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KD-556J 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-556J 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 integrates 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.

Here's an analysis of the provided text regarding the acceptance criteria and supporting study for the KD-556J Fully Automatic Electronic Blood Pressure Monitor:

1. Table of Acceptance Criteria and Reported Device Performance:

The provided document does not explicitly state acceptance criteria in terms of specific performance metrics (e.g., accuracy ranges for blood pressure measurements) for the KD-556J. Instead, it relies on the device's conformance to established industry standards like ANSI/AAMI SP10 for safety and performance. The primary "performance" reported is its substantial equivalence to a predicate device.

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

• Sample Size for Test Set: The document states, "The clinical test report of KD-556(K091500) is applicable to our subject device." This implies that no new clinical test was performed for the KD-556J. The sample size for the original KD-556 (K091500) clinical test is not provided in this document.
• Data Provenance: The provenance of the data for KD-556 is not specified in this document (e.g., country of origin). Since it's referencing a prior 510(k) submission, that information would likely be found in the K091500 documentation. It's also not specified whether the original clinical study for KD-556 was retrospective or prospective.

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

• Number of Experts: Not specified. As no new clinical study was performed for KD-556J, and the document refers to the predicate device's clinical report, details about experts for the ground truth of the original study are not present here.
• Qualifications of Experts: Not specified Lehmann.

4. Adjudication Method for the Test Set:

• Adjudication Method: Not specified. This information would have been part of the original clinical study for KD-556, which is not detailed here.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size:

• MRMC Study: No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This device is a fully automatic electronic blood pressure monitor, not an AI-assisted diagnostic imaging tool where MRMC studies are typically employed to assess human reader improvement.
• Effect Size: Not applicable, as no MRMC study was performed.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:

• Standalone Performance: Yes, implicitly. The device itself is a "Fully Automatic Electronic Blood Pressure Monitor" designed to measure and display blood pressure and pulse rate without human intervention beyond placing the cuff and starting the measurement. Its performance is evaluated against the standards (AAMI SP10), which define accuracy requirements for such standalone devices. The non-clinical tests (EMC, electrical safety, SP10 compliance) and the reliance on the predicate's clinical data affirm its standalone nature.

7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.):

• Type of Ground Truth: The document refers to compliance with ANSI/AAMI SP10. This standard specifies the methodologies for determining the accuracy of blood pressure measurement devices. For such devices, the "ground truth" is typically established by simultaneous or near-simultaneous measurements using a reference method (e.g., auscultation by trained observers using a mercury sphygmomanometer), following a specific protocol to minimize bias and observer error. This is a form of expert consensus/reference standard comparison, but the document does not explicitly state the specific method used for the predicate study.

8. The Sample Size for the Training Set:

• Sample Size for Training Set: Not applicable. This device is an electronic blood pressure monitor based on oscillometric technology and silicon integrated pressure sensor technology, not a machine learning or AI-based device that typically requires a "training set" in the context of deep learning or similar algorithms. The term "training set" is generally used for AI/ML model development.

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

• Ground Truth for Training Set: Not applicable, as there is no "training set" in the AI/ML sense for this device.

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