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Measuring systolic and diastolic blood pressures and pulse rates in adult patients with arm circumference between 5 and 15 inches.

The Model BZ-576 Digital Blood Pressure Monitor uses the oscillometric method with Fuzzy arithmetic for measuring blood pressure, and the high accuracy and repeatability are achieved. The device is ideal for people who frequently monitor their own blood pressure, for its easy way to use at home, at work and during travel. The main components include a cuff, an integrated silicon pressure sensor, an electronic pump, an electronic valve, two buttons, a microcontroller and LCD display. The integrated silicon pressure sensor is used for detecting pressure within the cuff and the pulse wave component during the course of cuff pressure deflation, and guarantees the long period stability. The air pressure of inflation, deflation and rapid release are fully automatic by using an electronic pump and an electronic valve, and a constant deflation speed is controlled in the process of measurement for increasing the accuracy and reducing the measurement time. The blood pressure and pulse values are calculated, and are displayed with "mmHg" or "kPa" on LCD alternatively.

This document describes the premarket notification (510(k)) for the "BZ-576" Non-invasive Automatic Blood Pressure Monitor by The Buzz Group, LLC. It seeks to demonstrate substantial equivalence to the predicate device, the Omron HEM-757 Automatic Blood Pressure Monitor (K001670).

No specific acceptance criteria or a dedicated study proving the device meets said criteria are explicitly detailed in the provided text. The document primarily focuses on establishing substantial equivalence through a comparison of design, operating principles, and intended use, rather than presenting a standalone performance study with defined acceptance criteria and associated results.

However, based on the context of a 510(k) submission for a non-invasive blood pressure monitor, the implicit acceptance criteria would align with the performance standards for such devices, typically outlined in recognized consensus standards like ISO 81060-2 (Non-invasive sphygmomanometers - Part 2: Clinical investigation of automated measurement type). While the specific numerical acceptance criteria are not presented, regulatory bodies expect devices to meet accuracy and repeatability requirements for systolic and diastolic blood pressure measurements.

1. A table of acceptance criteria and the reported device performance

No explicit acceptance criteria table is provided. The document states that "The results of bench and user/clinical testing indicate that the new device is as safe and effective as the predicate devices," and mentions "high accuracy and repeatability are achieved" due to the oscillometric method with Fuzzy arithmetic. However, no specific performance metrics (e.g., mean difference, standard deviation) are quantified against defined acceptance thresholds.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document mentions "bench and user/clinical testing data" but does not specify the sample size for any clinical test sets. The data provenance (country of origin, retrospective or prospective) is also not stated.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not provided in the document. For blood pressure monitors, ground truth is typically established by trained clinical personnel (e.g., physicians, nurses) using a reference auscultatory method.

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

The document does not describe any adjudication method.

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

A Multi-Reader Multi-Case (MRMC) comparative effectiveness study is not applicable as this device is an automatic blood pressure monitor, not an AI-assisted diagnostic tool that involves human interpretation of images or data.

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

The device is an automatic blood pressure monitor designed for standalone use, meaning it operates without human intervention in the measurement process itself, beyond placement and initiation. The document implies that the device's performance was evaluated in this standalone capacity, reporting "high accuracy and repeatability."

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

The document does not explicitly state the type of ground truth used. However, for blood pressure monitors, the gold standard for clinical validation typically involves simultaneous or near-simultaneous measurements by trained observers using a mercury sphygmomanometer (auscultatory method) as the ground truth.

8. The sample size for the training set

No information is provided regarding a training set. While the device utilizes "Fuzzy arithmetic," suggesting an algorithm that might learn or be tuned, the document does not mention explicit training data or its size.

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

Not applicable, as no training set or its ground truth establishment is described.

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