(147 days)
KD-591 Fully Automatic Electronic Blood Pressure Monitor is for use by medical professionals or at home and is a 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-591 Fully Automatic Electronic Blood Pressure Monitor is Non-invasive blood pressure measurement system for only one person each time. Based on oscillometric and silicon integrate pressure sensor technology, the devices are used to monitor systolic, diastolic blood pressure and pulse rate which will be shown on a LCD with an electronic interface module. Buckling a cuff around the left upper arm automatically inflated and released by an internal pump, the device can analyze the signals promptly and display the results and remember circularly for some sets of data. It can storage and show 60 times measuring result with the day and time. Besides, the devices have the function of blood pressure level classification. And the cuff size is limited to 22-48cm.
The provided text describes a 510(k) submission for the KD-591 Fully Automatic Electronic Blood Pressure Monitor. Here's a breakdown of the acceptance criteria and the study proving the device meets them:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria (Standard) | Reported Device Performance |
|---|---|
| ANSI/AAMI SP10-2002 Accuracy Requirements | The results meet or exceed the accuracy requirements of ANSI/AAMI SP10-2002. |
2. Sample Size Used for the Test Set and Data Provenance:
- Test Set Sample Size: Not explicitly stated. The document only mentions "Clinical tests were performed."
- Data Provenance: Not explicitly stated. Given that the submitting company is based in Tianjin, P.R. China, and no other location is mentioned, it's most likely that the clinical tests were conducted in China. The nature (retrospective/prospective) is not specified.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts:
- Number of Experts: Not specified.
- Qualifications of Experts: Not specified. For blood pressure monitor validation, this typically involves trained observers (e.g., medical professionals) using a reference method (e.g., auscultation with a manometer) simultaneously with the device being tested.
4. Adjudication Method for the Test Set:
- Not specified. In blood pressure measurement validation studies, this often involves multiple observers taking readings and comparing them to the device, with specific protocols for handling discrepancies.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance:
- No MRMC study was done. This is a standalone device validation against a standard, not an AI-assisted human-in-the-loop system.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Yes, a standalone study was done. The clinical tests evaluated the KD-591 Fully Automatic Electronic Blood Pressure Monitor as a standalone device to measure blood pressure and pulse rate, comparing its readings to a reference standard (implicit in the ANSI/AAMI SP10-2002 compliance).
7. The Type of Ground Truth Used:
- The ground truth for the clinical tests was established by comparison to a reference method compliant with the ANSI/AAMI SP10-2002 standard. This standard specifies requirements for accuracy and clinical validation, usually involving simultaneous measurements against a calibrated reference sphygmomanometer by trained observers.
8. The Sample Size for the Training Set:
- Not applicable/Not specified. This device is a traditional oscillometric blood pressure monitor, not an AI/machine learning algorithm that requires a "training set" in the conventional sense. Its underlying algorithm is based on established oscillometric principles.
9. How the Ground Truth for the Training Set Was Established:
- Not applicable/Not specified. As mentioned above, there isn't a "training set" in the context of an AI algorithm. The device's foundational principles and calibration are based on established engineering and medical standards.
§ 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).