(282 days)
KD-927 and KD-928 Fully Automatic Electronic Blood Pressure Monitor are for use by medical professionals or at home and are non-invasive blood pressure measurement system intended to measure the diastolic and systolic blood pressures and pulse rate of an adult individual by using a non-invasive technique in which an inflatable cuff is wrapped around the upper arm. The cuff circumference is limited to 22cm-48cm.
KD-927 and KD-928 Fully Automatic Electronic Blood Pressure Monitor are designed and manufactured according to IEC80601-2-30--manual, electronic or automated sphygmanometers.
The operational principle is based on oscillometric and silicon integrates pressure sensor technology. It can calculate the systolic and diastolic blood pressure, the measurements results can also be classified by the function of blood pressure classification indicator. If any irregular heartbeat is detected, it can be shown to the user. More over, it also obtains the function of averaging the measurement results. Achieves its function by an LCD or cell phone.
Here's a breakdown of the acceptance criteria and study information for the Andon Health Co., Ltd. Fully Automatic Electronic Blood Pressure Monitors Models KD-927 and KD-928, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state acceptance criteria in a formal table with specific numerical targets. However, it implicitly refers to adherence to the standards listed. The "Performance Summary" section indicates that the device conforms to these standards, implying that meeting the requirements of these standards serves as the acceptance criteria.
| Acceptance Criteria (Implied by Standards) | Reported Device Performance |
|---|---|
| IEC 60601-1:2005/EN 60601-1:2006/AC:2010 | |
| (Medical electrical equipment -- Part 1: General requirements for basic safety and essential performance) | Device conforms to this standard. |
| IEC60601-1-2:2007/EN 60601-1-2:2007 /AC:2010 | |
| (Medical electrical equipment -- Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility -Requirements and tests) | Device conforms to this standard. |
| IEC 80601-2-30:2009+Cor.2010/EN 80601-2-30:2010 | |
| (Medical electrical equipment -Part 2-30: Particular requirements for the basic safety and essential performance of automated non-invasive sphygmomanometers) | Device conforms to this standard. |
| No new questions of safety and effectiveness demonstrated by non-clinical tests | "None of the test demonstrates that KD-927 and KD-928 Fully Automatic Electronic Blood Pressure Monitor bring new questions of safety and effectiveness." |
2. Sample Size Used for the Test Set and Data Provenance
The document mentions "non-clinical and clinical tests" but does not provide specific details on the sample size used for any clinical test set or the data provenance (e.g., country of origin, retrospective/prospective). The focus of the provided text is on demonstrating substantial equivalence to a predicate device through conformity to international standards and non-clinical testing.
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 a blood pressure monitor, the "ground truth" for its accuracy is typically established by comparing its readings against a validated reference measurement (e.g., auscultatory method by trained observers). The document does not describe the methodology of such a comparison or the experts involved.
4. Adjudication Method for the Test Set
This information is not provided in the document.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done, If So, What Was the Effect Size of How Much Human Readers Improve With AI vs Without AI Assistance
This section is not applicable. The device is an automatic blood pressure monitor, not an AI-assisted diagnostic tool that involves human readers interpreting cases.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done
Yes, the device is a standalone automatic blood pressure monitor. Its performance is evaluated on its ability to accurately measure blood pressure without human interpretation of its outputs; the device itself provides the final measurement.
7. The Type of Ground Truth Used
The document does not explicitly state the type of ground truth used for any clinical validation study. However, for blood pressure monitors complying with IEC 80601-2-30, the "ground truth" for accuracy is typically established by comparing the device's measurements against reference measurements obtained by trained observers using a mercury sphygmomanometer (auscultatory method) or other validated reference methods. This would fall under an expert consensus/reference measurement type of ground truth.
8. The Sample Size for the Training Set
This information is not provided in the document. As a non-AI automatic blood pressure monitor, the concept of a "training set" in the context of machine learning isn't directly applicable for its primary function. Its underlying algorithm is based on oscillometric principles, not typically "trained" in the dataset sense for AI.
9. How the Ground Truth for the Training Set Was Established
This information is not provided and is largely not applicable due to the nature of the device (non-AI, oscillometric blood pressure monitor).
§ 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).