(176 days)
KD-391 Semi 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-391 Semi 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 device is 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, 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 which is according to WHO standard.
Here's a breakdown of the acceptance criteria and the study information for the KD-391 Semi Automatic Electronic Blood Pressure Monitor, based on the provided text:
Acceptance Criteria and Device Performance
| Acceptance Criteria (Standard) | Reported Device Performance |
|---|---|
| ANSI/AAMI SP-10-2002 Accuracy Requirements | The clinical tests were performed, and the results "meet or exceed the accuracy requirements of ANSI/AAMI SP10-2002." |
Study Information
2. Sample size used for the test set and the data provenance:
- Test Set Sample Size: Not explicitly stated in the provided text. The document only mentions that "Clinical tests were performed and complied the accuracy requirements of ANSI/AAMISP10-2002." This standard defines the required number of participants for clinical validation, but the exact number used in this specific study is not provided.
- Data Provenance: Not explicitly stated. The document doesn't specify the country of origin for the data or whether it was retrospective or prospective.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not stated. The document references compliance with ANSI/AAMI SP-10-2002, which typically involves expert comparison measurements (e.g., from a trained observer using a mercury sphygmomanometer), but the number and qualifications of these experts are not detailed in this submission.
4. Adjudication method for the test set:
- Not stated. The ANSI/AAMI SP-10-2002 standard sets forth methods for comparing automated blood pressure devices to a reference method, which inherently involves some form of comparison and "agreement" between an automated reading and an expert's reading, but specific adjudication processes (like 2+1 or 3+1) are not mentioned.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done:
- No, a multi-reader multi-case comparative effectiveness study was not conducted or described. This type of study is typically for image-based diagnostic aids or decision support systems. Blood pressure monitors are standalone measurement devices and do not involve human readers interpreting output in the same way.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Yes, the performance described is a standalone (algorithm only) performance. The device itself measures and displays blood pressure and pulse rate. The clinical tests evaluate the accuracy of the device's measurements against a reference standard, not its performance in assisting a human.
7. The type of ground truth used:
- The ground truth would be established through a reference standard method as defined by ANSI/AAMI SP-10-2002, typically involving:
- Expert auscultation: Simultaneous measurements by trained observers using a mercury sphygmomanometer (or an equivalent validated reference device) as the gold standard.
8. The sample size for the training set:
- Not applicable/Not stated. Blood pressure monitors that use oscillometric principles are generally developed and calibrated using engineering principles and laboratory testing, rather than a "training set" in the machine learning sense. The clinical validation (test set) is performed to verify the accuracy of the final, developed device.
9. How the ground truth for the training set was established:
- Not applicable. See point 8. The "ground truth" during development would be associated with engineering validation and calibration processes, ensuring the device accurately converts oscillations into blood pressure values.
§ 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).