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KD-5965 series 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-5965 series 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.

For KD-5965, 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 60 times. If any irregular heartbeat is detected, it can be shown on the LCD. The LCD backlight, the touch key button and the voice function make it more convenient to use. The RCC (radio controlled clock) function can automatically receive the radio clock signal to adjust the clock accurately.

Here's an analysis of the provided text regarding the acceptance criteria and study for the KD-5965 series Fully Automatic Electronic Blood Pressure Monitor:

Disclaimer: The provided summary does not contain a detailed performance study with specific acceptance criteria and results. It primarily focuses on the device's adherence to relevant standards and its substantial equivalence to predicate devices. Therefore, much of the requested information cannot be extracted directly from the given text.

Acceptance Criteria and Reported Device Performance

The provided 510(k) summary states that the KD-5965 series will conform to several standards. These standards implicitly contain the acceptance criteria for a blood pressure monitor. However, the document does not explicitly state the acceptance criteria in a table format with corresponding device performance results. Instead, it only lists the standards to which the device is intended to conform.

Study Information (Based on Available Text)

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

   • The document states: "However, appropriate test will be conducted and specified acceptance criteria will be met before KD-5965 is marketed." This indicates that testing will be done, but the details of the test set sample size or data provenance (e.g., country of origin, retrospective/prospective) are not provided in this 510(k) summary.

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

   • Not mentioned in the provided text. The document refers to conformance with AAMI SP10, which typically involves clinical validation against auscultatory measurements performed by trained observers. However, the details of such a study, including the number and qualifications of experts, are not present here.

3. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

   • Not mentioned in the provided text.

4. 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:

   • No. This device is a fully automatic electronic blood pressure monitor, not an AI-assisted diagnostic tool for human readers. Therefore, an MRMC study is not applicable.

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

   • Yes, implicitly. The device is described as "Fully Automatic Electronic Blood Pressure Monitor," indicating its standalone measurement capability. The "Performance Summary" section refers to conformance with AAMI SP10, which requires validation of the device's accuracy against a reference standard. This would constitute a standalone performance evaluation. However, the details of this standalone study (e.g., specific accuracy metrics, cohort demographics, methodology) are not included in this summary.

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

   • Based on conformance with AAMI SP10, the ground truth for blood pressure measurement devices is typically established through simultaneous auscultatory measurements (manual blood pressure readings using a stethoscope and sphygmomanometer) performed by trained observers.

7. The sample size for the training set:

   • Not applicable/not mentioned. This device does not appear to involve machine learning in a way that requires a distinct "training set" in the common AI sense. Its operational principle is based on "oscillometric and silicon integrate pressure sensor technology."

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

   • Not applicable/not mentioned. (See point 7).

Summary of Limitations:

The provided 510(k) summary is high-level and, as is common for these types of documents, it focuses on demonstrating substantial equivalence to predicate devices and conformance to recognized standards. It does not contain the detailed results of the performance testing that would explicitly list acceptance criteria and a comprehensive report of the device's performance against those criteria. The statement "appropriate test will be conducted and specified acceptance criteria will be met before KD-5965 is marketed" implies that such detailed testing and reporting would occur internally as part of the manufacturer's quality system procedures, but the specific details are not part of this public K-summary.

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