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Fully Automatic Electronic Blood Pressure Monitor are for use by KD-512 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-712 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 wrist. The cuff circumference is limited to 14cm-25cm.

KD-512 Fully Automatic Electronic Blood Pressure Monitor are 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-712 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 wrist. The cuff circumference is limited to 14cm-25cm.

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. It can calculate the systolic and diastolic blood pressure, and display the result on the LCD. If any irregular heartbeat is detected, it can also be shown on the LCD. More over, it also calculates the average of the last three measurements.

The provided text describes a 510(k) summary for fully automatic electronic blood pressure monitors (models KD-512 and KD-712). While it mentions that the devices conform to standards like AAMI SP10, it does not explicitly list specific acceptance criteria or report device performance against those criteria in a table format. It states that the "test in this submission provides demonstration that these small differences do not raise any new questions of safety and effectiveness to the new devices," implying that testing was conducted to fulfill the requirements of the standards.

Therefore, many of the requested details about the study are not directly available in the provided text.

Here's an attempt to answer based on the provided information, highlighting what is and is not present:

Acceptance Criteria and Study Information

The document states that the devices conform to AAMI SP10:2002, Manual, electronic or automated sphygmomanometers, along with its amendments. This standard outlines the performance requirements and testing methods for non-invasive blood pressure monitors. While the specific numerical acceptance criteria from AAMI SP10 are not explicitly listed in the submission, conformance to this standard implies meeting its accuracy and safety requirements.

Table of Acceptance Criteria and Reported Device Performance

2. Sample size used for the test set and the data provenance

• Sample Size for Test Set: Not explicitly stated. Conformance to AAMI SP10 typically requires a certain number of subjects (e.g., 85 subjects for clinical validation).
• Data Provenance: Not explicitly stated (e.g., country of origin, retrospective or prospective).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

• Number of Experts: Not explicitly stated. AAMI SP10 clinical validation protocols typically involve trained observers taking reference measurements.
• Qualifications of Experts: Not explicitly stated. AAMI SP10 protocols usually require the observers to be trained and certified in auscultatory blood pressure measurement.

4. Adjudication method for the test set

• Adjudication Method: Not explicitly stated. AAMI SP10 typically involves simultaneous readings by trained observers using a reference sphygmomanometer, the results of which are compared to the device under test.

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

• MRMC Study: Not applicable. This device is a blood pressure monitor, not an AI-assisted diagnostic tool for human readers.

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

• Standalone Performance: Yes, implicitly. The device is a fully automatic electronic blood pressure monitor, meaning its primary function is to provide a measurement result independently. The testing conducted to conform to AAMI SP10 would evaluate its standalone accuracy.

7. The type of ground truth used

• Type of Ground Truth: Based on conformance to AAMI SP10, the ground truth would typically be auscultatory blood pressure measurements taken by trained observers using a standardized reference sphygmomanometer.

8. The sample size for the training set

• Sample Size for Training Set: Not applicable/Not mentioned. This device is not described as being based on a machine learning algorithm that requires a separate "training set" in the conventional sense. Its operational principle is described as "oscillometric and silicon integrate pressure sensor technology."

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

• Ground Truth for Training Set: Not applicable, as no training set for a machine learning model is suggested by the provided information.

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