Search Results

KD-5961,KD-5962,KD-5902 Fully Automatic Electronic Blood Pressure Monitor is for use by medical professionals or at home and is a noninvasive 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-5961,KD-5962,KD-5902 Fully Automatic Electronic Blood Pressure Monitor is for use by medical professionals or at home and is a noninvasive 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.

It is designed and manufactured according to ANSI/AAMI SP10--manual, electronic or automated sphygmanometers.

The operational principle is based on oscillometric and silicon integrate pressure sensor technology, the result will be shown on a LCD with an electronic interface module, the result can also be classified and displayed by the function of blood pressure classification indicator, If any irregular heartbeat is detected, it can be shown on the LCD.

Here's a breakdown of the acceptance criteria and the study information based on the provided 510(k) summary:

This device is a Fully Automatic Electronic Blood Pressure Monitor, and the 510(k) summary focuses heavily on its substantial equivalence to previously cleared predicate devices rather than detailing a de novo performance study with specific acceptance criteria and outcome metrics.

1. A table of acceptance criteria and the reported device performance

The document does not explicitly state device-specific acceptance criteria for performance metrics (like accuracy targets for blood pressure readings) in a quantifiable table. Instead, it relies on conformance to recognized standards.

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

The document does not provide details about a specific test set, its sample size, or data provenance for a dedicated clinical performance study. The statement "the test in this submission provides demonstration that these small differences do not raise any new questions of safety and effectiveness" implies that tests were conducted, likely to demonstrate conformance to the AAMI SP10 standard, but the specifics are not included in this summary.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)

This information is not provided in the given 510(k) summary. For blood pressure monitors, ground truth is typically established by trained human observers using a reference method (e.g., auscultation with a mercury sphygmomanometer), but the details of such a process are absent.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set

This information is not provided in the given 510(k) summary.

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

No MRMC comparative effectiveness study was done or reported. This device is a standalone blood pressure monitor, not an AI-powered diagnostic tool requiring human reader involvement.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Yes, a standalone performance evaluation would have been conducted as this is an algorithm-only device in terms of its measurement function. The performance of the blood pressure monitor itself, as per AAMI SP10, is a standalone assessment of its accuracy against a reference measurement. However, the results of this standalone performance test (e.g., mean difference, standard deviation) are not detailed in this 510(k) summary. The summary only states that the device conforms to the AAMI SP10 standard, which implies successful standalone performance.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

While not explicitly stated for this specific submission, the "ground truth" for non-invasive blood pressure monitors conforming to AAMI SP10 is typically established by trained human observers performing auscultatory measurements using a calibrated reference sphygmomanometer (e.g., mercury sphygmomanometer). This is generally considered the "expert consensus" or reference standard for blood pressure.

8. The sample size for the training set

Not applicable/Not provided. This device is a traditional electronic medical device based on oscillometric principles, not a machine learning or AI device that requires a "training set" in the computational sense. Its design and calibration would be based on engineering principles and established physiological models, and its performance validated against clinical standards.

9. How the ground truth for the training set was established

Not applicable/Not provided. As stated above, this is not an AI/ML device that requires a training set.

Ask a specific question about this device