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KD-557 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-557 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. 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, the memory capability is 2×60 times. If any irregular heartbeat is detected, it can be shown on the LCD. It also has the function of averaging the last three measurements.

The provided text describes a 510(k) premarket notification for the KD-557 Fully Automatic Electronic Blood Pressure Monitor. However, it does not explicitly detail a study conducted to demonstrate the device's performance against specific acceptance criteria in the way typically expected for an AI/ML medical device. Instead, the submission focuses on demonstrating substantial equivalence to a predicate device (KD-556).

The key approach described is conformity to established medical device standards for non-invasive blood pressure monitors.

Here's a breakdown based on the information provided, with an emphasis on what is not present given the context of an AI/ML device performance study:

1. Table of Acceptance Criteria and Reported Device Performance

The submission does not provide a table with explicit acceptance criteria for a new performance study of the KD-557, nor does it present "reported device performance" in terms of clinical metrics (e.g., sensitivity, specificity, accuracy against a gold standard) typically found in AI/ML device studies. Instead, it states conformity to standards relevant for blood pressure monitors.

2. Sample Size Used for the Test Set and Data Provenance

The document does not describe a new clinical test set with a specific sample size, data provenance (country, retrospective/prospective), or patient characteristics for the KD-557. The "performance summary" indicates adherence to standards, implying testing was done to meet those standards, but the details of such testing (e.g., number of subjects, demographic breakdown) are not provided in this 510(k) summary.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

Since a specific clinical test set and ground truth adjudication process for the KD-557's performance are not detailed, information on the number and qualifications of experts for ground truth establishment is not provided. For blood pressure devices conforming to AAMI SP10, ground truth is typically established by trained observers using auscultatory methods against a reference standard or by invasive arterial pressure measurements.

4. Adjudication Method for the Test Set

No adjudication method for a test set is described, as the summary focuses on standards conformity and substantial equivalence rather than a new clinical study with expert consensus for ground truth.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No MRMC study is mentioned. This type of study is more common for diagnostic imaging AI algorithms where human readers interpret cases with or without AI assistance. This device is an automated blood pressure monitor.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

Yes, in a sense. The KD-557 is a "Fully Automatic Electronic Blood Pressure Monitor," implying its operation and measurement output are standalone ("algorithm only" in a broader sense of an automated device). The performance is assessed by comparing its automated readings against reference methods as specified by standards like AAMI SP10, without direct human intervention in the measurement process itself beyond placing the cuff and initiating the measurement.

7. The Type of Ground Truth Used

For blood pressure monitors conforming to AAMI SP10, the ground truth for accuracy testing is typically established by:

• Simultaneous auscultatory measurements by trained observers using a mercury sphygmomanometer or validated aneroid device.
• Invasive intra-arterial blood pressure measurements, which are considered the gold standard for accuracy.

The specific "ground truth" method used for demonstrating the KD-557's conformity to AAMI SP10 is not explicitly detailed in this summary but would align with these established methods for blood pressure device validation.

8. The Sample Size for the Training Set

No training set is mentioned for the KD-557. This product is a device based on oscillometric technology and pressure sensors, not an AI/ML algorithm that requires a training set in the conventional sense. The "training" for such a device largely involves engineering calibration and validation against physical standards and clinical data to meet the performance specifications of the AAMI SP10 standard.

9. How the Ground Truth for the Training Set Was Established

As no training set (for an AI/ML algorithm) is applicable here, this information is not provided.

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