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KD-513LU and KD-513LC 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-513LU and KD-513 LC 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.

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 all stored measurement of the same period(example: morning or afternoon) of the last 7 days.

The provided FDA 510(k) summary for the KD-513LU and KD-513LC Fully Automatic Electronic Blood Pressure Monitors focuses on demonstrating substantial equivalence to predicate devices rather than providing a detailed study report with specific acceptance criteria and performance data for the new device itself.

Therefore, many of the requested details about acceptance criteria, study specifics, sample sizes, ground truth establishment, and MRMC studies are not available in the provided document. The 510(k) essentially argues that because the new device is technologically similar to previously cleared devices and meets relevant standards, it is safe and effective.

Here's an analysis based on the available information:

1. Table of Acceptance Criteria and Reported Device Performance

This specific table, detailing explicit numeric acceptance criteria and the new device's performance against them, is not provided in the given text.

The document states that the new devices conform to standards, which implicitly means they meet the performance requirements of those standards. The relevant standard mentioned for performance is:

• AAMI SP10:2002, Manual, electronic or automated sphygmomanometers.
• AAMI / ANSI SP10:2002/A1:2003 --, Amendment 1 to ANSI/AAMI SP10:2002 Manual, electronic, or automated sphygmomanometers.
• AAMI / ANSI SP10:2002/A2:2006 --, Amendment 2 to ANSI/AAMI SP10:2002 Manual, electronic, or automated sphygmomanometers.

These standards define the accuracy requirements for blood pressure monitors. For AAMI SP10, typical acceptance criteria for accuracy are:

• Mean difference: ≤ ±5 mmHg
• Standard deviation: ≤ 8 mmHg

However, the specific "reported device performance" (e.g., actual mean difference and standard deviation achieved by KD-513LU/LC in a clinical trial) against these criteria is not explicitly stated in this 510(k) summary. The document only states "appropriate test have been conducted and conform that the new devices are the same safe and effective as the predicate devices."

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

Not explicitly stated for the KD-513LU and KD-513LC.

For blood pressure monitors seeking ISO 81060-2 or AAMI SP10 compliance, a clinical validation study typically involves a minimum of 85 participants (both genders, various age groups, and blood pressure levels). The document only generally states that "appropriate test have been conducted." There is no mention of the country of origin of 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 explicitly stated. For AAMI SP10 compliance, the ground truth (reference blood pressure measurements) is typically established by trained observers (often medical professionals) using a auscultatory method (stethoscope and sphygmomanometer) following a specific protocol, with multiple observers for inter-observer variability assessment.

4. Adjudication method for the test set

Not explicitly stated. For clinical validation according to AAMI SP10, a specific protocol involving multiple observers and averaged readings from a mercury sphygmomanometer against which the device readings are compared is used. This is less about "adjudication" in the sense of expert consensus on a diagnosis, but rather a direct comparison to a validated reference method.

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

Not applicable and not done. This device is a blood pressure monitor, not an AI-powered diagnostic imaging tool. MRMC studies are not relevant for this type of device.

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

Yes, implicitly. Blood pressure monitors are inherently standalone devices in their primary function of measuring blood pressure. The performance testing (conformance to AAMI SP10) assesses the algorithm's ability to accurately measure blood pressure without human interpretation of the measurement itself (though a human activates the device).

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

Implicitly, reference measurements from a validated standard method (typically auscultatory measurements using a mercury sphygmomanometer) obtained by trained observers. This is the standard for blood pressure device validation.

8. The sample size for the training set

Not applicable/Not stated. This device is not described as using machine learning that would require a separate "training set." Its operational principle is based on oscillometric and silicon integrated pressure sensor technology, which relies on established physiological principles and signal processing, not a "training set" in the AI sense.

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

Not applicable. See point 8.

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