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KD-5966 series 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-5966 series 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 systelic 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.

For KD-5966, 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 results can also be classified and displayed by the function of blood pressure classification indicator, the memory capability is 2×60 times. If any irregular heartbeat is detected, it can also be stapular the LCD. More over, it also has the function of averaging the last three measurements.

The provided 510(k) summary for the KD-5966 series Fully Automatic Electronic Blood Pressure Monitor does not contain sufficient information to comprehensively answer all aspects of your request regarding acceptance criteria and the study proving device performance in the format you've requested.

Specifically, it states that the device "conforms to the following standards," which implies that meeting these standards constitutes the acceptance criteria. However, it does not explicitly detail the performance metrics or numerical thresholds that comprise these criteria, nor does it provide a detailed study report that proves the device met those criteria.

Here's what can be extracted and what information is missing:

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

The document states that the device "conforms to the following standards" and that "appropriate test will be conducted and specified acceptance criteria will be met before KD-5966 is marketed." This implies the acceptance criteria are defined by these standards. However, the specific numerical performance targets (e.g., mean difference in mmHg, standard deviation) from these standards are not explicitly stated in this document. Thus, a table of "reported device performance" as direct numerical results is not available in the provided text.

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

This information is not provided in the document. The document only mentions that "appropriate test will be conducted."

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. The determination of ground truth for a blood pressure monitor typically involves comparison against a reference method (e.g., auscultation by trained observers), not "experts" in the sense of image interpretation. However, the details of such a comparison are missing.

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

This information is not provided.

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 device is a Fully Automatic Electronic Blood Pressure Monitor, which is a standalone measurement device, not an AI-assisted diagnostic tool for "human readers." Therefore, an MRMC study is not applicable and was not performed.

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

Yes, implicitly. As an "Automatic Electronic Blood Pressure Monitor," the device operates in a standalone mode to measure blood pressure. Its performance would have been evaluated directly against a reference standard to demonstrate its accuracy. However, the details of this standalone performance evaluation, beyond stating conformance to standards, are not provided in this summary.

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

The ground truth for a blood pressure monitor is typically established by comparative measurements using a standardized oscillometric or auscultatory reference method, often involving simultaneous readings by trained observers using a mercury sphygmomanometer or validated automated oscillometric device. The document does not explicitly state the type of ground truth method used, but it would be based on these established clinical measurement practices.

8. The sample size for the training set

This device is an automated blood pressure monitor based on oscillometric principles, not a machine learning or AI algorithm that requires a "training set" in the conventional sense. Therefore, the concept of a training set for this device is not applicable. The device's underlying algorithm is based on physiological principles and validated engineering rather than data-driven learning.

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

As previously stated, the concept of a training set is not applicable for this type of device.

In summary: The 510(k) summary focuses on demonstrating substantial equivalence to predicate devices and adherence to recognized performance and safety standards for blood pressure monitors. It does not provide the detailed study reports or specific numerical performance data against acceptance criteria that would typically be found in a more comprehensive clinical or validation study report. The document relies on the implicitly defined performance criteria within the cited AAMI SP10 standard.

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