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KD-5971 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-7971 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 wrist. The cuff circumference is limited to 14cm-25cm.

KD-5971 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-7971 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 wrist. The cuff circumference is limited to 14cm-25cm.

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 of KD-5971 and KD-7971 are both 2*30 times. If any irregular heartbeat is detected, it can be shown on the LCD, KD-5971 and KD-7971 also have the voice function.

The provided text describes a submission for a 510(k) premarket notification for fully automatic electronic blood pressure monitors (KD-5971 and KD-7971). It outlines the device information, classification, comparison to predicate devices, and a performance summary. However, it does not include detailed acceptance criteria or a specific study proving the device meets acceptance criteria in the manner requested (e.g., in terms of accuracy metrics like sensitivity, specificity, or comparison to a gold standard with statistical analysis).

Instead, the document states that the devices conform to certain recognized standards for medical electrical equipment and sphygmomanometers (AAMI SP10). The primary claim of the submission is substantial equivalence to predicate devices (KD-5915 and KD-7962). The "Performance summary" section only lists the standards to which the devices conform, implying that meeting these standards is sufficient for demonstrating performance.

Based on the provided text, here's what can be extracted and what information is missing:

1. Acceptance Criteria and Reported Device Performance

The document does not explicitly state acceptance criteria in terms of specific performance metrics (e.g., accuracy ranges for blood pressure measurements compared to a reference method) or report specific device performance data against such metrics. Instead, it states conformity to recognized standards.

Implicit Acceptance Criteria (based on standards adherence):

Note: The AAMI SP10 standard itself specifies accuracy requirements for blood pressure devices (e.g., mean difference and standard deviation between the device and a reference measurement). However, the specific values obtained for these parameters for the KD-5971 and KD-7971 devices are not reported in this 510(k) summary.

2. Sample Size for Test Set and Data Provenance

The document does not report any specific sample size for a test set used in a performance study or the data provenance (e.g., country of origin, retrospective/prospective). Instead, it relies on conformity to standards.

3. Number of Experts and Qualifications for Ground Truth

The document does not specify the number of experts or their qualifications used to establish ground truth for a test set. This type of information would typically be found in a detailed study report comparing the device to a reference standard with expert-validated measurements.

4. Adjudication Method for Test Set

The document does not describe any adjudication method like 2+1 or 3+1. This is not applicable as no specific test set requiring expert adjudication is discussed.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

There is no mention of a Multi-Reader Multi-Case (MRMC) comparative effectiveness study, nor any effect size regarding human reader improvement with or without AI assistance. This device is a standalone blood pressure monitor, not an AI-assisted diagnostic tool for human readers.

6. Standalone Performance Study

The document does not explicitly describe a standalone performance study in terms of reporting specific accuracy metrics. It states conformity to AAMI SP10, which implies that such a study (comparing the device to a reference standard like mercury sphygmomanometry) was likely performed to demonstrate compliance. However, the results of such a study are not presented in this summary.

7. Type of Ground Truth Used

The document does not explicitly state the type of ground truth used. For blood pressure monitors conforming to AAMI SP10, the ground truth is typically established by simultaneous or sequential auscultatory measurements performed by trained observers using a reference standard (e.g., mercury sphygmomanometer) in a clinical environment.

8. Sample Size for Training Set

The device is a traditional electronic blood pressure monitor based on oscillometric technology and does not appear to utilize machine learning or AI that would require a "training set" in the computational sense. Therefore, the concept of a training set sample size is not applicable to this device as described.

9. How Ground Truth for Training Set Was Established

As there is no mention of a training set for machine learning/AI, the method for establishing its ground truth is not applicable.

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