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KD-5961 Fully Automatic Electronic Blood Pressure Monitor is intended for use by medical professionals or at home to monitor and display diastolic, systolic blood pressure and pulse rate of adult each time, with the cuff around the left upper arm according to the instruction in the user's guide manual, which is same as predicated device.

KD-5961 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-5961 Fully Automatic Electronic Blood Pressure Monitor is Non-invasive blood pressure measurement system for only one person each time. Based on oscillometric and silicon integrate pressure sensor technology, the device is used to monitor systolic, diastolic blood pressure and pulse rate which will be shown on a LCD with an electronic interface module. Buckling a cuff around the left upper arm, which cuff circumference is limited to 22cm-48cm, the device can analyze the signals promptly and display the test results. It has some other functions, such as LCD backlighting, touch button, 120 memory recall / 2 users and calculating average of last 3 readings.

This document is a 510(k) premarket notification for the KD-5961 Fully Automatic Electronic Blood Pressure Monitor. It aims to demonstrate substantial equivalence to a predicate device (KD-591, K080319). The document focuses on regulatory compliance and does not contain a study designed to prove the device meets specific acceptance criteria in the way a clinical trial for a new therapeutic or diagnostic might.

Here's a breakdown based on your request, highlighting what is and isn't present in this specific regulatory filing:

1. Table of acceptance criteria and the reported device performance:

The document implicitly refers to acceptance criteria by stating that the device "meets the following standards" and by claiming "Performance: Identical" to the predicate device. However, it does not provide a table with specific quantitative acceptance criteria or detailed reported device performance in terms of accuracy or clinical metrics.

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

The document does not specify a sample size for a test set or data provenance in terms of country of origin or whether it was retrospective/prospective. The approval is based on demonstrating substantial equivalence to a predicate device, primarily through technological comparison and adherence to recognized standards, rather than a new clinical performance study with a distinct test set. The ANSI/AAMI SP-10 standard itself outlines performance requirements and testing methodologies for blood pressure monitors, which would include testing on a specified number of subjects, but these details are not provided in this 510(k) summary.

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

This information is not provided in the document. The approval is based on compliance with established standards, not on expert-adjudicated ground truth from a clinical study within this 510(k) submission. For the ANSI/AAMI SP-10 standard validation, it typically involves comparison to a reference standard obtained by trained observers (often physicians or technicians) using auscultation.

4. Adjudication method for the test set:

Not applicable based on the information provided. There is no explicit adjudication method described for a test set in this 510(k) summary related to establishing ground truth.

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. This device is a Fully Automatic Electronic Blood Pressure Monitor, not an AI-assisted diagnostic tool involving human readers or interpretation of medical images. Hence, an MRMC study is not relevant to this submission.

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

The device is described as "Fully Automatic Electronic Blood Pressure Monitor" and measures blood pressure using oscillometric technology, displaying results on an LCD. This inherently represents standalone algorithmic performance for blood pressure measurement, as it doesn't require human interpretation of complex data for the reading itself. The performance is expected to meet the accuracy requirements of the ANSI/AAMI SP-10 standard in its automated function.

7. The type of ground truth used:

While not explicitly stated in this document for the KD-5961 itself, the ground truth for validating blood pressure monitors against standards like ANSI/AAMI SP-10 typically involves simultaneous or near-simultaneous measurements using a reference standard method, most commonly auscultation performed by trained observers with a mercury sphygmomanometer.

8. The sample size for the training set:

Not applicable and not provided. This device is based on a well-established oscillometric measurement principle and is not an AI/machine learning model that requires a distinct "training set" in the conventional sense for learning patterns. Its "training" is in its design and calibration to meet the physiological measurement principles and accuracy standards.

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

Not applicable. As noted above, the device doesn't use a "training set" in the machine learning context. The underlying principles and validation methods for blood pressure measurement, which would include comparison to reference standards like auscultation, are well-established within the ANSI/AAMI SP-10 standard.

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