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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 17cm-48cm (approx, 6 11/16"- 18 29/32").

Fully Automatic Electronic Blood Pressure Monitor is designed and manufactured according to IEC 80601-2-30. The operational principle is based on oscillometric and silicon integrates pressure sensor technology. It can calculate the systolic and diastolic blood pressure, the measurements results can also be classified. If any irregular heartbeat is detected, it can be shown to the user.

The provided FDA 510(k) summary for the "Fully Automatic Electronic Blood Pressure Monitor" pertains to a Class II medical device, specifically a non-invasive blood pressure measurement system. The acceptance criteria and the study proving the device meets these criteria are outlined, primarily focusing on the device's accuracy in measuring blood pressure and pulse rate.

Here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for blood pressure monitors are typically defined by international standards like ISO 81060-2. While the exact numerical criteria for "Criteria 1" and "Criteria 2" are not explicitly stated in this document (e.g., mean difference and standard deviation), the document states that the device "met criteria 1 and criteria 2 of ISO 81060-2."

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

• Sample Size: 231 patients (107 males and 124 females) were invited for the study.
• Data Provenance: The document does not specify the country of origin for the data. The study appears to be prospective, as patients were "invited for the study" and a "standard auscultation method was used as the reference blood pressure monitor measuring," indicating a controlled clinical trial setting.

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

• Number of Experts: Not specified.
• Qualifications of Experts: The ground truth was established using the "standard auscultation method." This method typically involves trained medical professionals (e.g., doctors, nurses) using a stethoscope and sphygmomanometer. The qualifications of the individuals performing the auscultation are not detailed in this document.

4. Adjudication Method for the Test Set

• The document states that the "standard auscultation method was used as the reference blood pressure monitor measuring, and same sequential method was chosen." This suggests that the reference measurements were obtained sequentially. There is no mention of a multi-reader/adjudication method for resolving discrepancies in ground truth establishment, as the auscultation method itself is the direct reference measurement.

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 document describes the validation of an automated blood pressure monitor, not an AI-assisted diagnostic tool where human readers interact with AI. Therefore, an MRMC study and effect size of human reader improvement with AI assistance are not relevant to this device's validation.

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

• Yes. The study evaluates the "Fully Automatic Electronic Blood Pressure Monitor" directly against a "standard auscultation method." This is an assessment of the device's standalone performance, as it operates automatically to provide blood pressure readings without a human actively interpreting or modifying its output during the measurement process.

7. The Type of Ground Truth Used

• Expert Consensus/Reference Standard: The ground truth was established using the "standard auscultation method." This is considered the clinical gold standard reference for non-invasive blood pressure measurement.

8. The Sample Size for the Training Set

• Not applicable / Not specified. This document describes a validation study for a medical device's performance, not the development or training of an AI algorithm. Blood pressure monitors with oscillometric principles are based on established engineering principles and typically do not involve a "training set" in the context of machine learning model development. The document refers to "non-clinical tests" and a "clinical test," which relate to verification and validation of the device's design and performance against standards.

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

• Not applicable. As noted above, this section is not relevant to the type of device and validation described.

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