sphygmomanometer with auscultation, often performed by trained observers. While the document doesn't explicitly state the ground truth used for its testing, adherence to AAMI/ANSI SP10 implies such a reference method would be used.
8. The Sample Size for the Training Set
The provided text mentions an "Oscillometric method" that "utilizes the microcomputer to automatically sense the characteristics of the pulse signal." This implies some internal algorithm or model. However, the document does not provide any information regarding a "training set" sample size for this algorithm, nor does it detail any machine learning components that would necessitate such a set. It's likely that the device's algorithms were developed through traditional signal processing and control rather than contemporary machine learning that requires distinct training sets.
9. How the Ground Truth for the Training Set Was Established
Since no training set is described, information on how its ground truth was established is not provided.
§ 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).