(21 days)
KD-575 Memory Automatic Electronic Blood Pressure Monitor is intended for use by medical professionals or at home to monitor and display diastolic, systolic blood pressure and pulse rate on anyone each time, except infants and unconscious people, with the air cuff around the left upper arm according to the instruction in the user's guide manual.
The YA HORNG Automatic Digital Wrist Blood Pressure Monitor, Model AK-3000T, 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".
KD-575 Fully Automatic Electronic Blood Pressure Monitor is a Non-invasive blood pressure measurement system for only one person each time. Based on oscillometric and silicon integrate pressure sensor technology, this devise is used to monitor systolic, diastolic blood pressure and pulse rate which will be shown on a LCD with an electronic interface module. Swathing the air cuff around the left upper arm 1-2cm above elbow joint automatically inflated and released by an internal pump, the device can analyze the signals promptly and display the results. It can storage and show 120 times measuring result with the month, day, time of measuring.
This document (K042581) is a 510(k) summary for two different blood pressure monitors, only one of which is addressed in the study. The information below pertains to the KD-575 Memory Automatic Electronic Blood Pressure Monitor from Kodon (Tianjin) Electronic & Electrical Apparatus Co., LTD. The second device from Ya Horng Electronic Co., Ltd. (AK-3000T) has its own separate information in the document beyond the scope of a unified description.
Acceptance Criteria and Study for KD-575 Memory Automatic Electronic Blood Pressure Monitor
The acceptance criteria for the KD-575 device are based on the accuracy requirements of the ANSI/AAMI SP10-1992 standard. The study performed directly assesses the device's adherence to these requirements.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (ANSI/AAMI SP10-1992) | Reported Device Performance |
|---|---|
| Accuracy requirements of ANSI/AAMI SP10-1992 | "The results meet or exceed the accuracy requirements of ANSI/AAMI SP10-1992." |
Note: The 510(k) summary does not provide specific numerical values for accuracy (e.g., mean difference and standard deviation) from the study. It only states a qualitative conformance to the standard.
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 tests.
- Data Provenance: The document does not specify the country of origin of the data or whether the study was retrospective or prospective. It only states "Clinical tests were performed."
3. Number of Experts Used to Establish Ground Truth and Qualifications
This information is not provided in the 510(k) summary. For blood pressure monitors, ground truth is typically established by trained clinical personnel (e.g., physicians, nurses, or technicians) using auscultatory methods with a mercury sphygmomanometer or validated oscillometric devices as a reference, following a standardized protocol like the ANSI/AAMI SP10.
4. Adjudication Method for the Test Set
This information is not provided in the 510(k) summary. Given the nature of blood pressure measurement studies where reference measurements are taken by clinical personnel, formal adjudication for ground truth (as might be seen in imaging studies) is less common, but specific protocols for obtaining and reconciling reference readings would be part of the study design.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not mentioned or indicated.
- The study focuses on the standalone accuracy of the device against a standard, not on comparing human reader performance with and without AI assistance.
6. Standalone Performance Study
- Yes, a standalone study was presented. The "Clinical Tests" section directly reports on the device's performance, stating it "complied with the accuracy requirements of ANSI/AAMI SP10-1992" and that "The results meet or exceed the accuracy requirements of ANSI/AAMI SP10-1992." This indicates an assessment of the algorithm's performance without a human in the loop for measurement interpretation, only for operation.
7. Type of Ground Truth Used
The ground truth used for blood pressure monitor accuracy studies, such as those conforming to ANSI/AAMI SP10, is typically established through simultaneous or near-simultaneous measurements by trained observers using a validated reference method (e.g., auscultatory method with a mercury sphygmomanometer). While not explicitly stated as "expert consensus," the standard implicitly relies on trained human observers as the gold standard for comparison.
8. Sample Size for the Training Set
This information is not applicable and therefore not provided. This device is a traditional electronic blood pressure monitor based on oscillometric principles, not an AI/machine learning device that would typically have a separate "training set" in the computational sense. Its design and calibration are based on established physiological principles and engineering.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable as there is no mention of a training set for an AI/ML algorithm.
§ 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).